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.
Additional locations may be listed on ClinicalTrials.gov for NCT04379492.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorGenovefa A. Papanicolaou
