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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A - hydroxycholoroquine 		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.
  • Drug: 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.
Placebo Comparator
Arm B - placebo 		Participants will receive placebo
  • Other: Placebo
    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.

Recruiting Locations

More Details

NCT ID
NCT04379492
Status
Withdrawn
Sponsor
Memorial Sloan Kettering Cancer Center

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.