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

Phase 2

Withdrawn

• Conditions: COVID-19; COVID19; Sars-CoV2; SARS-Cov-2
• Interventions: Other: Placebo; Drug: Hydroxychloroquine

• Registration Number: NCT04379492
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Status Verified: 2020-10
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B - placebo	Placebo	Participants will receive placebo
Arm A - hydroxycholoroquine	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States