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Sökning: WFRF:(McBride Joshua C.) > (2020) > A phase 2 randomize...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00004524naa a2200529 4500
001oai:lup.lub.lu.se:bbb6bcb6-a722-42df-b3c5-0d5bbbabccf0
003SwePub
008200707s2020 | |||||||||||000 ||eng|
0247 a https://lup.lub.lu.se/record/bbb6bcb6-a722-42df-b3c5-0d5bbbabccf02 URI
0247 a https://doi.org/10.1128/AAC.00352-202 DOI
040 a (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a art2 swepub-publicationtype
072 7a ref2 swepub-contenttype
1001 a Lim, Jeremy J.u Genentech, Inc4 aut
2451 0a A phase 2 randomized, double-blind, placebo-controlled trial of MHAA4549A, a monoclonal antibody, plus oseltamivir in patients hospitalized with severe influenza a virus infection
264 1c 2020
520 a For patients hospitalized with severe influenza A virus infection, morbidity and mortality remain high. MHAA4549A, a human monoclonal antibody targeting the influenza A virus hemagglutinin stalk, has demonstrated pharmacological activity in animal studies and in a human influenza A challenge study. We evaluated the safety and efficacy of MHAA4549A plus oseltamivir against influenza A virus infection in hospitalized patients. The CRANE trial was a phase 2b randomized, double-blind, placebo-controlled study of single intravenous (i.v.) doses of placebo, 3,600 mg MHAA4549A, or 8,400 mg MHAA4549A each combined with oral oseltamivir (+OTV) in patients hospitalized with severe influenza A virus infection. Patients, enrolled across 68 clinical sites in 18 countries, were randomized 1:1:1. The primary outcome was the median time to normalization of respiratory function, defined as the time to removal of supplemental oxygen support to maintain a stable oxygen saturation (SpO2) of ≥95%. Safety, pharmacokinetics, and effects on influenza viral load were also assessed. One hundred sixty-six patients were randomized and analyzed during a preplanned interim analysis. Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV, 4.28 days; 3,600 mg MHAA4549A+OTV, 2.78 days; 8,400 mg MHAA4549A+OTV, 2.65 days), nor did it improve other secondary clinical outcomes. Adverse event frequency was balanced across cohorts. MHAA4549A+OTV did not further reduce viral load versus placebo+OTV. In hospitalized patients with influenza A virus infection, MHAA4549A did not improve clinical outcomes over OTV alone. Variability in patient removal from oxygen supplementation limited the utility of the primary endpoint. Validated endpoints are needed to assess novel treatments for severe influenza A virus infection. (This study has been registered at ClinicalTrials.gov under registration no. NCT02293863.).
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng
653 a Antiviral agents
653 a Influenza A virus
653 a MHAA4549A
653 a Monoclonal antibody
7001 a Nilsson, Anna C.u Lund University,Lunds universitet,Klinisk infektionsmedicin,Forskargrupper vid Lunds universitet,Clinical infection medicine,Lund University Research Groups4 aut0 (Swepub:lu)med-ann
7001 a Silverman, Michaelu London Health Sciences Centre, Ontario4 aut
7001 a Assy, Nimeru Bar-Ilan University,Galilee Medical Center4 aut
7001 a Kulkarni, Priyau Genentech, Inc4 aut
7001 a McBride, Jacqueline M.u Genentech, Inc4 aut
7001 a Deng, Rongu Genentech, Inc4 aut
7001 a Li, Chloeu Genentech, Inc4 aut
7001 a Yang, Xiaoyingu Genentech, Inc4 aut
7001 a Nguyen, Allenu Genentech, Inc4 aut
7001 a Horn, Priscillau Genentech, Inc4 aut
7001 a Maia, Mauriciou Genentech, Inc4 aut
7001 a Castro, Aideu Genentech, Inc4 aut
7001 a Peck, Melicent C.u Genentech, Inc4 aut
7001 a Galanter, Joshuau Genentech, Inc4 aut
7001 a Chu, Tomu Genentech, Inc4 aut
7001 a Newton, Elizabeth M.u Genentech, Inc4 aut
7001 a Tavel, Jorge A.u Genentech, Inc4 aut
7102 a Genentech, Incb Klinisk infektionsmedicin4 org
7730 t Antimicrobial Agents and Chemotherapyg 64:7q 64:7x 0066-4804
8564 u http://dx.doi.org/10.1128/AAC.00352-20x freey FULLTEXT
8564 8u https://lup.lub.lu.se/record/bbb6bcb6-a722-42df-b3c5-0d5bbbabccf0
8564 8u https://doi.org/10.1128/AAC.00352-20

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