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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03376321
Ethics application status
Date submitted
12/12/2017
Date registered
18/12/2017
Date last updated
11/06/2020

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
Participant's Clinical Status Assessed by Hospital Recovery Scale - 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.
Timepoint [1] 0 0
Day 6
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [2] 0 0
Number of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability - Blood samples for hematology, serum chemistry, and urinalysis will be collected at predefined time points for clinical laboratory testing.
Timepoint [2] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [3] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability - 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.
Timepoint [3] 0 0
Screening, Days 28 and 33
Secondary outcome [4] 0 0
Number of Participants With Vital Signs abnormalities as a Measure of Safety and Tolerability - Number of participants with vital signs (temperature, pulse rate, respiratory rate and blood pressure) abnormalities will be reported.
Timepoint [4] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [5] 0 0
Number of Participants With Peripheral Capillary Oxygen Saturation (SpO2) Abnormalities as a Measure of Safety and Tolerability - Number of participants with SpO2 abnormalities will be reported.
Timepoint [5] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [6] 0 0
Time From Study Drug Start to Hospital Discharge - Total length of hospital stay includes total days of hospital stay that is, the time from start of study drug to hospital discharge.
Timepoint [6] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [7] 0 0
Time From Intensive Care Unit (ICU) Admission to ICU Discharge - 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.
Timepoint [7] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [8] 0 0
Time From Start to End of Mechanical Ventilation - Time from start to end of mechanical ventilation will be measured.
Timepoint [8] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [9] 0 0
Participant's Clinical Status Assessed by Hospital Recovery Scale - 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.
Timepoint [9] 0 0
Days 2 to 5 and 7 to 14
Secondary outcome [10] 0 0
Time to Return to Daily Activities - 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.
Timepoint [10] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [11] 0 0
Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment - 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]).
Timepoint [11] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [12] 0 0
Number of Participants with All-cause Mortality - The number of participants who died due to any cause while on treatment will be assessed.
Timepoint [12] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [13] 0 0
Percentage of Participants Receiving Antibiotic Treatment - Percentage of participants receiving antibiotic treatment will be reported.
Timepoint [13] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [14] 0 0
Duration of Antibiotic Treatment - Duration of antibiotic treatment taken will be reported.
Timepoint [14] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [15] 0 0
Number of Participants Receiving Extended Treatment - Number of participants receiving extended treatment will be reported.
Timepoint [15] 0 0
Day 6
Secondary outcome [16] 0 0
Number of Participants Requiring Re-hospitalization - Number of participants requiring re-hospitalization will be reported.
Timepoint [16] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [17] 0 0
Number of Participants not Hospitalized at Day 6 - Number of participants not hospitalized at Day 6 will be reported.
Timepoint [17] 0 0
Day 6
Secondary outcome [18] 0 0
Time to Clinical Response - 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.
Timepoint [18] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [19] 0 0
Time to Respiratory Response - 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.
Timepoint [19] 0 0
Up to 33 days (up to 28 days if no treatment extension)
Secondary outcome [20] 0 0
Maximum Plasma Concentration (Cmax) of pimodivir - The Cmax is the maximum plasma concentration after a dose of pimodivir.
Timepoint [20] 0 0
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
Secondary outcome [21] 0 0
Trough Plasma Concentration (Ctrough) of Pimodivir - The (Ctrough) is the plasma concentration just prior to the beginning or at the end of a dosing interval.
Timepoint [21] 0 0
Day 3: pre-dose; Day 5: pre-dose; and Day 6: 12 hours post dose
Secondary outcome [22] 0 0
Time to Reach Maximum Plasma Concentration (tmax) of Pimodivir - The tmax is defined as time to reach maximum analyte plasma concentration.
Timepoint [22] 0 0
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
Secondary outcome [23] 0 0
Area Under the Plasma Concentration-Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12) - The AUC(0-12) is the area under the plasma concentration-time curve from time zero to 12 hours.
Timepoint [23] 0 0
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
Secondary outcome [24] 0 0
Time to Influenza Viral Negativity - 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.
