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COMPLETED Phase 2

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

NCT03315104 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 65 participants
Start Date 2017-11-17
Est. Completion 2019-06-17
Phase Phase 2

Sponsor

Emergent BioSolutions

7 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03315104 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Georgia, Michigan, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03315104?

The interventions under investigation include: FLU-IGIV (BIOLOGICAL), Placebo for FLU-IGIV (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03315104?

This trial is sponsored by Emergent BioSolutions, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial