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

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 19 February 2024
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covid-19
SARS
hydroxychloroquine
acute respiratory syndrome (sars)

Summary

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

Details
Condition COVID19, Covid 19, Sars-CoV2, SARS-Cov-2
Age 18-100 years
Treatment Placebo, Hydroxychloroquine
Clinical Study IdentifierNCT04379492
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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