None listed
Conditions
Interventions
Group 1 Type of group
Adults (≥
Group 2 Type of group
Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institutions standard of care.
Sponsors
BioCryst Pharmaceuticals, Inc.,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Age =12 years of age, male or female. • Able to provide informed consent/assent, or for whom consent may be provided by guardian, unless informed consent provided by a guardian or a legally authorized representative is not consistent with applicable local or ethical concerns, procedures, directives and/or guidelines. • Subject must have at least one of the following clinical presentations at Screening: a. Oral temperature = 38.0 °C (=100.4 °F), =38.6°C (=101.4 °F) tympanic or rectal OR b. Oxygen saturation 24/minute • Heart rate >100/minute • Systolic BP <90 mmHg • Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe). • Presence of at least one constitutional symptom (headache, myalgia, feverishness, or fatigue) of any severity (mild, moderate, or severe). • Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
Exclusion criteria
Exclusion criteria: • Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department). • Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir in the previous 7 days. • Blood platelet count of 6 mg/dL or >102. 6 µmol/L at time of screening evaluation. • Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation. • Congestive heart failure of NYHA Class III or Class IV functional status. • Serum creatinine > 5.0 mg/dL or > 442 µmol/L at time of screening evaluation. • Subjects who require peritoneal dialysis. • Altered neurologic status as defined by a Glasgow Coma Score of = 9, unless medically induced. • Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or breastfeeding. • Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. Subjects who have completed treatment 30 days prior to enrollment are not excluded. Hormone treatment for cancer is also not excluded. • Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months. • HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly active antiretroviral therapy (HAART) for at least 6 months. • Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). Subjects with chronic osteomyelitis or Hepatitis B or C not requiring treatment are not excluded. • Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study. • Previous treatment with intravenous or intramuscular peramivir. • Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation. • Subjects diagnosed with Cystic Fibrosis. • ubjects confirmed clinical evidence of acute non-influenzal infection at the time of screening evaluation. • Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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). Measure:Time to Clinical Resolution (Kaplan-Meier Estimate) Timepoints:10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Change (Reduction) in Influenza Virus Titer Timepoints:Baseline and 24, 48, 108 hours ; Outcome name: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. Measure:Time to Alleviation of Clinical Symptoms of Influenza Timepoints:10 days ; Outcome name: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. Measure:Time to Resolution of Fever (Kaplan-Meier Estimate) Timepoints:10 days ; Outcome name: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. Measure:Time to Resumption of Usual Activities Timepoints:10 days ; Outcome name:The number of subjects requiring ICU admission post-randomization was summarized by treatment group. Measure:Number of Subjects With ICU Admission Tim | — |
Countries
Argentina, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, Germany, Hungaria, India, Israel, Latovia, Lebano, Peru, Poland, Russian Federation, Serbia, Slovakia, South Africa, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed