Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and
immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data
suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection
remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized
with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or
placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior
therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease
progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or
vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical
outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support,
and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will
examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic
markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial
will determine if HCQ is effective as treatment in hospitalized non-ICU patients with
COVID-19.
Phase:
Phase 2
Details
Lead Sponsor:
NYU Langone Health
Collaborator:
State University of New York - Downstate Medical Center