Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

Influenza 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 Teatment of Severe Influenza A

Status Enrolling by invitation

Clinical Trial Summary

Background:

Most people infected with the influenza virus have mild symptoms. But some get very sick and even die. Antibodies in the part of the blood called plasma fight germs like influenza. Researchers want to see if plasma with high levels of antibodies helps more than plasma with low levels when transfused into people with influenza. They have plasma from people with high levels of antibodies from being infected with influenza or getting the influenza vaccine. They also have plasma with low or no antibodies.

Objective:

To see if plasma with high levels of antibodies works better than plasma with low levels to treat influenza.

Eligibility:

People ages 2 weeks and older who are hospitalized for symptoms of influenza

Design:

Participants will be screened with medical history and blood and urine tests. They may have a nasal wash test for influenza. For this, they get a saline rinse in one nostril. A plastic tube inserted in the nostril collects fluid.

The study lasts 28 days.

Participants will get routine influenza care. This includes standard drugs and possible chest x-rays.

On Day 1, participants will have:

Physical exam

Blood tests

Throat swab

2 doses of plasma with high antibodies or low antibodies by IV catheter (tube) in a vein.

On Days 3 and 7, participants will return to the clinic, if no longer hospitalized, for 1-hour visits. The visits include:

Medical exam

Blood tests

Throat swab

On Days 2, 14, and 28, participants will be evaluated either at the clinic or by phone. They will talk about their symptoms.

Clinical Trial Description

Significant morbidity and mortality from influenza infections occur despite treatment with current antivirals. This randomized, double-blinded, multicenter phase 3 trial will assess the efficacy and safety of high-titer versus low-titer anti-influenza immune plasma in addition to standard care antivirals for the treatment of severe influenza A. Hospitalized subjects with severe influenza A will be eligible for study participation. Up to 40 sites in the United States will participate in this protocol. Adults and children may participate. There is no exclusion for pregnancy.

A total of 150 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-influenza plasma or control (low-titer) plasma. All plasma is from male donors to minimize the risk of TRALI.

Subjects will be assessed on Study Day 0 (baseline) and on Study Days 1, 2, 3, 7, 14, and 28. For participants who are not hospitalized on Days 2, 14, and 28, contact with the participant for the purpose of limited study data collection for those days may be performed by telephone. Study visits on Days 1, 3, 7 must occur in person. All subjects will undergo a series of efficacy, safety, and HAI assessments during the study. Blood samples will be collected on Day 0, 1, 3, and 7. OP swabs for influenza PCR will be obtained on Days 0 and 3. ;

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT02610478
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: November 19, 2015
• Completion date: November 29, 2019