Timepoint [24] 0 0
Up to Day 19 (up to Day 14, if no treatment extension)
Secondary outcome [25] 0 0
Viral Load Over Time - Viral load over time will be measured by qRT-PCR and viral culture in the MT nasal swabs and endotracheal samples.
Timepoint [25] 0 0
Up to Day 19 (up to Day 14, if no treatment extension)
Secondary outcome [26] 0 0
Number of Participants with Emergence of Viral Resistance to Pimodivir - Emergence of viral resistance to pimodivir will be detected by genotyping and/or phenotyping.
Timepoint [26] 0 0
Up to Day 19 (up to Day 14, if no treatment extension)
Secondary outcome [27] 0 0
Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire - 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.
Timepoint [27] 0 0
Days 1 and 5 (evening) or 6 (morning)
Secondary outcome [28] 0 0
Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire - 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.
Timepoint [28] 0 0
Days 1 and 5 (evening) or 6 (morning)

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [8] 0 0
Townsville Hospital - Townsville
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4814 - Townsville
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Bahia Blanca
Country [23] 0 0
Argentina
State/province [23] 0 0
C.a.b.a.
Country [24] 0 0
Argentina
State/province [24] 0 0
Cordoba
Country [25] 0 0
Argentina
State/province [25] 0 0
Córdoba
Country [26] 0 0
Argentina
State/province [26] 0 0
El Palomar
Country [27] 0 0
Argentina
State/province [27] 0 0
General Roca
Country [28] 0 0
Argentina
State/province [28] 0 0
La Plata Lpl Lpl
Country [29] 0 0
Argentina
State/province [29] 0 0
La Plata
Country [30] 0 0
Argentina
State/province [30] 0 0
Pilar
Country [31] 0 0
Argentina
State/province [31] 0 0
Rosario
Country [32] 0 0
Argentina
State/province [32] 0 0
Vicente Lopez
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Belgium
State/province [34] 0 0
Aalst
Country [35] 0 0
Belgium
State/province [35] 0 0
Brussel
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Brazil
State/province [37] 0 0
Belo Horizonte
Country [38] 0 0
Brazil
State/province [38] 0 0
Brasil
Country [39] 0 0
Brazil
State/province [39] 0 0
Campinas
Country [40] 0 0
Brazil
State/province [40] 0 0
Canoas
Country [41] 0 0
Brazil
State/province [41] 0 0
Jaú
Country [42] 0 0
Brazil
State/province [42] 0 0
Juiz de Fora
Country [43] 0 0
Brazil
State/province [43] 0 0
Passo Fundo
Country [44] 0 0
Brazil
State/province [44] 0 0
Porto Alegre
Country [45] 0 0
Brazil
State/province [45] 0 0
Ribeirão Preto
Country [46] 0 0
Brazil
State/province [46] 0 0
Sao Paulo
Country [47] 0 0
Brazil
State/province [47] 0 0
São José do Rio Preto
Country [48] 0 0
Brazil
State/province [48] 0 0
São Paulo
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Ruse
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Sofia
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Veliko Tarnovo
Country [52] 0 0
Canada
State/province [52] 0 0
Ontario
Country [53] 0 0
Canada
State/province [53] 0 0
Quebec
Country [54] 0 0
Canada
State/province [54] 0 0
Vancouver
Country [55] 0 0
Chile
State/province [55] 0 0
Puente Alto
Country [56] 0 0
Chile
State/province [56] 0 0
San Bernardo
Country [57] 0 0
Chile
State/province [57] 0 0
Talca
Country [58] 0 0
Chile
State/province [58] 0 0
Temuco
Country [59] 0 0
China
State/province [59] 0 0
Beijing
Country [60] 0 0
China
State/province [60] 0 0
Changsha
