A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19

Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.

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