Protocol IRC002 “A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational anti-Influenza Immune Plasma for the Treatment of Influenza”

Project: Research project

Project Details

Description

Influenza A/H1N1 2009 (also referred to as "swine flu") is a novel influenza virus. H1N1 vaccines are available, but much of the population remains unvaccinated. Initial reports suggested a high mortality rate (6-7%). More recent statistics suggest a much lower mortality rate similar to seasonal influenza, though in contrast to seasonal influenza, influenza A/H1N1 2009 affects a younger, healthier population.

Morbidity and mortality occur despite treatment with current antivirals. Circulating influenza A/H1N1 2009 isolates are highly resistant to amantadine and rimantadine, whereas previous seasonal H1N1 isolates were highly resistant to oseltamivir. So there is concern that the 2009 H1N1 virus may also acquire oseltamivir resistance.

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. Hospitalized subjects with influenza A at risk for severe disease (as defined in the inclusion criteria) will be eligible for study participation.

This study will NOT enroll pregnant women or children at the Northwestern University site at this time. If a female subject becomes pregnant or later determined to be pregnant, during her participation in this study, monthly follow-ups will be required with one final follow-up after delivery.
StatusFinished
Effective start/end date4/1/1510/31/15

Funding

  • Social & Scientific Systems, Inc. (HHSN261200800001E/11XS088)
  • National Cancer Institute (HHSN261200800001E/11XS088)

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