Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03379675
Registration number
NCT03379675
Ethics application status
Date submitted
15/12/2017
Date registered
20/12/2017
Date last updated
30/08/2024
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
Query!
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
Query!
Secondary ID [1]
0
0
2017-003252-24
Query!
Secondary ID [2]
0
0
CR108419
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
Query!
Assessment method [1]
0
0
Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Query!
Timepoint [1]
0
0
Baseline through Day 3
Query!
Primary outcome [2]
0
0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Query!
Assessment method [2]
0
0
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Query!
Timepoint [2]
0
0
Baseline through Day 5
Query!
Primary outcome [3]
0
0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Query!
Assessment method [3]
0
0
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Query!
Timepoint [3]
0
0
Baseline through Day 8
Query!
Primary outcome [4]
0
0
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Query!
Assessment method [4]
0
0
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Query!
Timepoint [4]
0
0
Baseline through Day 14
Query!
Primary outcome [5]
0
0
Change From Baseline in RSV Viral Load at Day 3
Query!
Assessment method [5]
0
0
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [5]
0
0
Baseline to Day 3
Query!
Primary outcome [6]
0
0
Change From Baseline in RSV Viral Load at Day 5
Query!
Assessment method [6]
0
0
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [6]
0
0
Baseline to Day 5
Query!
Primary outcome [7]
0
0
Change From Baseline in RSV Viral Load at Day 8
Query!
Assessment method [7]
0
0
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [7]
0
0
Baseline to Day 8
Query!
Primary outcome [8]
0
0
Change From Baseline in RSV Viral Load at Day 14
Query!
Assessment method [8]
0
0
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [8]
0
0
Baseline to Day 14
Query!
Primary outcome [9]
0
0
Change From Baseline in RSV Viral Load at Day 21
Query!
Assessment method [9]
0
0
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [9]
0
0
Baseline to Day 21
Query!
Primary outcome [10]
0
0
RSV Viral Load at Baseline
Query!
Assessment method [10]
0
0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [10]
0
0
Baseline
Query!
Primary outcome [11]
0
0
RSV Viral Load at Day 3
Query!
Assessment method [11]
0
0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [11]
0
0
Day 3
Query!
Primary outcome [12]
0
0
RSV Viral Load at Day 5
Query!
Assessment method [12]
0
0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [12]
0
0
Day 5
Query!
Primary outcome [13]
0
0
RSV Viral Load at Day 8
Query!
Assessment method [13]
0
0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [13]
0
0
Day 8
Query!
Primary outcome [14]
0
0
RSV Viral Load at Day 14
Query!
Assessment method [14]
0
0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [14]
0
0
Day 14
Query!
Primary outcome [15]
0
0
RSV Viral Load at Day 21
Query!
Assessment method [15]
0
0
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Query!
Timepoint [15]
0
0
Day 21
Query!
Primary outcome [16]
0
0
Time to Undetectable RSV Viral Load
Query!
Assessment method [16]
0
0
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Query!
Timepoint [16]
0
0
Up to Day 21
Query!
Primary outcome [17]
0
0
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Query!
Assessment method [17]
0
0
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Query!
Timepoint [17]
0
0
Day 3
Query!
Primary outcome [18]
0
0
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Query!
Assessment method [18]
0
0
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Query!
Timepoint [18]
0
0
Day 5
Query!
Primary outcome [19]
0
0
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Query!
Assessment method [19]
0
0
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Query!
Timepoint [19]
0
0
Day 8
Query!
Primary outcome [20]
0
0
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Query!
Assessment method [20]
0
0
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Query!
Timepoint [20]
0
0
Day 14
Query!
Primary outcome [21]
0
0
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Query!
Assessment method [21]
0
0
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
Query!
Timepoint [21]
0
0
Day 21
Query!
Secondary outcome [1]
0
0
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to Day 28
Query!
Secondary outcome [2]
0
0
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Query!
Assessment method [2]
0
0
Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (\< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).
Query!
Timepoint [2]
0
0
Up to Day 28
Query!
Secondary outcome [3]
0
0
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Query!
