Influenza A Virus
Conditions
Keywords
Influenza A virus, JNJ-63623872, Oseltamivir
Brief summary
The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to \<= 85 years) compared to adults (aged 18 to \<= 64 years) with influenza A infection.
Detailed description
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of JNJ-63623872 in combination with oseltamivir in participants with influenza A infection. The study consists of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and follow up Phase (21 Days). The duration of participation in the study for each participant is approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured. Participants' safety will be monitored throughout the study.
Interventions
DRUGJNJ-63623872
Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
DRUGPlacebo
Participants will be administered placebo tablets orally twice daily for 7 days.
DRUGOseltamivir
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection * Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay * Participants must be capable of swallowing study medication tablets and capsules * Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study * Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
Exclusion criteria
* Participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening * Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens * Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant) * Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration * Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (\<=)30 milliliter (mL)/minute (min)/1.73 meter\^2 (m\^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Pimodivir | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 | Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years). |
| Minimum Observed Plasma Concentration (Cmin) of Pimodivir | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 | Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years). |
| Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 | AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Decline in Viral Load | Up to Day 7 | Rate of decline in viral load (Log10 viral particles per milliliter per day \[log10 vp/mL/day\]) during treatment was measured by qRT-PCR. Viral Load Limit of quantification (LOQ) = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results \< LOQ and greater than \> LOD (target detected) are imputed with 2.12 log10 vp/mL. Results \<LOD (target not detected) are imputed with 0 log10 vp/mL. |
| Area Under the Plasma Concentration-time Curve (AUC) of Viral Load | Baseline up to Day 8 | Viral load AUC was determined by qRT-PCR assay of nasal swabs. Viral Load LOQ = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results \<LOQ and \>LOD (target detected) are imputed with 2.12 log10 vp/mL. Results \<LOD (target not detected) are imputed with 0 log10 vp/mL. |
| Percentage of Participants With Influenza Complications | Up to 28 Days | Percentage of participants with following Influenza Complications: bacterial pneumonia (culture confirmed where possible), bacterial superinfections, respiratory failure, pulmonary disease (example, asthma, chronic obstructive pulmonary disease \[COPD\]), cardiovascular and cerebrovascular disease (example, myocardial infarction, congestive heart failure \[CHF\], arrhythmia, stroke) and all complications were reported. |
| Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33 | FLU-PRO assesses 32 influenza symptoms in each of the following body areas (domains): Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal and Body/Systemic . Participants rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, that is (i.e), vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 (Never) to 4 (Always).The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms). |
| Time to Improvement of Vital Signs | Up to 28 Days | Time to improvement of vital signs was defined as the time from first study treatment to when at least 4 of 5 symptoms (temperature, blood oxygen saturation, heart rate, systolic blood pressure, and respiration rate) had recovered, including normalization of temperature and blood oxygen saturation. Resolution criteria for vital signs: for Temperature: oral temperature less than or equal to (\<=) 36.5 degree Celsius (C) for elderly and \<=37.2 C for adults; for oxygen saturation: greater than or equal to (\>=) 92 percent (%) on room air without supplemental oxygen; for respiratory rate: \<= 24 per minutes; for heart rate: \<= 100 per minutes and for systolic blood pressure: \>= 90 millimeters of mercury (mmHg). |
| Time to Improvement of Respiratory Status | Up to 28 Days | The time to improvement of respiratory status was defined as the time from first study treatment until the first assessment of a successive series of 3 recording where normalization of blood oxygen saturation and respiration rate occurred at respiration rate \<=24 per minutes). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) | Up to 28 Days | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir | Up to 28 Days | Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported. |
| Time to Return to Premorbid Functional Status | Up to Day 33 | Time to return to premorbid functional status (time to return usual activities) was defined as time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 7 (Have you returned to your usual activities today?). |
| Time to Hospital Discharge | Up to 28 Days | Time to hospital discharge was calculated from the date of first study drug intake during hospitalization up to date of discharge. |
| Time to Return to Usual Health | Up to Day 33 | Time to return to usual health was defined as the time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 9 (Have you returned to your health today?). |
