A phase II/III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intramuscular peramivir in subjects with uncomplicated acute influenza - The IMPROVE 2 Study

INTERVENTION: Product Name: Peramivir Product Code: BCX‐1812 Pharmaceutical Form: Solution for injection Current Sponsor code: BCX‐1812 Other descriptive name: Peramivir Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Uncomplicated acute influenza PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of peramivir compared to placebo when administered intramuscularly on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza A. Primary end point(s): Clinical: Time to alleviation of clinical symptoms of influenza in subjects with influenza A. Secondary Objective: To evaluate the safety and tolerability of peramivir administered intramuscularly;; To evaluate secondary clinical outcomes in response to treatment;; To evaluate changes in influenza virus titer (viral shedding) in response to treatment;; To assess pharmacoeconomic measures in response to treatment;; To assess changes in influenza viral susceptibility to neuraminidase inhibitors following treatment; INCLUSION CRITERIA: 1. Male and non‐pregnant female subjects age =18 years. 2. A positive Influenza A Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer’s instructions. A negative initial RAT should be repeated within one hour. Subjects with a positive influenza B or mixed A and B RAT will be excluded. 3. Presence of fever at time of Screening of =38.0 ºC (=100.4 ºF) taken orally, or =38.5 ºC (=101.2 ºF) taken rectally. A subject self‐report of a history of fever or feverishness within the 24 hours prior to Screening will also qualify for enrollment in the absence of documented fever at the time of Screening. 4. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity. 5. Presence of at least one constitutional symptom (myalgia [muscle aches], headache, feverishness, or fatigue) of at least moderate severity. 6.