Country [61] 0 0
China
State/province [61] 0 0
Chengdu
Country [62] 0 0
China
State/province [62] 0 0
Chongqing
Country [63] 0 0
China
State/province [63] 0 0
Guangzhou
Country [64] 0 0
China
State/province [64] 0 0
Guiyang
Country [65] 0 0
China
State/province [65] 0 0
Harbin
Country [66] 0 0
China
State/province [66] 0 0
Nanjing
Country [67] 0 0
China
State/province [67] 0 0
Qingdao
Country [68] 0 0
China
State/province [68] 0 0
Shanghai
Country [69] 0 0
China
State/province [69] 0 0
Wuxi
Country [70] 0 0
China
State/province [70] 0 0
Zhejiang
Country [71] 0 0
China
State/province [71] 0 0
Zhengzhou
Country [72] 0 0
Czechia
State/province [72] 0 0
Brno
Country [73] 0 0
Czechia
State/province [73] 0 0
Kyjov
Country [74] 0 0
Czechia
State/province [74] 0 0
Ostrava - Poruba
Country [75] 0 0
Czechia
State/province [75] 0 0
Praha 8
Country [76] 0 0
Czechia
State/province [76] 0 0
Zlin
Country [77] 0 0
France
State/province [77] 0 0
Agen cedex 9
Country [78] 0 0
France
State/province [78] 0 0
Amiens Cedex
Country [79] 0 0
France
State/province [79] 0 0
Colombes
Country [80] 0 0
France
State/province [80] 0 0
Creteil cedex
Country [81] 0 0
France
State/province [81] 0 0
Dijon
Country [82] 0 0
France
State/province [82] 0 0
La Roche S/ Yon Cedex 9
Country [83] 0 0
France
State/province [83] 0 0
La Tronche
Country [84] 0 0
France
State/province [84] 0 0
Lille cedex
Country [85] 0 0
France
State/province [85] 0 0
Limoges
Country [86] 0 0
France
State/province [86] 0 0
Lyon
Country [87] 0 0
France
State/province [87] 0 0
Marseille cedex 20
Country [88] 0 0
France
State/province [88] 0 0
NANTES Cedex 01
Country [89] 0 0
France
State/province [89] 0 0
Nantes Cedex 1
Country [90] 0 0
France
State/province [90] 0 0
Nantes cedex
Country [91] 0 0
France
State/province [91] 0 0
Nice Cedex 3
Country [92] 0 0
France
State/province [92] 0 0
Paris cedex 10
Country [93] 0 0
France
State/province [93] 0 0
Paris
Country [94] 0 0
France
State/province [94] 0 0
Poitiers
Country [95] 0 0
France
State/province [95] 0 0
Saint-Etienne Cedex 2
Country [96] 0 0
France
State/province [96] 0 0
Tours
Country [97] 0 0
Germany
State/province [97] 0 0
Borstel
Country [98] 0 0
Germany
State/province [98] 0 0
Donaustauf
Country [99] 0 0
Germany
State/province [99] 0 0
Dresden
Country [100] 0 0
Germany
State/province [100] 0 0
Erlangen
Country [101] 0 0
Germany
State/province [101] 0 0
Freiburg
Country [102] 0 0
Germany
State/province [102] 0 0
Hessen
Country [103] 0 0
Germany
State/province [103] 0 0
Koeln
Country [104] 0 0
Germany
State/province [104] 0 0
Luebeck
Country [105] 0 0
Germany
State/province [105] 0 0
Marburg
Country [106] 0 0
Germany
State/province [106] 0 0
Muenchen
Country [107] 0 0
Germany
State/province [107] 0 0
Rostock
Country [108] 0 0
Germany
State/province [108] 0 0
Weiden
Country [109] 0 0
Germany
State/province [109] 0 0
Wurzburg
Country [110] 0 0
Hungary
State/province [110] 0 0
Farkasgyepü
Country [111] 0 0
Hungary
State/province [111] 0 0
Nyíregyháza
Country [112] 0 0
Hungary
State/province [112] 0 0
Torokbalint
Country [113] 0 0
Hungary
State/province [113] 0 0
Veszprem
Country [114] 0 0
Hungary
State/province [114] 0 0
Zalaegerszeg
Country [115] 0 0
India
State/province [115] 0 0
Ahmedabad
Country [116] 0 0
India
State/province [116] 0 0
Balaga
Country [117] 0 0
India
State/province [117] 0 0
Bangalore
Country [118] 0 0
India
State/province [118] 0 0
Belgaum
