Treating Covid-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind, Randomized Controlled Trial in Hospitalized Patients

Ulrich, Robert J; Troxel, Andrea B; Carmody, Ellie; Eapen, Jaishvi; Bäcker, Martin; DeHovitz, Jack A; Prasad, Prithiv J; Li, Yi; Delgado, Camila; Jrada, Morris; Robbins, Gabriel A; Henderson, Brooklyn; Hrycko, Alexander; Delpachitra, Dinuli; Raabe, Vanessa; Austrian, Jonathan S; Dubrovskaya, Yanina; Mulligan, Mark J

BACKGROUND: Effective therapies to combat COVID-19 are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against SARS-CoV-2, but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. METHODS: We conducted a multicenter, double-blind, randomized clinical trial of HCQ among patients hospitalized with laboratory confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for five days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite endpoint (death, ICU admission, mechanical ventilation, ECMO, and/or vasopressor use) at day 14. RESULTS: A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between HCQ (N=67) and placebo (N=61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression endpoint, but this did not achieve statistical significance (P=.350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend towards an increased length of stay. CONCLUSIONS: In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.