Influenza
Conditions
Keywords
influenza, flu
Brief summary
This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.
Interventions
DRUGPeramivir 200 mg
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
DRUGPeramivir 400 mg
Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)
DRUGOseltamivir
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Sponsors
BioCryst Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years of age, male or female * Able to provide informed consent, or for whom consent may be provided by guardian * Presence of fever at time of screening of ≥38.0°C (≥ 100.0°F) taken orally, or ≥38.5°C (≥101.2°F) taken rectally. This requirement is waived if the subject has (1) a history of fever within 24 hours prior to screening and administered any antipyretic(s) in the 24 hours prior to screening, or (2) has no history of documented fever as defined above, but reports a symptom of feverishness at some time during 48 hours prior to screening * Presence of at least 1 respiratory symptom (cough, sore throat, nasal congestion/symptoms) of any severity (mild, moderate, severe) * Presence of at least 1 constitutional symptom (headache, myalgia, feverishness, malaise, fatigue) of any severity (mild, moderate, severe) * Onset of illness no more than 72 hours before presentation. Time of onset of illness defined as either (1) the time when temperature (oral or rectal) was elevated (at least 1°C of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least 1 respiratory symptom AND the presence of at least 1 constitutional symptom * Presence of 1 or more of the following factors in a subject willing to be hospitalized for inpatient observation and treatment: * Age ≥60 years * Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy * History of congestive heart failure with or without medically significant recent change in cardiac status, but without signs or symptoms compatible with NYHA Class IV functional status * Presence of diabetes mellitus, clinically stable or unstable * Transcutaneous oxygen saturation \<94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value * Systolic blood pressure \<90 mmHg * Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care * Positive rapid antigen test (RAT) for influenza A and/or influenza B (using an approved test kit) or other test for influenza virus antigen performed in a clinical laboratory at the screening/enrollment evaluation * Females of childbearing potential must report one of the following: * Be surgically sterile or clinically post-menopausal * Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study-drug administration for all perimenopausal women or women of child-bearing potential * Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study-drug administration for all perimenopausal women or women of child-bearing potential * Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration for all perimenopausal women or women of child-bearing potential
Exclusion criteria
* Immunized against influenza with live attenuated virus vaccine in the previous weeks * Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in the previous 7 days * Current clinical evidence of a recognized or suspected acute non-influenzal infectious illness with onset prior to Screening * Serum creatinine laboratory result at Screening \>1.6 mg/dL or a result \>25% above the upper limit of normal for the laboratory performing the test * History of clinically significant proteinuria (≥1000 mg/24 hrs) * History of moderate or severe renal impairment and/or previous clinical laboratory data indicating an estimated creatinine clearance \<50 mL/min during the previous 12 months * Electrocardiogram (ECG) at Screening visit showing evidence of acute ischemia, or presence of a medically significant dysrhythmia * Presence of cardiac signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina (see NYHA Appendix V) * Presence of diagnosed COPD or other chronic lung condition requiring either continuous or intermittent oxygen therapy as an outpatient. Note: Subjects who are determined to require acute supplemental oxygen therapy at the time of Screening and/or at hospital admission may be enrolled, if
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical Stability (Kaplan-Meier Estimate) | 14 days | Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Scores of Symptoms of Influenza | Baseline, Days 2, 3, 4, 5, 10, and 14 | Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia \[aches and pains\]; headache; feverishness; and fatigue, each graded on a 4-point severity scale \[0, absent; 1, mild; 2, moderate; 3, severe\]) were tabulated by treatment group. Missing data were excluded. |
| Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate) | 14 days | Changes in each subject's ability to perform usual activities as determined from the visual analog scale (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) were summarized by study visit and treatment group. The time to resumption of a subject's ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data). |
| Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study) | 14 days | The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group. |
| Time to Hospital Discharge (Kaplan-Meier Estimate) | 14 days | Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment. |
| Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Baseline, and 12, 24, 36, 48, 72, and 96 hours | Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group. |
Countries
Australia, Canada, Hong Kong, New Zealand, Singapore, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peramivir 200 mg Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment | 45 |
| Peramivir 400 mg Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) | 46 |
| Oseltamivir Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL) | 46 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Subject Request | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Peramivir 200 mg | Peramivir 400 mg | Oseltamivir | Total |
|---|---|---|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 24 | 58.5 years STANDARD_DEVIATION 20.9 | 62.0 years STANDARD_DEVIATION 21.3 | 59.2 years STANDARD_DEVIATION 22 |
| Current Smoking Status Missing | 1 participants | 1 participants | 0 participants | 2 participants |
| Current Smoking Status Nonsmoker | 36 participants | 40 participants | 42 participants | 118 participants |
| Current Smoking Status Smoker | 8 participants | 5 participants | 4 participants | 17 participants |
| Duration of Illness at Randomization < 48 hours | 31 participants | 32 participants | 31 participants | 94 participants |
| Duration of Illness at Randomization >= 48 hours to <=72 hours | 14 participants | 14 participants | 15 participants | 43 participants |
| Height | 163.0 cm STANDARD_DEVIATION 9.9 | 161.6 cm STANDARD_DEVIATION 11.8 | 168.4 cm STANDARD_DEVIATION 11.8 | 164.4 cm STANDARD_DEVIATION 11.5 |
| Influenza Infection Confirmed Influenza A | 26 participants | 34 participants | 30 participants | 90 participants |
| Influenza Infection Confirmed Influenza B | 15 participants | 6 participants | 11 participants | 32 participants |
| Influenza Infection Not confirmed | 4 participants | 6 participants | 5 participants | 15 participants |
| Initial Composite Symptom Score | 12.7 units on a scale STANDARD_DEVIATION 5.19 | 12.2 units on a scale STANDARD_DEVIATION 5.95 | 12.3 units on a scale STANDARD_DEVIATION 5.46 | 12.4 units on a scale STANDARD_DEVIATION 5.51 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 13 participants | 10 participants | 13 participants | 36 participants |
| Race/Ethnicity, Customized Black or African American | 8 participants | 14 participants | 12 participants | 34 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White or Caucasian | 23 participants | 21 participants | 20 participants | 64 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 25 Participants | 76 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 21 Participants | 61 Participants |
| Transcutaneous Oxygen Saturation at Randomization < 94% | 14 participants | 14 participants | 14 participants | 42 participants |
| Transcutaneous Oxygen Saturation at Randomization >= 94% | 31 participants | 32 participants | 32 participants | 95 participants |
| Weight | 64.9 kg STANDARD_DEVIATION 19.8 | 72.4 kg STANDARD_DEVIATION 22.9 | 79.5 kg STANDARD_DEVIATION 22.7 | 72.4 kg STANDARD_DEVIATION 22.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 45 | 21 / 46 | 19 / 46 |
| serious Total, serious adverse events | 2 / 45 | 8 / 46 | 4 / 46 |
Outcome results
Primary
Time to Clinical Stability (Kaplan-Meier Estimate)
Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).
Time frame: 14 days
Population: The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 200 mg | Time to Clinical Stability (Kaplan-Meier Estimate) | 23.7 hours |
| Peramivir 400 mg | Time to Clinical Stability (Kaplan-Meier Estimate) | 37.0 hours |
| Oseltamivir | Time to Clinical Stability (Kaplan-Meier Estimate) | 28.1 hours |
p-value: 0.306Log Rank
Secondary
Change From Baseline in Scores of Symptoms of Influenza
Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia \[aches and pains\]; headache; feverishness; and fatigue, each graded on a 4-point severity scale \[0, absent; 1, mild; 2, moderate; 3, severe\]) were tabulated by treatment group. Missing data were excluded.
Time frame: Baseline, Days 2, 3, 4, 5, 10, and 14
Population: The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 3 | -1.5 units on a scale | Standard Deviation 1.01 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 10 | -1.7 units on a scale | Standard Deviation 1.05 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 5 | -1.2 units on a scale | Standard Deviation 0.97 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Baseline | 1.3 units on a scale | Standard Deviation 1.17 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 5 | -1.6 units on a scale | Standard Deviation 1.09 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 10 | -1.4 units on a scale | Standard Deviation 0.97 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 3 | -0.8 units on a scale | Standard Deviation 1.05 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 14 | -1.9 units on a scale | Standard Deviation 1.21 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 14 | -1.6 units on a scale | Standard Deviation 1.06 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 2 | -1.4 units on a scale | Standard Deviation 1.02 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 4 | -1.4 units on a scale | Standard Deviation 1.21 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Baseline | 1.8 units on a scale | Standard Deviation 1.3 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 2 | -0.2 units on a scale | Standard Deviation 1.06 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 3 | -1.2 units on a scale | Standard Deviation 1.02 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 2 | -0.8 units on a scale | Standard Deviation 1.01 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 10 | -2.0 units on a scale | Standard Deviation 1.07 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 2 | -0.9 units on a scale | Standard Deviation 0.96 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 3 | -1.3 units on a scale | Standard Deviation 1.14 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Baseline | 2.1 units on a scale | Standard Deviation 1.04 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Baseline | 2.3 units on a scale | Standard Deviation 0.78 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 4 | -1.5 units on a scale | Standard Deviation 1.28 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 3 | -0.7 units on a scale | Standard Deviation 1.18 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 14 | -1.7 units on a scale | Standard Deviation 1.35 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 5 | -1.6 units on a scale | Standard Deviation 1.31 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 5 | -1.1 units on a scale | Standard Deviation 1.07 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 10 | -1.7 units on a scale | Standard Deviation 1.38 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 14 | -1.3 units on a scale | Standard Deviation 1.19 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 4 | -0.8 units on a scale | Standard Deviation 1.32 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 2 | -0.2 units on a scale | Standard Deviation 0.95 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 10 | -1.3 units on a scale | Standard Deviation 1.24 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 5 | -0.9 units on a scale | Standard Deviation 1.27 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 5 | -1.9 units on a scale | Standard Deviation 1.02 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 5 | -1.2 units on a scale | Standard Deviation 1.21 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 10 | -1.1 units on a scale | Standard Deviation 1.23 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 10 | -1.2 units on a scale | Standard Deviation 1.03 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 4 | -1.0 units on a scale | Standard Deviation 1.25 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 14 | -1.0 units on a scale | Standard Deviation 1.22 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Baseline | 1.3 units on a scale | Standard Deviation 1.09 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 3 | -0.9 units on a scale | Standard Deviation 1.16 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Baseline | 2.2 units on a scale | Standard Deviation 0.73 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 4 | -1.8 units on a scale | Standard Deviation 1.15 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 2 | -0.5 units on a scale | Standard Deviation 1.11 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 2 | -0.4 units on a scale | Standard Deviation 0.88 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 14 | -1.2 units on a scale | Standard Deviation 1.05 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Baseline | 1.5 units on a scale | Standard Deviation 1.22 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 3 | -0.9 units on a scale | Standard Deviation 0.91 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 4 | -0.9 units on a scale | Standard Deviation 1.13 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 14 | -1.7 units on a scale | Standard Deviation 1.13 |
| Peramivir 200 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 4 | -1.1 units on a scale | Standard Deviation 1.1 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 4 | -1.2 units on a scale | Standard Deviation 1.3 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 2 | -0.3 units on a scale | Standard Deviation 1.09 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 3 | -0.7 units on a scale | Standard Deviation 1.24 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 4 | -0.9 units on a scale | Standard Deviation 1.24 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 5 | -0.9 units on a scale | Standard Deviation 1.2 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 10 | -1.1 units on a scale | Standard Deviation 1.15 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 14 | -1.1 units on a scale | Standard Deviation 1.16 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Baseline | 1.5 units on a scale | Standard Deviation 1.03 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 2 | -0.5 units on a scale | Standard Deviation 0.82 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 3 | -0.9 units on a scale | Standard Deviation 0.99 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 4 | -1.1 units on a scale | Standard Deviation 1.06 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 5 | -1.2 units on a scale | Standard Deviation 1.17 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 10 | -1.2 units on a scale | Standard Deviation 1.27 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 14 | -1.2 units on a scale | Standard Deviation 1.17 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Baseline | 2.0 units on a scale | Standard Deviation 0.77 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 2 | -0.3 units on a scale | Standard Deviation 0.74 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 3 | -0.9 units on a scale | Standard Deviation 1.07 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 4 | -1.1 units on a scale | Standard Deviation 1.05 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 5 | -1.1 units on a scale | Standard Deviation 1.23 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 10 | -1.2 units on a scale | Standard Deviation 1.07 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 14 | -1.4 units on a scale | Standard Deviation 1.01 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Baseline | 1.9 units on a scale | Standard Deviation 1.13 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 2 | -0.8 units on a scale | Standard Deviation 0.91 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 3 | -1.4 units on a scale | Standard Deviation 1.18 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 4 | -1.6 units on a scale | Standard Deviation 1.21 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 5 | -1.6 units on a scale | Standard Deviation 1.23 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 10 | -1.7 units on a scale | Standard Deviation 1.12 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 14 | -1.6 units on a scale | Standard Deviation 1.11 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Baseline | 2.0 units on a scale | Standard Deviation 0.96 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 2 | -0.5 units on a scale | Standard Deviation 1.12 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 3 | -1.0 units on a scale | Standard Deviation 1.26 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 5 | -1.3 units on a scale | Standard Deviation 1.27 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 10 | -1.4 units on a scale | Standard Deviation 1.13 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 14 | -1.6 units on a scale | Standard Deviation 1.01 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Baseline | 1.3 units on a scale | Standard Deviation 1.34 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 2 | -0.5 units on a scale | Standard Deviation 1.12 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 3 | -1.0 units on a scale | Standard Deviation 1.26 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 4 | -1.1 units on a scale | Standard Deviation 1.3 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 5 | -1.1 units on a scale | Standard Deviation 1.28 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 10 | -1.2 units on a scale | Standard Deviation 1.35 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 14 | -1.2 units on a scale | Standard Deviation 1.35 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Baseline | 1.9 units on a scale | Standard Deviation 0.99 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 2 | -1.0 units on a scale | Standard Deviation 0.94 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 3 | -1.5 units on a scale | Standard Deviation 0.93 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 4 | -1.8 units on a scale | Standard Deviation 0.97 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 5 | -1.8 units on a scale | Standard Deviation 1.02 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 10 | -1.8 units on a scale | Standard Deviation 1 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 14 | -1.7 units on a scale | Standard Deviation 1.01 |