Country [119] 0 0
India
State/province [119] 0 0
Gandhinagar
Country [120] 0 0
India
State/province [120] 0 0
Hyderabad
Country [121] 0 0
India
State/province [121] 0 0
Jaipur
Country [122] 0 0
India
State/province [122] 0 0
Kolkata
Country [123] 0 0
India
State/province [123] 0 0
Lucknow
Country [124] 0 0
India
State/province [124] 0 0
Mangalore
Country [125] 0 0
India
State/province [125] 0 0
Manipal
Country [126] 0 0
India
State/province [126] 0 0
Mumbai
Country [127] 0 0
India
State/province [127] 0 0
Nagpur
Country [128] 0 0
India
State/province [128] 0 0
Nashik
Country [129] 0 0
India
State/province [129] 0 0
New Delhi
Country [130] 0 0
India
State/province [130] 0 0
Pune
Country [131] 0 0
India
State/province [131] 0 0
Rajkot
Country [132] 0 0
India
State/province [132] 0 0
Surat
Country [133] 0 0
India
State/province [133] 0 0
Vadodara
Country [134] 0 0
Israel
State/province [134] 0 0
Afula
Country [135] 0 0
Israel
State/province [135] 0 0
Ashkelon
Country [136] 0 0
Israel
State/province [136] 0 0
Beersheba
Country [137] 0 0
Israel
State/province [137] 0 0
Haifa
Country [138] 0 0
Israel
State/province [138] 0 0
Holon
Country [139] 0 0
Israel
State/province [139] 0 0
Jerusalem
Country [140] 0 0
Israel
State/province [140] 0 0
Kfar-Saba
Country [141] 0 0
Israel
State/province [141] 0 0
Nahariya
Country [142] 0 0
Israel
State/province [142] 0 0
Petach Tikva
Country [143] 0 0
Israel
State/province [143] 0 0
Ramat Gan
Country [144] 0 0
Israel
State/province [144] 0 0
Rechovot
Country [145] 0 0
Israel
State/province [145] 0 0
Safed
Country [146] 0 0
Israel
State/province [146] 0 0
Tel Aviv
Country [147] 0 0
Italy
State/province [147] 0 0
Bergamo
Country [148] 0 0
Italy
State/province [148] 0 0
Cona, Ferrara
Country [149] 0 0
Italy
State/province [149] 0 0
Milano
Country [150] 0 0
Italy
State/province [150] 0 0
Modena
Country [151] 0 0
Italy
State/province [151] 0 0
Monza
Country [152] 0 0
Italy
State/province [152] 0 0
Novara
Country [153] 0 0
Italy
State/province [153] 0 0
Palermo
Country [154] 0 0
Italy
State/province [154] 0 0
Perugia
Country [155] 0 0
Italy
State/province [155] 0 0
Rimini
Country [156] 0 0
Italy
State/province [156] 0 0
Roma
Country [157] 0 0
Italy
State/province [157] 0 0
Torino
Country [158] 0 0
Italy
State/province [158] 0 0
Verona
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Ansan-si
Country [160] 0 0
Korea, Republic of
State/province [160] 0 0
Cheongju-si
Country [161] 0 0
Korea, Republic of
State/province [161] 0 0
Gangwon-do
Country [162] 0 0
Korea, Republic of
State/province [162] 0 0
Hwaseong-si
Country [163] 0 0
Korea, Republic of
State/province [163] 0 0
Incheon
Country [164] 0 0
Korea, Republic of
State/province [164] 0 0
Pusan
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Seoul
Country [166] 0 0
Korea, Republic of
State/province [166] 0 0
Suwon-si
Country [167] 0 0
Latvia
State/province [167] 0 0
Daugavpils
Country [168] 0 0
Latvia
State/province [168] 0 0
Liepaja
Country [169] 0 0
Latvia
State/province [169] 0 0
Rezekne
Country [170] 0 0
Latvia
State/province [170] 0 0
Riga District
Country [171] 0 0
Latvia
State/province [171] 0 0
Riga
Country [172] 0 0
Latvia
State/province [172] 0 0
Valmiera
Country [173] 0 0
Lithuania
State/province [173] 0 0
Kaunas
Country [174] 0 0
Lithuania
State/province [174] 0 0
Klaipeda
Country [175] 0 0
Lithuania
State/province [175] 0 0
Siauliai
Country [176] 0 0
