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

Ulrich et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofaa446, TEACH, NCT04369742

Sep 2020

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Small RCT on very late stage use of HCQ, with 48% on oxygen at baseline. 67 HCQ patients, 61 control. Baseline states were not comparable - 82% more HCQ patients had the highest severity at baseline, there was 32% more male HCQ patients, and 44% more control patients used AZ. The HCQ group also had significantly more patients with cerebrovascular disease, cardiovascular disease (non-hypertension), renal disease (non-dialysis), and a history of organ transplants. This study is excluded in the after exclusion results of meta analysis: very late stage, >50% on oxygen/ventilation at baseline.

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risk of death, 6.0% higher, RR 1.06, p = 1.00, treatment 7 of 67 (10.4%), control 6 of 61 (9.8%).

risk of mechanical ventilation, 51.7% higher, RR 1.52, p = 0.72, treatment 5 of 67 (7.5%), control 3 of 61 (4.9%).

risk of ICU admission, 173.1% higher, RR 2.73, p = 0.13, treatment 9 of 67 (13.4%), control 3 of 61 (4.9%).

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Ulrich et al., 23 Sep 2020, Randomized Controlled Trial, USA, peer-reviewed, baseline oxygen required 63.3%, mean age 66.2, 18 authors, study period 17 April, 2020 - 12 May, 2020, average treatment delay 7.0 days, trial NCT04369742 (history) (TEACH).

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TREATING COVID-19 WITH HYDROXYCHLOROQUINE (TEACH): A MULTICENTER, DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL IN HOSPITALIZED PATIENTS

MD Robert J Ulrich, Andrea B Troxel Scd, MD Ellie Carmody, MD Jaishvi Eapen, MD Martin Bäcker, MD, MPH, MHCDS, FACP Jack A Dehovitz, MBBS Prithiv J Prasad, MS Yi Li, PhD Camila Delgado, MD Morris Jrada, MD Gabriel A Robbins, RN Brooklyn Henderson, MD Alexander Hrycko, MBBS Dinuli Delpachitra, MD Vanessa Raabe, MD Jonathan S Austrian, PharmD Yanina Dubrovskaya, MD, FIDSA Mark J Mulligan, Ave First, Clinicaltrials Gov # Nct04369742

doi:10.1093/ofid/ofaa446/5910201

Author Contributions: RJU, ABT, EC, VR and MJM contributed to the concept, design and protocol development. RJU, EC, JE, MB, JAD and PJP contributed as site leaders overseeing all trial operations and data quality from each site. MJ, GAR, BH, AH, DD and YD contributed to trial operations and data entry. RJU, ABT, CD, and YL contributed to data analysis. JSA created novel information technology for trial operations. RJU and ABT drafted the manuscript. All authors provided critical revisions and approved the final manuscript.

inancial Disclosures The authors have no relevant financial disclosures. Abbreviations: HCQ, hydroxychloroquine; IQR, interquartile range; SD, standard deviation; RT-PCR, reverse transcriptase polymerase chain reaction; AST, aspartate aminotransferase; ALT alanine aminotransferase; U, units; WBC, white blood cell count; LDH, lactic acid dehydrogenase

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