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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003002-17 | EudraCT Number | ||
| 63623872FLZ2002 | Other Identifier | Janssen Research & Development, LLC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-63623872 plus Oseltamivir | Experimental | Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. |
|
| Placebo plus Oseltamivir | Experimental | Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63623872 | Drug | Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 |
| 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). | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 |
| 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). | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresno | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32604406 | Derived | O'Neil B, Ison MG, Hallouin-Bernard MC, Nilsson AC, Torres A, Wilburn JM, van Duijnhoven W, Van Dromme I, Anderson D, Deleu S, Kosoglou T, Vingerhoets J, Rossenu S, Leopold L. A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study. J Infect Dis. 2022 Aug 12;226(1):109-118. doi: 10.1093/infdis/jiaa376. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2016 | Feb 6, 2020 |
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| Placebo | Drug | Participants will be administered placebo tablets orally twice daily for 7 days. |
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| Oseltamivir | Drug | Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days. |
|
| Up to 28 Days |
| 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 \ | Up to 14 Days |
| 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 \ | Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 |
| 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 \ | Up to Day 7 |
| 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 \ | Baseline up to Day 8 |
| 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. | Up to 28 Days |
| 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). | 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 |
| 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). | Up to 28 Days |
| 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). | Up to 28 Days |
| 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. | Day 8 |
| 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. | Up to 28 Days |
| 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?). | Up to Day 33 |
| 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. | Up to 28 Days |
| 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?). | Up to Day 33 |
| 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). | Up to Day 33 |
| 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). | 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 |
| Long Beach |
| California |
| United States |
| Stanford | California | United States |
| Atlantis | Florida | United States |
| Miami | Florida | United States |
| Chicago | Illinois | United States |
| Detroit | Michigan | United States |
| Royal Oak | Michigan | United States |
| Troy | Michigan | United States |
| Minneapolis | Minnesota | United States |
| St Louis | Missouri | United States |
| Teaneck | New Jersey | United States |
| Winston-Salem | North Carolina | United States |
| Houston | Texas | United States |
| Cairns | Australia |
| South Brisbane | Australia |
| Westmead | Australia |
| Aalst | Belgium |
| Brussels | Belgium |
| Leuven | Belgium |
| Passo Fundo | Brazil |
| Porto Alegre | Brazil |
| São Paulo | Brazil |
| Hamilton | Ontario | Canada |
| Québec | Quebec | Canada |
| Dijon | France |
| Grenoble | France |
| Limoges | France |
| Lyon | France |
| Nantes | France |
| Paris | France |
| Poitiers | France |
| Rennes | France |
| Saint-Priest-en-Jarez | France |
| Tours | France |
| Donaustauf | Germany |
| Jena | Germany |
| Hong Kong | Hong Kong |
| Kota Bharu | Malaysia |
| Kuala | Malaysia |
| Kuala Lumpur | Malaysia |
| Kuching | Malaysia |
| Malacca | Malaysia |
| Miri | Malaysia |
| Sungai Buloh | Malaysia |
| Taiping | Malaysia |
| Rotterdam | Netherlands |
| Utrecht | Netherlands |
| Zutphen | Netherlands |
| Hamilton | New Zealand |
| Singapore | Singapore |
| Alicante | Spain |
| Barcelona | Spain |
| Bizkaia | Spain |
| Elche | Spain |
| Granada | Spain |
| Madrid | Spain |
| Mataró | Spain |
| San Sebastián | Spain |
| Vigo | Spain |
| Malmö | Sweden |
| Umeå | Sweden |
| Uppsala | Sweden |
| Ankara | Turkey (Türkiye) |
| Eskişehir | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Trabzon | Turkey (Türkiye) |
| 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. |
| Full Analysis Set |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis set was defined as all participants who received at least 1 dose of study drug and analyzed as treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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). | Posted | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 |
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| 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). | 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. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 |
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| 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). | 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. | Posted | Mean | Standard Deviation | nanogram hours per milliliter (ng*h/mL) | Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3 |
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| 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. | Safety analysis set included all participants who received at least one dose of study drug(s) and were analyzed by drug received. | Posted | Count of Participants | Participants | Up to 28 Days |
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| 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 \ | 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. | Posted | Median | 95% Confidence Interval | Days | Up to 14 Days |
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| 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 \ | 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. | Posted | Mean | Standard Deviation | Log 10 vp/mL | Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 |
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| 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 \ | 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. | Posted | Median | 95% Confidence Interval | Log10 vp/mL/day | Up to Day 7 |
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| 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 \ | 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. | Posted | Mean | 95% Confidence Interval | Days*vp/mL | Baseline up to Day 8 |
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| 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. | 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. | Posted | Number | Percentage of participants | Up to 28 Days |
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| 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| 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). | 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. | Posted | Median | 95% Confidence Interval | Hours | Up to 28 Days |
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| 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). | 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. | Posted | Median | 95% Confidence Interval | Hours | Up to 28 Days |
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| 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. | 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. | Posted | Number | Percentage of Participants | Day 8 |
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| 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. | 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. | Posted | Count of Participants | Participants | Up to 28 Days |
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| 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?). | 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. | Posted | Median | 95% Confidence Interval | Hours | Up to Day 33 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | Up to 28 Days |
|
| |||||||||||||||||||||||||||||
| 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?). | 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. | Posted | Median | 95% Confidence Interval | Hours | Up to Day 33 |
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Median | 95% Confidence Interval | Hours | Up to Day 33 |
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | Percentage of participants | 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 |
|
Up to 28 days
Safety analysis set included all participants who received at least one dose of study drug(s) and were analyzed by drug received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 64 | 11 | 64 | 45 | 64 |
| EG001 | 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. | 0 | 35 | 4 | 35 | 24 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bladder outlet obstruction | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Amaurosis | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| International normalised ratio | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2017 | Mar 26, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000605010 | pimodivir |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| More than one race |
|
| Other |
|
| Unknown or Not Reported |
|
| White |
|
| FRANCE |
|
| GERMANY |
|
| HONG KONG |
|
| MALAYSIA |
|
| NETHERLANDS |
|
| SINGAPORE |
|
| SPAIN |
|
| SWEDEN |
|
| TURKEY |
|
| UNITED STATES |
|
|
|
|
| OG001 | 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. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | 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. |
|
|
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.
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|