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Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

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  • 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 Luetkemeyer
  • Stuart H Cohen
  • Robert W Finberg
  • Patrick E H Jackson
  • Babafemi Taiwo
  • Catharine I Paules
  • Henry Arguinchona
  • Nathaniel Erdmann
  • Neera Ahuja
  • Maria Frank
  • Myoung-Don Oh
  • Eu-Suk 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
  • Mat Makowski
  • Anabela Cardoso
  • Stephanie Bono, de
  • Tyler Bonnett
  • Michael Proschan
  • Gregory A Deye
  • Walla Dempsey
  • Seema U Nayak
  • Lori E Dodd
  • John H Beigel
  • ACTT-2 Study Group Members
  • Jens Dilling Lundgren (Member of study group)
  • Daniel D. Murray (Member of study group)
  • Tomas Østergaard Jensen (Member of study group)
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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; ClinicalTrials.gov number, NCT04401579.).

Original languageEnglish
JournalThe New England journal of medicine
Volume384
Issue number9
Pages (from-to)795-807
Number of pages13
ISSN0028-4793
DOIs
Publication statusPublished - 4 Mar 2021

    Research areas

  • Adenosine Monophosphate/adverse effects, Adult, Aged, Alanine/adverse effects, Antiviral Agents/adverse effects, Azetidines/adverse effects, COVID-19/drug therapy, Double-Blind Method, Drug Therapy, Combination, Female, Hospital Mortality, Hospitalization, Humans, Janus Kinase Inhibitors/adverse effects, Male, Middle Aged, Oxygen Inhalation Therapy, Purines/adverse effects, Pyrazoles/adverse effects, Respiration, Artificial, Sulfonamides/adverse effects, Treatment Outcome

ID: 64084993