Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients. (23rd September 2020)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Open forum infectious diseases. Volume 7:Number 10(2020)
• Publication Date: 2020-09-23
• Subjects: COVID-19 -- hydroxychloroquine -- randomized controlled trial -- SARS-CoV-2; Communicable diseases -- Periodicals; Medical microbiology -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.1093/ofid/ofaa446
• Languages: English
• ISSNs: 2328-8957

Abstract

Abstract: Background: Effective 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. 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 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. Results: A 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. 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. Abstract : 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.