Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: People Who Have Been Diagnosed With Covid-19
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Age: Between 18 years - 80 years
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Gender: Male or Female
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Other Inclusion Criteria:
High-risk cohort- Subjects who are 18 to 80 years of age, inclusive, at the time of signing the informed consent
- Subjects who are willing and able to provide informed consent
- Subject who have laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
- Subjects has 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
- Body mass index =30 (self-reported)
- Subjects who are 18 to 59 years of age, inclusive without any risk factors for developing severe COVID-19 disease (point 5 above)
- Subjects willing and able to provide informed consent
- Subjects with laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
- Access to device and internet for Telehealth visits
You may not be eligible for this study if the following are true:
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- Subjects who have known hypersensitivity to HCQ or other 4-aminoquinoline compounds
- Subjects with known hypersensitivity to azithromycin or other azalide or macrolide antibiotics
- Subjects currently hospitalized
- Has signs of respiratory distress prior to randomization, including respiratory rate >24
- Subjects whose current medications include HCQ
- Concomitant use of other anti-malarial treatment or chemoprophylaxis
- Subjects with history of retinopathy of any etiology
- Subjects with Psoriasis
- Subjects with Porphyria
- Subjects who have Chronic kidney disease (Stage IV or receiving dialysis)
- Subjects who have known bone marrow disorders
- Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen
- Subjects who have known cirrhosis or personal or family history of long QT syndrome
- Subjects with history of coronary artery disease with history of graft or stent
- History of heart failure, Class 2 or greater using the New York Heart Association functional class
- Subjects taking medications associated with prolonged QT such as antipsychotic medications or antidepressants (e.g., citalopram, venlafaxine, and bupropion) and unable to stop during the trial
- Subjects taking warfarin (Coumadin or Jantoven)
- Subjects who have known history of glucose-6-phosphate-dehydrogenase deficiency
- Subjects who have history of myasthenia gravis
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.