Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza
Condition: Influenza A; Influenza B
MeSH terms: Influenza, Human
Intervention: Anti-Influenza Immune Plasma; Standard Care
Intervention description: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline; All subjects will receive an anti-influenza antiviral (e.g., oseltamivir or zanamivir), but may include treatment with licensed antivirals in patient populations or at doses not covered in the package insert, or with medications available under a EUA. Standard care may also include antibiotics and other medications.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Healthy volunteers: No
Keywords: Antiviral; Anti-Influenza Immune Plasma; Emerging Infectious Disease; Swine Flu

Summary:

      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 or B.
      Hospitalized subjects with influenza A or B that have either a low oxygen level or a high
      respiratory rate will be eligible for study participation. This study will enroll adults,
      children and pregnant women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of influenza A or B within 72 hours prior to enrollment (by local assay
             including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction
             (PCR), or culture, and must be able to detect and distinguish influenza A from
             influenza B)

          -  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 (respiratory rate above an age adjusted normal range)

          -  Agree to the storage of specimens and data

          -  ABO compatible plasma available on site or available within 24 hours after
             randomization with activity against locally circulating strains of influenza

        Exclusion Criteria:

          -  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 non
             approved doses, off-label indications, or drugs available under an Emergency Use
             Authorization (EUA).

          -  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 acute illness is primarily due to a condition
             other than active influenza virus replication (e.g., a bacterial or fungal infection)