Assessment method [3]
0
0
Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (\<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - \< 100 mmHg, Grade 2 (moderate)- greater than or equal to (\>=)100 mmHg to \< 110 mmHg, Grade 3 (severe)- \>=110 mmHg; DBP: Abnormally low- \<=90 mmHg, Grade 1 (mild)- 140 mmHg - \< 160 mmHg, Grade 2 (moderate)- \>=160 mmHg to \< 180 mmHg, Grade 3 (severe)- \>=180 mmHg.
Query!
Timepoint [3]
0
0
Up to Day 28
Query!
Secondary outcome [4]
0
0
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
Query!
Assessment method [4]
0
0
The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval (\[450 milliseconds {ms}, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval (\[450 ms, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]).
Query!
Timepoint [4]
0
0
Up to Day 28
Query!
Secondary outcome [5]
0
0
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Query!
Assessment method [5]
0
0
Peripheral capillary oxygen saturation was measured by the investigator over time.
Query!
Timepoint [5]
0
0
Baseline, Days 3, 8, 14, and 21
Query!
Secondary outcome [6]
0
0
Change From Baseline in Peripheral Capillary Oxygen Saturation
Query!
Assessment method [6]
0
0
Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.
Query!
Timepoint [6]
0
0
Baseline to Days 3, 8, 14 and 21
Query!
Secondary outcome [7]
0
0
Pulse Rate Over Time
Query!
Assessment method [7]
0
0
Pulse rate was measured by the investigator over time.
Query!
Timepoint [7]
0
0
Baseline, Days 3, 8, 14 and 21
Query!
Secondary outcome [8]
0
0
Change From Baseline in Pulse Rate
Query!
Assessment method [8]
0
0
Change from baseline in pulse rate was calculated and reported by the investigator.
Query!
Timepoint [8]
0
0
Baseline to Days 3, 8, 14 and 21
Query!
Secondary outcome [9]
0
0
Respiratory Rate Over Time
Query!
Assessment method [9]
0
0
Respiratory rate was measured by the investigator over time.
Query!
Timepoint [9]
0
0
Baseline, Days 3, 8, 14 and 21
Query!
Secondary outcome [10]
0
0
Change From Baseline in Respiratory Rate
Query!
Assessment method [10]
0
0
Change from baseline in respiratory rate was calculated and reported by the investigator.
Query!
Timepoint [10]
0
0
Baseline to Days 3, 8, 14 and 21
Query!
Secondary outcome [11]
0
0
Body Temperature Over Time
Query!
Assessment method [11]
0
0
Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Query!
Timepoint [11]
0
0
Baseline, Days 3, 8, 14 and 21
Query!
Secondary outcome [12]
0
0
Change From Baseline in Body Temperature
Query!
Assessment method [12]
0
0
Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Query!
Timepoint [12]
0
0
Baseline to Days 3, 5, 8, 14 and 21
Query!
Secondary outcome [13]
0
0
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
Query!
Assessment method [13]
0
0
AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.
Query!
Timepoint [13]
0
0
0 to 24 hours post dose on Days 1 and 7
Query!
Secondary outcome [14]
0
0
Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
Query!
Assessment method [14]
0
0
The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.
Query!
Timepoint [14]
0
0
Baseline, Days 3, 5, 8, 14 and 21
Query!
Secondary outcome [15]
0
0
Duration of Signs and Symptoms of RSV Assessed by RI-PRO
Query!
Assessment method [15]
0
0
Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Query!
Timepoint [15]
0
0
Baseline up to Day 21
Query!
Secondary outcome [16]
0
0
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
Query!
Assessment method [16]
0
0
Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Query!
Timepoint [16]
0
0
Up to Day 21
Query!
Secondary outcome [17]
0
0
Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
Query!
Assessment method [17]
0
0
Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.
Query!
Timepoint [17]
0
0
Up to Day 21
Query!
Secondary outcome [18]
0
0
Predose Plasma Concentration (Ctrough) of JNJ-53718678
Query!
Assessment method [18]
0
0
Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
Query!
Timepoint [18]
0
0
Predose on Days 1 and 7
Query!
Secondary outcome [19]
0
0
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Query!
Assessment method [19]
0
0
Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
Query!
Timepoint [19]
0
0
Days 1 and 7
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/02/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/12/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
72
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Paratus Clinical Blacktown Clinic - Blacktown
Query!
Recruitment hospital [2]
0
0
Barwon Health - University Hospital Geelong - Geelong
Query!
