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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03379675




Registration number
NCT03379675
Ethics application status
Date submitted
15/12/2017
Date registered
20/12/2017
Date last updated
22/01/2020

Titles & IDs
Public title
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
Scientific title
A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
Secondary ID [1] 0 0
2017-003252-24
Secondary ID [2] 0 0
CR108419
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678 500 mg
Treatment: Drugs - JNJ-53718678 80 mg
Treatment: Drugs - Placebo

Experimental: Treatment A: JNJ-53718678 500 mg - Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.

Experimental: Treatment B: JNJ-53718678 80 mg + Placebo - Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Placebo Comparator: Treatment C: Placebo - Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.


Treatment: Drugs: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

Treatment: Drugs: JNJ-53718678 80 mg
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Treatment: Drugs: Placebo
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Viral Load-time Curve (AUC) - Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Timepoint [1] 0 0
Baseline up to Day 3
Primary outcome [2] 0 0
Area Under the Viral Load-time Curve (AUC) - Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Timepoint [2] 0 0
Baseline up to Day 5
Primary outcome [3] 0 0
Area Under the Viral Load-time Curve (AUC) - Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Timepoint [3] 0 0
Baseline up to Day 8
Primary outcome [4] 0 0
Area Under the Viral Load-time Curve (AUC) - Viral load (VL) AUC will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Timepoint [4] 0 0
Baseline up to Day 14
Primary outcome [5] 0 0
RSV (Respiratory Syncytial Virus) Viral Load Over Time - RSV viral load over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [5] 0 0
Up to Day 21
Primary outcome [6] 0 0
Change from Baseline in RSV Viral Load Over Time - Change from baseline in RSV viral load over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Timepoint [6] 0 0
Baseline up to Day 21
Primary outcome [7] 0 0
Time to Undetectable RSV Viral Load - Time (hours) to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.
Timepoint [7] 0 0
Up to Day 21
Primary outcome [8] 0 0
Proportion of Participants with Undetectable RSV Viral Load - Proportion of participants with undetectable RSV viral load will be reported.
Timepoint [8] 0 0
Up to Day 21
Secondary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) 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 Day 28
Secondary outcome [2] 0 0
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Findings - Number of participants with abnormalities in vital signs, physical examinations, ECG and laboratory findings will be measured.
Timepoint [2] 0 0
Up to Day 28
Secondary outcome [3] 0 0
Duration of Signs and Symptoms of RSV Infection as Assessed by RI-PRO Questionnaire - Duration of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (the Respiratory Infection-Patient Reported Outcomes [RI-PRO] questionnaire). RI-PRO score ranges from 0 (not at all) to 4 (very much).
Timepoint [3] 0 0
Up to Day 21
Secondary outcome [4] 0 0
Severity of Signs and Symptoms of RSV Infection as Assessed by RI-PRO Questionnaire - Severity of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (RI-PRO questionnaire). RI-PRO score ranges from 0 (not at all) to 4 (very much).
Timepoint [4] 0 0
Up to Day 21
Secondary outcome [5] 0 0
Duration of Signs and Symptoms of RSV Infection as Assessed by RiiQ Questionnaire - Duration of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (the Respiratory Infection Intensity and Impact Questionnaire [RiiQ] questionnaire). RiiQ score ranges from 0 (not at all) to 3 (very much).
Timepoint [5] 0 0
Up to Day 21
Secondary outcome [6] 0 0
Severity of Signs and Symptoms of RSV Infection as Assessed by RiiQ Questionnaire - Severity of signs and symptoms of RSV infection assessed through an instrument for patient-reported symptoms (RiiQ questionnaire). RiiQ score ranges from 0 (not at all) to 3 (very much).
Timepoint [6] 0 0
Up to Day 21
Secondary outcome [7] 0 0
Time to Resolution of Selected RSV Symptoms as Assessed by RI-PRO Questionnaire - Time to resolution of selected RSV symptoms will be assessed through an instrument for patient-reported symptoms (RI-PRO questionnaire). RI-PRO score ranges from 0 (not at all) to 4 (very much).
Timepoint [7] 0 0
Up to Day 21
Secondary outcome [8] 0 0
Time to Resolution of Selected RSV Symptoms as Assessed by RiiQ Questionnaire - Time to resolution of selected RSV symptoms will be assessed through an instrument for patient-reported symptoms (RiiQ questionnaire). RiiQ score ranges from 0 (not at all) to 3 (very much).
Timepoint [8] 0 0
Up to Day 21
Secondary outcome [9] 0 0
Change from Baseline in Respiratory Rate - Respiratory rate (number of breaths per minute) will be assessed by the investigator.
Timepoint [9] 0 0
Baseline up to Day 28
Secondary outcome [10] 0 0
Change from Baseline in Heart Rate - Heart Rate (beats per minute) will be assessed by the investigator.
Timepoint [10] 0 0
Baseline up to Day 28
Secondary outcome [11] 0 0
Change from Baseline in Body Temperature - Body temperature (degrees Celsius) will be assessed by the investigator.
Timepoint [11] 0 0
Baseline up to Day 28
Secondary outcome [12] 0 0
Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2) - Change from baseline in Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator.
Timepoint [12] 0 0
Baseline up to Day 28
Secondary outcome [13] 0 0
Plasma Concentrations of JNJ-53718678 - Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.
Timepoint [13] 0 0
Day 3 and Day 8

Eligibility
Key inclusion criteria
- Participants must have an acute respiratory illness with signs and symptoms consistent
with a viral infection (example, fever, cough, nasal congestion, runny nose, sore
throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or
equal to 5 days from the anticipated time of randomization. Onset of symptoms is
defined as the time the participant becomes aware of the first sign and/or symptom
consistent with a viral infection

- Participant has been diagnosed with respiratory syncytial virus (RSV) infection using
a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test

- Before randomization, a woman must be not of childbearing potential defined as:
Premenarchal, Postmenopausal or Permanently sterile

- A male participant must agree to the use of acceptable contraceptive measures

- With the exception of the RSV-related illness the participant must be medically stable
on the basis of physical examination, medical history, vital signs, and
electrocardiogram (ECG) performed at screening
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hospitalized participants or participants expected to be hospitalized within 24 hours
of screening

- History of or concurrent illness (beyond a comorbid condition) that in the opinion of
the investigator, might confound the results of the study or pose an additional risk
in administering study drug to the participant or that could prevent, limit, or
confound the protocol-specified assessments

- Participants who had major surgery within the 28 days prior to randomization or have
planned major surgery through the course of the study

- Participants who are considered by the investigator to be immunocompromised within the
past 12 months

- Participant has known or suspected chronic or acute hepatitis B or C infection

- Women who are pregnant or breastfeeding

- Participants with clinically significant abnormal ECG findings (other than QT-interval
corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500
millisecond [ms]) not consistent with the underlying condition in the study
population, as judged by the investigator

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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
Paratus Clinical Blacktown Clinic - Blacktown
Recruitment hospital [2] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [4] 0 0
Paratus Clinical Kippa Ring Clinic - Kippa Ring
Recruitment hospital [5] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2060 - Blacktown
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2059 - Kanwal
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
Argentina
State/province [10] 0 0
Bahia Blanca
Country [11] 0 0
Argentina
State/province [11] 0 0
Barrio Parque Velez Sarfield
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad De La Plata
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudadela
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Córdoba
Country [17] 0 0
Argentina
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General Roca
Country [18] 0 0
Argentina
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Rosario
Country [19] 0 0
Argentina
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San Miguel de Tucuman
Country [20] 0 0
Belgium
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Bruxelles
Country [21] 0 0
Belgium
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Ham
Country [22] 0 0
Belgium
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Massemen
Country [23] 0 0
Belgium
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Tessenderlo
Country [24] 0 0
Brazil
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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Florianopolis
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Brazil
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Natal
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Bulgaria
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Kozloduy
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Bulgaria
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Pernik
Country [35] 0 0
Bulgaria
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Ruse
Country [36] 0 0
Bulgaria
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Smolyan
Country [37] 0 0
Bulgaria
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Sofia
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Bulgaria
State/province [38] 0 0
Troyan
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
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Canada
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Quebec
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France
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Agen cedex 9
Country [42] 0 0
France
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Angers
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France
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Murs Erigne
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France
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Nantes
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Luebeck
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Japan
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Fukui-shi
Country [51] 0 0
Japan
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Kawasaki
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Japan
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Kitakyusyu
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Japan
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Koganei-Shi
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Japan
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Kumamoto-shi
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Japan
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Osaka
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Japan
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Shinagawa-ku
Country [57] 0 0
Japan
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Tokorozawa-shi
Country [58] 0 0
Japan
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Toyota
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Japan
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Yukuhashi
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
Country [64] 0 0
Korea, Republic of
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Suwon-si
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Mexico
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Aguascalientes
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Ostrow Wielkopolski
Country [73] 0 0
Poland
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Wroclaw
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Krasnogorsk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Saint-Petersburg
Country [76] 0 0
Russian Federation
State/province [76] 0 0
St. Petersburg
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South Africa
State/province [77] 0 0
Johannesburg
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South Africa
State/province [78] 0 0
Pretoria
Country [79] 0 0
South Africa
State/province [79] 0 0
Welkom
Country [80] 0 0
Spain
State/province [80] 0 0
Alicante
Country [81] 0 0
Spain
State/province [81] 0 0
Elche
Country [82] 0 0
Spain
State/province [82] 0 0
Granada
Country [83] 0 0
Spain
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Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Santiago de Compostela
Country [85] 0 0
Spain
State/province [85] 0 0
Vigo
Country [86] 0 0
Sweden
State/province [86] 0 0
Malmö
Country [87] 0 0
Sweden
State/province [87] 0 0
Umeå
Country [88] 0 0
Sweden
State/province [88] 0 0
Uppsala
Country [89] 0 0
Taiwan
State/province [89] 0 0
Kaohsiung
Country [90] 0 0
Taiwan
State/province [90] 0 0
New Taipei
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taichung City
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei City
Country [93] 0 0
Taiwan
State/province [93] 0 0
Taipei
Country [94] 0 0
Ukraine
State/province [94] 0 0
Kharkiv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kherson
Country [96] 0 0
Ukraine
State/province [96] 0 0
Kyiv
Country [97] 0 0
Ukraine
State/province [97] 0 0
Vinnytsia
Country [98] 0 0
Ukraine
State/province [98] 0 0
Vinnytsya

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 explore the antiviral effect of JNJ-53718678 at 2 dose levels
(80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial
Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative
reverse transcription polymerase chain reaction (qRT-PCR) assay.
Trial website
https://clinicaltrials.gov/show/NCT03379675
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
Other publications