A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
405
* Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. * Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Unnamed facility
La Mesa, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Modesto, California, United States
Unnamed facility
Oceanside, California, United States
Pulmonary Consultants PC Physicians Medical Group, Inc.
Orange, California, United States
Time to Clinical Resolution (Kaplan-Meier Estimate)
Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).
Time frame: 10 days
Change (Reduction) in Influenza Virus Titer
The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.
Time frame: Baseline and 24, 48, 108 hours
Time to Alleviation of Clinical Symptoms of Influenza
Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia \[aches and pains\], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.
Time frame: 10 days
Time to Resolution of Fever (Kaplan-Meier Estimate)
Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.
Time frame: 10 days
Time to Resumption of Usual Activities
Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.
Time frame: 10 days
Number of Subjects With ICU Admission
The number of subjects requiring ICU admission post-randomization was summarized by treatment group.
Time frame: 10 days
Duration of All ICU Admissions (Kaplan-Meier Estimate)
Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.
Time frame: 10 days
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Unnamed facility
Orange, California, United States
UC Davis Medical Center
Sacramento, California, United States
Sharp Chula Vista Medical Center
San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Denver, Colorado, United States
...and 186 more locations