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

• Status: Withdrawn
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Hydroxychloroquine

Criteria

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