Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Kalil, A. C.; Patterson, T. F.; Mehta, A. K.; Tomashek, K. M.; Wolfe, C. R.; Ghazaryan, V.; Marconi, V. C.; Ruiz-Palacios, G. M.; Hsieh, L.; Kline, S.; Tapson, V.; Iovine, N. M.; Jain, M. K.; Sweeney, D. A.; El Sahly, H. M.; Branche, A. R.; Pineda, J. Regalado; Lye, D. C.; Sandkovsky, U.; Luetkemeyer, A. F.; Cohen, S. H.; Finberg, R. W.; Jackson, P. E. H.; Taiwo, B.; Paules, C. I.; Arguinchona, H.; Erdmann, N.; Ahuja, N.; Frank, M.; Oh, M.; Kim, E. -S.; Tan, S. Y.; Mularski, R. A.; Nielsen, H.; Ponce, P. O.; Taylor, B. S.; Larson, L. A.; Rouphael, N. G.; Saklawi, Y.; Cantos, V. D.; Ko, E. R.; Engemann, J. J.; Amin, A. N.; Watanabe, M.; Billings, J.; Elie, M. -C.; Davey, R. T.; Burgess, T. H.; Ferreira, J.; Green, M.; Makowski, M.; Cardoso, A.; de Bono, S.; Bonnett, T.; Proschan, M.; Deye, G. A.; Dempsey, W.; Nayak, S. U.; Dodd, L. E.; Beigel, J. H.; the ACTT-2 Study Group Member; Park, Wan Beom; Oh, Myoung Don; Kim, NAM JOONG; Kim, Hong Bin

doi:10.1056/NEJMoa2031994

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Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

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Authors: Kalil, A. C.; Patterson, T. F.; Mehta, A. K.; Tomashek, K. M.; Wolfe, C. R.; Ghazaryan, V.; Marconi, V. C.; Ruiz-Palacios, G. M.; Hsieh, L.; Kline, S.; Tapson, V.; Iovine, N. M.; Jain, M. K.; Sweeney, D. A.; El Sahly, H. M.; Branche, A. R.; Pineda, J. Regalado; Lye, D. C.; Sandkovsky, U.; Luetkemeyer, A. F.; Cohen, S. H.; Finberg, R. W.; Jackson, P. E. H.; Taiwo, B.; Paules, C. I.; Arguinchona, H.; Erdmann, N.; Ahuja, N.; Frank, M.; Oh, M.; Kim, E. -S.; Tan, S. Y.; Mularski, R. A.; Nielsen, H.; Ponce, P. O.; Taylor, B. S.; Larson, L. A.; Rouphael, N. G.; Saklawi, Y.; Cantos, V. D.; Ko, E. R.; Engemann, J. J.; Amin, A. N.; Watanabe, M.; Billings, J.; Elie, M. -C.; Davey, R. T.; Burgess, T. H.; Ferreira, J.; Green, M.; Makowski, M.; Cardoso, A.; de Bono, S.; Bonnett, T.; Proschan, M.; Deye, G. A.; Dempsey, W.; Nayak, S. U.; Dodd, L. E.; Beigel, J. H.; the ACTT-2 Study Group Member; Park, Wan Beom; Oh, Myoung Don; Kim, NAM JOONG; Kim, Hong Bin

Issue Date: 2021-03

Publisher: Massachusetts Medical Society

Citation: New England Journal of Medicine, Vol.384 No.9, pp.795-807

Abstract: 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.)