| Time to Significant Reduction in FLU-PRO Influenza Symptom Severity | Up to Day 33 | Time to significant reduction in influenza symptom severity (mild/none) is time from first dose of investigational drug until first of 2 successive recordings in which total score for each of 2 recordings is lower or equal to 1 and all domain scores is lower or equal to 1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on 5-point scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, i.e, vomiting/diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing and coughed up mucus or phlegm evaluated on scale from 0=Never to 4=Always. FLU-PRO total score is computed as mean score across all 32 items and ranges from 0 (symptom free) to 4 (very severe symptoms). |
| Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 and 33 | Percentage of participants with significant reduction in influenza symptom severity was defined as time from first dose of investigational product until first of 2 successive recordings in which FLU-PRO total score for each of 2 recordings \<= to 1 and all FLU-PRO domain scores is \<=1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on a 5-point ordinal scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed as numerical frequency i.e, vomiting or diarrhea (0-4 or more times); with frequency of sneezing, coughing, coughed up mucus or phlegm evaluated on a scale from 0 (Never)-4 (Always). FLU-PRO total score is computed as a mean score across all 32 items comprising instrument and ranges from 0 (symptom free) to 4 (very severe symptoms). |
| Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8 | The ordinal scale was used to assess participant's clinical outcome. It consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered, where 1- Death, 2- Admitted to intensive care unit (ICU) or mechanically ventilated/ extracorporeal membrane oxygenation (ECMO), 3- Non-ICU plus supplemental oxygen, 4- Non-ICU plus no supplemental oxygen, 5- Not hospitalized, but unable to continue activity, 6- Not hospitalized (NH) and continues activities. |
| Time to Influenza A Viral Negativity | Up to 14 Days | Time to influenza A viral negativity was determined based on quantitative reverse transcription polymerase chain reaction (qRT-PCR). A participant was considered influenza A viral negative at the time point that the first negative nasal midturbinate (MT) swab was recorded (in days). Viral Load Limit of detection (LOD) = 2.18 log10 viral particles per milliliter (vp/mL). Results less than (\<) limit of quantification (LOQ) and greater than (\>) LOD (target detected) are imputed with 2.12 log10 vp/mL, results \<LOD (target not detected) are imputed with 0 log10 vp/mL. |
| Influenza Viral Load Over Time | Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 | Influenza viral load over time (Log 10 viral particles per milliliter \[vp/mL\]) was measured by qRT-PCR. Viral Load LOD = 2.18 log10 vp/mL. Results \< LOQ and \> LOD (target detected) are imputed with 2.12 log10 vp/mL and results \<LOD (target not detected) are imputed with 0 log10 vp/mL. |
Countries
Australia, Belgium, Brazil, Canada, France, Germany, Hong Kong, Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
In total, 102 participants were randomized. 3 participants were randomized but not treated due to withdrawal of consent before treatment start. Therefore, the Safety Set, comprising all participants who received at least 1 dose of study drug(s), consisted of 99 participants.
Participants by arm
| Arm | Count |
|---|---|
| Pimodivir 600 mg Plus Oseltamivir 75 mg Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value. | 64 |
| Placebo Plus Oseltamivir 75 mg Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value. | 35 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | Placebo Plus Oseltamivir 75 mg | Total | Pimodivir 600 mg Plus Oseltamivir 75 mg |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 13.71 | 57.8 years STANDARD_DEVIATION 15.21 | 58.1 years STANDARD_DEVIATION 16.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 87 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 12 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 67 Participants | 48 Participants |
| Region of Enrollment BELGIUM | 0 Participants | 3 Participants | 3 Participants |
| Region of Enrollment FRANCE | 2 Participants | 8 Participants | 6 Participants |
| Region of Enrollment GERMANY | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment HONG KONG | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment MALAYSIA | 4 Participants | 7 Participants | 3 Participants |
| Region of Enrollment NETHERLANDS | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment SINGAPORE | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment SPAIN | 7 Participants | 23 Participants | 16 Participants |
| Region of Enrollment SWEDEN | 4 Participants | 12 Participants | 8 Participants |
| Region of Enrollment TURKEY | 3 Participants | 9 Participants | 6 Participants |
| Region of Enrollment UNITED STATES | 11 Participants | 29 Participants | 18 Participants |
| Sex: Female, Male Female | 18 Participants | 45 Participants | 27 Participants |
| Sex: Female, Male Male | 17 Participants | 54 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 64 | 0 / 35 |
| other Total, other adverse events | 45 / 64 | 24 / 35 |
| serious Total, serious adverse events | 11 / 64 | 4 / 35 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Population: PK analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir | 27386 nanogram hours per milliliter (ng*h/mL) | Standard Deviation 25191 |
| Non-elderly Adults (18 to <=64 Years) | Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir | 20101 nanogram hours per milliliter (ng*h/mL) | Standard Deviation 11063 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years).
