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/NCT03381196




Registration number
NCT03381196
Ethics application status
Date submitted
18/12/2017
Date registered
18/12/2017
Date last updated
29/01/2019

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 Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications
Secondary ID [1] 0 0
2017-002217-59
Secondary ID [2] 0 0
CR108400
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
Description of intervention(s) / exposure
Treatment: Drugs - Pimodivir 600 mg
Treatment: Drugs - Placebo
Other interventions - SOC Treatment

Experimental: Treatment Arm 1 (pimodivir + 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 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).

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 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.


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).

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).

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 made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).

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
Time to Resolution of 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.
Timepoint [1] 0 0
Baseline up to Day 28
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 28 days
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 28 days
Secondary outcome [3] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability - Number of participants with ECG abnormalities will be reported.
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [4] 0 0
Number of Participants With Vital Sign abnormalities as a Measure of Safety and Tolerability - Number of participants with vital sign (temperature, pulse rate, respiratory rate and blood pressure) abnormalities will be reported.
Timepoint [4] 0 0
Up to 28 days
Secondary outcome [5] 0 0
Percentage of Participants Hospitalized - Percentage of participants hospitalized 28 days after treatment initiation will be reported.
Timepoint [5] 0 0
Up to 28 days
Secondary outcome [6] 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, severe dehydration, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).
Timepoint [6] 0 0
Up to 28 days
Secondary outcome [7] 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 through 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 [7] 0 0
Up to 28 days
Secondary outcome [8] 0 0
Time to Resolution of Fever - Resolution of fever is defined as a body temperature less than (<) 37.0°C (degree centigrade) during a period of 24 hours without the use of antipyretics.
Timepoint [8] 0 0
Up to Day 14
Secondary outcome [9] 0 0
Number of Participants with All-cause Mortality - The number of participants who died due to any cause will be assessed.
Timepoint [9] 0 0
Up to 28 days
Secondary outcome [10] 0 0
Maximum Plasma Concentration (Cmax) of pimodivir - The Cmax is the maximum plasma concentration after a dose of pimodivir.
Timepoint [10] 0 0
Day 3, and Day 6 (12 hours post last dose on Day 5 evening)
Secondary outcome [11] 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 [11] 0 0
Day 6: 12 hours post last dose on Day 5 evening
Secondary outcome [12] 0 0
Time to Reach Maximum Plasma Concentration (tmax) of Pimodivir - The tmax is defined as time to reach maximum analyte plasma concentration.
Timepoint [12] 0 0
Day 3, and Day 6 (12 hours post last dose on Day 5 evening)
Secondary outcome [13] 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 [13] 0 0
Day 3, and Day 6 (12 hours post last dose on Day 5 evening)
Secondary outcome [14] 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 [14] 0 0
Days 1 and 5 (evening) or 6 (morning)
Secondary outcome [15] 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 [15] 0 0
Days 1 and 5 (evening) or 6 (morning)
Secondary outcome [16] 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 [16] 0 0
Up to Day 14
Secondary outcome [17] 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 midturbinate (MT) swabs.
Timepoint [17] 0 0
Up to Day 14
Secondary outcome [18] 0 0
Viral Load Over Time - Viral load over time will be measured by qRT-PCR and viral culture in the MT nasal swabs samples.
Timepoint [18] 0 0
Up to Day 14
Secondary outcome [19] 0 0
Time to Resolution of Each of the 10 Individual Influenza-Related Symptoms as Assessed by the PRO Measure Flu-iiQ - The resolution of each influenza-related symptom is defined as the beginning of the 24-hour period when the influenza symptom score is at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Timepoint [19] 0 0
Up to Day 28

Eligibility
Key inclusion criteria
- Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and
have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at
least "moderate" if the symptom did not pre-exist before influenza onset, or scored
worse than usual if the symptom pre-existed as determined by subject's ratings on
Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device.
Symptoms must include the following by category: a) Respiratory symptoms: cough, sore
throat, nasal congestion b) Systemic symptoms: headache, body aches or pain,
feverishness, fatigue

- Tested positive for influenza A infection after the onset of symptoms, using a rapid
influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction
(PCR)-based or other rapid molecular diagnostic assay

- Not be in need of hospitalized medical care at screening. Emergency room or hospital
observation status for an anticipated duration of less than (<)24 hours is not
considered hospitalization as long as a determination of the need for hospitalization
has not been made

- Enrollment and initiation of study drug treatment less than or equal to (<=)72 hours
after onset of influenza symptoms

- Participants 13 to 65 years of age, inclusive must also have at least 1 of the
following: a) Cardiovascular or cerebrovascular disease (including congenital heart
disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated
hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung
disease [COPD] or cystic fibrosis); c) Weakened immune system due to disease or
medication (for example, participants with human immunodeficiency virus [HIV], cancer,
or chronic liver or kidney disease [presence of kidney damage for >3 months, defined
by structural or functional abnormalities of the kidney, with or without decreased GFR
manifested by: pathological abnormalities; OR markers of kidney damage, including
abnormalities in the composition of the blood or urine or abnormalities in imaging
tests], or participants taking chronic systemic steroids)
Minimum age
13 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received more than (>)1 dose of influenza antiviral medication (for example,
oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to
first study drug intake, or received intravenous (IV) peramivir >1 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, history of a lung transplant)

