Status:
WITHDRAWN
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
COVID-19
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04379492
Start Date
May 5 2020
End Date
September 25 2020
Last Update
May 16 2025
Active Locations (1)
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1
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021