Journal Article

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

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

2020

Overview

Abstract BackgroundEffective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (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. MethodsWe 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 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. ResultsA total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the 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 end point, 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 toward an increased length of stay. ConclusionsIn 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. Treatments for patients hospitalized with COVID-19 are urgently needed. In this multicenter, double-blind, randomized trial, five days of hydroxychloroquine (N=67) did not suggest benefit compared to placebo (N=61). Hydroxychloroquine increased qT interval, D-dimer, and trended towards an increased length of stay. Larger trials are needed.

• Publisher: Oxford University Press
• Subject: Clinical trials / COVID-19 / Hospitalization / Major / Severe acute respiratory syndrome coronavirus 2