This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
Drug: Hydroxychloroquine
Participants will receive hydroxycholoroquine (200-mg tablets) 2 tablets orally q12h for 2 doses on day 1 (load), followed by 1 tablet orally q12h for days 2-5.
Other: Placebo
Participants will receive masked placebo given as 2 tablets orally q12h for 2 doses on day 1, followed by 1 tablet orally q12h for days 2-5.
Inclusion Criteria:
- Age 18 years and older
- Subjects must have a documented positive test for the SARS-CoV-2 infection within 7
days of randomization
- Subject must be hospitalized within 72 hours of randomization
- Subjects must be receiving standard of care for SARS-CoV-2
- Subject/Legally Authorized Representative (LAR) must have the ability to understand
and give informed consent
- Subject must be able to take and absorb hydroxychloroquine at the discretion of the
investigator
Exclusion Criteria:
- Prior receipt of hydroxychloroquine for treatment or prophylaxis of SARS-CoV-2 or
patient is taking hydroxychloroquine for other approved indications (e.g., lupus,
rheumatoid arthritis)
- No documented SARS-CoV-2 infection
- Mechanical ventilation
- Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
Preexisting retinopathy documented in medical history
- Pregnancy or Breastfeeding
- Concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins
(rifampin, rifabutin)
- Antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine,
flecainide)
- History of glucose-6-phosphate dehydrogenase deficiency
- Pre-treatment corrected QT interval (QTc) >500 milliseconds
- Pressor requirement to maintain blood pressure
- Alanine aminotransferase (ALT) and/or asparate aminotransferase (AST) level > 5X upper
limit of normal
- Creatinine clearance <30 mL/min or requirement of dialysis or continuous venovenous
hemofiltration
- Concomitant participation in a therapeutic trial for SARS-CoV-2 or receiving any
experimental treatment for SARS-CoV-2 within 7 days of randomization
- Any condition that in the opinion of the principal investigator would prevent
participation in the trial or would interfere with the trial endpoints
Memorial Sloan - Kettering Cancer Center
New York, New York, United States
Genovefa Papanicolaou, MD, Principal Investigator
Memorial Sloan Kettering Cancer Center