COVID19, COVID-19, Sars-CoV2, SARS-Cov-2
Conditions
Keywords
Sars-CoV2, SARS-Cov-2, COVID-19, COVID19, Hydroxycholoroquine, Memorial Sloan Kettering Cancer Center, 20-187
Brief summary
This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
Interventions
DRUGHydroxychloroquine
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.
OTHERPlacebo
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI) | 14 days | Clinical improvement is defined as a composite endpoint of a two-point clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19 |
| Number of participants requiring mechanical ventilation for respiratory failure | 14 days | Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization. |
Countries
United States
Outcome results
None listed