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

Memorial Sloan Kettering Cancer Center (MSK) logo

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Withdrawn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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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