MedTrace Logo

Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza

NCT01052480 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-09-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

Anti-Influenza Immune Plasma

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

DRUG

Standard Care

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • John Beigel, MD · Leidos Biomedical Research, Inc. in support of Laboratory of Immunoregulation, NIAID, NIH

  • Richard Davey, MD · Laboratory of Immunoregulation, NIAID, NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-03-31
Completion
2015-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01052480 on ClinicalTrials.gov