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
Northside Health - Coffs Harbour
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
2145 - Sydney
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
South Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
Argentina
State/province [28] 0 0
Ciudad De Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Cordoba
Country [30] 0 0
Argentina
State/province [30] 0 0
Córdoba
Country [31] 0 0
Argentina
State/province [31] 0 0
El Palomar
Country [32] 0 0
Argentina
State/province [32] 0 0
General Roca
Country [33] 0 0
Argentina
State/province [33] 0 0
Ituzaingo
Country [34] 0 0
Argentina
State/province [34] 0 0
La Plata Lpl Lpl
Country [35] 0 0
Argentina
State/province [35] 0 0
La Plata
Country [36] 0 0
Argentina
State/province [36] 0 0
Rosario
Country [37] 0 0
Argentina
State/province [37] 0 0
Santa Fe
Country [38] 0 0
Argentina
State/province [38] 0 0
Vicente Lopez
Country [39] 0 0
Belgium
State/province [39] 0 0
Brussel
Country [40] 0 0
Belgium
State/province [40] 0 0
Bruxelles
Country [41] 0 0
Belgium
State/province [41] 0 0
Gozée
Country [42] 0 0
Belgium
State/province [42] 0 0
Ham
Country [43] 0 0
Belgium
State/province [43] 0 0
Herbeumont
Country [44] 0 0
Belgium
State/province [44] 0 0
Linkebeek
Country [45] 0 0
Belgium
State/province [45] 0 0
Massemen
Country [46] 0 0
Belgium
State/province [46] 0 0
Tessenderlo
Country [47] 0 0
Brazil
State/province [47] 0 0
Belo Horizonte
Country [48] 0 0
Brazil
State/province [48] 0 0
Brasil
Country [49] 0 0
Brazil
State/province [49] 0 0
Campinas
Country [50] 0 0
Brazil
State/province [50] 0 0
Canoas
Country [51] 0 0
Brazil
State/province [51] 0 0
Jaú
Country [52] 0 0
Brazil
State/province [52] 0 0
Juiz De Fora
Country [53] 0 0
Brazil
State/province [53] 0 0
Passo Fundo
Country [54] 0 0
Brazil
State/province [54] 0 0
Porto Alegre
Country [55] 0 0
Brazil
State/province [55] 0 0
Ribeirao Preto
Country [56] 0 0
Brazil
State/province [56] 0 0
Rio De Janeiro
Country [57] 0 0
Brazil
State/province [57] 0 0
Santo André
Country [58] 0 0
Brazil
State/province [58] 0 0
São Bernardo Do Campo
Country [59] 0 0
Brazil
State/province [59] 0 0
São Paulo
Country [60] 0 0
Bulgaria
State/province [60] 0 0
Ruse
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Sofia
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Veliko Tarnovo
Country [63] 0 0
Bulgaria
State/province [63] 0 0
Vidin
Country [64] 0 0
Canada
State/province [64] 0 0
Alberta
Country [65] 0 0
Canada
State/province [65] 0 0
Ontario
Country [66] 0 0
Canada
State/province [66] 0 0
Quebec
Country [67] 0 0
Canada
State/province [67] 0 0
Saskatchewan
Country [68] 0 0
Canada
State/province [68] 0 0
Mount Pearl
Country [69] 0 0
Chile
State/province [69] 0 0
Providencia
Country [70] 0 0
Chile
State/province [70] 0 0
San Bernardo
Country [71] 0 0
Chile
State/province [71] 0 0
Talca
Country [72] 0 0
Chile
State/province [72] 0 0
Temuco
Country [73] 0 0
Chile
State/province [73] 0 0
Viña
Country [74] 0 0
Czechia
State/province [74] 0 0
Benatky Nad Jizerou
Country [75] 0 0
Czechia
State/province [75] 0 0
Ceske Budejovice
Country [76] 0 0
Czechia
State/province [76] 0 0
Ceské Budejovice
Country [77] 0 0
Czechia
State/province [77] 0 0
Kyjov
Country [78] 0 0
Czechia
State/province [78] 0 0
Pribram
Country [79] 0 0
Czechia
State/province [79] 0 0
Slany
Country [80] 0 0
Czechia
State/province [80] 0 0
Sokolov
Country [81] 0 0
Czechia
State/province [81] 0 0
Zlin
Country [82] 0 0
Estonia
State/province [82] 0 0
Paide
Country [83] 0 0
Estonia
State/province [83] 0 0
Tallinn
Country [84] 0 0
Estonia
State/province [84] 0 0
Tartu
