Research
Should I Join a Research Study?
Right now, physicians and scientists have many questions about COVID-19 and are using research studies to answer them. You may be considering joining one of these studies to help answer these questions.
Joining a research study is always your choice. It's important to ask any question you may have - and get answers - before joining. Learn more:
COVID-19 Research Participant Flyer [English]
COVID-19 Research Participant Flyer [Spanish]
COVID-19 Research Participant Flyer [Haitian_Creole]
COVID-19 Research at BMC
BMC is running a number of research studies related to COVID-19. Some are only for patients in the hospital, while others are for people outside the hospital with COVID-19 or households of people with COVID-19.
Studies for People Outside the Hospital (Ambulatory Studies)
"Pfizer COVID Vaccine (IRB: H-40266)
Study Contact: Debra Mclaud: [email protected]
NCT# and link for additional information: NCT04368728
Purpose: The purpose of the study is to rapidly describe the safety, tolerability, immunogenicity, and potential efficacy of 4 BNT162 RNA-based COVID-19 vaccine candidates against COVID-19 in healthy adults.
Eligible Participants:
- Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage).
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Payment: You will be reimbursed by the research site for each visit you complete to cover your out-of-pocket expenses related to this study, such as travel and parking. This reimbursement will be in the form of a ClinCard, which you can use like a debit card. The money will be put on the ClinCard when you complete each study visit. The amount of reimbursement will be as follows: $200 at each of the two vaccination visits; $150 each at the 4 follow-up visits (1 month, 6 months, 12 months, 24 months)
A study for household contacts of people who have recently been tested for COVID-19
Guidelines this this study are:
- Participants can sign up for the study themselves or by clinician referral.
- Enrollment must take place within four days of the positive test.
- The study takes place remotely, and includes a call with a research assistant, a call with a health provider, and study materials delivered and picked up by courier.
- Financial incentives will be given.
For more information or to enroll yourself, visit the study website.
A study for people who have recently tested positive for COVID-19
This study is enrolling participants who:
- Are 18-80 years old
- Have a laboratory-confirmed positive COVID-19 result within three days prior to enrollment
- Have a smart phone
Participants can sign up for the study themselves or by clinician referral. They will receive a kit with tools to measure their vitals and EKG at home, and will get compensation for their participation. This study takes place remotely, and include a call with a research assistant, a call with a health provider, and study materials delivered and picked up by courier.
COVID-19 PEP (IRB H-40144)
Study Contact: Lori Henault: [email protected]
NCT# and link for additional information: NCT04328961
Purpose: We are doing the research to understand if taking a medication called hydroxychloroquine can reduce the risk of becoming infected with the virus that causes COVID-19, or developing symptoms of COVID-19 after having contact with an infected person.
Taking a medication to prevent becoming sick after exposure to an infected person is called “post-exposure prophylaxis” or “PEP.” The current standard of care is no treatment for people who had contact with a known or suspected case of COVID-19.
Eligible Participants:
- Are 18-80 years old
- Have a laboratory-confirmed positive COVID-19 result within three days prior to enrollment
- Have a smart phone
Payment: If you complete all parts of the study, you will be paid $200.
Additional Information: You will be in the study for 28 days if you decide to stay for the whole study. If you agree, you will be assigned by chance (chance is like flipping a coin) to either take hydroxychloroquine PEP or vitamin C. You will take two pills by mouth for three days, followed by one pill by mouth for 11 days, for a total of 14 days of treatment.
Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial (H-40176)
Study Contact: Ve Truong: [email protected]
NCT# and link for additional information: NCT04354428
Purpose: We are doing the research to understand if taking hydroxychloroquine (HCQ) used to treat malaria and autoimmune diseases plus azithromycin which is used to treat pneumonia and sinus infections may help treat people infected with early SARS-CoV-2 infection.
This study will show us whether early treatment of SARS-CoV-2 infection is effective at preventing more severe illness. We will study these medications in people who are well enough to be treated in their homes. We will study the medication in people who are at increased risk for developing complications of SARS-CoV-2 infection, and also people who do not have identified risk factors for more severe infection.