| Peramivir 400 mg | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Baseline | 1.1 units on a scale | Standard Deviation 1.17 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 10 | -1.7 units on a scale | Standard Deviation 1.09 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 3 | -0.9 units on a scale | Standard Deviation 0.87 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 3 | -1.6 units on a scale | Standard Deviation 1.2 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 14 | -2.0 units on a scale | Standard Deviation 0.97 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 2 | -0.2 units on a scale | Standard Deviation 0.81 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 10 | -1.2 units on a scale | Standard Deviation 1.18 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Baseline | 1.4 units on a scale | Standard Deviation 1.3 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Baseline | 2.1 units on a scale | Standard Deviation 0.76 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 14 | -1.8 units on a scale | Standard Deviation 1.23 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 2 | -0.6 units on a scale | Standard Deviation 0.94 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 14 | -1.3 units on a scale | Standard Deviation 1.08 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 4 | -1.6 units on a scale | Standard Deviation 1.48 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 3 | -1.0 units on a scale | Standard Deviation 1.1 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 10 | -1.1 units on a scale | Standard Deviation 1.17 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 5 | -1.1 units on a scale | Standard Deviation 1.24 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 4 | -1.1 units on a scale | Standard Deviation 1.3 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 5 | -1.1 units on a scale | Standard Deviation 1.1 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 3 | -0.8 units on a scale | Standard Deviation 1.04 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 5 | -1.3 units on a scale | Standard Deviation 1.3 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 4 | -1.0 units on a scale | Standard Deviation 1.16 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 5 | -1.8 units on a scale | Standard Deviation 1.2 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 10 | -1.4 units on a scale | Standard Deviation 1.26 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 3 | -0.8 units on a scale | Standard Deviation 0.96 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 4 | -1.1 units on a scale | Standard Deviation 1.18 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Headache: Change at Day 14 | -1.3 units on a scale | Standard Deviation 1.34 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Change at Day 2 | -0.3 units on a scale | Standard Deviation 0.82 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 5 | -1.7 units on a scale | Standard Deviation 1.31 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 2 | -0.3 units on a scale | Standard Deviation 0.8 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 10 | -1.9 units on a scale | Standard Deviation 1.09 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 4 | -1.6 units on a scale | Standard Deviation 1.21 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Baseline | 1.8 units on a scale | Standard Deviation 1.2 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 14 | -1.7 units on a scale | Standard Deviation 1.3 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 3 | -1.4 units on a scale | Standard Deviation 1.14 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Nasal Congestion: Baseline | 1.3 units on a scale | Standard Deviation 1.08 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Baseline | 2.3 units on a scale | Standard Deviation 0.82 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Change at Day 2 | -0.8 units on a scale | Standard Deviation 1.08 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 10 | -1.8 units on a scale | Standard Deviation 1.18 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 2 | -1.0 units on a scale | Standard Deviation 1.11 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Aches and Pains: Baseline | 1.9 units on a scale | Standard Deviation 1.09 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Feeling Feverish: Change at Day 2 | -1.0 units on a scale | Standard Deviation 1.15 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 3 | -1.1 units on a scale | Standard Deviation 1.17 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 14 | -1.5 units on a scale | Standard Deviation 1.09 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 10 | -1.3 units on a scale | Standard Deviation 1.11 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 4 | -1.6 units on a scale | Standard Deviation 1.11 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 5 | -1.1 units on a scale | Standard Deviation 1.17 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Change at Day 14 | -1.1 units on a scale | Standard Deviation 1.17 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Fatigue: Change at Day 5 | -1.7 units on a scale | Standard Deviation 1.09 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Cough: Change at Day 4 | -1.0 units on a scale | Standard Deviation 1.07 |
| Oseltamivir | Change From Baseline in Scores of Symptoms of Influenza | Sore Throat: Baseline | 1.2 units on a scale | Standard Deviation 1.19 |
Comparison: Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Comparison: Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Comparison: Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Comparison: Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Comparison: Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Comparison: Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Comparison: Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14p-value: >0.05Wilcoxon Rank Sum Test
Secondary
Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)
Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.
