evauj5y

Property	Value
?:abstract	BACKGROUND: The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. METHODS: We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses. RESULTS: We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo. CONCLUSIONS: Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).
is ?:annotates of	<https://research.tib.eu/covid-19/entity/4evauj5y_hasAnnotation_C0015967> <https://research.tib.eu/covid-19/entity/4evauj5y_hasAnnotation_C0027627> <https://research.tib.eu/covid-19/entity/4evauj5y_hasAnnotation_C0231218> <https://research.tib.eu/covid-19/entity/4evauj5y_hasAnnotation_C3714514> <https://research.tib.eu/covid-19/entity/4evauj5y_hasAnnotation_C5203676>
?:creator	<https://research.tib.eu/covid-19/entity/Stone%2C_John_H%3B_Frigault%2C_Matthew_J%3B_Serling-Boyd%2C_Naomi_J%3B_Fernandes%2C_Ana_D%3B_Harvey%2C_Liam%3B_Foulkes%2C_Andrea_S%3B_Horick%2C_Nora_K%3B_Healy%2C_Brian_C%3B_Shah%2C_Ruta%3B_Bensaci%2C_Ana_Maria%3B_Woolley%2C_Ann_E%3B_Nikiforow%2C_Sarah%3B_Lin%2C_Nina%3B_Sagar%2C_Manish%3B_Schrager%2C_Harry%3B_Huckins%2C_David_S%3B_Axelrod%2C_Matthew%3B_Pincus%2C_Michael_D%3B_Fleisher%2C_Jorge%3B_Sacks%2C_Chana_A%3B_Dougan%2C_Michael%3B_North%2C_Crystal_M%3B_Halvorsen%2C_Yuan-Di%3B_Thurber%2C_Tara_K%3B_Dagher%2C_Zeina%3B_Scherer%2C_Allison%3B_Wallwork%2C_Rachel_S%3B_Kim%2C_Arthur_Y%3B_Schoenfeld%2C_Sara%3B_Sen%2C_Pritha%3B_Neilan%2C_Tomas_G%3B_Perugino%2C_Cory_A%3B_Unizony%2C_Sebastian_H%3B_Collier%2C_Deborah_S%3B_Matza%2C_Mark_A%3B_Yinh%2C_Janeth_M%3B_Bowman%2C_Kathryn_A%3B_Meyerowitz%2C_Eric%3B_Zafar%2C_Amna%3B_Drobni%2C_Zsofia_D%3B_Bolster%2C_Marcy_B%3B_Kohler%2C_Minna%3B_D039%2C%3B_Silva%2C_Kristin_M%3B_Dau%2C_Jonathan%3B_Lockwood%2C_Megan_M%3B_Cubbison%2C_Caroline%3B_Weber%2C_Brittany_N%3B_Mansour%2C_Michael_K>
?:journal	N_Engl_J_Med
?:license	unk
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
?:source	WHO
?:title	Efficacy of Tocilizumab in Patients Hospitalized with Covid-19
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:who_covidence_id	#1023985 #882973
?:year	2020

Property

Value

?:abstract

BACKGROUND: The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. METHODS: We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses. RESULTS: We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo. CONCLUSIONS: Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).

is ?:annotates of