Eligible Participants:
- Men or women 18 to 80 years of age, inclusive, at the time of signing the informed consent
- Laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
- Access to device and internet for Telehealth visits
- At increased risk of developing severe COVID-19 disease (at least one of the following)
- Age ≥60 years
- Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema
- Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
- Hypertension, requiring at least 1 oral medication for treatment
- Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of <200/mm3)
- Immunocompromised status due to medication (e.g., persons taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, or cancer therapies)
- Body mass index ≥30 (self-reported)
Payment: If you complete all parts of the study, you will be paid $250.
A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART" (IRB: H-40136)
Study Contact: Yachana Kataria, PhD: [email protected]
Purpose: The current standard test used to diagnose COVID-19 often takes a long time because of the way the test needs to be processed in the laboratory. In many cases, it can take hours to several days to get the result of the test. A rapid assay, like the test being studied here, that does not require sophisticated laboratory equipment and techniques could make it much easier for doctors to screen and ultimately treat patients, as the results can be obtained faster.
Eligible Participants:
- Adult, age 18+
- Provision of signed and dated informed consent form
- Subject with COVID-19 clinical symptoms as determined by clinician referral to the Hospital services
Payment: You will not be paid for being in this study
Studies for People in the Hospital (Inpatient Studies)
Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects with COVID-19 (IRB: H-40355)
Study Contact: Denise Fine: [email protected]
NCT# and link for additional information: NCT04358549
Purpose: In this research study we want to learn more about the drug favipiravir and the effect it has when combined with the standard of care treatment for patients with coronavirus disease (COVID-19).
Eligible Participants: Adults 18-80 years old within 72 hours of hospitalization for COVID-19
Payment: If you complete all parts of the study, you will be paid up to $360.
Additional Information:
About 50 subjects will take part in this research study. About 10 volunteers will take part at Boston Medical Center (BMC). The study doctor will determine whether you qualify to participate in the study based upon the results from your screening visit.
If you choose to take part in this study, you will be placed in one of the study groups and either receive the study drug with our standard care (the things we currently do at BMC for coronavirus patients) or standard care by itself with no study drug. Whether you receive study drug with standard care or standard care only is based on chance (like tossing a coin).
If you decide to join this research study, the following things will happen: review of medical history and concomitant medications, physical exam, assessment of vital signs, blood sample collection, urine or blood pregnancy test (if you are a woman of childbearing age), taking the study drug twice daily by mouth, and nasopharyngeal (nose) and oropharyngeal (mouth) swabs.
It will take 60 days to complete the study. During this time, we will ask to monitor you during your inpatient stay and will ask you to make up to nine study visits (depending on when you are discharged) to the Boston Medical Center.
At the end of the study, we will compare the results from people who received the study drug with the results from people who received standard care.
You may (or may not) not benefit from taking part in this research study. If you receive favipiravir, it is possible that your COVID-19 symptoms will improve while you are taking it.
COVID-19 Rapid Diagnostic Evaluation (IRB: H-40106)
Study Contact: Belok, Samuel, MD: [email protected]
Purpose: We are conducting this pilot study to assess the utility and accuracy of a new diagnostic test COVID-19 to see if the test can tell us who does have the disease, and who does not have the disease.
We will use a swab to collect a nasopharyngeal (NP) sample from deep in your nose in the part of your throat that covers the roof of your mouth. This sample on the swab will be tested for the presence or absence of COVID-19 using the new test that we are studying. We will also collect some information from your medical record relating to the COVID-19 test you had as part of your medical care (such as whether your test for COVID-19 was positive or negative).
We will not provide you with your results since this test is new and has not yet been approved. Depending on the result of the test, we may tell you to follow up with your doctor, but we will not give you a specific result.
Your participation in this study may help us develop new diagnostic tests for diseases such as COVID19.
Eligible Participants:
- 18 years or older
- Cases: Patients who have tested positive for COVID-19
- Controls: Patients who have both a low clinical suspicion for COVID-19 and have already tested negative for COVID-19
Payment: You will not be paid for being in this study.