Time frame: Baseline, and 12, 24, 36, 48, 72, and 96 hours
Population: Among the 122 subjects with confirmed influenza (intent-to-treat infected \[ITTI\]) population, a total of 112 subjects had positive virus cultures obtained from baseline nasopharyngeal specimens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Baseline | 3.6 log10 TCID50/mL | Standard Deviation 1.33 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 12 hours | -1.5 log10 TCID50/mL | Standard Deviation 1.33 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 24 hours | -2.5 log10 TCID50/mL | Standard Deviation 0.93 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 48 hours | -2.4 log10 TCID50/mL | Standard Deviation 0.93 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 96 hours | -2.8 log10 TCID50/mL | Standard Deviation 1.28 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Baseline | 2.8 log10 TCID50/mL | Standard Deviation 1.38 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 12 hours | -1.1 log10 TCID50/mL | Standard Deviation 1.03 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 24 hours | -1.4 log10 TCID50/mL | Standard Deviation 0.92 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 48 hours | -1.8 log10 TCID50/mL | Standard Deviation 1.17 |
| Peramivir 200 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 96 hours | -2.6 log10 TCID50/mL | Standard Deviation 1.29 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 48 hours | -1.9 log10 TCID50/mL | Standard Deviation 1.16 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Baseline | 3.5 log10 TCID50/mL | Standard Deviation 1.01 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Baseline | 2.6 log10 TCID50/mL | Standard Deviation 1.35 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 96 hours | -3.0 log10 TCID50/mL | Standard Deviation 0.97 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 12 hours | -1.6 log10 TCID50/mL | Standard Deviation 1.29 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 96 hours | -2.0 log10 TCID50/mL | Standard Deviation 1.38 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 24 hours | -1.7 log10 TCID50/mL | Standard Deviation 1.22 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 24 hours | -2.2 log10 TCID50/mL | Standard Deviation 0.84 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 12 hours | -1.5 log10 TCID50/mL | Standard Deviation 1.27 |
| Peramivir 400 mg | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 48 hours | -2.9 log10 TCID50/mL | Standard Deviation 0.77 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 24 hours | -1.0 log10 TCID50/mL | Standard Deviation 0.75 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 48 hours | -2.5 log10 TCID50/mL | Standard Deviation 1.45 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 96 hours | -2.8 log10 TCID50/mL | Standard Deviation 1.05 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Baseline | 2.5 log10 TCID50/mL | Standard Deviation 1.27 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 48 hours | -1.5 log10 TCID50/mL | Standard Deviation 0.85 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 12 hours | -0.7 log10 TCID50/mL | Standard Deviation 1.12 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Baseline | 3.4 log10 TCID50/mL | Standard Deviation 1.44 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration ≥48 and ≤72 hours: Change at 96 hours | -1.7 log10 TCID50/mL | Standard Deviation 1.44 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 12 hours | -1.5 log10 TCID50/mL | Standard Deviation 1.01 |
| Oseltamivir | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Duration <48 Hours: Change at 24 hours | -2.2 log10 TCID50/mL | Standard Deviation 0.99 |
Comparison: Change from Baseline at 12 hoursp-value: >0.05Wilcoxon Rank Sum Test
Comparison: Change from Baseline at 24 hoursp-value: >0.05Wilcoxon Rank Sum Test
Comparison: Change from Baseline at 36 hoursp-value: >0.05Wilcoxon Rank Sum Test
Comparison: Change from Baseline at 48 hoursp-value: >0.05Wilcoxon Rank Sum Test
Comparison: Change from Baseline at 72 hoursp-value: >0.05Wilcoxon Rank Sum Test
Comparison: Change from Baseline at 96 hoursp-value: >0.05Wilcoxon Rank Sum Test
Secondary
Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)
The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.
Time frame: 14 days
Population: The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peramivir 200 mg | Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study) | 0 participants |
| Peramivir 400 mg | Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study) | 0 participants |
| Oseltamivir | Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study) | 0 participants |
Secondary
Time to Hospital Discharge (Kaplan-Meier Estimate)
Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.
Time frame: 14 days
Population: The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 200 mg | Time to Hospital Discharge (Kaplan-Meier Estimate) | 4.0 hours |
| Peramivir 400 mg | Time to Hospital Discharge (Kaplan-Meier Estimate) | 3.8 hours |
| Oseltamivir | Time to Hospital Discharge (Kaplan-Meier Estimate) | 4.0 hours |
p-value: 0.994Log Rank
Secondary
Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)
Changes in each subject's ability to perform usual activities as determined from the visual analog scale (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) were summarized by study visit and treatment group. The time to resumption of a subject's ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).
Time frame: 14 days
Population: The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peramivir 200 mg | Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate) | 8.8 hours |
| Peramivir 400 mg | Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate) | 9.0 hours |
| Oseltamivir | Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate) | 13.7 hours |
p-value: 0.276Log Rank