Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19
| Autor: | Kalil, Andre C, Patterson, Thomas F, Mehta, Aneesh K, Tomashek, Kay M, Wolfe, Cameron R, Ghazaryan, Varduhi, Marconi, Vincent C, Ruiz-Palacios, Guillermo M, Hsieh, Lanny, Kline, Susan, Tapson, Victor, Iovine, Nicole M, Jain, Mamta K, Sweeney, Daniel A, El Sahly, Hana M, Branche, Angela R, Regalado Pineda, Justino, Lye, David C, Sandkovsky, Uriel, Luetkemeyer, Anne F, Cohen, Stuart H, Finberg, Robert W, Jackson, Patrick EH, Taiwo, Babafemi, Paules, Catharine I, Arguinchona, Henry, Erdmann, Nathaniel, Ahuja, Neera, Frank, Maria, Oh, Myoung-Don, Kim, Eu-Suk, Tan, Seow Y, Mularski, Richard A, Nielsen, Henrik, Ponce, Philip O, Taylor, Barbara S, Larson, LuAnn, Rouphael, Nadine G, Saklawi, Youssef, Cantos, Valeria D, Ko, Emily R, Engemann, John J, Amin, Alpesh N, Watanabe, Miki, Billings, Joanne, Elie, Marie-Carmelle, Davey, Richard T, Burgess, Timothy H, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Cardoso, Anabela, de Bono, Stephanie, Bonnett, Tyler, Proschan, Michael, Deye, Gregory A, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, ACTT-2 Study Group Members |
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| Rok vydání: | 2021 |
| Předmět: |
Male
030204 cardiovascular system & hematology Rate ratio Medical and Health Sciences law.invention 0302 clinical medicine Randomized controlled trial law Hospital Mortality 030212 general & internal medicine Lung Sulfonamides Alanine Respiration Rehabilitation Hazard ratio General Medicine Middle Aged Hospitalization Editorial Treatment Outcome 6.1 Pharmaceuticals Combination Artificial Drug Therapy Combination Female Original Article Adult medicine.medical_specialty Randomization Clinical Trials and Supportive Activities Placebo Antiviral Agents 03 medical and health sciences Drug Therapy Double-Blind Method Clinical Research General & Internal Medicine Internal medicine medicine ACTT-2 Study Group Members Janus Kinase Inhibitors Humans Adverse effect Aged SARS-CoV-2 business.industry Oxygen Inhalation Therapy COVID-19 Evaluation of treatments and therapeutic interventions Odds ratio Respiration Artificial Adenosine Monophosphate Confidence interval COVID-19 Drug Treatment Good Health and Well Being Purines Azetidines Pyrazoles business |
| Zdroj: | The New England Journal of Medicine New England Journal of Medicine The New England journal of medicine, vol 384, iss 9 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, Regalado Pineda, J, 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, Tan, S Y, Mularski, R A, Nielsen, H, Ponce, P O, Taylor, B S, Larson, L, Rouphael, N G, Saklawi, Y, Cantos, V D, Ko, E R, Engemann, J J, Amin, A N, Watanabe, M, Billings, J, Elie, M, Davey, R T, Burgess, T H, Ferreira, J, Green, M & ACTT-2 Study Group 2021, ' Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19 ', New England Journal of Medicine, vol. 384, no. 9, pp. 795-807 . https://doi.org/10.1056/NEJMoa2031994 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, Regalado Pineda, J, 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, Goepfert, P, 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, 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 & ACTT-2 Study Group Members 2021, ' Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19 ', New England Journal of Medicine, vol. 384, no. 9, pp. 795-807 . https://doi.org/10.1056/NEJMoa2031994 |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | 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.). |
| Databáze: | OpenAIRE |
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