APPEX-19 – Awake Prone Position for Early hypoxemia in COVID-19 (IRB: H-40070)
Study Contact: Nicholas Bosch: [email protected]
NCT# and link for additional information: NCT04344587
Purpose: Prone positioning is a well-studied and validated treatment for severe acute respiratory distress syndrome (ARDS). However there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission.
The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.
Eligible Participants:
- Adult patient (> 18 years old)
- Admission to the medical wards or planned admission to the medical wards from the ED within the previous 24 hours (not ICU)
- Confirmed COVID-19 infection or under evaluation for COVID-19
- Have access to their own functioning smartphone that can connect to the internet and receive text messages in the hospital room
- Ability to read simple instructions and answer simple written questions
Payment: You will not be paid for being in this study.
RUXCOVID-DEVENT (IRB: H-40222)
Study Contact: Nhieu Dang: [email protected]
NCT# and link for additional information: NCT04362137
Purpose: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19-associated ARDS who require mechanical ventilation. This study is double-blind, which means that during the study you and your study doctor will not know if you are receiving ruxolitinib or placebo.
Eligible Participants:
- Male or female participants aged ≥ 18 years.
- Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 2 weeks prior to randomization by any test with local regulatory approval.
- Participants who are currently hospitalized, intubated (orotracheal or nasotracheal), and receiving invasive mechanical ventilation due to COVID-19–associated ARDS. Participants must have confirmed PaO2/FiO2 of ≤ 300 mmHg within 6 hours of randomization.
- Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.
Payment: You and/or your caregiver will receive a total of $100 for the completion of day 15 and day 29 in-person visits. The $100 per visit is intended to cover costs associated with travel and time commitment.
XPORT-CoV-1001 (IRB: H-40180)
Study Contact: Salli Fennessey: [email protected]
NCT# and link for additional information: NCT04349098
Purpose: The purpose of this research study is to see if selinexor speeds up your recovery, decreases your viral load, shortens your hospitalization, and reduces morbidity and mortality compared to standard of care treatment.
Eligible Participants:
- Male or female participants aged ≥ 18 years.
- Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved RT-PCR assay or equivalent FDA-approved testing (local labs)
- Currently hospitalized and consented within the first 48 hours of hospitalization
- Informed consent provided as above (patients must be dosed with study drug within 12 hours of consent)
- Has symptoms of severe COVID-19 as demonstrated by:
- At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress
- Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: respiratory rate ≥30 breaths/min, heart rate ≥125/min, SaO2 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2
Payment: You will not be paid for being in this research study.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tocilizumab Compared to Placebo in Hospitalized Patients with COVID-19 and Inflammation (IRB: H-40208)
Study Contact: Jennifer Bombard: [email protected]
NCT# and link for additional information: NCT04356937
Purpose: The purpose of this research study is to assess the effectiveness of tocilizumab in reducing organ failure and inflammation in patient’s severe COVID-19 infection.
If you decide to join this research study, you will be enrolled for up to 28 days after you receive the study drug. While you are hospitalized, we will collect blood samples and other clinical information, such as vital signs and electrocardiograms, to assess how well your body has responded to the medication. This will take about 2 hours in total over about 6 visits to your hospital room. After you are discharged, we will ask you to come back to the hospital once or contact you by phone.
If you agree to take part in the study, you will be randomly assigned by chance (like the flip of a coin) to receive either tocilizumab or placebo (inactive substance). You will have a 2 in 3 chance of being assigned to tocilizumab.
This is a double-blind study, which means that neither you nor the study doctor will know to which of these two groups you are assigned
Eligible Participants:
- Age > 18 and < 80 years old
- Male or female gender
- Confirmed SARS-CoV-2 infection by NP swab PCR
- Admitted to non-ICU level care at MGH
- WITH evidence of severe COVID-19 (at least one of the following):
- Fever > 38C
- Bilateral pulmonary infiltrates on chest X ray
- Need for supplemental O2 to maintain saturation > 92%
- AND at least one of the following:
- Ferritin > 500 ng/ml
- CRP > 50 mg/L
Payment: You will not receive compensation as part of this study.
Phase 3 multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab on cytokine release syndrome in patients with COVID-19-induced pneumonia (CAN-COVID)(IRB: H-40162)
Study Contact: Kimberly Finch: [email protected]
Purpose: We are conducting this research study to find out if the study treatment canakinumab (also known as ACZ885) is safe and effective in helping people who have coronavirus (COVID-19) pneumonia and inflammation.
