U.S.-Based State Plasma Studies & Medical Research Trials
(alphabetically by state)
The studies listed below are being conducted in specific states. Many are surveys and data collection studies. Please help scientists learn as much as they can about COVID-19 by participating in these studies. Some drug studies are also listed. Please also check our webpage for studies that are happening nationally and internationally.
United States
California
Zofin to Treat COVID-19 Long Haulers (Newport Beach)
The purpose of this study is to assess the safety and potential efficacy of Zofin administered intravenously in subjects experiencing prolonged symptoms (> 6 weeks and < 12 months) of COVID-19.
Inclusion Criteria:
Subjects age > 18 years at the time of signing the informed consent form.
Male or female.
COVID-19 survivor and had documented SARS-CoV-2 positive (FDA EUA approved RT-PCR).
Subjects with history of COVID-19 infection who are experiencing prolonged fatigue over 6 weeks after their COVID-19 RT-PCR negative test.
Subject has not fully recovered from COVID-19 for at least over 6 weeks despite a negative SARS-COV-02 test.
Subjects tested positive for anti-SARS-CoV-2 antibodies using FDA EUA approved test.
Subject is experiencing the following three symptoms for at least over 6 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms i.e., subject didn't have symptoms, and had not sought medical treatment for the symptoms prior to COVID-19:
Extreme fatigue - feeling overtired with low energy and a strong desire to sleep but unable to have good sleep.
Body aches - muscle soreness or generalized achiness throughout the body.
Joint pain - pain in the joints due to inflammation not experienced before illness.
Chalder Fatigue Scale Bimodal Score ≥ 4 at the time of Screening.
Fatigue Severity Scale (FSS) ≥ 4 at the time of Screening.
Fatigue Assessment Scale Score (FAS) ≥ 10.5 at the time of Screening.
Beck Depression Inventory (BDI) score <9 at the time of Screening (score of 9 is an exclusion).
Investigator(s) has access to medical documentation of previous COVID-19 treatments.
Ability of subject to understand and the willingness to sign a written informed consent document.
Subjects must be reasonably able to return for multiple follow-up visits.
Adequate venous access.
For Subjects of Child-Bearing Potential only, willingness to use FDA-recommended birth control until 6 months post-treatment. The FDA-approved and cleared methods for birth control are listed below:
Permanent sterilization
Long-acting reversible contraceptives (LARC)
Contraceptive injection
Short-acting hormonal methods
Barrier methods
Emergency contraception
Any male subject must agree to use contraceptives and not donate sperm during the study.
Exclusion Criteria:
Tested positive for SARS-CoV-2 infection at the time of screening (acute infection) which will involve a nasal swab sample or another FDA-approved test.
Subjects who had recovered fully from COVID-19 and have a new onset of extreme fatigue, body aches, or joint pain that were due to other etiologies, not COVID-19 are excluded.
Subjects with serious co-morbidities are excluded. For example:
Liver enzymes are >2X ULN;
eGFR is <60 ml/min by the CKD- EPI equation;
Hb is <11 mg/dL;
Platelet count is <100K;
Uncontrolled arrhythmias;
BP systolic <90 mmHg or >160 mmHg;
Pulse is <60 or >100;
Respiratory rate is <12 or >25;
Abnormal ECG or any signs of active ischemic heart disease;
Heart failure of any degree (including NYHA classification Class 1- 4).
History of migraines prior to COVID-19 infection.
History of neuropathy prior to COVID-19 infection.
History of inflammatory and irritable bowel disease prior to COVID-19 infection.
History of depression and anxiety disorders prior to COVID-19 infection.
History of chronic fatigue syndrome, fibromyalgia, and arthritic disorders prior to COVID-19 infection.
Exhibiting signs of moderate or severe chronic respiratory disease (such as COPD, asthma, or pulmonary fibrosis) and history of these illnesses prior to COVID-19 infection.
Patient with rheumatologic disorders.
History of chronic liver disease or patient showing signs of clinical jaundice at the time of screening.
History of severe chronic kidney disease or requiring dialysis.
Showing signs of severe pneumonia, acute respiratory distress syndrome (ARDS), or respiratory failure needing mechanical ventilation.
Subjects with a history of bleeding disorders or currently on anticoagulation therapy that cannot be stopped prior to infusion which is not related to previous COVID-19 infection.
Oxygen-dependent on nasal canula greater than 2-L per minute.
Patient with pulse oxygen saturation (SpO2) of <94% on room air.
Active or recently treated malignancies.
Any unstable condition of clinical significance, e.g., uncontrolled hypertension, unstable angina pectoris, worsening asthma.
Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit.
Albuterol as nebulizer for the off-label treatment of COVID-19 within 7 days prior to the screening visit
Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
Subject has a body mass index (BMI) greater than 42 kg/m2
Subject has or had an active infection requiring systemic antibiotics within 12 weeks of enrollment in the study
Inability to perform any of the assessments required for endpoint analysis.
Active listing (or expected future listing) for transplant of any organ.
Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
Have a history of organ or cell transplant rejection.
History of drug abuse (illegal "street" drugs except marijuana, if it is legal to use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
Patients with untreated HIV infection. However, patients can be enrolled if have been treated for HIV and the test negative for HIV viral load but still test positive for antibodies.
Contact: Mari Mitrani, MD, PhD | (888) 963-7881| mari@organicell.com
[CONTROLS NEEDED] Stanford Dysautonomia COVID Study (Palo Alto)
The purpose of this study is to identify people who develop dysautonomia after COVID-19 infection (and controls) and then perform detailed autonomic and biofluid testing. The research team hopes that this study improves understanding of the mechanisms of long-COVID.
If you want to be part of the study, you will be asked to perform a telephone screening interview to help determine whether you meet the inclusion criteria for the study. If eligible, you will be required to come to the Stanford Neurosciences Health Center for one half-day of testing. Testing will take about 3-4 hours in total and include the following:
- Autonomic testing including the use of transcutaneous doppler ultrasound
- Blood draws including IV placement
- Skin biopsy (small 3mm dermatology punch biopsy at 3 sites; minimally invasive, only band aid required)
The risks associated with this study are very low. Most of the procedures are considered standard of care in the field of autonomics. The autonomic testing and doppler ultrasound are not invasive and pose minimal risk. You may experience slight physical discomfort during blood draws. Participants in this study will receive a 100 US dollar stipend and will be contributing to a better understanding of dysautonomia after viral infection in POTS.
Inclusion criteria:
1) Absence of an excessive heart rate increase or blood pressure drop on standing
2) Absence of pre-existing conditions or symptoms suggestive of dysautonomia prior to COVID
3) Confirmed SARS-CoV-2 nasal PCR positive result
4) SARS-CoV-2 infection ≥ 3 months prior to enrollment
5) Age 18 years or older
Exclusion Criteria
1) Age less then 18 years
2) Pregnant women
3) COVID not confirmed by positive SARS-CoV-2 nasal PCR
4) Pre-existing conditions or symptoms suggestive of dysautonomia prior to SARS-CoV-2 infection
5) Symptoms that persisted beyond 1 months after infection (Long-Haul COVID symptoms)
Contact: If you are interested in volunteering for this study, please reply by email for more information. Alternatively, you may email Ruba Shaik, Clinical Research Coordinator, at rubas@stanford.edu or call her at 650-546-1436. For general information about participant rights, contact 1-866-680-2906.
Qigong for Post Acute Sequelae of COVID-19 Infection (Sacramento)
The purpose of this study is to conduct a pilot feasibility study of external qigong on health-related quality of life in individuals with prolonged symptoms following COVID-19 infection.
Inclusion Criteria:
English-speaking adults age 18 or greater
History of a COVID-19 infection with lingering symptoms lasting longer than 12 weeks
Willing and able to access the internet to complete questionnaires
Willing and able to travel to the qigong sessions.
Exclusion Criteria:
Lung scarring secondary to COVID-19 infection as evidenced by signs of parenchymal lung damage on imaging or FVC < 80% (any patient with post COVID-related shortness of breath must have PFTs to be considered for enrollment).
Dementia
Any other condition that makes it difficult for the individual to complete questionnaires or attend the qigong sessions.
Contact: Michelle Dossett, MD, PhD, MPH | 916-734-5367 | mdossett@ucdavis.edu
La Jolla Institute Long COVID Study (San Diego)
Consuli has teamed up with La Jolla Institute for Immunology to support their research to help understand how is COVID is directly affecting neurological health.
Participants will be asked to complete a one time blood donation at the La Jolla Institute for Immunology. The goal is to enroll 20 Long COVID patients in this study.
To limit the spread of COVID-19, personal protective equipment (PPE) will be used to protect our participants and staff against the spread of the virus.
Paid participants can receive $100.00 USD.
You may qualify to participate if you:
Are 18 years of age or over.
Had a positive COVID-19 test with symptoms including of a neurological nature that caused you to be seen by a neurologist (neurological symptoms must be lasting at least 3 months or more).
Can physically provide a blood sample at the La Jolla Institute for Immunology offices in San Diego, California USA.
Follow this link to take the study eligibility survey.
Contact: Emily Fink, Consuli Member Success Ambassador | emily.fink@consuli.net
This is a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
Inclusion Criteria:
Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
Willing to follow contraception guidelines
Exclusion Criteria:
Clinically improving pulmonary status over the month prior to screening
Undergone a previous stem cell infusion unrelated to this trial
Pregnant or breast feeding or planning for either during the study
Suspected uncontrolled active bacterial, fungal, viral, or other infection
Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
History of a splenectomy, lung transplant or lung lobectomy
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Contact: Mike Royal, MD | (858)203-4100 ext 4146 | mroyal@sorrentotherapeutics.com
La Jolla Institute for Immunology (La Jolla)
Participants must be:
A generally healthy male or female, over 18 years of age.
Told you have COVID-19 or have had a positive test for COVID-19.
Recovered from COVID-19.
La Jolla Institute is looking at how the virus affects the human immune system, focusing on T and B cell immune responses in patients with symptoms and history of COVID-19 disease.
Register: www.lji.org/faculty-research/scientific/clinical-studies
The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19 (Orange)
The purpose of this research study is to assess if glutathione, along with NAC (N-acetyl cysteine) and Alpha lipoic acid (ALA), can help reverse some of the COVID long-haul symptoms.
Subjects will be randomized in to one of two groups. Depending on the group they are randomized in to, subjects will be taking either a combination of NAC, Alamax CR, and liposomal GSH or the same three nutritional supplements with a multivitamin and magnesium. Regardless of the group, subjects will be asked questions to assess their COVID symptoms, physical and mental health status. They will also be asked to take blood samples.
Inclusion Criteria:
Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list
Exclusion Criteria:
History of a severe sulfa sensitivity (i.e., anaphylaxis, Stevens Johnson Syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to NAC, alpha lipoic acid and/or GSH.
Contact: Jeein Kim | 714-509-2487 | jeeink2@hs.uci.edu
Comparison of ME/CFS and Long COVID-19 Patients (Los Angeles)
The purpose of the You + ME Registry and Biobank is to collect clinical and patient-reported data and biological samples (e.g. blood) from people living with Myalgic Encephalomyelitis (also known as chronic fatigue syndrome or ME/CFS), people with long-COVID and control volunteers to improve understanding, diagnosis and treatment of these diseases.
Eligibility:
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria: Patients with ME/CFS, those without ME/CFS, patients with long-COVID, patients with COVID who recovered.
Exclusion Criteria: Those who never had COVID.
Contacts: Kira Poplowski, PhD | 310-463-2953 | kpoplowski@solvecfs.org
Allison Ramiller | aramiller@solvecfs.org
The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) on clinician- and patient-level outcomes. LC&FIRP is a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with PASC, ME/CFS, and OPIFI. The secondary objective is to determine the feasibility, acceptability, and sustainability of LC&FIRP. Study findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.
Inclusion Criteria:
Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI, and 4) being willing and able to actively participate in LC&FIRP.
Exclusion Criteria:
There are no exclusion criteria.
Contact: Jane Samaniego, MS | 619-515-2300 | janes@fhcsd.org
Job Godino, PhD | 619-515-2344 ext 2344 | jobg@fhcsd.org
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC) (San Francisco)
The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID.
The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection ("Long COVID"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET).
In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promoter score).
Inclusion Criteria:
Age 18 years or older
Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required.
Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms.
Reduced exercise capacity <85% predicted and adjusted heart rate reserve achieved <80% on maximal CPET (RER>1.05). If there are difficulties with recruitment we may include individuals with exercise capacity between 85-99% predicted.
Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus.
Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating.
Exclusion Criteria:
Pregnant or intention to become pregnant during study
Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction <40% within 90 days prior to enrollment (Class I indications for cardiac rehabilitation)
Acute myocarditis diagnosed <90 days prior
Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
Implanted pacemaker or defibrillator
Chronic lung disease requiring the use of home oxygen therapy
Inability to ride a sitting bicycle for CPET
Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation
Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator
Contact: Matthew S Durstenfeld, MD MAS | 628-206-5562 | matthew.durstenfeld@ucsf.edu
Long-term Impact of Infection With Novel Coronavirus (COVID-19) (LIINC) (San Francisco)
LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.
Inclusion Criteria:
Willing and able to provide written informed consent, and
Age >/= 18 years, and
A history of SARS-CoV-2 infection, as evidenced by:
Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or
Reference by the participant to a laboratory test performed on respiratory tract secretions or blood, finger stick, or saliva test that was reported to the participant to be positive for SARS-CoV-2 or COVID-19 infection,
And a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier.
Exclusion Criteria:
Self-reported or documented chronic anemia with hemoglobin < 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.
Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements or to give informed consent.
Contacts:
Rebecca Hoh, MS, RD | 415-476-4082 ext 139 | rebecca.hoh@ucsf.edu
Michael J Peluso, MD | 415-476-9363 | michael.peluso@ucsf.edu
Colorado
A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients (Aurora)
This is a study to evaluate the effectiveness and safety of the BIO 300 Oral Suspension for impaired lung function in patients that were previously hospitalized due to complications from COVID-19. Study participants will receive either BIO 300 Oral Suspension or a placebo.
Participants will take the study treatment orally once per day for 12 weeks. During this time, participants will complete a combination of weekly in-person and virtual visits to evaluate their lung function and overall health. Participants will also complete in-person follow up visits at 6 months and 12 months following initiation of the study treatment.
Participants will receive $50 for each in-person clinic visit (6 total visits) and healthcare services associated with completion of the study requirements free of charge.
To be eligible, participants must:
Be at least 18 years old;
Have been hospitalized due to COVID-19 related complications and are ready to be discharged, or were discharged within the past 365 days;
Have been diagnosed with (or met the criteria for) acute respiratory distress syndrome (ARDS) while hospitalized;
Must be able to commute to the University of Colorado – Anschutz campus for the in-person clinic visits.
Principal Investigator: Ellen Burnham, MD
Contact: Jeffrey McKeehan | BIO300@cuanschutz.edu
Connecticut
Kidney Disease After COVID-19 (New Haven)
The purpose of this study is to understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
Inclusion Criteria:
Adults, age ≥18 years
Confirmed diagnosis of COVID-19
Exclusion Criteria:
• No confirmed diagnosis of COVID-19
Contact:
Evren U. Azeloglu, PhD | 212-241-8519 | evren.azeloglu@mssm.edu
Lili Chan, MD, MSCR | (212) 241-4860 | lili.chan@mountsinai.org
District of Columbia/ Washington, D.C.
Pediatric COVID-19 and MIS-C Long-term Follow-up (Washington, D.C)
This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations.
Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years.
Household contacts (aged ≤21 years) of the infected participants will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes.
Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2.
Inclusion Criteria:
Survivors and household contacts:
In order to be eligible to participate in this study as a survivor or household contact, an individual must meet all of the following criteria:
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).
Willing to allow storage of samples and data for future research.
At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation.
In addition, an individual must meet all criteria for one of the following cohorts.
Symptomatic survivor cohort (including MIS-C):
Documented prior COVID-19 or MIS-C as evidenced by one of the following:
detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA) and a history of clinical manifestation compatible with COVID-19*; or
positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19*; or
meeting CDC case definition for MIS-C (see Appendix 1).
Onset of COVID-19/MIS-C symptoms is at least 4 weeks before screening. *one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
Asymptomatic survivor cohort:
Documented prior SARS-CoV-2 infection as evidenced by one of the following:
detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without history of clinical manifestation compatible with COVID-19; or
positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA without history of clinical manifestation compatible with COVID-19*.
Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before screening. *one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
Household contact (control) cohort:
Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).
No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19.
Parents and guardians:
In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria:
Is a parent or guardian of a participant enrolled as a survivor or household contact.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Willing to allow storage of data for future research.
Exclusion Criteria:
Survivors and household contacts:
An individual who meets any of the following criteria will be excluded from participation in this study:
Any symptoms suggestive of an ongoing infection within 15 days of screening, including but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain).
Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
Pregnancy.
Parents and guardians:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment.
Contact: Roberta DeBiasi, MD, MS | 2024761708 |
CN-NIAID-pedsCOVIDstudy@childrensnational.org
Florida
Researching Covid Outcomes in Diabetes (RECODE) (Orlando)
This study aims to measure the prevalence of organ volume changes and damage in lungs, heart, kidney, liver, pancreas, spleen as assessed by MRI among out-patients who were initially hospitalized with laboratory-confirmed SARS-CoV-2 infection [COVID-19 disease], who are no-longer considered infectious by approved bioassay (e.g., RT-PCR negative and/or seropositive on appropriate antibody testing). Assessing the severity and sequelae of COVID-19 in patients is crucial to enable global planning for health-care needs.
Inclusion Criteria:
For Type 2 Diabetes (T2D)
Male or female 18 years of age and older willing and able to give informed consent to participate in the study
Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 12 months).
Diagnosis of T2D according to American Diabetes Association (ADA) criteria.
Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.
For participant without Type 2 Diabetes (T2D)
Male or female 18 years of age and older willing and able to give informed consent to participate in the study
Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 12 months).
Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.
Exclusion Criteria:
Symptoms of active respiratory viral infection:
high temperature (over 37.8°C/100.4°F)
cough (consistent for over an hour; 3 or more episodes in 24 hours)
Any history of Type I diabetes
The participant may not enter the study with any known contraindication to magnetic resonance imaging including
Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
Metal implants (pacemaker, aneurysm clips) based on Investigator’s judgment at Screening
Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator’s judgment at Screening
Unable to tolerate MRI imaging or claustrophobia
Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant’s ability to participate.
Contact: AdventHealth TRI | 407-303-7193 | CFD.TRI.Recruitment@AdventHealth.com
Interview and Examination of COVID-19 Survivors for Book Project (Gainesville)
Dr. Jon Mukand, a Rehabilitation Medicine physician and faculty member at Brown University and Tufts University, is working on a book about recovery from COVID-19 (pulmonary, cardiac, neurological, cognitive, psychological, musculoskeletal (contractures, amputations), fatigue, gastrointestinal, olfactory, etc.). Dr. Mukand wishes to interview and examine persons with significant, documented conditions caused by COVID-19.
All descriptions of these persons will be de-identified, except for gender and general age (e. g. a man in his 50s), and the narrative will be approved by each interviewee before publication.
There will be no doctor-patient relationship, as this is a journalistic project.
One or two people may also be featured in an article in the RI Medical Journal; the author is serving as a guest editor for a special issue on COVID-19.
Contact: Jon Mukand | jmukand@cox.net
Georgia
This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.
Major Inclusion Criteria:
The patient is male or female, 18 to 65 years of age, inclusive.
The patient has a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.
The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.
Major Exclusion Criteria:
The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
Contact: Clinical Program Manager | 203-482-3938 | megha.tevar@tonixpharma.com
Illinois
ILLInet RECOVER Study (Chicago, Peoria)
The goal of the ILLInet RECOVER Study is to understand why some people recover differently from COVID-19.
Study participants will complete in-person medical exams and fill out questionnaires over the course of 4 years.
Participants will be compensated up to $800 for their time and effort.
The study aims to enroll about 1,050 participants with COVID-19 and 150 without.
In Illinois, any adult may be eligible to participate in the RECOVER Study.
The study is now seeking volunteers infected with COVID for the FIRST time in the past 3 weeks or those who have never had COVID.
To enroll, fill out the online form.
Contact: 855-461-8185 | info@illinet.org
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS (POTS) (Glenview)
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS).
Inclusion Criteria:
Reached the age of consent when signing the informed consent form
Capable of providing signed informed consent and complying with protocol requirements
Diagnosed with new-onset POTS post-COVID-19 established by the following:
Prior COVID-19 confirmed by documentation of historical PCR test
Tilt table or orthostatic vital sign measurements during screening consistent with consensus criteria: sustained HR increase of ≥30 bpm within 10 min of standing or head up tilt (≥40 bpm for individuals aged 18 to 19 years) and/or HR reaching >120 bpm within 10 min; absence of sustained 20 mmHg decrease in systolic blood pressure (SBP)
Ongoing symptoms of POTS confirmed by the investigator with at least 3 symptoms in each of the following areas lasting longer than 12 weeks after either diagnosis of COVID-19 or after hospital discharge for COVID-19:
i. Vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. Sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis
COMPASS 31 ≥35 at screening
Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies and the following:
Male participants Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving IMP. Contraceptive requirements.Body mass index (BMI) <35 kg/m2
Exclusion Criteria:
Diagnosis of or receiving treatment for the following conditions before COVID-19: peripheral neuropathy, POTS, myalgic encephalomyelitis encephalitis/chronic fatigue syndrome, Ehlers Danlos syndrome confirmed by genetic testing, autonomic neuropathy, multiple sclerosis, stroke, spinal cord injury, or any known lesions in the central nervous system by imaging or neurological exam
History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis, or critical illness-related polyneuropathy or myopathy
Known autoimmune disease that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms of post-COVID-19 POTS or puts the participant at undue risk
Known HIV disease or common variable immunodeficiency
History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Adequately-treated participants with the following cancers may be included at any time:
Basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening
Positive serum test at screening for an active infection with any of the following:
Hepatitis B virus (HBV) that is indicative of an acute or chronic infection, unless associated with a negative HB surface antigen (HBsAg) or negative HBV DNA test
Hepatitis C virus (HCV) based on HCV antibody assay unless a negative RNA test is available
HIV
A medical condition that could confound the results of the study or put the participant at undue risk in the investigator's judgment
Clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other condition that in the opinion of the investigator could confound the results of the study or put the participant at undue risk
Total IgG <4 g/L at screening
Received within 12 weeks or 5 half-lives (whichever is longer) before screening an investigational product
Received within 12 weeks before screening either intravenous immunoglobulin (Ig) IV or SC or plasmapheresis/plasma exchange (PLEX)
Received a live or live-attenuated vaccine less than 4 weeks before screening
Known hypersensitivity to IMP or 1 of its excipients
Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP
Currently participating in another interventional clinical study
History (within 12 months of screening) of or current alcohol, drug, or medication abuse
Pregnant or lactating or intends to become pregnant during the study
Unwilling to remain on a stable regimen of medications during the study
Unwilling to avoid initiation of new physical rehabilitation or other physician-prescribed exercise programs during the 24-week treatment period
Contact: LaKesha Legree, MD | +1 800 201 8725 | Llegree@argenx.com
Iowa
tDCS for Post COVID-19 Fatigue (Iowa City)
The objective of this study is to investigate the short- and long-term effects of multiple sessions of 4 mA M1 tDCS on fatigue and brain activity in recovered COVID-19 patients using established measures of perception of fatigue, performance fatigability, and cerebral glucose uptake. The central hypothesis is that tDCS will improve fatigue short- and long-term, and thus will improve quality of life (QOL) in recovered COVID-19 patients and that these changes will be associated with alterations in brain activity.
Only those that are discharged from the UIHC COVID-19 inpatient clinic and/or that meet the CDC guidelines for discontinuing home isolation (i.e., fever free for at least 24 hours, all symptoms improved after 10 days) will initially be considered as long as they meet the rest of the following criteria:
Inclusion criteria:
18-80 yrs.
Meet CDC guidelines (https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html) for discontinuation of home isolation
Meet the criteria for fatigue, based on the Chalder Fatigue Scale CFQ-11 case definition of fatigue
Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history, such as cardiovascular disease.
Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
Able to use and be contacted by telephone
Able to speak, read, and understand English, and complete questionnaires in English
Exclusion criteria:
Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), or neurological disorders
History/presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
Alcohol dependence or abuse (>2 drinks/day), or present history of drug abuse (last six months)
History of significant traumatic brain injury or hydrocephalus
Pregnancy
Contact: Thorsten Rudroff, PHD | thorsten-rudroff@uiowa.edu.
Kansas
Post COVID-19 Biorepository (Kansas City)
The purpose of this study is to establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit.
Inclusion Criteria:
The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
The participant has a previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up.
Patient is ≥ 18 years of age or older.
Exclusion Criteria:
Participant declines to participate.
Participant or healthcare surrogate is unable to provide informed consent.
Contact: Luigi R Boccardi, BS | 9135884022 | lboccardi@kumc.edu
Christina Pantalunan, RN-BSN | 913-588-3851 | cpantalunan@kumc.edu
Kentucky
Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound (Louisville)
The researchers of this study hypothesize that recovered COVID-19 patients suffer long term cardiovascular and pulmonary complications, which can be detected by point of care ultrasound. The goal is to comprehensively delineate the long term cardiovascular and pulmonary ultrasound findings in recovered COVID-19 patients, identify risks factors for prolonged heart/lung injury, evaluate long term effects of applied treatment, and assess late medication/vaccine side effects in COVID-19 patients.
Inclusion Criteria:
>18 years of age
Consent to participate in this research
Confirmed SARS-CoV-2 infection by RT-PCR or serological tests.
Exclusion Criteria:
Refusal to participate in this research
Contact: Jiapeng Huang, MD, PhD | 5028528157 | jiapeng.huang@louisville.edu
Louisiana
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development (New Orleans)
Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand the natural history of SARS-COV-2 infections among special populations and characterize post-COVID morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding.
Thousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein/antibody and RNA) response, and possibly test in vitro antibody neutralization activity.
Population 1:
Inclusion Criteria:
Positive diagnostic test for COVID-19, influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus
Patient or legally authorized representative has provided verbal consent / verbal HIPAA (or parental permission form and assent form, as appropriate)
Exclusion Criteria:
None
Population 2:
Inclusion Criteria:
Positive diagnostic test for COVID-19 >14 days prior, OR potential to have been exposed to (and mounted antibodies against) COVID-19, OR positive diagnostic test for influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus
Patient or legally authorized representative has signed informed consent (or parental permission form and assent form, as appropriate)
Exclusion Criteria:
Patients with the following criteria:
Aged under 6 months old
Anemia (Hgb <7)
Platelet <80
Contact: Dahlene Fusco, MD, PhD | 504-988-7316 | dfusco@tulane.edu
Bhoomija Chatwani, MPH, BDS | 504-208-0680 | bchatwani@tulane.edu
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (PREVAIL) (New Orleans, Prairieville)
This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.
Major Inclusion Criteria:
The patient is male or female, 18 to 65 years of age, inclusive.
The patient has a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.
The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.
Major Exclusion Criteria:
The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
Contact: Clinical Program Manager | 203-482-3938 | megha.tevar@tonixpharma.com
Maryland
Kidney Disease After COVID-19 (Baltimore)
The purpose of this study is to understafnd the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
Inclusion Criteria:
Adults, age ≥18 years
Confirmed diagnosis of COVID-19
Exclusion Criteria:
• No confirmed diagnosis of COVID-19
Contact:
Evren U. Azeloglu, PhD | 212-241-8519 | evren.azeloglu@mssm.edu
Lili Chan, MD, MSCR | (212) 241-4860 | lili.chan@mountsinai.org
Understanding the long term impact of COVID-19 on the brain through advanced MR imaging and spectroscopy (Baltimore)
This study aims to understand the long-term impact of COVID-19 on the brain through imaging. This is a multi-site study led by University of Minnesota, Mayo Clinic Rochester, and Harvard University and is supported by the National Institutes of Health (NIH).
Researchers are looking for individuals who had COVID-19 and are still having symptoms like headaches, “brain fog”, feeling tired, dizziness, memory problems, or loss of taste or smell. They are also looking for individuals who did not have COVID-19. The research team aims to review the neuroinflammatory, neurodegenerative and hypoxic/ischemic sequelae of COVID-19.
The eligibility survey can be found here.
If you agree to participate in this study, the researchers will ask you to come to the study center for the following:
Medical history collection
Physical examination
MRI scan – the scan does not include contrast or any tasks in scanner
Blood draw
Cognitive (e.g. memory, reasoning, attention) testing
Study questionnaires
The team will reach out to you every three months while you are in this study to check in on your symptoms and see if you have any questions. They may invite you for a second visit about two years after the first visit.
You will be compensated for each completed study visit. There is a $150 stipend for completed visits. You will also not be responsible for the cost of any study procedure and any public transportation fees or parking costs will be provided. If you need to stop study procedures for any reason, you will receive partial payment for your time.
Eligibility Criteria:
At least 18 years of age
With or without prior history of COVID-19
Ongoing symptoms such as headaches, brain fog, memory problems if you had COVID-19
Able to undergo MR scanning
English or Spanish speaking
Contact: covidbrainstudy@umn.edu
Procedural Motor Memory in Long COVID-19 (Bethesda)
The objective of this study is to test motor memory in people with long COVID, compared to healthy volunteers.
INCLUSION CRITERIA:
In order to be eligible to participate in this study, patient volunteers must meet all of the following criteria:
Ability of subject to understand and the willingness to review an informed consent
Aged at least 18 years at the time of enrollment, and no older than 90 years of age.
Identity of dominant hand
Question: Which hand would you choose to hold the pen to write a formal letter?
Note: No specific answer is required for inclusion, but it is required for the next question.
English-Speaking
Ability to type without discomfort using non-dominant hand
Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health in the post-COVID convalescence arm (i.e. reports having started recovery from an acute COVID- 19 infection within past six month and is able to provide documentation of a positive COVID-19 PCR or antibody test)
In order to be eligible to participate in this study, healthy volunteers must meet all of the following criteria:
Ability of subject to understand and the willingness to review an acknowledgement of participation agreement
Aged at least 18 years at the time of enrollment, and no older than 90 years of age
English-speaking
Ability to identify dominant hand
Question: Which hand would you choose to hold the pen to write a formal letter?
Note: no specific answer is required for inclusion, but it is required for the next question.
Ability to type without discomfort using non-dominant hand
Deny active infection with COVID-19, or ongoing symptoms following COVID-19 infection
Ability to use an internet-connected laptop or desktop computer in a private setting located in the continental U.S. to complete the study task.
This protocol can enroll NIH Employees/staff, including NINDS employees/staff. Staff members from our section and their immediate family members are excluded from participation.
EXCLUSION CRITERIA:
Patient group: A patient who meets any of the following criteria will be excluded from participation in this study:
A condition prior to the diagnosis of COVID-19 infection that would significantly confound interpretation of the behavioral task, as determined by the screening clinician (e.g., prior diagnosis of a neurologic condition such as large stroke, Alzheimer's disease or Parkinson's disease, or severe psychiatric condition).
Staff from our section, and their immediate family members
Healthy Volunteer group: A person who meets any of the following criteria will be excluded from participation in this study:
A condition that would significantly confound interpretation of the research tests as determined by the screening clinician (e.g., prior diagnosis of a neurologic condition such as large stroke, Alzheimer's disease or Parkinson's disease, or severe psychiatric condition)
Fever, respiratory symptoms or diagnosis of COVID-19 in the last 14 days.
History of COVID-19 with residual neurologic symptoms following diagnosis that did not resolve within 14 days of disease onset.
Previous participation in this study (platform filter).
Contact: Margaret K Hayward, C.R.N.P. | (301) 451-1335 | mimi.hayward@nih.gov
Leonardo G Cohen, M.D. | (301) 496-9782 | cohenl1@mail.nih.gov
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health (Bethesda)
People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 in different ways. In this study, researchers will use survey data to describe the different ways people experience and recover from COVID-19. They will also use the data to help create future studies to understand why some people do not fully recover. The objective of the study is to learn more about the range and timing of symptoms that people have before, during, and after COVID-19 infection.
Eligibility: People ages 18 and older who can give documentation of a positive COVID-19 or antibody test.
Contact: Angelique Gavin | (301) 402-0880 | angelique.gavin@nih.gov
Avindra Nath, M.D. | (301) 496-1561 | natha@mail.nih.gov
Pediatric COVID-19 and MIS-C Long-term Follow-up (Bethesda)
This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations.
Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years.
Household contacts (aged ≤21 years) of the infected participants will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes.
Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2.
Inclusion Criteria:
Survivors and household contacts:
In order to be eligible to participate in this study as a survivor or household contact, an individual must meet all of the following criteria:
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).
Willing to allow storage of samples and data for future research.
At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation.
In addition, an individual must meet all criteria for one of the following cohorts.
Symptomatic survivor cohort (including MIS-C):
Documented prior COVID-19 or MIS-C as evidenced by one of the following:
detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA) and a history of clinical manifestation compatible with COVID-19*; or
positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19*; or
meeting CDC case definition for MIS-C (see Appendix 1).
Onset of COVID-19/MIS-C symptoms is at least 4 weeks before screening. *one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
Asymptomatic survivor cohort:
Documented prior SARS-CoV-2 infection as evidenced by one of the following:
detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without history of clinical manifestation compatible with COVID-19; or
positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA without history of clinical manifestation compatible with COVID-19*.
