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Exploratory Analysis of CRANE Influenza Study to Assess Impact of MHAA4549A among Subgroups Classified by Influenza Severity
Proposal
6080
Title of Proposed Research
Exploratory Analysis of CRANE Influenza Study to Assess Impact of MHAA4549A among Subgroups Classified by Influenza Severity
Lead Researcher
Robin Bliss
Affiliation
Veristat
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
12 November 2019
Lay Summary
Mixed results have been observed in recent clinical trials assessing the efficacy of novel treatments for hospitalized influenza patients. Current literature summarizing the CRANE Influenza Study has examined the impact of MHAA4549A, a broadly neutralizing monoclonal antibody. The antibody targets the hemagglutinin stalk of influenza A virus, with potential to neutralize the virus and its impact on the human body.The effect of MHAA4549A on mortality and hospitalized intervention among less severely ill subjects has not been published. This information will help motivate and design additional clinical trials in the same influenza treatment space but with refined study populations. It will also help clinicians better understand the infection pathway and overall patient risk when admitted to hospital with influenza.Objectives:1) Assess the mortality rate among hospitalized, non-intubated subjects treated with MHAA4549A or comparator2) Assess the mortality rate among hospitalized, non-intubated, non-ICU subjects treated with MHAA4549A or comparator3) Assess rates of hospital interventions and outcomes, including (but not limited to) ventilator use, post-baseline admittance to ICU, time to discharge, etc. among hospitalized, non-intubated subjects4) Assess rates of hospital interventions and outcomes among hospitalized, non-intubated, non-ICU subjects
Study Data Provided
[{ "PostingID": 19857, "Title": "ROCHE-GV29216", "Description": "A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection" }]
Statistical Analysis Plan
Publication Citation
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