Clinical Trials Logo
  1. Home
  2. Influenza A Virus Infection
  3. NCT02572817

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

Influenza A Virus Infection 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 Treatment of Severe Influenza A

Clinical Trial 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.

Clinical Trial Description

Despite antivirals and vaccines, influenza is responsible for thousands of hospitalizations and deaths each year worldwide. Because of this, additional treatments for influenza are needed. One potential treatment may be the use of high-titer anti-influenza immune plasma. The purpose of this study is to evaluate the efficacy and safety of treatment with high-titer versus low-titer anti-influenza immune plasma, in addition to standard care, in participants hospitalized with severe influenza A infection.

This study enrolled people aged 2 weeks or older who are hospitalized with severe influenza A infection. Participants were randomly assigned to receive either high-titer anti-influenza plasma or low-titer (control) anti-influenza plasma on Day 0. In addition, all participants received standard care antivirals. Participants were assessed on Day 0 (baseline) and on Days 1, 2, 3, 7, 14, and 28. For participants who were not hospitalized on Days 2, 14, and 28, researchers could contact participants by telephone. Study procedures included clinical assessments, blood collection, and oropharyngeal swabs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02572817
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 3
Start date November 2015
Completion date May 18, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT02250274 - Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents Phase 4
Completed NCT01175122 - Evaluation of the Safety and Immunogenicity of a Live Attenuated Virus Vaccine for the Prevention of H2N3 Influenza Phase 1
Completed NCT00984451 - A Pilot Study for Collection of Anti-Influenza A Immune Plasma
Completed NCT00985582 - Antiviral Therapy for Influenza A H1N1 N/A
Completed NCT01459081 - Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China Phase 3
Completed NCT03651544 - The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Phase 1
Withdrawn NCT00844155 - Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit N/A
Completed NCT00491985 - Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children Phase 2
Completed NCT01146535 - Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment Phase 2
Completed NCT00457509 - Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults Phase 1
Completed NCT01546506 - Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells Phase 2
Completed NCT01136057 - Blood and Plasma Collection For Use in Future Clinical Trials