A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza A Immune Plasma for the Treatment of Influenza A (IRC002)
Trial status: Open for Enrollment
Why is this study being done?
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 enroll adults, children and pregnant women.
Approximately 40 sites in the United States will participate in this protocol. One hundred eligible subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric equivalent) of anti-influenza plasma on Study Day 0 in addition to standard care or standard care alone (50 subjects receiving standard care alone; 50 subjects receiving anti-influenza plasma and standard care).
Subjects will be assessed on Study Day 0 (pre-dose), 30 minutes post-dose, and on Study Days 1, 2, 4, 7, 14, and 28. All subjects will undergo a series of efficacy, safety, and PK (HAI) assessments during the study. Blood samples will be collected at each time point (except Day 1).
Who is eligible to participate?
- Diagnosis of influenza A (confirmed by local assay that may test for either influenza A or more specific influenza A H1N1 2009, including rapid antigen, direct fluorescent antibody [DFA], polymerase chain reaction [PCR], or culture)
- Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
- Abnormal respiratory status, defined as room air saturation of oxygen (SaO2) less than 93% or tachypnea
- Agree to the storage of specimens and data
- ABO compatible H1N1 plasma available
- Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to receive any time during the study). This does not include licensed drugs at nonapproved doses, off-label indications, or drugs available under an Emergency Use Authorization (EUA).
- Symptoms or signs of the acute influenza-like illness have occurred for more than 7 days prior to enrollment.
- History of severe allergic reaction to blood products (as judged by the investigator).
- Medical conditions for which receipt of 500 mL volume (or 8 mL/kg for pediatric patients) may be dangerous to the subject (e.g. decompensated congestive heart failure [CHF], etc.)
- Clinical suspicion that etiology of illness is primarily bacterial