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Population: Pharmacokinetic (PK) analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Maximum Observed Plasma Concentration (Cmax) of Pimodivir | 5933 Nanogram per milliliter (ng/mL) | Standard Deviation 4427 |
| Non-elderly Adults (18 to <=64 Years) | Maximum Observed Plasma Concentration (Cmax) of Pimodivir | 5378 Nanogram per milliliter (ng/mL) | Standard Deviation 3888 |
Primary
Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
Time frame: Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Population: PK analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Minimum Observed Plasma Concentration (Cmin) of Pimodivir | 738 ng/mL | Standard Deviation 892 |
| Non-elderly Adults (18 to <=64 Years) | Minimum Observed Plasma Concentration (Cmin) of Pimodivir | 507 ng/mL | Standard Deviation 414 |
Secondary
Area Under the Plasma Concentration-time Curve (AUC) of Viral Load
Viral load AUC was determined by qRT-PCR assay of nasal swabs. Viral Load LOQ = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results \<LOQ and \>LOD (target detected) are imputed with 2.12 log10 vp/mL. Results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Time frame: Baseline up to Day 8
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Area Under the Plasma Concentration-time Curve (AUC) of Viral Load | 22.8 Days*vp/mL |
| Non-elderly Adults (18 to <=64 Years) | Area Under the Plasma Concentration-time Curve (AUC) of Viral Load | 22.1 Days*vp/mL |
Secondary
Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score
FLU-PRO assesses 32 influenza symptoms in each of the following body areas (domains): Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal and Body/Systemic . Participants rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, that is (i.e), vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 (Never) to 4 (Always).The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms).
Time frame: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 33 | -0.94 Units on a scale | — |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 3 | -0.60 Units on a scale | Standard Deviation 0.624 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 6 | -0.85 Units on a scale | Standard Deviation 0.692 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 7 | -0.87 Units on a scale | Standard Deviation 0.738 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 8 | -0.89 Units on a scale | Standard Deviation 0.729 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 10 | -0.91 Units on a scale | Standard Deviation 0.723 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 11 | -0.87 Units on a scale | Standard Deviation 0.756 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 12 | -0.87 Units on a scale | Standard Deviation 0.725 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 13 | -0.93 Units on a scale | Standard Deviation 0.702 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 14 | -0.85 Units on a scale | Standard Deviation 0.613 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 15 | -0.88 Units on a scale | Standard Deviation 0.63 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 16 | -0.84 Units on a scale | Standard Deviation 0.588 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 18 | -1.06 Units on a scale | Standard Deviation 0.753 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 19 | -1.06 Units on a scale | Standard Deviation 0.749 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 20 | -1.03 Units on a scale | Standard Deviation 0.71 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 1 | -0.08 Units on a scale | Standard Deviation 0.247 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 2 | -0.48 Units on a scale | Standard Deviation 0.644 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 9 | -0.93 Units on a scale | Standard Deviation 0.764 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 17 | -0.98 Units on a scale | Standard Deviation 0.69 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 21 | -1.00 Units on a scale | Standard Deviation 0.701 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 22 | -1.02 Units on a scale | Standard Deviation 0.789 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 23 | -1.11 Units on a scale | Standard Deviation 0.858 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 24 | -0.87 Units on a scale | Standard Deviation 0.534 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 25 | -0.94 Units on a scale | Standard Deviation 0.659 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 26 | -0.86 Units on a scale | Standard Deviation 0.755 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 27 | -1.02 Units on a scale | Standard Deviation 0.745 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 28 | -0.60 Units on a scale | Standard Deviation 0.505 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 29 | -1.13 Units on a scale | Standard Deviation 0.354 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 30 | -0.61 Units on a scale | Standard Deviation 0.552 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 31 | -0.75 Units on a scale | — |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 32 | -0.61 Units on a scale | Standard Deviation 0.42 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 4 | -0.71 Units on a scale | Standard Deviation 0.702 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 5 | -0.76 Units on a scale | Standard Deviation 0.689 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 3 | -0.52 Units on a scale | Standard Deviation 0.641 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 20 | -1.03 Units on a scale | Standard Deviation 0.847 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 4 | -0.56 Units on a scale | Standard Deviation 0.625 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 27 | -0.74 Units on a scale | Standard Deviation 0.734 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 5 | -0.67 Units on a scale | Standard Deviation 0.643 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 1 | -0.11 Units on a scale | Standard Deviation 0.349 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 6 | -0.75 Units on a scale | Standard Deviation 0.659 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 24 | -0.91 Units on a scale | Standard Deviation 0.58 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 7 | -0.69 Units on a scale | Standard Deviation 0.623 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 29 | -1.63 Units on a scale | Standard Deviation 0.398 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 8 | -0.80 Units on a scale | Standard Deviation 0.764 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 9 | -0.84 Units on a scale | Standard Deviation 0.732 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 10 | -0.81 Units on a scale | Standard Deviation 0.743 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 13 | -0.94 Units on a scale | Standard Deviation 0.65 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 11 | -0.76 Units on a scale | Standard Deviation 0.534 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 25 | -0.85 Units on a scale | Standard Deviation 0.661 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 12 | -0.89 Units on a scale | Standard Deviation 0.695 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 17 | -0.97 Units on a scale | Standard Deviation 0.774 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 28 | -0.82 Units on a scale | Standard Deviation 0.675 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 14 | -0.92 Units on a scale | Standard Deviation 0.67 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 21 | -0.98 Units on a scale | Standard Deviation 0.849 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 15 | -0.90 Units on a scale | Standard Deviation 0.724 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 26 | -0.87 Units on a scale | Standard Deviation 0.742 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 16 | -0.90 Units on a scale | Standard Deviation 0.762 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 22 | -0.92 Units on a scale | Standard Deviation 0.69 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 18 | -1.00 Units on a scale | Standard Deviation 0.868 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 2 | -0.33 Units on a scale | Standard Deviation 0.798 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 19 | -1.05 Units on a scale | Standard Deviation 0.88 |
| Non-elderly Adults (18 to <=64 Years) | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score | Day 23 | -0.96 Units on a scale | Standard Deviation 0.731 |
Secondary
Influenza Viral Load Over Time
Influenza viral load over time (Log 10 viral particles per milliliter \[vp/mL\]) was measured by qRT-PCR. Viral Load LOD = 2.18 log10 vp/mL. Results \< LOQ and \> LOD (target detected) are imputed with 2.12 log10 vp/mL and results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Time frame: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 7 | 1.95 Log 10 vp/mL | Standard Deviation 1.478 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Baseline | 5.45 Log 10 vp/mL | Standard Deviation 1.737 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 8 | 1.82 Log 10 vp/mL | Standard Deviation 1.709 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 9 | 1.51 Log 10 vp/mL | Standard Deviation 1.034 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 4 | 3.00 Log 10 vp/mL | Standard Deviation 1.486 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 10 | 1.39 Log 10 vp/mL | Standard Deviation 1.676 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 2 | 4.75 Log 10 vp/mL | Standard Deviation 1.29 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 11 | 0.42 Log 10 vp/mL | Standard Deviation 1.017 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 5 | 2.57 Log 10 vp/mL | Standard Deviation 1.716 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 12 | 1.06 Log 10 vp/mL | Standard Deviation 1.499 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 13 | 1.06 Log 10 vp/mL | Standard Deviation 1.499 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 14 | 1.05 Log 10 vp/mL | Standard Deviation 1.636 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 1 | 6.40 Log 10 vp/mL | Standard Deviation 0.757 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 6 | 2.07 Log 10 vp/mL | Standard Deviation 1.454 |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Influenza Viral Load Over Time | Day 3 | 3.83 Log 10 vp/mL | Standard Deviation 1.31 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 14 | 0.20 Log 10 vp/mL | Standard Deviation 0.646 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Baseline | 5.90 Log 10 vp/mL | Standard Deviation 1.513 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 1 | 4.43 Log 10 vp/mL | — |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 2 | 4.63 Log 10 vp/mL | Standard Deviation 1.757 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 3 | 3.98 Log 10 vp/mL | Standard Deviation 1.924 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 4 | 3.14 Log 10 vp/mL | Standard Deviation 1.806 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 5 | 2.60 Log 10 vp/mL | Standard Deviation 1.803 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 6 | 2.18 Log 10 vp/mL | Standard Deviation 2.457 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 7 | 2.38 Log 10 vp/mL | Standard Deviation 2.212 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 9 | 0.00 Log 10 vp/mL | — |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 10 | 0.99 Log 10 vp/mL | Standard Deviation 1.295 |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 11 | 0.00 Log 10 vp/mL | — |
| Non-elderly Adults (18 to <=64 Years) | Influenza Viral Load Over Time | Day 8 | 1.43 Log 10 vp/mL | Standard Deviation 1.648 |
Secondary
Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir
Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported.
Time frame: Up to 28 Days
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir | Emergence of Pimodivir Mutation | 0 Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir | Emergence of OST Mutation | 0 Participants |
| Non-elderly Adults (18 to <=64 Years) | Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir | Emergence of Pimodivir Mutation | 0 Participants |
| Non-elderly Adults (18 to <=64 Years) | Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir | Emergence of OST Mutation | 1 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to 28 Days
Population: Safety analysis set included all participants who received at least one dose of study drug(s) and were analyzed by drug received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) | TESAEs | 11 Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) | TEAEs | 48 Participants |
| Non-elderly Adults (18 to <=64 Years) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) | TEAEs | 25 Participants |
| Non-elderly Adults (18 to <=64 Years) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) | TESAEs | 4 Participants |
Secondary
Percentage of Participants With Clinical Outcome Based on Ordinal Scale
The ordinal scale was used to assess participant's clinical outcome. It consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered, where 1- Death, 2- Admitted to intensive care unit (ICU) or mechanically ventilated/ extracorporeal membrane oxygenation (ECMO), 3- Non-ICU plus supplemental oxygen, 4- Non-ICU plus no supplemental oxygen, 5- Not hospitalized, but unable to continue activity, 6- Not hospitalized (NH) and continues activities.
Time frame: Day 8
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: NH and Continues Activities | 40.3 Percentage of Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: NH, but Unable to Continue Activity | 27.4 Percentage of Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Non-ICU+No Supplemental Oxygen | 14.5 Percentage of Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Non-ICU+Supplemental Oxygen | 8.1 Percentage of Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Death | 1.6 Percentage of Participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Missing | 8.1 Percentage of Participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Death | 0 Percentage of Participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: NH and Continues Activities | 29.0 Percentage of Participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Non-ICU+Supplemental Oxygen | 3.2 Percentage of Participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: NH, but Unable to Continue Activity | 45.2 Percentage of Participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Missing | 16.1 Percentage of Participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Clinical Outcome Based on Ordinal Scale | Day 8: Non-ICU+No Supplemental Oxygen | 6.5 Percentage of Participants |
Secondary
Percentage of Participants With Influenza Complications
Percentage of participants with following Influenza Complications: bacterial pneumonia (culture confirmed where possible), bacterial superinfections, respiratory failure, pulmonary disease (example, asthma, chronic obstructive pulmonary disease \[COPD\]), cardiovascular and cerebrovascular disease (example, myocardial infarction, congestive heart failure \[CHF\], arrhythmia, stroke) and all complications were reported.
