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NCT03315104 · ClinicalTrials.gov registry record · Phase 2
Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
A Phase 2 study of Influenza A H3N2 and Influenza A H1N1, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT03315104 is a Phase 2 study of Influenza A H3N2 and Influenza A H1N1 that has completed, run by Emergent BioSolutions. The registered enrollment target is 65 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT03315104, a Phase 2 study of Influenza A H3N2 and Influenza A H1N1, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- BIOLOGICAL FLU-IGIV
- OTHER Placebo for FLU-IGIV
Study Locations (20)
Georgia
- Northside Hospital - Atlanta
- Atlanta Institute for Medical Research Inc. - Atlanta
- Augusta University - Augusta
Michigan
- Wayne State University/Detroit Receiving Hospital - Detroit
- Wayne State University/Sinai Grace Hospital - Detroit
- Providence-Providence Park Hospital, Southfield - Southfield
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- HonorHealth - Scottsdale
Arkansas
- Baptist Health Center for Clinical Research - Little Rock
California
- University of California, Irvine Emergency Medicine - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2019-06-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03315104
The ClinicalTrials.gov registry entry for NCT03315104 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Influenza A H3N2 appearing as the primary indexed condition, and to 2 interventions - of which FLU-IGIV is the first listed.
NCT03315104 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Georgia, Michigan, Illinois.
Frequently Asked Questions
What is clinical trial NCT03315104 about?
NCT03315104 is a clinical study titled "Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A". 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 ...
What is the current status of trial NCT03315104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2017-11-17. Estimated completion is 2019-06-17.
What conditions does trial NCT03315104 study?
This clinical trial studies the following conditions: Influenza A H3N2, Influenza A H1N1.
What interventions are being tested in trial NCT03315104?
The interventions under investigation include: FLU-IGIV (BIOLOGICAL), Placebo for FLU-IGIV (OTHER).
Who is sponsoring clinical trial NCT03315104?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03315104 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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