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A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376321
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date May 13, 2020
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
Participant's Clinical Status Assessed by Hospital Recovery Scale [ Time Frame: Day 6 ]
The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    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.
  • Number of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Blood samples for hematology, serum chemistry, and urinalysis will be collected at predefined time points for clinical laboratory testing.
  • Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Screening, Days 28 and 33 ]
    A 12-lead ECG will be performed. An ECG recorded within 1 calendar day before signing of the informed consent form (ICF)/assent form can be used in lieu of the baseline ECG requirement.
  • Number of Participants With Vital Signs abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants with vital signs (temperature, pulse rate, respiratory rate and blood pressure) abnormalities will be reported.
  • Number of Participants With Peripheral Capillary Oxygen Saturation (SpO2) Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants with SpO2 abnormalities will be reported.
  • Time From Study Drug Start to Hospital Discharge [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Total length of hospital stay includes total days of hospital stay that is, the time from start of study drug to hospital discharge.
  • Time From Intensive Care Unit (ICU) Admission to ICU Discharge [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    In the event that a participant required intensive care, the duration for how long the participant remained in the ICU that is (i.e.) the time from ICU admission to ICU discharge will be measured.
  • Time From Start to End of Mechanical Ventilation [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time from start to end of mechanical ventilation will be measured.
  • Participant's Clinical Status Assessed by Hospital Recovery Scale [ Time Frame: Days 2 to 5 and 7 to 14 ]
    The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.
  • Time to Return to Daily Activities [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to return to daily activities will be assessed by means of the participant's response to the question 'Over the past 24 hours, how much has influenza interfered with your ability to carry out your daily activities'. Participants will respond to the above question via an electronic Patient-reported Outcome (ePRO) device by means of the following response scale: Not at all; A little bit; Somewhat; Quite a bit; Very much.
  • Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Percentage of participants with complications associated with influenza after the start of study will be reported. Complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).
  • Number of Participants with All-cause Mortality [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    The number of participants who died due to any cause while on treatment will be assessed.
  • Percentage of Participants Receiving Antibiotic Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Percentage of participants receiving antibiotic treatment will be reported.
  • Duration of Antibiotic Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Duration of antibiotic treatment taken will be reported.
  • Number of Participants Receiving Extended Treatment [ Time Frame: Day 6 ]
    Number of participants receiving extended treatment will be reported.
  • Number of Participants Requiring Re-hospitalization [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants requiring re-hospitalization will be reported.
  • Number of Participants not Hospitalized at Day 6 [ Time Frame: Day 6 ]
    Number of participants not hospitalized at Day 6 will be reported.
  • Time to Clinical Response [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to achieve the clinical response will be determined. Clinical response is defined as achieving 4 of the 5 following vital signs resolution criteria, including at least the fever and oxygen saturation criteria, maintained for at least 24 hours: having no fever (without the use of antipyretics within 8 hours), oxygen saturation of at least 94 percent (%) without oxygen supplementation or return to pre-influenza infection oxygen saturation (in patients with a known pre-influenza oxygen saturation level less than [<] 94%), improved respiratory status (a respiratory rate less than or equal to [<=]24 breaths per min without supplemental oxygen or return to pre-influenza infection supplemental oxygen requirement in patients with chronic oxygen use), heart rate 100 beats per minute or lower, systolic blood pressure of 90 millimeter of mercury (mmHg) or higher without inotropic support given within 2 hours of assessment.
  • Time to Respiratory Response [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to improvement of respiratory response will be determined. Respiratory response is defined as achieving the following 2 criteria for at least 24 hours: improved oxygen saturation of at least 94 percent (%) without oxygen supplementation (return to pre-influenza infection oxygen saturation in patients with a known pre-influenza oxygen saturation level <94%) and improved respiratory status characterized by a respiratory rate <=24 breaths per min without supplemental oxygen or return to pre-influenza infection supplemental oxygen requirement in patients with chronic oxygen use.
  • Maximum Plasma Concentration (Cmax) of pimodivir [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The Cmax is the maximum plasma concentration after a dose of pimodivir.
  • Trough Plasma Concentration (Ctrough) of Pimodivir [ Time Frame: Day 3: pre-dose; Day 5: pre-dose; and Day 6: 12 hours post dose ]
    The (Ctrough) is the plasma concentration just prior to the beginning or at the end of a dosing interval.
  • Time to Reach Maximum Plasma Concentration (tmax) of Pimodivir [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The tmax is defined as time to reach maximum analyte plasma concentration.
  • Area Under the Plasma Concentration-Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12) [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The AUC(0-12) is the area under the plasma concentration-time curve from time zero to 12 hours.
  • Time to Influenza Viral Negativity [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Time to influenza viral negativity will be determined by quantitative real time - polymerase chain reaction (qRT-PCR) and viral culture from nasal mid-turbinate (MT) swabs.
  • Viral Load Over Time [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Viral load over time will be measured by qRT-PCR and viral culture in the MT nasal swabs and endotracheal samples.
  • Number of Participants with Emergence of Viral Resistance to Pimodivir [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Emergence of viral resistance to pimodivir will be detected by genotyping and/or phenotyping.
  • Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire [ Time Frame: Days 1 and 5 (evening) or 6 (morning) ]
    Acceptability of the pimodivir formulation in adolescents will be measured by a taste questionnaire. For overall taste, questions will be answered on a following response scale: No taste, Weak taste, Moderate taste, and Strong taste.
  • Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire [ Time Frame: Days 1 and 5 (evening) or 6 (morning) ]
    Acceptability of the pimodivir formulation in adolescents will be measured by a swallowability questionnaire. Swallowability questions will be answered on a response scale of 1 to 7: 1. Very difficult; 2. Moderately difficult; 3. Slightly difficult; 4. Neither difficult or easy; 5. Slightly easy; 6. Moderately easy; and 7. Very easy.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    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.
  • Number of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Blood samples for hematology, serum chemistry, and urinalysis will be collected at predefined time points for clinical laboratory testing.
  • Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Screening, Days 28 and 33 ]
    A 12-lead ECG will be performed.
  • Number of Participants With Vital Signs abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants with vital signs (temperature, pulse rate, respiratory rate and blood pressure) abnormalities will be reported.
  • Number of Participants With Peripheral Capillary Oxygen Saturation (SpO2) Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants with SpO2 abnormalities will be reported.
  • Length of Hospital Stay [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Length of hospital stay includes total days length of hospital stay from admission to discharge.
  • Length of Time in the Intensive Care Unit (ICU) [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    In the event that a participant required intensive care, the duration for how long the participant remained in the ICU will be measured.
  • Length of Time on Mechanical Ventilation [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Length of time requiring mechanical ventilation will be measured.
  • Participant's Clinical Status Assessed by Hospital Recovery Scale [ Time Frame: Days 4 to 5 and 7 to 14 ]
    The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.
  • Time to Return to Daily Activities [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to return to daily activities will be assessed by means of the participant's response to the question 'Over the past 24 hours, how much has influenza interfered with your ability to carry out your daily activities'. Participants will respond to the above question via an electronic Patient-reported Outcome (ePRO) device by means of the following response scale: Not at all; A little bit; Somewhat; Quite a bit; Very much.
  • Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Percentage of participants with complications associated with influenza after the start of study will be reported. Complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).
  • Number of Participants with All-cause Mortality [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    The number of participants who died due to any cause while on treatment will be assessed.
  • Percentage of Participants Receiving Antibiotic Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Percentage of participants receiving antibiotic treatment will be reported.
  • Duration of Antibiotic Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Duration of antibiotic treatment taken will be reported.
  • Number of Participants Receiving Extended Treatment [ Time Frame: Day 6 ]
    Number of participants receiving extended treatment will be reported.
  • Number of Participants Requiring Re-hospitalization [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants requiring re-hospitalization will be reported.
  • Number of Participants not Hospitalized at Day 6 [ Time Frame: Day 6 ]
    Number of participants not hospitalized at Day 6 will be reported.
  • Time to Clinical Response [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to achieve the clinical response will be determined. Clinical response is defined as achieving 4 of the 5 following vital signs resolution criteria, including at least the fever and oxygen saturation criteria, maintained for at least 24 hours: having no fever (without the use of antipyretics within 8 hours), oxygen saturation of at least 94 percent (%) without oxygen supplementation for at least 24 hours, improved respiratory status (return to pre- influenza infection oxygen requirement in participants with chronic oxygen use, or a respiratory rate less than or equal to 24 breaths per min without supplemental oxygen), heart rate 100 beats per minute or lower, systolic blood pressure of 90 millimeter of mercury (mmHg) or higher without inotropic support given within 2 hours of assessment.
  • Time to Respiratory Response [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to improvement of respiratory response will be determined. Improvement of respiratory response is defined as meeting both the oxygen saturation and respiration status criterion.
  • Maximum Plasma Concentration (Cmax) of pimodivir [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The Cmax is the maximum plasma concentration after a dose of pimodivir.
  • Trough Plasma Concentration (Ctrough) of Pimodivir [ Time Frame: Day 3: pre-dose; Day 5: pre-dose; and Day 6: 12 hours post dose ]
    The (Ctrough) is the plasma concentration just prior to the beginning or at the end of a dosing interval.
  • Time to Reach Maximum Plasma Concentration (tmax) of Pimodivir [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The tmax is defined as time to reach maximum analyte plasma concentration.
  • Area Under the Plasma Concentration-Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12) [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The AUC(0-12) is the area under the plasma concentration-time curve from time zero to 12 hours.
  • Time to Influenza Viral Negativity [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Time to influenza viral negativity will be determined by quantitative real time - polymerase chain reaction (qRT-PCR) and viral culture from nasal mid-turbinate (MT) swabs.
  • Viral Load Over Time [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Viral load over time will be measured by qRT-PCR and viral culture in the MT nasal swabs and endotracheal samples.
  • Number of Participants with Emergence of Viral Resistance to Pimodivir [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Emergence of viral resistance to pimodivir will be detected by genotyping and/or phenotyping.
  • Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire [ Time Frame: Days 1 and 5 (evening) or 6 (morning) ]
    Acceptability of the pimodivir formulation in adolescents will be measured by a taste questionnaire. For overall taste, questions will be answered on a following response scale: No taste, Weak taste, Moderate taste, and Strong taste.
  • Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire [ Time Frame: Days 1 and 5 (evening) or 6 (morning) ]
    Acceptability of the pimodivir formulation in adolescents will be measured by a swallowability questionnaire. Swallowability questions will be answered on a response scale of 1 to 7: 1. Very difficult; 2. Moderately difficult; 3. Slightly difficult; 4. Neither difficult or easy; 5. Slightly easy; 6. Moderately easy; and 7. Very easy.
  • Virologic Response by Baseline Viral Resistance to Pimodivir/Other Antivirals [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Virologic response by baseline viral resistance to pimodivir/other antivirals will be determined by qRT-PCR and viral culture.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection
Official Title  ICMJE A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
Brief Summary 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.
Detailed Description 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, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Influenza A
Intervention  ICMJE
  • Drug: Pimodivir 600 mg
    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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).
  • Drug: Placebo
    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 who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).
  • Other: SOC Treatment
    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 started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Study Arms  ICMJE
  • Experimental: Treatment Arm 1 (pimodivir + Standard-of-Care [SOC] treatment)
    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 SOC treatment. Participants who meet all treatment extension criteria as defined in the protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment is determined by investigator based on local practice, may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of SOC cannot be changed (example, switching one influenza antiviral for another) during either treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in case of suspected adverse event (AE).
    Interventions:
    • Drug: Pimodivir 600 mg
    • Other: SOC Treatment
  • Placebo Comparator: Treatment Arm 2 (placebo + 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 morning of Day 6) along with SOC treatment. Participants who meet all treatment extension criteria as defined in protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment determined by investigator based on local practice, 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 of first study drug intake. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either treatment period/extension phase, with the exception that an influenza antiviral may be discontinued in case of a suspected AE.
    Interventions:
    • Drug: Placebo
    • Other: SOC Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
  • Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU)
  • Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms
  • Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening
  • Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4

Exclusion Criteria:

  • Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening
  • Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
  • Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
  • Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
  • Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant)
  • Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czechia,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Peru,   Poland,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries Romania,   Slovenia
 
Administrative Information
NCT Number  ICMJE NCT03376321
Other Study ID Numbers  ICMJE CR108399
2017-002156-84 ( EudraCT Number )
63623872FLZ3001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP