zsdo5zqu

Property	Value
?: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.).
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?:creator	<https://research.tib.eu/covid-19/entity/Kalil%2C_Andre_C%3B_Patterson%2C_Thomas_F%3B_Mehta%2C_Aneesh_K%3B_Tomashek%2C_Kay_M%3B_Wolfe%2C_Cameron_R%3B_Ghazaryan%2C_Varduhi%3B_Marconi%2C_Vincent_C%3B_Ruiz-Palacios%2C_Guillermo_M%3B_Hsieh%2C_Lanny%3B_Kline%2C_Susan%3B_Tapson%2C_Victor%3B_Iovine%2C_Nicole_M%3B_Jain%2C_Mamta_K%3B_Sweeney%2C_Daniel_A%3B_El_Sahly%2C_Hana_M%3B_Branche%2C_Angela_R%3B_Regalado_Pineda%2C_Justino%3B_Lye%2C_David_C%3B_Sandkovsky%2C_Uriel%3B_Luetkemeyer%2C_Anne_F%3B_Cohen%2C_Stuart_H%3B_Finberg%2C_Robert_W%3B_Jackson%2C_Patrick_E_H%3B_Taiwo%2C_Babafemi%3B_Paules%2C_Catherine_I%3B_Arguinchona%2C_Henry%3B_Goepfert%2C_Paul%3B_Ahuja%2C_Neera%3B_Frank%2C_Maria%3B_Oh%2C_Myoung-Don%3B_Kim%2C_Eu_S%3B_Tan%2C_Seow_Y%3B_Mularski%2C_Richard_A%3B_Nielsen%2C_Henrik%3B_Ponce%2C_Philip_O%3B_Taylor%2C_Barbara_S%3B_Larson%2C_LuAnn%3B_Rouphael%2C_Nadine_G%3B_Saklawi%2C_Youssef%3B_Cantos%2C_Valeria_D%3B_Ko%2C_Emily_R%3B_Engemann%2C_John_J%3B_Amin%2C_Alpesh_N%3B_Watanabe%2C_Miki%3B_Billings%2C_Joanne%3B_Elie%2C_Marie-Carmelle%3B_Davey%2C_Richard_T%3B_Burgess%2C_Timothy_H%3B_Ferreira%2C_Jennifer%3B_Green%2C_Michelle>
?:journal	N._Engl._j._med
?:license	unk
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
is ?:relation_isRelatedTo_publication of	<https://research.tib.eu/covid-19/entity/zsdo5zqu_HAS_C0021368_COEXISTS_WITH_C5203670> <https://research.tib.eu/covid-19/entity/zsdo5zqu_HAS_C4726677_PREVENTS_C5203670>
?:source	WHO
?:title	Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:who_covidence_id	#972740
?:year	2020

Property

Value

?: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.).

is ?:annotates of