CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 138 enrolled
Drug / intervention
High-titer anti-influenza plasma +1 morebiological
Likely dose
High-titer anti-influenza plasma 350 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02572817
NCT02572817Phase 3Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 9, 2015·Updated Jun 25, 2019

In Brief

A Phase 3 clinical trial evaluating High-titer anti-influenza plasma and Low-titer anti-influenza plasma for Influenza A Virus Infection. Completed, enrolled 138 participants across 30 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza A Virus Infection
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartNov 1, 2015
Primary CompletionApr 26, 2018
Study CompletionMay 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.7 years ago

Interventions

High-titer anti-influenza plasmabiological

Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of at least 1:80

Low-titer anti-influenza plasmabiological

Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of 1:10 or less