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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Withdrawn; Phase 2

Conditions: Sars-CoV2; COVID-19; SARS-Cov-2; COVID19

Treatments: Other: Placebo; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04379492

20-187

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Arm A - hydroxycholoroquine

Experimental group

Description:

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.

Treatment:

Drug: Hydroxychloroquine

Arm B - placebo

Placebo Comparator group

Description:

Participants will receive placebo

Treatment:

Other: Placebo