Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Type Journal Article Author Andre C. Kalil Author Thomas F. Patterson Author Aneesh K. Mehta Author Kay M. Tomashek Author Cameron R. Wolfe Author Varduhi Ghazaryan Author Vincent C. Marconi Author Guillermo M. Ruiz-Palacios Author Lanny Hsieh Author Susan Kline Author Victor Tapson Author Nicole M. Iovine Author Mamta K. Jain Author Daniel A. Sweeney Author Hana M. El Sahly Author Angela R. Branche Author Justino Regalado Pineda Author David C. Lye Author Uriel Sandkovsky Author Anne F. Luetkemeyer Author Stuart H. Cohen Author Robert W. Finberg Author Patrick E. H. Jackson Author Babafemi Taiwo Author Catherine I. Paules Author Henry Arguinchona Author Paul Goepfert Author Neera Ahuja Author Maria Frank Author Myoung-don Oh Author Eu S. Kim Author Seow Y. Tan Author Richard A. Mularski Author Henrik Nielsen Author Philip O. Ponce Author Barbara S. Taylor Author LuAnn Larson Author Nadine G. Rouphael Author Youssef Saklawi Author Valeria D. Cantos Author Emily R. Ko Author John J. Engemann Author Alpesh N. Amin Author Miki Watanabe Author Joanne Billings Author Marie-Carmelle Elie Author Richard T. Davey Author Timothy H. Burgess Author Jennifer Ferreira Author Michelle Green Author Mat Makowski Author Anabela Cardoso Author Stephanie de Bono Author Tyler Bonnett Author Michael Proschan Author Gregory A. Deye Author Walla Dempsey Author Seema U. Nayak Author Lori E. Dodd Author John H. Beigel URL https://www.nejm.org/doi/10.1056/NEJMoa2031994 Rights Copyright © 2020 Massachusetts Medical Society. All rights reserved. Publication New England Journal of Medicine Date 11/12/2020 Loc. in Archive world Extra Publisher: Massachusetts Medical Society DOI 10.1056/NEJMoa2031994 Library Catalog www.nejm.org Language en Abstract Original Article from The New England Journal of Medicine — Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19 Background Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known. Methods We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15. Results A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P=0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, −5.0 percentage points; 95% CI, −9.8 to −0.3; P=0.03), as were new infections (5.9% vs. 11.2%; difference, −5.3 percentage points; 95% CI, −8.7 to −1.9; P=0.003).