Country [85] 0 0
France
State/province [85] 0 0
Agen Cedex 9
Country [86] 0 0
France
State/province [86] 0 0
Creteil Cedex
Country [87] 0 0
France
State/province [87] 0 0
La Tronche
Country [88] 0 0
France
State/province [88] 0 0
Nantes Cedex 1
Country [89] 0 0
France
State/province [89] 0 0
Nice Cedex 3
Country [90] 0 0
France
State/province [90] 0 0
Paris
Country [91] 0 0
France
State/province [91] 0 0
Tours
Country [92] 0 0
Germany
State/province [92] 0 0
Cottbus
Country [93] 0 0
Germany
State/province [93] 0 0
Deggingen
Country [94] 0 0
Germany
State/province [94] 0 0
Erlangen
Country [95] 0 0
Germany
State/province [95] 0 0
Ettenheim
Country [96] 0 0
Germany
State/province [96] 0 0
Freiburg
Country [97] 0 0
Germany
State/province [97] 0 0
Freital
Country [98] 0 0
Germany
State/province [98] 0 0
Kehl
Country [99] 0 0
Germany
State/province [99] 0 0
Koeln
Country [100] 0 0
Germany
State/province [100] 0 0
Kuenzing
Country [101] 0 0
Germany
State/province [101] 0 0
Leipzig
Country [102] 0 0
Germany
State/province [102] 0 0
Marburg
Country [103] 0 0
Germany
State/province [103] 0 0
Muenchen
Country [104] 0 0
Germany
State/province [104] 0 0
Rodgau
Country [105] 0 0
Germany
State/province [105] 0 0
Rostock
Country [106] 0 0
Germany
State/province [106] 0 0
Stuhr
Country [107] 0 0
Germany
State/province [107] 0 0
Wurzburg
Country [108] 0 0
Hungary
State/province [108] 0 0
Balatonfured
Country [109] 0 0
Hungary
State/province [109] 0 0
Biatorbagy
Country [110] 0 0
Hungary
State/province [110] 0 0
Budapest
Country [111] 0 0
Hungary
State/province [111] 0 0
Gyongyos
Country [112] 0 0
Hungary
State/province [112] 0 0
Hatvan
Country [113] 0 0
Hungary
State/province [113] 0 0
Miskolc
Country [114] 0 0
Hungary
State/province [114] 0 0
Mohacs
Country [115] 0 0
Hungary
State/province [115] 0 0
Nyiregyhaza
Country [116] 0 0
Hungary
State/province [116] 0 0
Szentendre
Country [117] 0 0
Hungary
State/province [117] 0 0
Torokbalint
Country [118] 0 0
Hungary
State/province [118] 0 0
Zamardi
Country [119] 0 0
Hungary
State/province [119] 0 0
Zirc
Country [120] 0 0
India
State/province [120] 0 0
Ahmedabad
Country [121] 0 0
India
State/province [121] 0 0
Bangalore
Country [122] 0 0
India
State/province [122] 0 0
Jaipur
Country [123] 0 0
India
State/province [123] 0 0
Manipal
Country [124] 0 0
India
State/province [124] 0 0
Nashik
Country [125] 0 0
India
State/province [125] 0 0
New Dehi
Country [126] 0 0
India
State/province [126] 0 0
New Delhi
Country [127] 0 0
India
State/province [127] 0 0
Surat
Country [128] 0 0
India
State/province [128] 0 0
Vadodara
Country [129] 0 0
Israel
State/province [129] 0 0
Ashkelon
Country [130] 0 0
Israel
State/province [130] 0 0
Haifa
Country [131] 0 0
Israel
State/province [131] 0 0
Nahariya
Country [132] 0 0
Israel
State/province [132] 0 0
Ramat Gan
Country [133] 0 0
Israel
State/province [133] 0 0
Rechovot
Country [134] 0 0
Israel
State/province [134] 0 0
Safed
Country [135] 0 0
Italy
State/province [135] 0 0
Milano
Country [136] 0 0
Italy
State/province [136] 0 0
Modena
Country [137] 0 0
Italy
State/province [137] 0 0
Monza
Country [138] 0 0
Italy
State/province [138] 0 0
Perugia
Country [139] 0 0
Korea, Republic of
State/province [139] 0 0
Gangwon-Do
Country [140] 0 0
Korea, Republic of
State/province [140] 0 0
Hwaseong-Si
Country [141] 0 0
Korea, Republic of
State/province [141] 0 0
Incheon
Country [142] 0 0
Korea, Republic of
State/province [142] 0 0
Seoul
Country [143] 0 0
Korea, Republic of
State/province [143] 0 0
Suwon-Si
Country [144] 0 0
Latvia
State/province [144] 0 0
Balvi
Country [145] 0 0
Latvia
State/province [145] 0 0
Daugavpils
Country [146] 0 0
Latvia
State/province [146] 0 0
Gulbene
Country [147] 0 0
Latvia
State/province [147] 0 0
Kuldiga
Country [148] 0 0
Latvia
State/province [148] 0 0
Liepaja
Country [149] 0 0
Latvia
State/province [149] 0 0
Ogre
Country [150] 0 0
Latvia
State/province [150] 0 0
Riga
Country [151] 0 0
Latvia
State/province [151] 0 0
Valmiera
Country [152] 0 0
Latvia
State/province [152] 0 0
Ventspils
Country [153] 0 0
Lithuania
State/province [153] 0 0
Kaunas
Country [154] 0 0
Lithuania
State/province [154] 0 0
Siauliai
Country [155] 0 0
Lithuania
State/province [155] 0 0
Vilnius
Country [156] 0 0
Malaysia
State/province [156] 0 0
Cheras Baru
Country [157] 0 0
Malaysia
State/province [157] 0 0
Kuang
Country [158] 0 0
Malaysia
State/province [158] 0 0
Miri
Country [159] 0 0
Malaysia
State/province [159] 0 0
Taiping
Country [160] 0 0
Mexico
State/province [160] 0 0
Aguascalientes
Country [161] 0 0
Mexico
State/province [161] 0 0
Ciudad De Mexico
Country [162] 0 0
Mexico
State/province [162] 0 0
Culiacan
Country [163] 0 0
Mexico
State/province [163] 0 0
Guadalajara
Country [164] 0 0
Mexico
State/province [164] 0 0
Jojutla De Juárez
Country [165] 0 0
Mexico
State/province [165] 0 0
Juarez
Country [166] 0 0
Mexico
State/province [166] 0 0
Monterrey
Country [167] 0 0
Mexico
State/province [167] 0 0
Pahucha
Country [168] 0 0
Mexico
State/province [168] 0 0
Zapopan
Country [169] 0 0
Netherlands
State/province [169] 0 0
Den Haag
Country [170] 0 0
Netherlands
State/province [170] 0 0
Rotterdam
Country [171] 0 0
Netherlands
State/province [171] 0 0
Zwijndrecht
Country [172] 0 0
New Zealand
State/province [172] 0 0
Auckland
Country [173] 0 0
New Zealand
State/province [173] 0 0
Rotorua
Country [174] 0 0
New Zealand
State/province [174] 0 0
Wellington
Country [175] 0 0
Peru
State/province [175] 0 0
Callao
Country [176] 0 0
Peru
State/province [176] 0 0
El Agustino
Country [177] 0 0
Peru
State/province [177] 0 0
Lima
Country [178] 0 0
Peru
State/province [178] 0 0
San Martin De Porres
Country [179] 0 0
Peru
State/province [179] 0 0
Trujillo
Country [180] 0 0
Peru
State/province [180] 0 0
Wanchaq
Country [181] 0 0
Poland
State/province [181] 0 0
Lancut
Country [182] 0 0
Poland
State/province [182] 0 0
Lodz
Country [183] 0 0
Poland
State/province [183] 0 0
Lublin
Country [184] 0 0
Poland
State/province [184] 0 0
Siedlce
Country [185] 0 0
Poland
State/province [185] 0 0
Specjalistyczna W Brzegu Dolnym
Country [186] 0 0
Poland
State/province [186] 0 0
Wroclaw
Country [187] 0 0
Romania
State/province [187] 0 0
Brasov
Country [188] 0 0
Romania
State/province [188] 0 0
Bucuresti
Country [189] 0 0
Romania
State/province [189] 0 0
Constanta
Country [190] 0 0
Romania
State/province [190] 0 0
Craiova
Country [191] 0 0
Romania
State/province [191] 0 0
Judet Galati
Country [192] 0 0
Romania
State/province [192] 0 0
Judet Suceava
Country [193] 0 0
Russian Federation
State/province [193] 0 0
Perm
Country [194] 0 0
Russian Federation
State/province [194] 0 0
Rostov-On-Don
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Saint-Petersburg
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Smolensk
Country [197] 0 0
Russian Federation
State/province [197] 0 0
St. Petersburg
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Yaroslavl
Country [199] 0 0
Slovakia
State/province [199] 0 0
Bratislava
Country [200] 0 0
Slovakia
State/province [200] 0 0
Kosice
Country [201] 0 0
Slovakia
State/province [201] 0 0
Spisska Nova Ves
Country [202] 0 0
Slovakia
State/province [202] 0 0
Trnava
Country [203] 0 0
South Africa
State/province [203] 0 0
Bloemfontein
Country [204] 0 0
South Africa
