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
The purpose of this study is to develop a possible new treatment for influenza. This new treatment uses antibodies against this virus. Antibodies are natural proteins made by the body that attack influenza and other germs. We want to see if the plasma with higher levels of antibodies helps people with influenza improve more than plasma with lower levels or no antibodies. The plasma is given in addition to standard anti-influenza medications.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Subjects 2 weeks or older
Hospitalized due to signs and symptoms of Influenza
Primary disease category: HIV/AIDS & Infectious Disease
Secondary disease categories: Trauma & Emergency Medicine
Sponsor: National Institutes of Health
Protocol number: IRC-005
Projected enrollment dates: November 2015 to November 2018
Official study 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