CD2H COVID-19

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

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

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

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

Arm	Description	Assigned Intervention
Experimental Arm A - hydroxycholoroquine	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.	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.
Placebo Comparator Arm B - placebo	Participants will receive placebo	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.