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A Study of Hydroxychloroquine Compared to Placebo as Treatment for Patients with COVID-19

Trial Status: Withdrawn

This phase II trial studies how well hydroxychloroquine works in reducing the severity of symptoms in patients with coronavirus disease 2019 (COVID-19). Hydroxychloroquine is approved for the treatment of autoimmune diseases. An autoimmune disease is a condition in which the immune system mistakenly attacks the body. Researchers think that hydroxychloroquine may prevent the immune system from becoming overactive when it is fighting COVID-19. What is learned from this study may help doctors learn more about hydroxychloroquine as a treatment for COVID-19.

Inclusion Criteria

  • 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
  • Pre-existing 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 aspartate aminotransferase (AST) level > 5 x upper limit of normal
  • Creatinine clearance < 30 mL/min or requirement of dialysis or continuous veno-venous 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

New York

New York
Memorial Sloan Kettering Cancer Center
Status: WITHDRAWN
Contact: Genovefa A. Papanicolaou
Phone: 212-639-8361

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of hydroxychloroquine sulfate (hydroxychloroquine [HC]) in reducing the severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

SECONDARY OBJECTIVES:

I. Determine the proportions of SAR-CoV-2 positivity up to 28 days after therapy in each arm.

II. Determine the safety and tolerability of HC in this patient population.

III. Determine overall mortality at 28 days from time of randomization in each arm.

IV. Determine SARS-CoV-2 attributable mortality at day 14 and day 28 after randomization.

V. Determine the proportion of patients requiring mechanical ventilation by day 14 and day 28 in each arm.

VI. Determine the time to clinical improvement (time from randomization to a 2-point improvement on Ordinal Scale for Clinical Improvement [OSCI] or live discharge, whichever comes first) in each arm.

VII. Determine the proportion of patients with 2-point improvement on the OSCI by days 7, 14, 28 after randomization in each arm.

VIII. Determine the proportion of patients with antibodies (immunoglobulin [Ig]M/IgG) to COVID-19 at days, 1, 14 and day 28 after randomization.

EXPLORATORY OBJECTIVES:

I. To evaluate the number of oxygen-free days within the first 28 days of after randomization.

II. To evaluate the total number of days of hospitalization from randomization until the subject returns to maintaining an oxygen (O2) saturation > 94% without the use of supplemental oxygen in each arm.

III. To evaluate the effectiveness of each arm based on duration between time of first symptoms and time of randomization.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive hydroxychloroquine sulfate orally (PO) every 12 hours (Q12H) on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive supportive care as per standard of care.

ARM B: Patients receive placebo PO Q12H on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive supportive care as per standard of care.

After completion of study treatment, patients are followed up for 28 days.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Genovefa A. Papanicolaou

  • Primary ID 20-187
  • Secondary IDs NCI-2020-03471
  • Clinicaltrials.gov ID NCT04379492