State/province [204] 0 0
Brandfort
Country [205] 0 0
South Africa
State/province [205] 0 0
Breyten
Country [206] 0 0
South Africa
State/province [206] 0 0
Cape Town
Country [207] 0 0
South Africa
State/province [207] 0 0
Chatsworth
Country [208] 0 0
South Africa
State/province [208] 0 0
Durban North
Country [209] 0 0
South Africa
State/province [209] 0 0
Durban
Country [210] 0 0
South Africa
State/province [210] 0 0
Johannesburg
Country [211] 0 0
South Africa
State/province [211] 0 0
Kempton Park
Country [212] 0 0
South Africa
State/province [212] 0 0
Krugersdorp
Country [213] 0 0
South Africa
State/province [213] 0 0
Kwazulu-Natal
Country [214] 0 0
South Africa
State/province [214] 0 0
Midrand
Country [215] 0 0
South Africa
State/province [215] 0 0
Moloto
Country [216] 0 0
South Africa
State/province [216] 0 0
Newtown
Country [217] 0 0
South Africa
State/province [217] 0 0
Ottawa
Country [218] 0 0
South Africa
State/province [218] 0 0
Port Elizabeth
Country [219] 0 0
South Africa
State/province [219] 0 0
Pretoria
Country [220] 0 0
South Africa
State/province [220] 0 0
Soweto
Country [221] 0 0
South Africa
State/province [221] 0 0
Thabazimbi
Country [222] 0 0
South Africa
State/province [222] 0 0
Van Der Bijl
Country [223] 0 0
South Africa
State/province [223] 0 0
Welkom
Country [224] 0 0
Spain
State/province [224] 0 0
Elche
Country [225] 0 0
Spain
State/province [225] 0 0
Esplugues De Llobregat
Country [226] 0 0
Spain
State/province [226] 0 0
Granada
Country [227] 0 0
Spain
State/province [227] 0 0
Madrid
Country [228] 0 0
Spain
State/province [228] 0 0
Santiago De Compostela
Country [229] 0 0
Spain
State/province [229] 0 0
Vigo
Country [230] 0 0
Sweden
State/province [230] 0 0
Malmö
Country [231] 0 0
Sweden
State/province [231] 0 0
Stockholm
Country [232] 0 0
Sweden
State/province [232] 0 0
Umeå
Country [233] 0 0
Sweden
State/province [233] 0 0
Uppsala
Country [234] 0 0
Taiwan
State/province [234] 0 0
New Taipei City
Country [235] 0 0
Taiwan
State/province [235] 0 0
Taichung
Country [236] 0 0
Taiwan
State/province [236] 0 0
Taipei City
Country [237] 0 0
Taiwan
State/province [237] 0 0
Taipei
Country [238] 0 0
Thailand
State/province [238] 0 0
Bangkok
Country [239] 0 0
Thailand
State/province [239] 0 0
Muang
Country [240] 0 0
Thailand
State/province [240] 0 0
Nonthaburi
Country [241] 0 0
Thailand
State/province [241] 0 0
Wattana
Country [242] 0 0
Turkey
State/province [242] 0 0
Ankara
Country [243] 0 0
Turkey
State/province [243] 0 0
Aydin
Country [244] 0 0
Turkey
State/province [244] 0 0
Bursa
Country [245] 0 0
Turkey
State/province [245] 0 0
Diyarbakir
Country [246] 0 0
Turkey
State/province [246] 0 0
Istanbul
Country [247] 0 0
Turkey
State/province [247] 0 0
Kocaeli
Country [248] 0 0
Turkey
State/province [248] 0 0
Samanpazari, Altindag
Country [249] 0 0
Turkey
State/province [249] 0 0
Trabzon
Country [250] 0 0
Ukraine
State/province [250] 0 0
Kharkiv
Country [251] 0 0
Ukraine
State/province [251] 0 0
Kyiv
Country [252] 0 0
Ukraine
State/province [252] 0 0
Odesa
Country [253] 0 0
Ukraine
State/province [253] 0 0
Poltava
Country [254] 0 0
Ukraine
State/province [254] 0 0
Sumy
Country [255] 0 0
Ukraine
State/province [255] 0 0
Vinnytsia
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Ely
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Glasgow
Country [258] 0 0
Vietnam
State/province [258] 0 0
Hanoi
Country [259] 0 0
Vietnam
State/province [259] 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/NCT03381196
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

No data has been provided for results reporting
Summary results
Not applicable