CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
Anti-Influenza Immune Plasma +1 morebiological
Likely dose
Anti-Influenza Immune Plasma 2 unitsfrom 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/NCT01052480
NCT01052480Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 20, 2010·Updated Sep 5, 2017

In Brief

A Phase 2 clinical trial evaluating Anti-Influenza Immune Plasma and Standard Care for Influenza A and Influenza B. Completed, enrolled 98 participants across 35 sites.

Detailed Summary

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza A, Influenza B
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2010
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.4 years ago

Interventions

Anti-Influenza Immune Plasmabiological

2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Caredrug

All subjects will receive an anti-influenza antiviral (e.g., oseltamivir or zanamivir), but may include treatment with licensed antivirals in patient populations or at doses not covered in the package insert, or with medications available under a EUA. Standard care may also include antibiotics and other medications.