Lithuania
State/province [176] 0 0
Vilnius
Country [177] 0 0
Malaysia
State/province [177] 0 0
Alor Setar
Country [178] 0 0
Malaysia
State/province [178] 0 0
Batu Caves
Country [179] 0 0
Malaysia
State/province [179] 0 0
Kota Kinabalu
Country [180] 0 0
Malaysia
State/province [180] 0 0
Kuala
Country [181] 0 0
Malaysia
State/province [181] 0 0
Kuching
Country [182] 0 0
Malaysia
State/province [182] 0 0
Miri
Country [183] 0 0
Malaysia
State/province [183] 0 0
Seremban
Country [184] 0 0
Malaysia
State/province [184] 0 0
Sibu
Country [185] 0 0
Malaysia
State/province [185] 0 0
Sungai Buloh
Country [186] 0 0
Malaysia
State/province [186] 0 0
Taiping
Country [187] 0 0
Mexico
State/province [187] 0 0
Ciudad De Mexico
Country [188] 0 0
Mexico
State/province [188] 0 0
Cuernavaca
Country [189] 0 0
Mexico
State/province [189] 0 0
Culiacan
Country [190] 0 0
Mexico
State/province [190] 0 0
Guadalajara
Country [191] 0 0
Mexico
State/province [191] 0 0
Mexico
Country [192] 0 0
Mexico
State/province [192] 0 0
Pahucha
Country [193] 0 0
Netherlands
State/province [193] 0 0
Assen
Country [194] 0 0
Netherlands
State/province [194] 0 0
Dordrecht
Country [195] 0 0
Netherlands
State/province [195] 0 0
s-Hertogenbosch
Country [196] 0 0
Netherlands
State/province [196] 0 0
Utrecht
Country [197] 0 0
Netherlands
State/province [197] 0 0
Zutphen
Country [198] 0 0
Netherlands
State/province [198] 0 0
Zwijndrecht
Country [199] 0 0
New Zealand
State/province [199] 0 0
Christchurch
Country [200] 0 0
New Zealand
State/province [200] 0 0
Hamilton
Country [201] 0 0
New Zealand
State/province [201] 0 0
Rotorua
Country [202] 0 0
New Zealand
State/province [202] 0 0
Tauranga
Country [203] 0 0
New Zealand
State/province [203] 0 0
Wellington
Country [204] 0 0
Peru
State/province [204] 0 0
Callao
Country [205] 0 0
Peru
State/province [205] 0 0
El Agustino
Country [206] 0 0
Peru
State/province [206] 0 0
Lima
Country [207] 0 0
Peru
State/province [207] 0 0
Miraflores
Country [208] 0 0
Peru
State/province [208] 0 0
Trujillo
Country [209] 0 0
Peru
State/province [209] 0 0
Wanchaq
Country [210] 0 0
Poland
State/province [210] 0 0
Checiny
Country [211] 0 0
Poland
State/province [211] 0 0
Debica
Country [212] 0 0
Poland
State/province [212] 0 0
Lancut
Country [213] 0 0
Poland
State/province [213] 0 0
Lodz
Country [214] 0 0
Poland
State/province [214] 0 0
Tarnow
Country [215] 0 0
Poland
State/province [215] 0 0
Wroclaw
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Chelyabinsk
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Moscow
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Saint-Petersburg
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Smolensk
Country [220] 0 0
Russian Federation
State/province [220] 0 0
St. Petersburg
Country [221] 0 0
Russian Federation
State/province [221] 0 0
St.Petersburg
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Stavropol
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Tomsk
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Yaroslavl
Country [225] 0 0
Singapore
State/province [225] 0 0
Singapore
Country [226] 0 0
Slovakia
State/province [226] 0 0
Bratislava
Country [227] 0 0
Slovakia
State/province [227] 0 0
Malacky
Country [228] 0 0
Slovakia
State/province [228] 0 0
Michalovce
Country [229] 0 0
Slovakia
State/province [229] 0 0
Ruzomberok
Country [230] 0 0
Slovakia
State/province [230] 0 0
Svidnik
Country [231] 0 0
South Africa
