Influenza A Virus Infection Clinical Trial
Official title:
A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
This study assessed the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.
Despite antivirals and vaccines, influenza is responsible for thousands of hospitalizations
and deaths each year worldwide. Because of this, additional treatments for influenza are
needed. One potential treatment may be the use of high-titer anti-influenza immune plasma.
The purpose of this study is to evaluate the efficacy and safety of treatment with high-titer
versus low-titer anti-influenza immune plasma, in addition to standard care, in participants
hospitalized with severe influenza A infection.
This study enrolled people aged 2 weeks or older who are hospitalized with severe influenza A
infection. Participants were randomly assigned to receive either high-titer anti-influenza
plasma or low-titer (control) anti-influenza plasma on Day 0. In addition, all participants
received standard care antivirals. Participants were assessed on Day 0 (baseline) and on Days
1, 2, 3, 7, 14, and 28. For participants who were not hospitalized on Days 2, 14, and 28,
researchers could contact participants by telephone. Study procedures included clinical
assessments, blood collection, and oropharyngeal swabs.
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