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Completed Phase 2 Interventional Results available

Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

ClinicalTrials.gov ID: NCT03315104

Public ClinicalTrials.gov record NCT03315104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients With Serious Influenza A Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

Study identification

NCT ID
NCT03315104
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Emergent BioSolutions
Industry
Enrollment
65 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 17, 2017 (Actual)
Primary completion
Jun 17, 2019 (Actual)
Completion
Jun 17, 2019 (Actual)
Last update posted
Mar 18, 2024

2017 – 2019

United States locations

U.S. sites
42
U.S. states
28
U.S. cities
37
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
HonorHealth Scottsdale Arizona 85258 —
Baptist Health Center for Clinical Research Little Rock Arkansas 72205 —
University of California, Irvine Emergency Medicine Orange California 92868 —
Denver public Health Denver Colorado 80212 —
Yale University School of Medicine New Haven Connecticut 06519 —
Christiana Care Health Systems Newark Delaware 19718 —
Northside Hospital Atlanta Georgia 30342 —
Atlanta Institute for Medical Research Inc. Atlanta Georgia 30350 —
Augusta University Augusta Georgia 30912 —
Northwestern University Chicago Illinois 60611 —
University of Chicago Chicago Illinois 60637 —
University of Iowa Iowa City Iowa 52242 —
University of Kansas medical Center Kansas City Kansas 66160 —
John Hopkins Hospital Baltimore Maryland 21287 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01605 —
Wayne State University/Detroit Receiving Hospital Detroit Michigan 48201 —
Wayne State University/Sinai Grace Hospital Detroit Michigan 48202 —
Providence-Providence Park Hospital, Southfield Southfield Michigan 48075 —
Mayo Clinic Rochester Minnesota 55905 —
Washington University St Louis Missouri 63110 —
University of Nebraska Medical Center Omaha Nebraska 985400 —
University Medical Center of Southern Nevada Las Vegas Nevada 89102 —
Montefiore Medical Center The Bronx New York 10467 —
University of North Carolina Chapel Hill North Carolina 27599 —
Pulmonlx LLC Pulmonary & Critical Care Medicine Greensboro North Carolina 27403 —
Premier Health Miami Valley Hospital Dayton Ohio 45409 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
St Luke's University Health Network Bethlehem Pennsylvania 18015 —
Einstein Medical Center Philadelphia Pennsylvania 19141 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Reading Hospital West Reading Pennsylvania 19611 —
Regional Health Rapid City South Dakota 57701 —
UT Southwestern Medical Center Dallas Texas 75390 —
Baylor University Medical Center Dallas Texas 77030 —
Baylor College of Medicine Houston Texas 77030 —
Michael E. DeBakey VA Medical Center Houston Texas 77030 —
UT Health San Antonio San Antonio Texas 78229 —
University of Utah HealthCare Salt Lake City Utah 84108 —
Carilion Medical Center Roanoke Virginia 24014 —
MultiCare Institute for Research & Innovation Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03315104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 18, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03315104 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →