TY - JOUR T1 - Efficacy of Tocilizumab in Patients Hospitalized with Covid-19. AU - Stone,John H, AU - Frigault,Matthew J, AU - Serling-Boyd,Naomi J, AU - Fernandes,Ana D, AU - Harvey,Liam, AU - Foulkes,Andrea S, AU - Horick,Nora K, AU - Healy,Brian C, AU - Shah,Ruta, AU - Bensaci,Ana Maria, AU - Woolley,Ann E, AU - Nikiforow,Sarah, AU - Lin,Nina, AU - Sagar,Manish, AU - Schrager,Harry, AU - Huckins,David S, AU - Axelrod,Matthew, AU - Pincus,Michael D, AU - Fleisher,Jorge, AU - Sacks,Chana A, AU - Dougan,Michael, AU - North,Crystal M, AU - Halvorsen,Yuan-Di, AU - Thurber,Tara K, AU - Dagher,Zeina, AU - Scherer,Allison, AU - Wallwork,Rachel S, AU - Kim,Arthur Y, AU - Schoenfeld,Sara, AU - Sen,Pritha, AU - Neilan,Tomas G, AU - Perugino,Cory A, AU - Unizony,Sebastian H, AU - Collier,Deborah S, AU - Matza,Mark A, AU - Yinh,Janeth M, AU - Bowman,Kathryn A, AU - Meyerowitz,Eric, AU - Zafar,Amna, AU - Drobni,Zsofia D, AU - Bolster,Marcy B, AU - Kohler,Minna, AU - D'Silva,Kristin M, AU - Dau,Jonathan, AU - Lockwood,Megan M, AU - Cubbison,Caroline, AU - Weber,Brittany N, AU - Mansour,Michael K, AU - ,, Y1 - 2020/10/21/ PY - 2020/10/22/pubmed PY - 2020/12/18/medline PY - 2020/10/21/entrez SP - 2333 EP - 2344 JF - The New England journal of medicine JO - N Engl J Med VL - 383 IS - 24 N2 - 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.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/33085857/Efficacy_of_Tocilizumab_in_Patients_Hospitalized_with_Covid_19_ DB - PRIME DP - Unbound Medicine ER -