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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03376321




Registration number
NCT03376321
Ethics application status
Date submitted
12/12/2017
Date registered
18/12/2017
Date last updated
14/04/2021

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2017-002156-84
Secondary ID [2] 0 0
CR108399
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Pimodivir 600 mg
Treatment: Drugs - Placebo
Other interventions - SOC Treatment

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).

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.


Treatment: Drugs: 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).

Treatment: Drugs: 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 interventions: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Hospital Recovery Scale on Day 6
Timepoint [1] 0 0
Day 6
Secondary outcome [1] 0 0
Time to Hospital Discharge
Timepoint [1] 0 0
Up to Day 33
Secondary outcome [2] 0 0
Number of Participants With Adjudicated Influenza Complications
Timepoint [2] 0 0
Up to Day 33
Secondary outcome [3] 0 0
Viral Load Over Time
Timepoint [3] 0 0
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
Secondary outcome [4] 0 0
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Timepoint [4] 0 0
Up to Day 33
Secondary outcome [5] 0 0
Number of Participants With Emergence of Viral Resistance to Pimodivir
Timepoint [5] 0 0
Up to Day 33
Secondary outcome [6] 0 0
Plasma Concentration of Pimodivir
Timepoint [6] 0 0
Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Changes in Laboratory Tests
Timepoint [7] 0 0
Up to Day 33
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Timepoint [8] 0 0
Up to Day 33
Secondary outcome [9] 0 0
Number of Participants With Clinically Significant Changes in Vital Signs
Timepoint [9] 0 0
Up to Day 33

Eligibility
Key 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
Minimum age
13 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2020
Sample size
Target
Accrual to date
Final
334
Recruitment in Australia
Recruitment state(s)
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Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Townsville Hospital - Townsville
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
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3050 - Melbourne
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4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4814 - Townsville
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Turkey
State/province [191] 0 0
Samanpazari, Altindag
Country [192] 0 0
Turkey
State/province [192] 0 0
Trabzon
Country [193] 0 0
Ukraine
State/province [193] 0 0
Kharkiv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Kyiv
Country [195] 0 0
Ukraine
State/province [195] 0 0
Poltava
Country [196] 0 0
Ukraine
State/province [196] 0 0
Vinnytsia
Country [197] 0 0
Ukraine
State/province [197] 0 0
Zhytomyr
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Aberdeen
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Edinburgh
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Leeds
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Manchester
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Taunton
Country [203] 0 0
Vietnam
State/province [203] 0 0
Hanoi
Country [204] 0 0
Vietnam
State/province [204] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03376321
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03376321