Eligible Participants:
- Male or female
- Adults (≥ 18 years old)
- Body weight ≥ 40 kg
- Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan
Payment: You will not be paid for being in this study.
Additional Information: Eligible subjects will be randomly assigned by chance to EITHER canakinumab or to a placebo (inactive substance) after completing the screening procedures. Neither you nor your study doctor will know what treatment you are getting
You will be in the study for about 4.5 months.
During the time while you are hospitalized a study doctor will see you every day up to your discharge or day 29, whichever comes first. After discharge, you will not be required to return to the hospital for the purpose of this study and will receive follow up by phone call at days 15, 29, 57 and 127 after starting the study medication. See Section 3 and Section 4 for more details.
At the study visits in the hospital, the following procedures should happen: your health status will be assessed, your oxygen level will be measured and blood will be collected, and, during phone calls, your health status and medications that you are taking will be assessed.
Natural History of COVID-19 Confirmed Cases at Boston Medical Center, COVID-19 Survivors and COVID-19’s Impact on Healthcare Workers (IRB: H-40047)
Study Contact: Nahid Bhadelia, MD: [email protected]
NCT# and link for additional information: NCT04344587
Purpose: The main objective of this research is to examine the clinical course of adult and pediatric patients with COVID-19 disease presenting to BMC and to collect samples for current and future research on COVID-19’s impact of the immune system. The immune system includes specific organs and the actions they take (or their “response”) to help the body resist and fight disease. Understanding how the body handles the virus may lead to new approaches to treatment and vaccines.
Eligible Participants:
Inpatient Cohort
- Any hospitalized patient with confirmed COVID-19 infection by any diagnostic testing modality who meets the prevailing CDC definition of COVID-19 at the time of recruitment.
- Ability to provide informed consent or have an LAR available who can provide consent.
- Patients who are co-enrolled in therapeutic trials for COVID-19 will still be eligible to participate in this observational trial. Blood draw schedules will be adjusted to ensure maximum amounts are not exceeded.
Survivor Cohort
- Any adult (≥18 years) who had confirmed COVID-19 disease (confirmed by test result, study PI attestation, or physician attestation) who is at least 15 days post-resolution of symptoms.
Payment: You will receive $25 for each week of study participation during your hospitalization. You will receive a maximum of $150 for study participation.
A Phase II Single-Center, Open-Label, Safety and Efficacy Study of Etoposide in Patients with COVID-19 Infection (IRB: H-40102)
Study Contact: Nhieu Dang: [email protected]
NCT# and link for additional information: NCT04356690
Purpose: This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on days one and four in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.
Eligible Participants:
- Age 18 years or older
- Confirmed COVID-19 infection
Payment: You will not be paid for being in this study.
REMDACTA (IRB: 40505)
Contact: Dr. Nina Lin at 617-414-5242 or Samantha Roche at 617-414-3511; [email protected]
Purpose: Boston Medical Center is participating in a global phase III, randomised, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra (tocilizumab) plus the antiviral remdesivir versus remdesivir plus placebo in hospitalized patients with severe COVID-19 pneumonia.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Participants will be followed for 60 days post-randomization. While hospitalized, clinical information will be collected such as vital signs and physical exams along with blood samples and nasal swabs. After discharge, participants will be asked to come back to the hospital 1-2 times for follow-up.
Eligible participants: Hospitalized with COVID-19 pneumonia which has been confirmed by both:
- PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid). The PCR test must have been collected <= 7 days before randomization
- Chest X-ray or CT scan
The key exclusion criteria for the study are as follows:
- Aged below 12 years
- Participation in another clinical trial for the treatment of COVID-19 while participating in this study
- Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
- Prior or current treatment with remdesivir for COVID-19
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Known hypersensitivity to remdesivir
- Active TB infection/suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- Estimated glomerular filtration rate (eGFR) < 30 mL/min
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours
Payment: Compensation will be provided.
Please note that most research with human participants that is not related to COVID-19 has been suspended.