bh8i14e

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	<https://research.tib.eu/covid-19/entity/0bh8i14e_hasAnnotation_C0020517> <https://research.tib.eu/covid-19/entity/0bh8i14e_hasAnnotation_C0021368> <https://research.tib.eu/covid-19/entity/0bh8i14e_hasAnnotation_C0027627> <https://research.tib.eu/covid-19/entity/0bh8i14e_hasAnnotation_C1415068> <https://research.tib.eu/covid-19/entity/0bh8i14e_hasAnnotation_C3854325>
?: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%3B_Makowski%2C_Mat%3B_Cardoso%2C_Anabela%3B_de_Bono%2C_Stephanie%3B_Bonnett%2C_Tyler%3B_Proschan%2C_Michael%3B_Deye%2C_Gregory_A.%3B_Dempsey%2C_Walla%3B_Nayak%2C_Seema_U.%3B_Dodd%2C_Lori_E.%3B_Beigel%2C_John_H.>
?:doi	10.1056/nejmoa2031994
?:doi	<https://research.tib.eu/covid-19/entity/10.1056/nejmoa2031994>
?:journal	N_Engl_J_Med
?:license	no-cc
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?:pmcid	<https://research.tib.eu/covid-19/entity/PMC7745180>
?:pmid	<https://research.tib.eu/covid-19/entity/33306283.0>
?:pmid	33306283.0
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
is ?:relation_isRelatedTo_publication of	<https://research.tib.eu/covid-19/entity/0bh8i14e_HAS_C0021368_COEXISTS_WITH_C5203670> <https://research.tib.eu/covid-19/entity/0bh8i14e_HAS_C4726677_PREVENTS_C5203670>
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?:source	Medline; PMC
?:title	Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:year	2020-12-11

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

?: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%3B_Makowski%2C_Mat%3B_Cardoso%2C_Anabela%3B_de_Bono%2C_Stephanie%3B_Bonnett%2C_Tyler%3B_Proschan%2C_Michael%3B_Deye%2C_Gregory_A.%3B_Dempsey%2C_Walla%3B_Nayak%2C_Seema_U.%3B_Dodd%2C_Lori_E.%3B_Beigel%2C_John_H.>

?:doi

10.1056/nejmoa2031994

?:doi

<https://research.tib.eu/covid-19/entity/10.1056/nejmoa2031994>

?:journal

N_Engl_J_Med

?:license

no-cc

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