Who is sponsoring IRC002?

IRC002 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does IRC002 study?

IRC002 studies Influenza A, Influenza B.

What drugs are being tested in IRC002?

Interventions: Anti-Influenza Immune Plasma, Standard Care.

Last reviewed 2017-08-03 · How we verify

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

NCT01052480 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	COMPLETED
Enrolment	98
Start date	2010-12
Completion	2015-11

Conditions

Influenza A
Influenza B

Interventions

Anti-Influenza Immune Plasma
Standard Care

Primary outcomes

Time to Normalization of Respiratory Status (Primary Efficacy Population) — Measured from Day 0 through Day 28
Normalized respiratory status is defined as room air saturation of oxygen \[SaO2\] greater than or equal to 93% AND respiratory rate within normal ranges.

Countries

United States