MARC details
| 000 -LEADER |
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| fixed length control field |
03237nam a22003857a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
220706s20222022 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
2328-8957 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1093/ofid/ofac104 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
ofac104 [pii] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
PMC8992313 [pmc] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
35493119 |
| 245 ## - TITLE STATEMENT |
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| Title |
Ibrutinib for Hospitalized Adults With Severe Coronavirus Disease 2019 Infection: Results of the Randomized, Double-Blind, Placebo-Controlled iNSPIRE Study. |
| 251 ## - Source |
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| Source |
Open Forum Infectious Diseases. 9(5):ofac104, 2022 May. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Open forum infect. dis.. 9(5):ofac104, 2022 May. |
| 253 ## - Journal Name |
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| Journal name |
Open forum infectious diseases |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2022 May |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
epublish |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Medline status |
PubMed-not-MEDLINE |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2022-07-06 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Background: 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 ## - SUMMARY, ETC. |
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| Abstract |
Clinical Trials Registration: NCT04375397. Copyright © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Conclusions: 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 ## - SUMMARY, ETC. |
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| Abstract |
Methods: 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 ## - SUMMARY, ETC. |
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| Abstract |
Results: 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 ## - LANGUAGE NOTE |
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| Language note |
English |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Barnett, Christopher |
| 790 ## - Authors |
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| All authors |
Alami NN, Barnett C, Coutre SE, Fort AC, Hoda D, Hu Y, Ninomoto J, Osiyemi O, Qaqish R, Ramgopal M, Styles L, Treon SP |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1093/ofid/ofac104">https://dx.doi.org/10.1093/ofid/ofac104</a> |
| Public note |
https://dx.doi.org/10.1093/ofid/ofac104 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