Recruitment hospital [3]
0
0
Paratus Clinical Kanwal Clinic - Kanwal
Query!
Recruitment hospital [4]
0
0
Paratus Clinical Kippa Ring Clinic - Kippa Ring
Query!
Recruitment hospital [5]
0
0
Mater Hospital Brisbane - South Brisbane
Query!
Recruitment hospital [6]
0
0
Westmead Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2060 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [3]
0
0
2059 - Kanwal
Query!
Recruitment postcode(s) [4]
0
0
4021 - Kippa Ring
Query!
Recruitment postcode(s) [5]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [6]
0
0
2145 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Idaho
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Michigan
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Minnesota
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Montana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oklahoma
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
South Carolina
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Bahia Blanca
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Barrio Parque Velez Sarfield
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Caba
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Ciudad De La Plata
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Ciudadela
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Cordoba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
General Roca
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Rosario
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
San Miguel de Tucuman
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Bruxelles
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Ham
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Massemen
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Tessenderlo
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Belo Horizonte
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Botucatu
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Florianopolis
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Natal
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Passo Fundo
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Porto Alegre
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Salvador
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Sao Paulo
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
São Paulo
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Kozloduy
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Pernik
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Ruse
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Smolyan
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Sofia
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Troyan
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Ontario
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Quebec
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Agen cedex 9
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Angers
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Murs Erigne
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Nantes
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Paris
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Berlin
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Frankfurt
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Hannover
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Luebeck
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Fukui-shi
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Kawasaki
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Kitakyusyu
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Koganei-Shi
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Kumamoto-shi
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Osaka
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Shinagawa-ku
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Tokorozawa-shi
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Toyota
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Yukuhashi
Query!
Country [59]
0
0
Korea, Republic of
Query!
State/province [59]
0
0
Bucheon
Query!
Country [60]
0
0
Korea, Republic of
Query!
State/province [60]
0
0
Daegu
Query!
Country [61]
0
0
Korea, Republic of
Query!
State/province [61]
0
0
Gyeonggi-do
Query!
Country [62]
0
0
Korea, Republic of
Query!
State/province [62]
0
0
Incheon
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Seoul
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Aguascalientes
Query!
Country [65]
0
0
Mexico
Query!
State/province [65]
0
0
Guadalajara
Query!
Country [66]
0
0
Mexico
Query!
State/province [66]
0
0
Mexico
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Monterrey
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Kielce
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Krakow
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Lodz
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Ostrow Wielkopolski
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Wroclaw
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Krasnogorsk
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Saint-Petersburg
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
St. Petersburg
Query!
Country [76]
0
0
South Africa
Query!
State/province [76]
0
0
Johannesburg
Query!
Country [77]
0
0
South Africa
Query!
State/province [77]
0
0
Pretoria
Query!
Country [78]
0
0
South Africa
Query!
State/province [78]
0
0
Welkom
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Alicante
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Elche
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Granada
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Madrid
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Santiago de Compostela
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Vigo
Query!
Country [85]
0
0
Sweden
Query!
State/province [85]
0
0
Malmö
Query!
Country [86]
0
0
Sweden
Query!
State/province [86]
0
0
Umeå
Query!
Country [87]
0
0
Sweden
Query!
State/province [87]
0
0
Uppsala
Query!
Country [88]
0
0
Taiwan
Query!
State/province [88]
0
0
Kaohsiung
Query!
Country [89]
0
0
Taiwan
Query!
State/province [89]
0
0
New Taipei
Query!
Country [90]
0
0
Taiwan
Query!
State/province [90]
0
0
Taichung City
Query!
Country [91]
0
0
Taiwan
Query!
State/province [91]
0
0
Taipei City
Query!
Country [92]
0
0
Taiwan
Query!
State/province [92]
0
0
Taipei
Query!
Country [93]
0
0
Ukraine
Query!
State/province [93]
0
0
Kharkiv
Query!
Country [94]
0
0
Ukraine
Query!
State/province [94]
0
0
Kherson
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Kyiv
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Vinnytsia
Query!
Country [97]
0
0
Ukraine
Query!
State/province [97]
0
0
Vinnytsya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03379675
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/75/NCT03379675/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/75/NCT03379675/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03379675
Download to PDF