Positive SARS-CoV-2 RNA or antigen test is at least 4 weeks before screening. *one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
Household contact (control) cohort:
Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).
No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19.
Parents and guardians:
In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria:
Is a parent or guardian of a participant enrolled as a survivor or household contact.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Willing to allow storage of data for future research.
Exclusion Criteria:
Survivors and household contacts:
An individual who meets any of the following criteria will be excluded from participation in this study:
Any symptoms suggestive of an ongoing infection within 15 days of screening, including but not limited to fever > 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain).
Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
Pregnancy.
Parents and guardians:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment.
Contact: Roberta DeBiasi, MD, MS | 2024761708 |
CN-NIAID-pedsCOVIDstudy@childrensnational.org
Who can join? Adults without prior heart disease or stroke, not receiving diabetes medication(s), and not having other chronic medical conditions. Participants must: Speak English, Be Age 18-75 years old, With or without history of COVID-19 infection, Able to have a MRI (brain scan), Meet other study criteria
What procedures will be done? A screening visit includes physical and neurological exams, Blood tests, answer questions and complete tests to evaluate your brain function, a brain MRI scan, and a spinal tap (optional)
Where? Health Sciences Research Facility III, 670 W. Baltimore St., Baltimore, MD 21201
Compensation? Participants will be compensated up to $200 for their time (for completing all procedures).
Interested volunteers can contact Dr. Huajun Liang at 410-706-1031 huajun.liang@som.umaryland.edu. or Dr.Julian Baptiste at 410-706-1029 Julian.Baptiste@som.umaryland.edu
NIH study on COVID’s impact on future flu infection
Researchers at the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) are conducting a study to evaluate the effect of prior SARS-CoV-2 infection on the antibody response to the seasonal influenza vaccine in healthy individuals with a history of symptomatic or asymptomatic SARS-CoV-2 infection and healthy volunteers with no history of COVID.
Researchers are looking for volunteers 18 years of age or older who have not yet gotten flu shot in the 2020-21 flu shot and have either: tested positive for COVID-19 (with a PCR or antibody test) and recovered OR have no history of COVID-19. Participants will receive the results of an FDA-approved SARS-CoV-2 antibody test and a flu shot.
Consider joining if YOU:
Are able to speak, read, and write English fluently
Are not pregnant or planning to become pregnant
Have no known allergy to vaccines of any kind
Have not had the seasonal flu vaccine for the current season and are willing to be vaccinated
The study takes place in Bethesda, Maryland. Compensation for participation is provided. Free on-site parking available.
CONTACT: NIH- Clinical Center Office of Patient Recruitment 800-411-1222 (Refer to NIH study #19-I-0126)
Email: prpl@cc.nih.gov
Online: https://go.usa.gov/xpPgw
Massachusetts
The goal of this study conducted at the VA hospital in Bedford, MA is to learn more about how a multisensor rapid health assessment device, MouthLab, can help predict or anticipate future health complications in patients with underline conditions after contracting COVID-19.
MouthLab is a non-invasive, hand-held device that works like a breathalyzer. An individual breathes into the device for 60 seconds and the MouthLab gathers more than 10 vital health parameters like temperature, heart rate, SpO2, ECG, and basic lung functions.
Participation in the study will last for 6 months, and the purpose is to gather health information from people who have been previously hospitalized with COVID-19. The research team will use the data to develop an algorithm that predicts future complications of COVID-19, especially among patients with complex conditions (i.e., heart failure, chronic kidney disease, diabetes, hypertension, asthma, chronic obstructive pulmonary disease), and enables early intervention.
Inclusion Criteria:
18 years of age or older
Individuals who have had a COVID-19 related hospitalization (3-6 months prior to enrollment)
Has at least one specified comorbidity (Diabetes, Heart Failure, Hypertension, Chronic Kidney Disease, Asthma, or COPD)
Willing and able to provide informed consent
Has no functional limitation that would impede the use of the MouthLab device, and is able to use the device with the left hand
Comfortable with using technology
Can commit to performing the required study tasks
Can speak/understand English
Exclusion Criteria:
Currently receiving hospice care
Left-sided hemiplegia or any other motor deficits that may restrict the use of the device.
Individuals with cognitive deficits that impede their ability to comprehend and give informed consent.
Chest, abdominal or eye surgery within the preceding 14 days
Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Contact: Jacklyn Pagliaro, MPH | 667-225-0471 | jaclyn.pagliaro@va.gov
Jenny Matthew, MSN/MBA | 443-627-3446 | jmathew@aidar.com
Pain in Long COVID: The Role of Sleep Disturbances (Boston, MA)
The goal of this study is to better understand pain in Long COVID and the role of sleep disturbances in the persistence of pain. The study involves:
A remote screening visit
Keeping a diary about sleep and wellbeing for two weeks
Staying for one night/one day in the Clinical Research Center in a private room. The research team will record your sleep, take a blood sample, and assess your responses to various stimuli such as heat or cold.
Eligibility criteria to participate: Women and men of > 18 years of age.
Contact: COVIDSleep@bidmc.harvard.edu | (617) 667-5243
Brigham and Women’s Hospital Translational Pain Research Program (Boston, MA)
The Translational Pain Research Program at Brigham and Women’s Hospital (BWH) is dedicated to the discovery of new drugs to treat chronic pain in patients with many different conditions and has been conducting clinical trials for many years now. If you would like to read more about their work, please visit www.paintrials.org.
The Program is currently looking for volunteers with lasting pain due to Long COVID to participate in a research study.
This study involves 6 visits to BWH and two follow-up telephone calls at the end of the study. During the study, you will receive the study drug to take daily. You will receive either the study drug or a placebo. During your visits, several procedures will be performed, including vital signs, blood draws, physical exam and questionnaires. It will take you up to 25 weeks to complete the study.
To qualify, you must:
-Be between ages 18 and 65
-Have tested positive for COVID-19 in the past
-Have new or worsening pain that developed during or after COVID-19 infection
Volunteers who qualify will be reimbursed for their time.
Study Link: https://rally.massgeneralbrigham.org/study/tonixlongcovidpain
***
The Translational Pain Research Program is also looking for volunteers to participate in a separate online survey to help gain a better understanding of the experiences of those suffering with Long COVID. Anyone over the age of 18 who has tested positive for COVID-19 or has had a positive COVID-19 antibody test is invited to participate in this research survey. It will take about 10 to 20 minutes. The survey will ask you questions about your medical history, COVID-19 symptoms, and recovery. Your participation in this survey is completely voluntary, and your answers will be kept confidential.
[ Survey Link: https://www.surveymonkey.com/r/Y9NVZW3 ]
Contact: (617) 525 – PAIN (7246) | paintrials@partners.org
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC) (Charlestown, Boston)
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.
Inclusion Criteria:
Ability to provide informed consent
A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking.
Exclusion Criteria:
History of epilepsy
Metallic implants in the head and neck,
Brain stimulators
Pacemakers
Pregnancy
Active substance dependence (except for tobacco)
Premorbid major neurological illness
Severe mental illness (e.g., bipolar disorder, schizophrenia)
Attention Deficit Hyperactivity Disorder
Contact: Hamdi Eryilmaz, Ph.D | 6176437462 | hamdi.eryilmaz@mgh.harvard.edu
Alexandra O'Neill, B.S. | (617) 726-8753 | agoneill@mgh.harvard.edu
This study aims to understand the long-term impact of COVID-19 on the brain through imaging. This is a multi-site study led by University of Minnesota, Mayo Clinic Rochester, and Harvard University and is supported by the National Institutes of Health (NIH).
Researchers are looking for individuals who had COVID-19 and are still having symptoms like headaches, “brain fog”, feeling tired, dizziness, memory problems, or loss of taste or smell. They are also looking for individuals who did not have COVID-19. The research team aims to review the neuroinflammatory, neurodegenerative and hypoxic/ischemic sequelae of COVID-19.
The eligibility survey can be found here.
If you agree to participate in this study, the researchers will ask you to come to the study center for the following:
Medical history collection
Physical examination
MRI scan – the scan does not include contrast or any tasks in scanner
Blood draw
Cognitive (e.g. memory, reasoning, attention) testing
Study questionnaires
The team will reach out to you every three months while you are in this study to check in on your symptoms and see if you have any questions. They may invite you for a second visit about two years after the first visit.
You will be compensated for each completed study visit. There is a $150 stipend for completed visits. You will also not be responsible for the cost of any study procedure and any public transportation fees or parking costs will be provided. If you need to stop study procedures for any reason, you will receive partial payment for your time.
Eligibility Criteria:
At least 18 years of age
With or without prior history of COVID-19
Ongoing symptoms such as headaches, brain fog, memory problems if you had COVID-19
Able to undergo MR scanning
English or Spanish speaking
Contact: covidbrainstudy@umn.edu
Blood specimens needed for an antibody study
Specimen works with researchers in pharmaceutical, biotech, diagnostic, and government organizations to help them find human specimens for their research. We are currently participating in a study with the Centers for Disease Control researchers to study our antibodies’ response to SARS2-COVID virus over time (www.ispecimen.com/news_items/ispecimen-to-supply-cdc-with-blood-samples-to-help-advance-understanding-of-covid-19-immunity/ ). Participation includes providing a blood sample either through a visit to one of our collection sites or a visit to your home by a mobile phlebotomist.
To participate, you must be:
at least 18 years of age
previously infected with COVID-19 or had a positive COVID-19 swab test
It has been 14-28 days since your first symptom or positive test result
located in one of the following areas: Boston, Massachusetts
Compensation will be provided. Please visit https://pages.ispecimen.com/DonorRegistration.html or email research@ispecimen.com for more information.
This study will recruit people who were infected with COVID-19 at least 2 months ago and continue to experience symptoms related to infection. Initially thought to be an acute illness like the flu, resulting in death for some or full recovery in most, scientists and clinicians are now appreciating that substantial numbers of COVID-19 illness survivors experience persistent, significant and sometimes disabling symptoms. Variously called "Long-COVID," "COVID long-haulers," or "chronic COVID syndrome", some of the most prominent symptoms are neurologic and neuropsychiatric, including cognitive impairment ('brain fog'), headache, fatigue, muscle aches and weakness, shortness of breath, hair loss and pain, among others. In this research study the investigators want to learn about whether taking Niagen (also known as Nicotinamide riboside, or NR), a daily supplement containing a form of Vitamin B3, can improve recovery of cognitive function, mood, and physical health in individuals who were infected with COVID-19 and continue to experience "brain fog" and other neurological and physical symptoms. The investigators think that this supplement may help improve thinking skills and other symptoms, and improve quality of life, in individuals who had COVID-19.
Participants will complete the following at baseline and every 5 weeks: 1) a standard cognitive battery and subjective cognitive complaints scales; 2) mood measures; 3) assessments of physical functioning, as well as of other common Covid-19-related symptoms; 4) blood draw; and 5) 2 optional MRIs. Participants will also wear a Fitbit and complete questionnaires to assess sleep and physical activity.
Inclusion Criteria:
History of SARS-CoV-2 PCR+ at least 2 months prior to study entry;
SARS-CoV-2 negative (PCR) at study entry;
Persistent cognitive difficulties (esp. "brain fog") that began around the time of the acute COVID-19;
At least two neurological and/or physical symptoms that started at COVID-19 infection and are ongoing at study entry, including fatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath, loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chest pain;
Willing and able to consent, complete all assessment and study procedures;
Not pregnant or lactating.
Exclusion Criteria:
Any specific central nervous system disease history (e.g. major clinical stroke, brain tumor, normal pressure hydrocephalus, etc);
Clinically significant unstable medical condition that could affect safety or compliance with the study;
Was intubated due to COVID-19;
Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
History of alcohol or other substance abuse or dependence within the past two years;
Any significant systemic illness or medical condition that could affect safety or compliance with study;
Current use of medications with psychoactive properties that may be deleteriously affecting cognition;
Any known hypersensitivity to nicotinamide riboside, or its principal metabolite, nicotinamide mononucleotide;
Use of other investigational agents or interventions one month prior to entry and for the duration of the trial;
If participating in the optional magnetic resonance imaging (MRI) sub-study: Any contraindication to undergo MRI;
Pregnant women or women who are planning to become pregnant within 7 months from study entry.
Contacts: Leidys Gutiérrez-Martínez, MD | 617-643-5147 | lgutierrezmartinez@mgh.harvard.edu
Gabriel J González-Irizarry, BS | 617-726-2671 | ggonzalezirizarry@mgh.harvard.edu
Michigan
The purpose of this study is to examine the feasibility of comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions.
The study team hypothesizes that combining evidence-based cognitive and affective therapies with lifestyle modifications is feasible and will improve the community integration (CI) and Quality of life (QoL) in patients with a neurocognitive disorder compared to usual care.
Inclusion Criteria:
Diagnosed with one of the following: Mild Trauma Brain injury (TBI), Multiple Sclerosis (MS), Long COVID, or Mild Cognitive Impairment (MCI)
MCI patients age older than 50 years old, all other diagnosis 21-65 years old and are receiving care through the Michigan medicine network
Participants that can provide consent or legally authorized representative who can provide consent on their behalf
Cognitive impairment ≥ 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
Exclusion Criteria:
TBI participants symptomatic at rest (headache, dizziness, nausea, or vertigo) will be referred to primary care physician (PCP)
History of TBI (except for participants with TBI)
MS participants with recent relapse (1 month prior to enrollment) or on Intravenous or oral steroids
MCI participants with disease duration greater than 1 year
Patients with other neurosensory or neurodegenerative diseases
Diagnosed with COVID-19 (except for Long COVID group)
Psychiatric disorders other than mild to moderate anxiety and depression
Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources and referred to patient's primary care provider
Diagnosed sleep disorders
Visual or auditory impairment,
Current or history of alcohol or substance abuse/dependence
Cognitive impairment less than 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
Cognitive impairment greater or equal to 1.0 standard deviation below the test score normed for age and education in 1 cognitive domain (verbal learning and memory, processing speed, or visuospatial memory)
Currently receiving CRT, CBT or Occupational therapy (OT) or another type of psychological therapy
Contact: Zee Petrie | 734-647-3357 | petrieli@med.umich.edu
Hala Darwish, PhD | 734-647-4929 | darwishh@med.umich.edu
Kidney Disease After COVID-19 (Ann Arbor)
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
Inclusion Criteria:
Adults, age ≥18 years
Confirmed diagnosis of COVID-19
Exclusion Criteria:
• No confirmed diagnosis of COVID-19
Contact:
Evren U. Azeloglu, PhD | 212-241-8519 | evren.azeloglu@mssm.edu
Lili Chan, MD, MSCR | (212) 241-4860 | lili.chan@mountsinai.org
Minnesota
Understanding the long term impact of COVID-19 on the brain through advanced MR imaging and spectroscopy (Minneapolis, Rochester)
This study aims to understand the long-term impact of COVID-19 on the brain through imaging. This is a multi-site study led by University of Minnesota, Mayo Clinic Rochester, and Harvard University and is supported by the National Institutes of Health (NIH).
Researchers are looking for individuals who had COVID-19 and are still having symptoms like headaches, “brain fog”, feeling tired, dizziness, memory problems, or loss of taste or smell. They are also looking for individuals who did not have COVID-19. The research team aims to review the neuroinflammatory, neurodegenerative and hypoxic/ischemic sequelae of COVID-19.
The eligibility survey can be found here.
If you agree to participate in this study, the researchers will ask you to come to the study center for the following:
Medical history collection
Physical examination
MRI scan – the scan does not include contrast or any tasks in scanner
Blood draw
Cognitive (e.g. memory, reasoning, attention) testing
Study questionnaires
The team will reach out to you every three months while you are in this study to check in on your symptoms and see if you have any questions. They may invite you for a second visit about two years after the first visit.
You will be compensated for each completed study visit. There is a $150 stipend for completed visits. You will also not be responsible for the cost of any study procedure and any public transportation fees or parking costs will be provided. If you need to stop study procedures for any reason, you will receive partial payment for your time.
Eligibility Criteria:
At least 18 years of age
With or without prior history of COVID-19
Ongoing symptoms such as headaches, brain fog, memory problems if you had COVID-19
Able to undergo MR scanning
English or Spanish speaking
Contact: covidbrainstudy@umn.edu
New Jersey
Kidney Disease After COVID-19 (Newark)
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
Inclusion Criteria:
Adults, age ≥18 years
Confirmed diagnosis of COVID-19
Exclusion Criteria:
• No confirmed diagnosis of COVID-19
Contact:
Evren U. Azeloglu, PhD | 212-241-8519 | evren.azeloglu@mssm.edu
Lili Chan, MD, MSCR | (212) 241-4860 | lili.chan@mountsinai.org
This is a two-arm, double blind randomized 12-week study to supplement omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) among 100 adults (age 18+) who had coronavirus-19 (covid-19) and are experiencing possible after-effects from post-acute sequelae of covid-19 (also called post-covid syndrome or long covid syndrome).
Inclusion Criteria:
Team member at Hackensack Meridian Health
Age: 18+
Willing to provide informed consent
Formal diagnosis of COVID-19 via Polymerase Chain Reaction (PCR)test (if home test was done, team member must confirm via PCR test)
Outpatient treatment only for covid-19; no hospitalization (most team members will be vaccinated and may likely have milder case)
Must be experiencing 1+ ongoing covid-19 symptom being measured in this study (respiratory symptoms (shortness of breath, cough), fatigue, loss of taste, loss of smell)
Symptom(s) have persisted for more than 12 weeks after initial infection
Symptom(s) coincided with covid-19 infection and were not present prior to covid-19 infection
Does not have soy allergy
Does not have allergy to fish
Able to participate in bi-weekly surveys in Research Electronic Data Capture (REDCap)
Able to take own blood pressure and record it in bi-weekly REDCap survey
Willing to participate in 12-week study and be assigned to either intervention or placebo arm
Not currently taking an omega-3 supplement or other high-dose supplement (over 2,000 IU) with potential for aiding recovery of long covid syndrome (e.g. zinc, Vit C, Elderberry).
Able to take/swallow six mini-pills daily
Able and willing to give a spot blood sample (2 drops) at baseline and end of study.
Exclusion Criteria:
Not a Team Member at Hackensack Meridian Health
Not age 18+
Unwilling to provide informed consent/ declined to take part
No formal diagnosis of COVID-19 via PCR test (if home test was done, team member must confirm via PCR test)
Were hospitalized for treatment of covid-19
Not experiencing 1+ ongoing covid-19 symptom being measured in this study (respiratory symptoms (shortness of breath, cough), fatigue, loss of taste, loss of smell)
Symptom(s) have persisted for more than 12 weeks after initial infection
Symptom(s) did not coincide with covid-19 infection and were present prior to covid-19 infection
Does have soy allergy
Does have allergy to fish
Not able to participate in bi-weekly surveys in REDCap
Able to take own blood pressure and record it in bi-weekly REDCap survey
Not willing to participate in 12-week study and be assigned to either intervention or placebo arm
Currently taking an omega-3 supplement or other high-dose supplement (over 2,000 IU) with potential for aiding recovery of long covid syndrome (e.g. zinc, Vit C, Elderberry).
Unable to take/swallow six mini-pills daily
Not able and not willing to give a spot blood sample (2 drops) at baseline and end of study.
Contact: Erin Speiser, Ph | 5519968071 | Erin.speiser@hmhn.org
Post-Acute Sequelae of COVID-19 (PASC) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study (PEACE) (Hackensack)
The PEACE study is designed to study two issues:
Whether beta blockers which have been utilized to treat tachycardias, POTS (postural orthostatic tachycardia syndrome), and hypertension will have similar effectiveness in PASC (Post-Acute Sequelae of COVID-19)
To determine appropriate dosing which may be different from those used on non PASC conditions.
Inclusion Criteria:
Subject should be between the ages of 18 and 40 with DOE (dyspnea on exertion) for 3 - 12 months
Subjects recovered from acute, PCR (polymerase chain reaction) positive, COVID-19 infection
Recovery from COVID-19 will be defined as substantial improvement in or essential resolution of initial clinical symptoms
Demonstration of tachycardia and/or dyspnea with minimal activity (subjectively different than pre-COVID 19 infection state)
Abnormal HUTT (heads up tilt test)
Normal chest x-ray
Left ventricular ejection fraction (LVEF) >50% by transthoracic echocardiography
Zva >3.5 as calculated from TTE (transthoracic echocardiogram).
Hemoglobin/Hematocrit within normal laboratory standards
Thyroid-stimulating hormone (TSH) within normal laboratory standards
Exclusion Criteria:
Active pregnancy (negative pregnancy test is the standard of care prior to HUTT)
Demonstrate a primary cause of appropriate DOE and sinus tachycardia
Fevers/infection
Hypovolemia
Anemia
Hyperthyroidism
Alcohol/drug/medication withdrawal
Currently taking beta blocker medications
Currently being treated for pre-existing neurally mediated hypotension/syncope or known dysautonomia.
Medical history of chronic lung disease or reactive airway syndrome.
Contact: Jana Tancredi, RN | (551) 996-2353 | Jana.tancredi@hmhn.org
New York
Dual Sympathetic Blocks Study (NYC - West Village)
The goal of this study led by Hudson Medical is to evaluate the effectiveness of Dual Sympathetic Blocks for patients experiencing symptoms of Long COVID. Effectiveness will be measured by the impact on autonomic symptoms and on patients’ self-reported physical, mental, and social health status.
Participation is expected to last up to 1 month and will consist of three study visits.
The study sponsor site will provide the study procedure at no charge.There is no guarantee that participants will benefit from this study - however, the information learned from this study may provide much needed insight into the state of the Long COVID disease and guidance for future clinical studies.
Eligibility: Participants must meet the following inclusion criteria to be eligible for participation in this study: Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing and persistent symptoms that continue four or more weeks after the start of a COVID-19 infection (including at least one quantified autonomic symptom on the screener Composite Autonomic Symptom Score (COMPASS-31) and quantified pain symptoms as reported by the patient on the screener Patient-Reported Outcomes Measurement Information System (PROMIS-29)).
Contact: Megan, Research Coordinator | mnicklay@hudsonmedical.com
The purpose of this study is to describe the long-term health effects of COVID-19 in a population of mostly Black and Latinx individuals and their households who were diagnosed with COVID-19 at Columbia University Irving Medical Center.
