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	18years - 100years
Treatment	Placebo, Hydroxychloroquine
Clinical Study Identifier	NCT04379492
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	19 February 2024

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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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Step 2 Get screened

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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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Study Definition

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