Time frame: Up to 28 Days
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Influenza Complications | All complications | 7.9 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Influenza Complications | Bacterial pneumonia | 0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Influenza Complications | Bacterial superinfections | 1.6 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Influenza Complications | Respiratory failure | 1.6 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Influenza Complications | Pulmonary disease | 3.2 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Influenza Complications | Cardiovascular and Cerebrovascular disease | 1.6 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Influenza Complications | Pulmonary disease | 6.3 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Influenza Complications | All complications | 15.6 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Influenza Complications | Respiratory failure | 0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Influenza Complications | Bacterial pneumonia | 0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Influenza Complications | Cardiovascular and Cerebrovascular disease | 0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Influenza Complications | Bacterial superinfections | 3.1 Percentage of participants |
Secondary
Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)
Percentage of participants with significant reduction in influenza symptom severity was defined as time from first dose of investigational product until first of 2 successive recordings in which FLU-PRO total score for each of 2 recordings \<= to 1 and all FLU-PRO domain scores is \<=1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on a 5-point ordinal scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed as numerical frequency i.e, vomiting or diarrhea (0-4 or more times); with frequency of sneezing, coughing, coughed up mucus or phlegm evaluated on a scale from 0 (Never)-4 (Always). FLU-PRO total score is computed as a mean score across all 32 items comprising instrument and ranges from 0 (symptom free) to 4 (very severe symptoms).
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 and 33
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 15 | 63.9 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 2 | 37.3 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 3 | 36.4 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 4 | 42.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 5 | 54.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 6 | 59.2 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 7 | 55.1 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 8 | 62.7 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 9 | 76.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 10 | 76.5 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 11 | 70.2 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 12 | 77.1 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 13 | 76.1 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 14 | 77.1 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 16 | 71.4 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 17 | 74.3 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 18 | 70.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 19 | 77.4 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 20 | 81.8 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 21 | 79.4 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 22 | 86.2 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 23 | 78.1 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 24 | 86.2 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 25 | 92.3 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 26 | 81.5 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 28 | 77.8 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 29 | 80.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 30 | 100.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 31 | 100.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 32 | 100.0 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 33 | 100 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 27 | 83.3 Percentage of participants |
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 1 | 9.4 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 26 | 57.1 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 15 | 57.9 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 27 | 50.0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 1 | 18.2 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 16 | 66.7 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 2 | 34.6 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 23 | 70.6 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 3 | 26.7 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 17 | 63.2 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 4 | 38.5 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 29 | 66.7 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 5 | 37.5 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 18 | 57.9 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 6 | 40.0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 24 | 66.7 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 7 | 34.8 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 19 | 58.8 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 8 | 32.0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 28 | 44.4 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 9 | 38.5 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 20 | 63.2 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 10 | 53.8 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 25 | 69.2 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 11 | 59.1 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 21 | 60.0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 12 | 72.0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 30 | 0 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 13 | 69.2 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 22 | 61.1 Percentage of participants |
| Non-elderly Adults (18 to <=64 Years) | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) | Day 14 | 65.4 Percentage of participants |
Secondary
Rate of Decline in Viral Load
Rate of decline in viral load (Log10 viral particles per milliliter per day \[log10 vp/mL/day\]) during treatment was measured by qRT-PCR. Viral Load Limit of quantification (LOQ) = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results \< LOQ and greater than \> LOD (target detected) are imputed with 2.12 log10 vp/mL. Results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Time frame: Up to Day 7
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Rate of Decline in Viral Load | -0.35 Log10 vp/mL/day |
| Non-elderly Adults (18 to <=64 Years) | Rate of Decline in Viral Load | -0.42 Log10 vp/mL/day |
Secondary
Time to Hospital Discharge
Time to hospital discharge was calculated from the date of first study drug intake during hospitalization up to date of discharge.
Time frame: Up to 28 Days
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Hospital Discharge | 4.00 Days |
| Non-elderly Adults (18 to <=64 Years) | Time to Hospital Discharge | 4.00 Days |
Secondary
Time to Improvement of Respiratory Status
The time to improvement of respiratory status was defined as the time from first study treatment until the first assessment of a successive series of 3 recording where normalization of blood oxygen saturation and respiration rate occurred at respiration rate \<=24 per minutes).
Time frame: Up to 28 Days
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Improvement of Respiratory Status | 33.53 Hours |
| Non-elderly Adults (18 to <=64 Years) | Time to Improvement of Respiratory Status | 40.57 Hours |
Secondary
Time to Improvement of Vital Signs
Time to improvement of vital signs was defined as the time from first study treatment to when at least 4 of 5 symptoms (temperature, blood oxygen saturation, heart rate, systolic blood pressure, and respiration rate) had recovered, including normalization of temperature and blood oxygen saturation. Resolution criteria for vital signs: for Temperature: oral temperature less than or equal to (\<=) 36.5 degree Celsius (C) for elderly and \<=37.2 C for adults; for oxygen saturation: greater than or equal to (\>=) 92 percent (%) on room air without supplemental oxygen; for respiratory rate: \<= 24 per minutes; for heart rate: \<= 100 per minutes and for systolic blood pressure: \>= 90 millimeters of mercury (mmHg).
Time frame: Up to 28 Days
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Improvement of Vital Signs | 169.92 Hours |
| Non-elderly Adults (18 to <=64 Years) | Time to Improvement of Vital Signs | 69.90 Hours |
Secondary
Time to Influenza A Viral Negativity
Time to influenza A viral negativity was determined based on quantitative reverse transcription polymerase chain reaction (qRT-PCR). A participant was considered influenza A viral negative at the time point that the first negative nasal midturbinate (MT) swab was recorded (in days). Viral Load Limit of detection (LOD) = 2.18 log10 viral particles per milliliter (vp/mL). Results less than (\<) limit of quantification (LOQ) and greater than (\>) LOD (target detected) are imputed with 2.12 log10 vp/mL, results \<LOD (target not detected) are imputed with 0 log10 vp/mL.
Time frame: Up to 14 Days
Population: Full Analysis set (FAS) was defined as all randomly assigned participants who received at least 1 dose of study drug and who had a confirmed infection with influenza A.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Influenza A Viral Negativity | 9.53 Days |
| Non-elderly Adults (18 to <=64 Years) | Time to Influenza A Viral Negativity | 9.74 Days |
Secondary
Time to Return to Premorbid Functional Status
Time to return to premorbid functional status (time to return usual activities) was defined as time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 7 (Have you returned to your usual activities today?).
Time frame: Up to Day 33
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Return to Premorbid Functional Status | 142.85 Hours |
| Non-elderly Adults (18 to <=64 Years) | Time to Return to Premorbid Functional Status | 154.83 Hours |
Secondary
Time to Return to Usual Health
Time to return to usual health was defined as the time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 9 (Have you returned to your health today?).
Time frame: Up to Day 33
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Return to Usual Health | 217.05 Hours |
| Non-elderly Adults (18 to <=64 Years) | Time to Return to Usual Health | 338.83 Hours |
Secondary
Time to Significant Reduction in FLU-PRO Influenza Symptom Severity
Time to significant reduction in influenza symptom severity (mild/none) is time from first dose of investigational drug until first of 2 successive recordings in which total score for each of 2 recordings is lower or equal to 1 and all domain scores is lower or equal to 1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on 5-point scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, i.e, vomiting/diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing and coughed up mucus or phlegm evaluated on scale from 0=Never to 4=Always. FLU-PRO total score is computed as mean score across all 32 items and ranges from 0 (symptom free) to 4 (very severe symptoms).
Time frame: Up to Day 33
Population: FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) | Time to Significant Reduction in FLU-PRO Influenza Symptom Severity | 118.45 Hours |
| Non-elderly Adults (18 to <=64 Years) | Time to Significant Reduction in FLU-PRO Influenza Symptom Severity | 218.72 Hours |