State/province [231] 0 0
Bloemfontein
Country [232] 0 0
South Africa
State/province [232] 0 0
Cape Town
Country [233] 0 0
South Africa
State/province [233] 0 0
Centurion
Country [234] 0 0
South Africa
State/province [234] 0 0
Durban
Country [235] 0 0
South Africa
State/province [235] 0 0
Krugersdorp
Country [236] 0 0
South Africa
State/province [236] 0 0
Pretoria
Country [237] 0 0
South Africa
State/province [237] 0 0
Thabazimbi
Country [238] 0 0
Spain
State/province [238] 0 0
Barcelona
Country [239] 0 0
Spain
State/province [239] 0 0
Donostia-San Sebastian
Country [240] 0 0
Spain
State/province [240] 0 0
Elche
Country [241] 0 0
Spain
State/province [241] 0 0
Getafe
Country [242] 0 0
Spain
State/province [242] 0 0
Girona
Country [243] 0 0
Spain
State/province [243] 0 0
Granada
Country [244] 0 0
Spain
State/province [244] 0 0
L'Hospitalet de Llobregat
Country [245] 0 0
Spain
State/province [245] 0 0
Madrid
Country [246] 0 0
Spain
State/province [246] 0 0
Mataro
Country [247] 0 0
Spain
State/province [247] 0 0
Palma de Mallorca
Country [248] 0 0
Spain
State/province [248] 0 0
Santiago de Compostela
Country [249] 0 0
Spain
State/province [249] 0 0
Terrassa
Country [250] 0 0
Spain
State/province [250] 0 0
Vigo
Country [251] 0 0
Sweden
State/province [251] 0 0
Malmö
Country [252] 0 0
Sweden
State/province [252] 0 0
Stockholm
Country [253] 0 0
Sweden
State/province [253] 0 0
Umeå
Country [254] 0 0
Sweden
State/province [254] 0 0
Uppsala
Country [255] 0 0
Taiwan
State/province [255] 0 0
Kaohsiung
Country [256] 0 0
Taiwan
State/province [256] 0 0
Taipei
Country [257] 0 0
Thailand
State/province [257] 0 0
Bangkok
Country [258] 0 0
Thailand
State/province [258] 0 0
Muang
Country [259] 0 0
Thailand
State/province [259] 0 0
Wattana
Country [260] 0 0
Turkey
State/province [260] 0 0
Ankara
Country [261] 0 0
Turkey
State/province [261] 0 0
Aydin
Country [262] 0 0
Turkey
State/province [262] 0 0
Diyarbakir
Country [263] 0 0
Turkey
State/province [263] 0 0
Istanbul
Country [264] 0 0
Turkey
State/province [264] 0 0
Kocaeli
Country [265] 0 0
Turkey
State/province [265] 0 0
Samanpazari, Altindag
Country [266] 0 0
Turkey
State/province [266] 0 0
Trabzon
Country [267] 0 0
Ukraine
State/province [267] 0 0
Dnipropetrovsk
Country [268] 0 0
Ukraine
State/province [268] 0 0
Kharkiv
Country [269] 0 0
Ukraine
State/province [269] 0 0
Kyiv
Country [270] 0 0
Ukraine
State/province [270] 0 0
Poltava
Country [271] 0 0
Ukraine
State/province [271] 0 0
Sumy
Country [272] 0 0
Ukraine
State/province [272] 0 0
Vinnytsia
Country [273] 0 0
Ukraine
State/province [273] 0 0
Zaporizhzhia
Country [274] 0 0
Ukraine
State/province [274] 0 0
Zaporizhzhya
Country [275] 0 0
Ukraine
State/province [275] 0 0
Zhytomyr
Country [276] 0 0
United Kingdom
State/province [276] 0 0
Aberdeen
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Edinburgh
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Leeds
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Manchester
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Taunton
Country [281] 0 0
United Kingdom
State/province [281] 0 0
Wirral
Country [282] 0 0
Vietnam
State/province [282] 0 0
Hanoi
Country [283] 0 0
Vietnam
State/province [283] 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/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
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

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