000			03237nam a22003857a 4500
008			220706s20222022 xxu||||| |||| 00| 0 eng d
022			_a2328-8957
024			_a10.1093/ofid/ofac104 [doi]
024			_aofac104 [pii]
024			_aPMC8992313 [pmc]
040			_aOvid MEDLINE(R)
099			_a35493119
245			_aIbrutinib for Hospitalized Adults With Severe Coronavirus Disease 2019 Infection: Results of the Randomized, Double-Blind, Placebo-Controlled iNSPIRE Study.
251			_aOpen Forum Infectious Diseases. 9(5):ofac104, 2022 May.
252			_aOpen forum infect. dis.. 9(5):ofac104, 2022 May.
253			_aOpen forum infectious diseases
260			_c2022
260			_fFY2022
260			_p2022 May
265			_sepublish
265			_tPubMed-not-MEDLINE
266			_d2022-07-06
520			_aBackground: Few therapies are approved for hospitalized patients with severe coronavirus disease 2019 (COVID-19). Ibrutinib, a once-daily Bruton tyrosine kinase inhibitor, may mitigate COVID-19-induced lung damage by reducing inflammatory cytokines. The multicenter, randomized, double-blind phase 2 iNSPIRE study evaluated ibrutinib for prevention of respiratory failure in hospitalized patients with severe COVID-19.
520			_aClinical Trials Registration: NCT04375397. Copyright © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
520			_aConclusions: Addition of ibrutinib to SOC did not improve the proportion of patients alive and without respiratory failure through day 28 in hospitalized patients with severe COVID-19. Ibrutinib had a manageable safety profile, with similar safety to placebo.
520			_aMethods: Adult patients with severe COVID-19 requiring hospitalization and supplemental oxygen but without respiratory failure were randomized 1:1 (stratified by remdesivir prescription) to ibrutinib 420 mg or placebo once daily for up to 28 days plus standard of care (SOC), including remdesivir and/or dexamethasone.
520			_aResults: Forty-six patients were randomized to ibrutinib plus SOC (n = 22) or placebo plus SOC (n = 24). The primary endpoint (proportion of patients alive and without respiratory failure through day 28) was not met, with no statistically significant difference adjusting for remdesivir prescription (86% with ibrutinib plus SOC vs 79% with placebo plus SOC; adjusted difference, 5.8% [80% confidence interval, -9.2% to 20.4%]; P = .599). Secondary endpoints also showed no statistically significant improvement with ibrutinib plus SOC. Median treatment duration was 14 days for ibrutinib and placebo. Adverse events were similar with ibrutinib plus SOC vs placebo plus SOC (overall: 55% vs 50%; serious: 18% vs 13%) and were consistent with the known safety profile of ibrutinib.
546			_aEnglish
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
700			_aBarnett, Christopher
790			_aAlami NN, Barnett C, Coutre SE, Fort AC, Hoda D, Hu Y, Ninomoto J, Osiyemi O, Qaqish R, Ramgopal M, Styles L, Treon SP
856			_uhttps://dx.doi.org/10.1093/ofid/ofac104 _zhttps://dx.doi.org/10.1093/ofid/ofac104
942			_cART _dArticle
999			_c443 _d443