In New York, the upper Manhattan and south Bronx communities neighboring Columbia University Irving Medical Center (CUIMC) have been two of the most impacted communities of the COVID-19 pandemic. These neighborhoods are predominantly non-Hispanic black or African American and Latinx.
This study will invite people who tested positive for COVID-19 and/or were treated at Columbia University Irving Medical Center to: 1) take a survey to ask about current symptoms and any health problems and 2) ask permission to review COVID-related health history including COVID-19 testing results (from the medical record) since infection to learn about health effects after COVID-19 infection; 3) invite anyone in their household to take a survey; and 4) for up to 500 patients who were hospitalized for COVID, give the option of doing a nasal swab to test for SARS-CoV-2 virus and blood test to check for antibody up to 12 months after diagnosis, to compare how results are different 12 months after infection.
The goal is to learn about how the severity of person's infection in 2020 influences long term health effects and how others in their household are impacted by COVID-19.
Inclusion Criteria - Objective 1 Participants:
Age 18 years and older
Having an electronic medical record at NYP
Laboratory confirmed COVID-19 infection diagnosed at NYP/CUIMC after March 1, 2020 or were diagnosed at least 9 months prior to administration of the online questionnaire on long-term outcomes and sequelae.
Able to provide informed consent
Exclusion Criteria:
Index cases less than 18 years of age.
Not COVID-19 diagnosed
Inclusion Criteria - Objective 2 Participants:
Age 18 years and older
Having an electronic medical record at NYP
Hospitalized at NYP/CUIMC after March 1 2020, or at least 9 months prior to administration of the online questionnaire on long-term outcomes and sequelae
Randomly selected: every 10th index case who was not hospitalized
Able to provide informed consent AND
Are willing to provide a nasal swab, blood sample in addition to completing the questionnaire.
Contact: Magda Sobieszczyk, MD | (845) 372-5023 | covid19idresearch@cumc.columbia.edu
MDHyperbaric | Hyperbaric Oxygen Therapy (HBOT) Long COVID Pilot Study (NYC)
MDHyperbaric is a New York-based treatment center practicing under the supervision of Medical Director, Dr. Martin J. O’Malley, MD. Dr. O’Malley has been using HBOT to accelerate recovery from surgery and wounds since December 2021.
MDHyperbaric is now conducting a pilot study utilizing Hyperbaric Oxygen Therapy (HBOT) for the treatment of patients with Long COVID. Hyperbaric oxygen therapy (HBOT) is a painless and non-invasive medical therapy that works by having the patient inhale 100% oxygen in a pressurized chamber. HBOT is currently being studied as an effective form of treatment for Long COVID due to its suggested ability to reverse hypoxia, reduce neuro-inflammation, and improve tissue oxygenation.
Through this pilot study, a total of 30 participants will receive:
10 free treatments over the course of two weeks
Each session will last 60 minutes
All sessions are supervised by a trained hyperbaric technician
Contact: Email contact@mdhyperbaric.com or fill out the online participation form.
Kidney Disease After COVID-19 (NYC)
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.
Inclusion Criteria:
Adults, age ≥18 years
Confirmed diagnosis of COVID-19
Exclusion Criteria:
• No confirmed diagnosis of COVID-19
Contact:
Evren U. Azeloglu, PhD | 212-241-8519 | evren.azeloglu@mssm.edu
Lili Chan, MD, MSCR | (212) 241-4860 | lili.chan@mountsinai.org
The purpose of this NYU Langone study is to develop brain imaging (PET/MRI) techniques to accurately assess immune system and blood vessel dysfunction in the brain related to neuropsychiatric long-haul COVID-19 (neuropsychiatric post-acute sequelae of SARS-CoV-2, or PASC).
Position-emission tomography (PET) uses radiation and magnetic resonance imaging (MRI) uses magnetic fields to create images to provide us information about the structure and function of different tissues in your body. PET/MRI is a Food and Drug Administration (FDA) approved way of providing this information simultaneously during a single imaging procedure. However, it is not considered the standard care method for evaluating neuropsychiatric post-acute sequelae of SARS-CoV-2 (long COVID-19).
An investigational tracer (dye) will be used during the PET-portion of the examination to image inflammation in the brain. The name of the tracer is ER176; the tracer targets cells that are active in inflamed brain regions. This tracer has been approved for use in this research study by the Radioactive Drug Research Committee (RDRC), which reviews research studies involving investigational radioactive drugs.
You may be eligible for this study if you meet the following criteria:
CONDITIONS: Coronavirus As The Cause Of Diseases Classified To Other Chapters
AGE: Between 18 - 50 Years
GENDER: Male or Female
OTHER INCLUSION CRITERIA:
Volunteers with neuropsychiatric symptoms following COVID:Cognitive dysfunction and or
Depression or anxiety symptoms
Volunteers who have a history of COVID, but no long term symptoms:
History of Infection with SARS-CoV-2
Does not meet criteria for any DSM-5 diagnosis
Perform within normal limits on cognitive tests
All:
At least 12th grade educational level
Infection with SARS-CoV-2 (3-12 months ago)
Able to sign informed consent as evaluated by the UCSD Brief Assessment of Capacity to Consent (UBACC) test.
You may not be eligible for this study if the following are true:
Less than 3 months past the last SARS-CoV-2 vaccine administration
Suicidal ideation
Pregnant women
Known history of serious our unstable medical illness associated with chronic inflammation other than PASC
Obese individuals (BMI >= 30) and individuals with cardiovascular risk factors
A history of chronic pre-existing neurological disease, i.e. neurological symptoms should be new onset for inclusion
A history of any of the following pre-existing DSM-5 psychiatric illnesses (i.e. symptoms should be new onset for inclusion): schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, anxiety disorders (e.g. Panic d/o, GAD, PTSD) which are considered the primary mental health problem, OCD or OCD-spectrum disorders, neurocognitive disorders
Clinical or laboratory evidence of hypothyroidism
Recent traumatic brain injury
Patients with substance use disorders, including alcohol, active within the last 12 months
Current use of any psychotropic drugs, including current use of antidepressants, benzodiazepines, hypnotics, anticonvulsants, antipsychotics
Patients who have had electroconvulsive therapy (ECT) within the preceding 6 months
Contraindications to 3T whole body MRI scanners
Contraindications for Gadolinium-based MRI contrast
Claustrophobia
Recent exposure to radiation which when combined with this study would be above the allowable limits of 5 rem per 12 months
If CSF sampling: contraindication for a lumbar puncture
Unable to sign informed consent or to comply with study assessments
Contact: Fill out the online contact form to learn more about this study.
Principal Investigator: Steven H. Baete, Ph.D., M.Sc.Eng
Understanding the Long-term Impact of COVID-19 in Adults (NYC)
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC.
Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.
Inclusion Criteria:
INFECTED COHORT -- ADULTS WITH SUSPECTED SARS-COV-2 INFECTION --
An adult qualifies as having suspected SARS-CoV-2 infection if meeting criteria a, b or c below:
Patients who meet the following clinical criteria plus one of the epidemiological criteria:
Clinical Criteria: Acute onset of fever and cough OR acute onset of any three of more of the following signs or symptoms: fever, cough, general weakness /fatigue, headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea, altered mental status.
Epidemiological Criteria:Residing or working in an area with a high risk of transmission of virus: closed residential settings, humanitarian settings such as camp and camp-like settings for displaced persons; anytime within the 14 days before symptom onset; or
Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; or
Working in any health care setting, including within health facilities or within the community; anytime within the 14 days before symptom onset.
A patient with severe acute respiratory illness: (acute respiratory infection with history of fever or measured fever of ≥38C°; and cough; with onset within the last 10 days; and requires hospitalization).
An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.
ADULTS WITH PROBABLE SARS-COV-2 INFECTION --
An adult qualifies as having probable SARS-CoV-2 infection if meeting any one of a-d below:
A patient who meets clinical criteria for suspected SARS-CoV-2 AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster;
A suspect case with chest imaging showing findings suggestive of COVID-19 disease;
A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause;
Death, not otherwise explained, in an adult with respiratory distress preceding death AND was a contact of a probable or confirmed case or linked to a COVID-19 cluster
ADULTS WITH CONFIRMED SARS-COV-2 INFECTION --
An adult qualifies as having confirmed SARS-CoV-2 infection if meeting any one of a-d below:
Any person with a positive Nucleic Acid Amplification Test (NAAT);
Any person with a positive SARS-CoV-2 Antigen-RDT OR positive SARS-CoV-2 antibody test* AND meeting either the probable case definition or suspect criteria A OR B;
An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who is a contact of a probable or confirmed case
Any person with a positive SARS-CoV-2 nucleocapsid protein antibody test OR a positive SARS-CoV-2 spike protein antibody test IF not vaccinated
(*)This protocol modifies the WHO criterion b to add detectable SARS-CoV-2 antibody as a qualifying test.
UNINFECTED COHORT -- ADULTS WITH NO SARS-COV-2 INFECTION --
Does not meet WHO criteria for a suspected, probable, or confirmed case of SARS-CoV-2 infection, AND
Has a documented negative SARS-CoV-2 PCR test from a respiratory specimen in the past, if being enrolled as a post-acute control (see XII.H), AND
Has a documented negative SARS-CoV-2 PCR test from a respiratory specimen at the time of enrollment/screening, AND
Has a negative SARS-CoV-2 nucleocapsid protein antibody and spike protein antibody test (spike only if not vaccinated) at the time of enrollment, AND
Live in the same communities or recruited from the same sources as those in the SARS-CoV-2 infected cohort, AND
Note: uninfected individuals may participate independent of their vaccination status
Exclusion Criteria:
Individuals who have not yet reached the age of majority
Unable to provide consent
Individuals in hospice care
Any serious medical condition which would prevent long-term participation
Individuals participating in the study NIH RECOVER-Pediatric: Understanding the long-term impact of COVID on children and families
Incarcerated individuals
Contact: Leora Horwitz, MD | 1-833-422-6819 | RECOVER_CSC@nyulangone.org
MeeLee Tom, MS, CCRA, ACRP-CP | 1-844.226.8192 | RECOVER_CSC@nyulangone.org
A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients (NYC)
This is a study to evaluate the effectiveness and safety of the BIO 300 Oral Suspension for impaired lung function in patients that were previously hospitalized due to complications from COVID-19. Study participants will receive either BIO 300 Oral Suspension or a placebo.
Participants will take the study treatment orally once per day for 12 weeks. During this time, participants will complete a combination of weekly in-person and virtual visits to evaluate their lung function and overall health. Participants will also complete in-person follow up visits at 6 months and 12 months following initiation of the study treatment.
Participants will receive $50 for each in-person clinic visit (6 total visits) and healthcare services associated with completion of the study requirements free of charge.
To be eligible, participants must:
Be at least 18 years old;
Have been hospitalized due to COVID-19 related complications and are ready to be discharged, or were discharged within the past 365 days;
Have been diagnosed with (or met the criteria for) acute respiratory distress syndrome (ARDS) while hospitalized;
Must be able to commute to the NYU Langone campus for the in-person clinic visits.
Principal Investigator: Rany Condos, MD
Contact: Lysy Gonzalez | BIO300@nyulangone.org
Recovery Corps | The Survivor Corps, Columbia University, & Sage Bionetworks sponsored, long-term health study of COVID survivors in New York (NYC)
This study aims to better understand why there are differences between how individuals recover from COVID-19 infection and what helps/hinders recovery. For the initial phase, the study is recruiting individuals in and around NYC with a prior confirmed COVID diagnosis on a lab test (PCR or antibody). If you live within 25 miles of Columbia University you are eligible! There is no cost and no insurance needed.
