Sökning: onr:"swepub:oai:lup.lub.lu.se:bbb6bcb6-a722-42df-b3c5-0d5bbbabccf0" > A phase 2 randomize...
Fältnamn | Indikatorer | Metadata |
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000 | 04524naa a2200529 4500 | |
001 | oai:lup.lub.lu.se:bbb6bcb6-a722-42df-b3c5-0d5bbbabccf0 | |
003 | SwePub | |
008 | 200707s2020 | |||||||||||000 ||eng| | |
024 | 7 | a https://lup.lub.lu.se/record/bbb6bcb6-a722-42df-b3c5-0d5bbbabccf02 URI |
024 | 7 | a https://doi.org/10.1128/AAC.00352-202 DOI |
040 | a (SwePub)lu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a art2 swepub-publicationtype |
072 | 7 | a ref2 swepub-contenttype |
100 | 1 | a Lim, Jeremy J.u Genentech, Inc4 aut |
245 | 1 0 | a 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 | 1 | c 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 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe |
650 | 7 | a 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 | |
700 | 1 | 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 |
700 | 1 | a Silverman, Michaelu London Health Sciences Centre, Ontario4 aut |
700 | 1 | a Assy, Nimeru Bar-Ilan University,Galilee Medical Center4 aut |
700 | 1 | a Kulkarni, Priyau Genentech, Inc4 aut |
700 | 1 | a McBride, Jacqueline M.u Genentech, Inc4 aut |
700 | 1 | a Deng, Rongu Genentech, Inc4 aut |
700 | 1 | a Li, Chloeu Genentech, Inc4 aut |
700 | 1 | a Yang, Xiaoyingu Genentech, Inc4 aut |
700 | 1 | a Nguyen, Allenu Genentech, Inc4 aut |
700 | 1 | a Horn, Priscillau Genentech, Inc4 aut |
700 | 1 | a Maia, Mauriciou Genentech, Inc4 aut |
700 | 1 | a Castro, Aideu Genentech, Inc4 aut |
700 | 1 | a Peck, Melicent C.u Genentech, Inc4 aut |
700 | 1 | a Galanter, Joshuau Genentech, Inc4 aut |
700 | 1 | a Chu, Tomu Genentech, Inc4 aut |
700 | 1 | a Newton, Elizabeth M.u Genentech, Inc4 aut |
700 | 1 | a Tavel, Jorge A.u Genentech, Inc4 aut |
710 | 2 | a Genentech, Incb Klinisk infektionsmedicin4 org |
773 | 0 | t Antimicrobial Agents and Chemotherapyg 64:7q 64:7x 0066-4804 |
856 | 4 | u http://dx.doi.org/10.1128/AAC.00352-20x freey FULLTEXT |
856 | 4 8 | u https://lup.lub.lu.se/record/bbb6bcb6-a722-42df-b3c5-0d5bbbabccf0 |
856 | 4 8 | u https://doi.org/10.1128/AAC.00352-20 |
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