Back to resultsA Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
Primary Purpose
Influenza A Virus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-63623872
Placebo
Oseltamivir
Sponsored by
About this trial
This is an interventional treatment trial for Influenza A Virus focused on measuring Influenza A virus, JNJ-63623872, Oseltamivir
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
JNJ-63623872 plus Oseltamivir
Placebo plus Oseltamivir
Arm Description
Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
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 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.
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.
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.
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.
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.
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 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 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).
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.
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 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 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 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 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).
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).
Full Information
NCT ID
NCT02532283
First Posted
August 21, 2015
Last Updated
March 26, 2020
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02532283
Brief Title
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 11, 2015 (Actual)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Virus
Keywords
Influenza A virus, JNJ-63623872, Oseltamivir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-63623872 plus Oseltamivir
Arm Type
Experimental
Arm Description
Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Arm Title
Placebo plus Oseltamivir
Arm Type
Experimental
Arm Description
Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
JNJ-63623872
Intervention Description
Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be administered placebo tablets orally twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Intervention Description
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Description
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
Title
Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Description
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
Title
Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Description
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
Title
Time to Influenza A Viral Negativity
Description
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
Title
Influenza Viral Load Over Time
Description
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
Title
Rate of Decline in Viral Load
Description
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
Title
Area Under the Plasma Concentration-time Curve (AUC) of Viral Load
Description
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
Title
Percentage of Participants With Influenza Complications
Description
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
Title
Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score
Description
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
Title
Time to Improvement of Vital Signs
Description
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
Title
Time to Improvement of Respiratory Status
Description
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
Title
Percentage of Participants With Clinical Outcome Based on Ordinal Scale
Description
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
Title
Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir
Description
Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported.
Time Frame
Up to 28 Days
Title
Time to Return to Premorbid Functional Status
Description
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
Title
Time to Hospital Discharge
Description
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
Title
Time to Return to Usual Health
Description
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
Title
Time to Significant Reduction in FLU-PRO Influenza Symptom Severity
Description
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
Title
Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Fresno
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Atlantis
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Teaneck
State/Province
New Jersey
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Cairns
Country
Australia
City
South Brisbane
Country
Australia
City
Westmead
Country
Australia
City
Aalst
Country
Belgium
City
Bruxelles
Country
Belgium
City
Leuven
Country
Belgium
City
Passo Fundo
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Hamilton
State/Province
Ontario
Country
Canada
City
Québec
State/Province
Quebec
Country
Canada
City
Dijon
Country
France
City
Grenoble
Country
France
City
Limoges
Country
France
City
Lyon
Country
France
City
Nantes
Country
France
City
Paris
Country
France
City
Poitiers
Country
France
City
Rennes
Country
France
City
Saint-Priest en Jarez
Country
France
City
Tours Cedex 9
Country
France
City
Donaustauf
Country
Germany
City
Jena
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Kota Bharu
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Kuala
Country
Malaysia
City
Kuching
Country
Malaysia
City
Melaka
Country
Malaysia
City
Miri
Country
Malaysia
City
Sungai Buloh
Country
Malaysia
City
Taiping
Country
Malaysia
City
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12. IPD Sharing Statement
Citations:
PubMed Identifier
32604406
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
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