For more details on how to participate see: https://www.survivorcorps.com/recoverycorps
Columbia University maintains a listing of all of their clinical trials that are recruiting participants. Many studies involve COVID patients. Please check the website for COVID related studies.
VNS for Long-COVID-19 (NYC)
The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function.
This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
At least 18 years of age
Clinical diagnosis of dysautonomia following an acute COVID-19 infection at least 3 months prior. See below for criteria:
clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider
2 or more if the following clinical assessment findings
symptomatic exacerbation during active stand test
tachycardia on active stand test
tachycardia on orthostatic vitals assessment
hypotension on orthostatic vitals assessment
hypertension in orthostatic vitals assessment
symptom exacerbation on orthostatic vitals assessment
English speaking
Exclusion Criteria:
• Pregnancy or lactation:
Pregnant persons will not be included in this study for the following reasons:
There is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (PCD). The results could be skewed due to pregnancy.
Of note, there are no risks for pregnant persons to participate.
According to the device manufacturer, the following contraindications will be followed during the screening process:
Patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic device
Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years)
Patients with diagnosed bradycardia
Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
Patients whose pain syndromes are undiagnosed
Pediatric patients
Pregnant women
Contact: Mackenzie Doerstling, MPH | 704-408-5674 | mackenzie.doerstling@mountsinai.org
Breast Milk Antibody Study (NYC)
Rebecca Powell, a human milk immunologist at New York City’s Icahn School of Medicine at Mount Sinai is seeking breast milk samples from Covid survivors — particularly from people living in New York City, but other locations are possible as well — to examine whether the antibodies lingering in human milk can protect babies from coronavirus and adults.
Contact: Covid19HumanMilkStudy@gmail.com.
New York Blood Center/Project ACHIEVE (NYC)
This is a study to better understand how infection of SARS-CoV-2, the coronavirus that causes COVID-19 illness, can be prevented and possibly develop treatments for the infection.
The researchers are looking for volunteers that meet the following eligibility criteria to participate in two COVID-19 research studies:
People who recently tested positive for SARS-CoV-2 so their immune response to this virus can be studied. Participants must have tested positive for SARS-CoV-2, be at least 18 years old, and not be pregnant. This study involves one required visit, followed by 3 optional visits. You will receive compensation for your time and travel expenses for the study visits ($75 for each visit).
People who have not tested positive for SARS-CoV-2, so we can study whether a vaccine and other strategies are effective in preventing this infection. Participants must not have tested positive for SARS-CoV-2, be at least 18 years old, and not be pregnant. These studies involve multiple visits over 12 months. You will receive compensation for your time and travel expenses for the study visits (up to $100 for a visit).
If interested in either study, go to beatcovidnyc.org to see if you are eligible to participate. You may also call Project ACHIEVE at the New York Blood Center at 212-388-0008 [Mondays-Fridays 9am-5pm], or visit www.projectachieve.org.
Rockefeller University Hospital COVID-19 Study (NYC)
The Rockefeller University Hospital is conducting a study to identify ways to block and prevent COVID-19 infection. To participate in the study you must be at least 18 years of age and either:
Were infected with Coronavirus and are now free of symptoms, or
Were sick, were in close contact with someone infected with Coronavirus (e.g. living in the same household) and are now free of symptoms
Participation includes:
1-2 visits to the Rockefeller University Outpatient Clinic for interview and blood work, OR:
Participate remotely (by phone/video & have blood work done locally). Compensation and parking are provided.
Contact: Recruitment Office | 1-800-RUCARES (1-800-782-2737) | RUCARES@rockefeller.edu
Columbia University Biobank (NYC)
The Columbia University biobank is focusing their research on COVID-19. This research is being conducted to help to advance understanding of the COVID-19 virus, including but not limited to: how the virus is spread, potential vaccines or other treatments, genetic susceptibility to severe disease, and other questions that will come up as we continue our research studies. Columbia University Biobank will facilitate this research by providing biological samples and medical information to Columbia-NYP researchers and our collaborators around the world who are working on vaccines and/or other treatments for this virus.
Contact: (212) 305 9941 | cubiobankcovid19@cumc.columbia.edu
Cardiopulmonary Rehabilitation in COVID-19 Longhaulers (NYC)
This study will test the efficacy of treadmill exercise combined with supplemental oxygen during exercise and recovery for the treatment of persistent post-acute COVID-19 symptoms. Participants will be pseudo-randomized (stratified by age) to one of four conditions for 8 treatment sessions: 1) treadmill exercise plus supplemental oxygen, 2) treadmill exercise plus air, 3) supplemental oxygen only, 4) air only. All participants will then cross-over and receive 16 additional sessions of treadmill exercise plus supplemental oxygen.
Inclusion Criteria:
Between the ages of 18-60
Contracted COVID-19 between February - July 2020
Has been clinician-diagnosed with COVID-19 based on PCR/antigen testing, antibody testing, or clinical symptoms
Is currently experiencing one or more of the following symptoms, which began only after contracting COVID-19 : dyspnea, cough, chest pain, tachycardia or other arrhythmias, hypertension, hypotension, blood pressure lability, oxygen desaturation, exercise/activity intolerance, fatigue, or dizziness.
Has been cleared by a physician for exercise and supplemental oxygen.
Has the capacity to provide written, informed consent
Able to complete questionnaires in English
Exclusion Criteria:
History of any of the following per the American College of Sports Medicine exercise testing guidelines (American College of Sports Medicine et al., 2018) to be determined during a screening consultation:
Acute myocardial infarction within the past two days
Ongoing unstable angina
Uncontrolled cardiac arrhythmias
Active endocarditis
Symptomatic severe aortic stenosis
Decompensated heart failure
Active pulmonary embolism, pulmonary infarction, or deep venous thrombosis
Active myocarditis or pericarditis
Acute aortic dissection
Physical disability that precludes safe and adequate testing
Participants who demonstrate orthostatic intolerance or oxygen desaturation (<90%) during the exercise tolerance test will no longer be eligible for the study because it is not safe for them to exercise on a treadmill.
Contact: Noah Greenspan, DPT | (212) 249-0904 | consult@covidpt.org
Julie Walsh-Messinger, Ph.D. | (937) 229-1380 | udcovidstudy@udayton.edu
Ohio
Participants are being asked to take part in this research study because they have had a previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent, recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). The Investigators are interested in studying the effects of Vitamin K2 (MK-7) and Vitamin D3 supplementation on PASC symptoms and the underlying inflammatory process.
Inclusion Criteria:
Previous COVID-19 infection as documented by a positive Nucleic Acid Amplification Test (NAAT) PCR test or any licensed SARS-CoV-2 antigen test kit and prolonged, recurrent or newly developed symptoms more than 3 months after the positive test result.
Male or Female age ≥18 years
Provides written informed consent and is capable of reading and comprehending the informed consent
Able to swallow pills.
No active nausea, vomiting
All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea for 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35mLU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male partner has undergone successful vasectomy with resulting azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Acceptable documentation of menopause, sterilization, and azoospermia is patient reported history.
All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.
Exclusion Criteria:
Subjects unable to consent due to language barrier or cognitive impairment.
Pregnancy/lactation.
Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
Subject receiving vitamin K antagonists (e.g. warfarin, coumadin)
Subject consuming supplements of vitamin K1, K2, or Vitamin D. A daily multivitamin will not be exclusionary as long as vitamin D is not > 600 UI daily.
Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
BMI <18 kg/m2.
Allergy or intolerance to vitamin K2 or vitamin D3
Hospitalization within the previous 28 days.
Inability or unwillingness of the individual to give written informed consent
Contact: Danielle Labbato, BSN | 2168442739 | Danielle.Labbato@uhhospitals.org
Oklahoma
This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.
Major Inclusion Criteria:
The patient is male or female, 18 to 65 years of age, inclusive.
The patient has a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.
The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.
Major Exclusion Criteria:
The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
Contact: Clinical Program Manager | 203-482-3938 | megha.tevar@tonixpharma.com
Pennsylvania
Long COVID Research Study: Study of Immune Response in Lymph Nodes and Blood (Philadelphia)
Researchers at the University of Pennsylvania are recruiting individuals who have received a diagnosis of long COVID for a research study. The researchers are aiming to investigate the immune system response in individuals who have not fully recovered from Sars-CoV-2 infection.
The research team is looking to recruit adults aged 18-80 years old. People who have a personal history of cancer, organ transplants, autoimmune disease, hospitalization for COVID, or treatment with monoclonal antibodies are not eligible for this study.
Participation in this study will involve up to three visits. At each visit, participants will be asked to have a blood draw and fine needle aspiration of cervical (neck) and/or axillary (armpit) lymph nodes. Each visit will take approximately 2-3 hours, and participants will be reimbursed $150 per visit.
You may opt-out of the study at any time by contacting the lead investigator. This will not affect any ongoing or future treatment.
Contact: Michela Locci, Lead Investigator | michela.locci@pennmedicine.upenn.edu
Hannah Sharpe | Hannah.sharpe@pennmedicine.upenn.edu
Rhode Island
Interview and Examination of COVID-19 Survivors for Book Project (Providence)
Dr. Jon Mukand, a Rehabilitation Medicine physician and faculty member at Brown University and Tufts University, is working on a book about recovery from COVID-19 (pulmonary, cardiac, neurological, cognitive, psychological, musculoskeletal (contractures, amputations), fatigue, gastrointestinal, olfactory, etc.). Dr. Mukand wishes to interview and examine persons with significant, documented conditions caused by COVID-19.
All descriptions of these persons will be de-identified, except for gender and general age (e. g. a man in his 50s), and the narrative will be approved by each interviewee before publication.
There will be no doctor-patient relationship, as this is a journalistic project.
One or two people may also be featured in an article in the RI Medical Journal; the author is serving as a guest editor for a special issue on COVID-19.
Contact: Jon Mukand | jmukand@cox.net
South Carolina
The University of South Carolina’s Aging Brain Cohort in collaboration with the Palmetto Health-USC Medical Group Division of Infectious Diseases is seeking participants who have recovered from COVID-19 for a study looking at the negative effects that COVID-19 may have on the brain, cognition, language and social-emotional impacts.
The study has 3 parts which include a questionnaire, virtual testing and in-person MRI visit. The questionnaire and testing are done virtually. The MRI is done at the Prisma Health Richland Hospital located in Columbia, SC. Participants have come from as far as Georgia to take part, however, participants must provide their own travel. Participants receive $70.
Participants must:
Have a positive test or Physician Diagnosis of COVID-19 and be recovered for 28 days
Be Adults between the ages of 20-80
Be MRI Compatible (e.g. no metal implants, not claustrophobic, etc.)
BMI <40
Proficient in English
Contact: abcstudy@mailbox.sc.edu | 803-576-8420
Tennessee
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome (Nashville)
The aim of this study is to test the hypothesis that reduced parasympathetic (PNS) activity is associated with persistent inflammation in patients with post-COVID-19 POTS / long COVID.
Inclusion Criteria:
Prior RT-PCR-confirmed COVID-19 infection.
Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (>30 bpm) and chronic (>3 months) pre-syncopal symptoms.
Exclusion criteria:
Heart Disease: Myocardial Infarction, angina, heart failure
History of stroke, or transient ischemic attack
Undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)
Uncontrolled hypertension defined as persistent blood pressure >140/90.
Post-menopausal women.
Diabetes Mellitus Type 1 or Type 2. ,
Impaired Hepatic function
Impaired renal function test (eGFR<60 mL/min/1.73m2).
Ongoing substance abuse.
Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study.
History of seizures.
Chronic use of steroids, NSAIDs.
On biologics such as anti-IL6 (omalizumab) and anti-TNF-alpha drugs
Pregnancy or breastfeeding
Contact: Cyndya Shibao, M.D. | 615-936-4584 | cyndya.shibao@vumc.org
Meena Golchha, MD | 615-421-2998 | meenakshi.golchha@vumc.org
Post Acute Sequelae of COVID-19 (PASC) (Nashville)
This study is designed to better understand the effects of SARS-CoV-2 that develop over time. This study will characterize the recovery process, epidemiology, and natural history of post-acute sequelae. This includes the clinical spectrum of recover and subsets of patients who have symptoms outside the standard course. Factors studied will include the individual, clinical context, severity of disease, duration of symptoms and the impact of treatment for acute SARS-CoV-2. This study will include a breadth of severity from those treated as outpatients, those requiring hospitalization, and those requiring critical care.
Inclusion Criteria:
18 years or older
COVID-19 diagnosis
Seen in a Vanderbilt clinic or affiliated health facility
Exclusion Criteria:
None
Contact: Carla M Sevin, MD | 6153222386 | carla.sevin@vumc.org
Peter J Edmonds, MD | 6153222386 | peter.j.edmonds@vumc.org
Texas
This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.
Major Inclusion Criteria:
The patient is male or female, 18 to 65 years of age, inclusive.
The patient has a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.
The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.
Major Exclusion Criteria:
The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
Contact: Clinical Program Manager | 203-482-3938 | megha.tevar@tonixpharma.com
This study aims to understand the long-term impact of COVID-19 on the brain through imaging. This is a multi-site study led by University of Minnesota, Mayo Clinic Rochester, and Harvard University and is supported by the National Institutes of Health (NIH).
Researchers are looking for individuals who had COVID-19 and are still having symptoms like headaches, “brain fog”, feeling tired, dizziness, memory problems, or loss of taste or smell. They are also looking for individuals who did not have COVID-19. The research team aims to review the neuroinflammatory, neurodegenerative and hypoxic/ischemic sequelae of COVID-19.
The eligibility survey can be found here.
If you agree to participate in this study, the researchers will ask you to come to the study center for the following:
Medical history collection
Physical examination
MRI scan – the scan does not include contrast or any tasks in scanner
Blood draw
Cognitive (e.g. memory, reasoning, attention) testing
Study questionnaires
The team will reach out to you every three months while you are in this study to check in on your symptoms and see if you have any questions. They may invite you for a second visit about two years after the first visit.
You will be compensated for each completed study visit. There is a $150 stipend for completed visits. You will also not be responsible for the cost of any study procedure and any public transportation fees or parking costs will be provided. If you need to stop study procedures for any reason, you will receive partial payment for your time.
Eligibility Criteria:
At least 18 years of age
With or without prior history of COVID-19
Ongoing symptoms such as headaches, brain fog, memory problems if you had COVID-19
Able to undergo MR scanning
English or Spanish speaking
Contact: covidbrainstudy@umn.edu
Body-mind treatment and brain function study (Dallas)
UT Southwestern Medical Center and Texas Tech University/Health Sciences Center are conducting a brain health and psychological well-being study in Dallas, Texas. The study aims to help adults reduce stress and fatigue, improve attention, emotion, cognition, and immune function. We know the COVID survivors also have symptoms such as difficulty focusing, cognitive declines, emotion dysregulations, sleep problems, and fatigue, and we would like to invite you to participate in our study which may help your recovery.
The study will use a non-invasive imaging (fMRI) widely used in research and clinic and a music-based mindfulness training and does not have any side effects. Participants will 1) receive an hour brain scan at UT Southwestern in Dallas and receive $25 payment (1st part of study); 2) receive ten 1-hour Zoom sessions of online training to reduce stress and fatigue, improve immune function, attention, emotion, and cognition; and 3) an hour brain scan and receive $225 payment (2nd part of study). After you complete the whole study, you will receive a CD with thousands of your brain images. We will cover all the research-related costs such as brain scans and parking at UT Southwestern.
Please email Dr. Tang and Dr. Pinho at tanglab2100@gmail.com to participate. Your participation is voluntary, and your responses are completely confidential. So far, this study is only open in Dallas, Texas but we will consider opening other sites if we receive requests.
A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients (Houston)
This is a study to evaluate the effectiveness and safety of the BIO 300 Oral Suspension for impaired lung function in patients that were previously hospitalized due to complications from COVID-19. Study participants will receive either BIO 300 Oral Suspension or a placebo.
Participants will take the study treatment orally once per day for 12 weeks. During this time, participants will complete a combination of weekly in-person and virtual visits to evaluate their lung function and overall health. Participants will also complete in-person follow up visits at 6 months and 12 months following initiation of the study treatment.
Participants will receive $50 for each in-person clinic visit (6 total visits) and healthcare services associated with completion of the study requirements free of charge.
To be eligible, participants must:
Be at least 18 years old;
Have been hospitalized due to COVID-19 related complications and are ready to be discharged, or were discharged within the past 365 days;
Have been diagnosed with (or met the criteria for) acute respiratory distress syndrome (ARDS) while hospitalized;
Must be able to commute to the Houston Methodist Research Institute for the in-person clinic visits.
Principal Investigator: Mahendra Jain, MD
Contact: Bela Jain | BIO300@houstonmethodist.org
Utah
Impact of Monoclonal Antibody Treatment on Post-Acute COVID-19 Syndrome (MAbPACs) (Murray)
It is now recognized that many patients who develop symptomatic COVID-19 infection continue to suffer from a variety of symptoms that persist well after the acute syndrome. This has been called post-acute COVID-19 (PACS), or "long COVID" syndrome. PACS is associated with significant morbidity, decreased quality of life, mental and behavioral health impact and healthcare cost. Neither the pathophysiology nor risk factors for PACS are well-understood and further research is needed to characterize this syndrome. Some studies have suggested that age, female gender, obesity, comorbid burden, symptoms at diagnosis and hospitalization during acute COVID-19 increase risk for PACS.
Because of the significant overall impact of PACS, there is significant interest in identifying therapies to prevent this condition. Early neutralizing therapy with anti-SARS-CoV-2 monoclonal antibodies (MAbs) addresses the initial phase of disease and has now been shown to be effective at decreasing viral load and preventing progression to severe disease, hospitalization and death. Understanding how MAb therapy may impact PACS symptoms is important to determining usage and value of these products and an important contribution to our understanding of how to prevent PACS. As such, the goal of the study is to use the Intermountain real-world MAb-treatment registry and control group to prospectively evaluate PACS symptoms at least 120 days after initial COVID-19 diagnosis.
Inclusion Criteria:
Age ≥18
Positive antigen or polymerase chain reaction test for SARS-CoV-2 December 1, 2020 to April 15, 2021
Symptomatic COVID-19
Between day 120 and day 150 from date of positive test
Not hospitalized or hypoxemic by day 7 of symptoms (Aim 1 only)
Exclusion Criteria:
Unwilling to participate
Not able to understand the English language survey questions
Prisoners
Inadequate cognitive capacity to provide consent and complete the survey
Contact: Brandon Webb, MD | (801) 507-7781 | Brandon.Webb@imail.org
An Open-Label Pilot Study with the Combination of Valacyclovir and Celecoxib for the Treatment of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (Salt Lake City)
The Bateman Horne Center is conducting a pilot study to test whether a combination of celecoxib and valacyclovir reduces fatigue and other symptoms in women with Long COVID between the age of 18-65 years. The combination of celecoxib and valacyclovir may inhibit herpes virus activation and replication.
Participants will be assigned to either the treatment arm or the standard of care arm. The treatment arm will have five (5) visits to the Bateman Horne Center over a 14-17 week period. The standard of care arm will have three (3) in-person visits to Bateman Horne Center over a 14-week period. Eligible participants will be compensated $50.00 for each in-person visit.
Contact: research@batemanhornecenter.org | (385) 262-9081
Washington
This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
Inclusion Criteria:
Age ≥ 18 years
Resident of Washington state
Diagnosis of a Post-COVID condition
Able to read, speak, and understand English
Availability of a telephone and internet access
Exclusion Criteria:
Severe cognitive impairment
Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)
Contact: Sydney Drever | 206-616-7671 | drevers@uw.edu
Lindsey Knowles, PhD | 206-744-9640 | lmknow@uw.edu
2021 COVID-19 Research (Tacoma)
This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.
Inclusion Criteria:
Have been tested for COVID at one of the MultiCare facilities,
AND 18 years old or older at the viral test,
AND have no problem understanding English or Spanish.
Exclusion Criteria:
Pediatric patients younger than 18 years old at the time of testing,
OR patients who are pregnant,
OR patients who plan to get pregnant in 3 months,
OR patients who are hospitalized at the time of recruitment,
OR patients who have cognitive impairment(s) at the recruitment.
Contact: Hollis Zeng | 2534037250 | hzeng38@emory.edu
Jin Mou | 2534037250 | jin.mou@multicare.org
Wisconsin
Impact of Lp299v on Vascular Function in Patients With PASC (Milwaukee)
Emerging data show that SARS-CoV-2 infection causes gut microbiome changes strongly associated with Post-Acute Sequelae of SARS-CoV-2 (PASC). The investigators and others have established that an orally ingested probiotic (Lactobacillus plantarum 299v, Lp299v) reduces circulating levels of cell-free mitochondrial DNA (cf-mtDNA), decreases toll-like receptor 9 (TLR9) activation [and downstream interleukin (IL-6)], and improves micro- and macrovascular (brachial artery) endothelial dysfunction [as measured by flow-mediated dilation (FMD%)] in humans. Recently published data also report impaired brachial FMD% and increased vascular stiffness post-SARS-CoV-2 infection. Based on these data, the investigators hypothesize that supplementation with Lp299v will attenuate SARS-CoV-2 associated endothelial dysfunction by reducing cf-mtDNA, TLR9 activation, and inflammation.
Inclusion Criteria:
Ages 18 to 89 years
30-180 days post-COVID-19 diagnosis
PASC diagnosed based on symptom report/expert physician judgement
Exclusion Criteria:
Antibiotics within four weeks of enrollment
History of chronic diseases (renal insufficiency, liver dysfunction, cancer requiring systemic treatment within 3 years of enrollment)
History of cognitive impairment/inability to follow study procedures
Short gut syndrome, inflammatory bowel disease, or an ileostomy.
Subjects currently taking Vitamin K antagonists such as coumadin or warfarin
Pregnant at the time of screening
Unstable coronary artery disease (new symptoms or event within 30 days of enrollment)
Daily alcohol use (may interfere with Lp299v's action)
Contact: Michael E Widlansky, MD, MPH | 414-955-6759 | mwidlans@mcw.edu
Molly Siegel | 414-955-6759 | msiegel@mcw.edu