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:

  • Conditions:
    People Who Have Been Diagnosed With Covid-19
  • Age: Between 18 years - 80 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    High-risk cohort
    1. Subjects who are 18 to 80 years of age, inclusive, at the time of signing the informed consent
    2. Subjects who are willing and able to provide informed consent
    3. Subject who have laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
    4. Subjects has access to device and internet for Telehealth visits
    5. 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)
    Low-risk cohort:
    1. Subjects who are 18 to 59 years of age, inclusive without any risk factors for developing severe COVID-19 disease (point 5 above)
    2. Subjects willing and able to provide informed consent
    3. Subjects with laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
    4. Access to device and internet for Telehealth visits

You may not be eligible for this study if the following are true:

    1. Subjects who have known hypersensitivity to HCQ or other 4-aminoquinoline compounds
    2. Subjects with known hypersensitivity to azithromycin or other azalide or macrolide antibiotics
    3. Subjects currently hospitalized
    4. Has signs of respiratory distress prior to randomization, including respiratory rate >24
    5. Subjects whose current medications include HCQ
    6. Concomitant use of other anti-malarial treatment or chemoprophylaxis
    7. Subjects with history of retinopathy of any etiology
    8. Subjects with Psoriasis
    9. Subjects with Porphyria
    10. Subjects who have Chronic kidney disease (Stage IV or receiving dialysis)
    11. Subjects who have known bone marrow disorders
    12. Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen
    13. Subjects who have known cirrhosis or personal or family history of long QT syndrome
    14. Subjects with history of coronary artery disease with history of graft or stent
    15. History of heart failure, Class 2 or greater using the New York Heart Association functional class
    16. 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
    17. Subjects taking warfarin (Coumadin or Jantoven)
    18. Subjects who have known history of glucose-6-phosphate-dehydrogenase deficiency
    19. Subjects who have history of myasthenia gravis



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