A Phase 3 interventional study of Pimodivir 600 mg and Placebo in Influenza A, sponsored by Janssen Research & Development, LLC. Terminated at 427 sites in 38 countries. Open to participants aged 13 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent (13 to 17 years), adult (18 to 65 years), and elderly (greater than [>] 65 but less than or equal to [\<=] 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days.
Exclusion Criteria:
Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE).
Drug: Pimodivir 600 mg · Other: SOC Treatment
Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 \[evening\], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Drug: Placebo · Other: SOC Treatment
Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6).
Also known as: JNJ-63623872
Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 \[evening\], dosing will continue until the morning of Day 6).
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).
Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Time frame: Up to Day 28
Number of Participants Hospitalized After Treatment Initiation
The number of participants hospitalized after treatment initiation were reported.
Time frame: Up to Day 28
Viral Load Over Time
Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
Time frame: Baseline, Day 3, 6, 10, 14
Number of Participants With Emergence of Viral Resistance to Pimodivir
Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
Time frame: Up to Day 28
Plasma Concentration of Pimodivir
Plasma concentration of Pimodivir was reported.
Time frame: Day 3, 6, 7
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to Day 28
Number of Participants With Clinically Significant Changes in Laboratory Tests
Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.
Time frame: Up to Day 28
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.
Time frame: Up to Day 28
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.
Time frame: Up to Day 28
| Milestone | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Started | 276 | 277 |
| Treated | 273 | 271 |
| Completed | 260 | 258 |
| Not completed | 16 | 19 |
| Withdrew: Withdrawal by subject | 7 | 7 |
| Withdrew: Other | 0 | 1 |
| Withdrew: Lost to follow-up | 5 | 4 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Randomized, not treated | 3 | 6 |
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
| hours | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ) | 92.62 (77.60 to 104.20) | 105.13 (92.73 to 128.63) |
The number of participants hospitalized after treatment initiation were reported.
| Participants | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Number of Participants Hospitalized After Treatment Initiation | 4 | 4 |
Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
| log 10 viral particles per milliliter | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Baseline | 5.891 ± 1.5745 | 5.914 ± 1.4947 |
| Day 3 | 3.558 ± 1.1918 | 4.244 ± 1.3535 |
| Day 6 | 2.644 ± 0.9159 | 2.833 ± 1.0432 |
| Day 10 | 2.234 ± 0.4586 | 2.289 ± 0.6279 |
| Day 14 | 2.153 ± 0.3904 | 2.162 ± 0.4355 |
Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
| Participants | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Number of Participants With Emergence of Viral Resistance to Pimodivir | 4 | 0 |
Plasma concentration of Pimodivir was reported.
| nanograms per milliliter (ng/mL) | Pimodivir + SOC |
|---|---|
| Day 3 | 1233.0 ± 1912.6 |
| Day 6 | 933.8 ± 2131.4 |
| Day 7 | 276.7 ± 308.6 |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
| Participants | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 123 | 101 |
Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.
| Participants | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Laboratory Tests | 0 | 0 |
Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.
| Participants | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | 0 | 0 |
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.
| Participants | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs | 0 | 0 |
Collected over Up to Day 28. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pimodivir + SOC | 0/273 (0%) | 3/273 (1.1%) | 122/273 (44.7%) |
| Placebo + SOC | 1/271 (0.4%) | 4/271 (1.5%) | 99/271 (36.5%) |
| Event | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| BacteraemiaInfections and infestations | 0/273 | 1/271 |
| Pneumonia PneumococcalInfections and infestations | 0/273 | 1/271 |
| Streptococcal SepsisInfections and infestations | 0/273 | 1/271 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/273 | 1/271 |
| AtelectasisRespiratory, thoracic and mediastinal disorders | 0/273 | 1/271 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 1/273 | 0/271 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/273 | 0/271 |
| Event | Pimodivir + SOC | Placebo + SOC |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 54/273 | 18/271 |
| Urinary Tract InfectionInfections and infestations | 11/273 | 2/271 |
| NauseaGastrointestinal disorders | 9/273 | 10/271 |
| VomitingGastrointestinal disorders | 5/273 | 9/271 |
| BronchitisInfections and infestations | 7/273 | 9/271 |
| NeutropeniaBlood and lymphatic system disorders | 3/273 | 7/271 |
| SinusitisInfections and infestations | 7/273 | 4/271 |
| Back PainMusculoskeletal and connective tissue disorders | 1/273 | 6/271 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 5/273 | 5/271 |
| PyrexiaGeneral disorders | 2/273 | 4/271 |
The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
| Age, Continuous(years) | Pimodivir + SOC | Placebo + SOC | Total |
|---|---|---|---|
| Mean | 51.1 ± 16.6 | 50.3 ± 17.35 | 50.7 ± 16.97 |
| Sex: Female, Male(Participants) | Pimodivir + SOC | Placebo + SOC | Total |
|---|---|---|---|
| Female | 152 | 141 | 293 |
| Male | 121 | 130 | 251 |
| Ethnicity (NIH/OMB)(Participants) | Pimodivir + SOC | Placebo + SOC | Total |
|---|---|---|---|
| Hispanic or Latino | 83 | 89 | 172 |
| Not Hispanic or Latino | 185 | 178 | 363 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Pimodivir + SOC | Placebo + SOC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 4 | 6 |
| Asian | 27 | 34 | 61 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 33 | 28 | 61 |
| White | 206 | 201 | 407 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Region of Enrollment(Participants) | Pimodivir + SOC | Placebo + SOC | Total |
|---|---|---|---|
| ARGENTINA | 13 | 12 | 25 |
| AUSTRALIA | 2 | 1 | 3 |
| BELGIUM | 3 | 1 | 4 |
| BRAZIL | 1 | 0 | 1 |
| BULGARIA | 8 | 2 | 10 |
| CANADA | 1 | 3 | 4 |
| ESTONIA | 0 | 1 | 1 |
| FRANCE | 1 | 1 | 2 |
| GERMANY | 2 | 2 | 4 |
| HUNGARY | 1 | 1 | 2 |
| INDIA | 5 | 3 | 8 |
| ITALY | 0 | 3 | 3 |
| LATVIA | 1 | 0 | 1 |
| LITHUANIA | 6 | 5 | 11 |
| MALAYSIA | 1 | 0 | 1 |
| MEXICO | 3 | 4 | 7 |
| POLAND | 1 | 2 | 3 |
| RUSSIAN FEDERATION | 1 | 1 | 2 |
| SOUTH AFRICA | 25 | 33 | 58 |
| SOUTH KOREA | 0 | 2 | 2 |
| SPAIN | 1 | 1 | 2 |
| SWEDEN | 1 | 0 | 1 |
| TAIWAN | 2 | 4 | 6 |
| THAILAND | 8 | 5 | 13 |
| TURKEY | 2 | 2 | 4 |
| UKRAINE | 6 | 4 | 10 |
| UNITED KINGDOM | 0 | 1 | 1 |
| UNITED STATES | 178 | 177 | 355 |
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