Research

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.

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.

Study Type: Ambulatory (clinic)

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.

Study Type: Ambulatory

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:

1. Men or women 18 to 80 years of age, inclusive, at the time of signing the informed consent
2. Laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
3. Access to device and internet for Telehealth visits
4. At increased risk of developing severe COVID-19 disease (at least one of the following)
   1. Age ≥60 years
   2. Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema
   3. Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
   4. Hypertension, requiring at least 1 oral medication for treatment
   5. Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of <200/mm3)
   6. 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)
   7. Body mass index ≥30 (self-reported)

Payment: If you complete all parts of the study, you will be paid $250.

Study Type: Ambulatory

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:

1. Adult, age 18+
2. Provision of signed and dated informed consent form
3. 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

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 Type: Inpatient

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.

Inpatient

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.

Study Type: Inpatient

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.

Study Type: Inpatient

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.

Study Type: Inpatient

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.

Study Type: Inpatient

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:

1. Age > 18 and < 80 years old
2. Male or female gender
3. Confirmed SARS-CoV-2 infection by NP swab PCR
4. Admitted to non-ICU level care at MGH
5. WITH evidence of severe COVID-19 (at least one of the following):
   1. Fever > 38C
   2. Bilateral pulmonary infiltrates on chest X ray
   3. Need for supplemental O2 to maintain saturation > 92%
6. AND at least one of the following:
   1. Ferritin > 500 ng/ml
   2. CRP > 50 mg/L

Payment: You will not receive compensation as part of this study.

Study Type: Inpatient

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.

Study Type: Ambulatory/Inpatient

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.

Study Type: Inpatient

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.