Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Andre C. Kalil, Thomas F. Patterson, Aneesh K. Mehta, Kay M. Tomashek, Cameron R. Wolfe, Varduhi Ghazaryan, Vincent C. Marconi, Guillermo M. Ruiz-Palacios, Lanny Hsieh, Susan Kline, Victor Tapson, Nicole M. Iovine, Mamta K. Jain, Daniel A. Sweeney, Hana M. El Sahly, Angela R. Branche, Justino Regalado Pineda, David C. Lye, Uriel Sandkovsky, Anne F. LuetkemeyerStuart H. Cohen, Robert W. Finberg, Patrick E.H. Jackson, Babafemi Taiwo, Catherine I. Paules, Henry Arguinchona, Paul Goepfert, Neera Ahuja, Maria Frank, Myoung-don Oh, Eu S. Kim, Seow Y. Tan, Richard A. Mularski, Henrik Nielsen, Philip O. Ponce, Barbara S. Taylor, LuAnn Larson, Nadine G. Rouphael, Youssef Saklawi, Valeria D. Cantos, Emily R. Ko, John J. Engemann, Alpesh N. Amin, Miki Watanabe, Joanne Billings, Marie-Carmelle Elie, Richard T. Davey, Timothy H. Burgess, Jennifer Ferreira, Michelle Green, ACTT-2 Study Group Members

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725 Citations (Scopus)


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).

CONCLUSIONS: Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; number, NCT04401579.).

Original languageEnglish
JournalNew England Journal of Medicine
Issue number9
Pages (from-to)795-807
Number of pages13
Publication statusPublished - 4 Mar 2021

Bibliographical note

The authors represent the ACTT-2 Study Group. A complete list of members of the
ACTT-2 Study Group is provided in the Supplementary Appendix, available at


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