Clinical Trial Results:
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
Summary
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EudraCT number |
2017-003252-24 |
Trial protocol |
BE ES SE PL BG |
Global end of trial date |
26 Dec 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2021
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First version publication date |
06 Jan 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
53718678RSV2004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03379675 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen Research and Development LLC
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Sponsor organisation address |
920 US, Route 202, P.O. Box 300, Raritan, United States, 08869
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Public contact |
Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jul 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Dec 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was 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.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety and tolerability were evaluated throughout the study from signing of the informed consent form (ICF) until the last study-related activity. Safety evaluations included monitoring of adverse events (AEs), clinical laboratory tests, vital signs measurements, physical examinations, electrocardiograms (ECGs), and assessment of specific toxicities.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Feb 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Argentina: 12
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Country: Number of subjects enrolled |
Belgium: 1
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Country: Number of subjects enrolled |
Bulgaria: 7
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Country: Number of subjects enrolled |
Brazil: 5
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Country: Number of subjects enrolled |
Canada: 10
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Country: Number of subjects enrolled |
Germany: 6
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Mexico: 6
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Country: Number of subjects enrolled |
Poland: 8
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Country: Number of subjects enrolled |
Russian Federation: 1
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Country: Number of subjects enrolled |
Sweden: 2
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Country: Number of subjects enrolled |
Taiwan: 2
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Country: Number of subjects enrolled |
Ukraine: 3
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Country: Number of subjects enrolled |
United States: 6
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Worldwide total number of subjects |
72
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EEA total number of subjects |
27
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
54
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From 65 to 84 years |
18
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 79 subjects were screened for this study, but only 72 subjects were randomized and received intervention. Out of the 72, 66 were RSV positive and thus included in the intent-to-treat infected (ITT-i) analysis. | ||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||
Arm description |
Subjects received matching placebo as an oral solution once daily for 7 days. | ||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were administered matching placebo once daily for 7 days.
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Arm title
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JNJ-53718678 80 mg | ||||||||||||||||||||||||||||
Arm description |
Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-53718678 80 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were administered JNJ-53718678 80 mg once daily for 7 days.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were administered JNJ-53718678 80 mg once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding.
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Arm title
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JNJ-53718678 500 mg | ||||||||||||||||||||||||||||
Arm description |
Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-53718678 500 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were administered JNJ-53718678 500 mg once daily for 7 days.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo as an oral solution once daily for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-53718678 80 mg
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Reporting group description |
Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-53718678 500 mg
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Reporting group description |
Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo as an oral solution once daily for 7 days. | ||
Reporting group title |
JNJ-53718678 80 mg
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Reporting group description |
Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding. | ||
Reporting group title |
JNJ-53718678 500 mg
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Reporting group description |
Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days. |
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End point title |
Area Under the Respiratory Syncytial Virus (RSV) Viral Load-time Curve (AUC) Over Time [1] | ||||||||||||||||||||||||||||||||
End point description |
Area under the RSV Viral Load (VL)-time curve 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. The intent-to-treat-infected (ITT-i) population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of subjects who were analyzed at specified timepoints.
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End point type |
Primary
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End point timeframe |
Baseline through Days 3, 5, 8 and 14
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics was done, no inferential statistical analyses was performed. |
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No statistical analyses for this end point |
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End point title |
Change from Baseline in RSV Viral Load Over Time [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in RSV viral load over time was measured as log10 copies per milliliter (Log10 copies/mL) by qRT-PCR assay in the mid-turbinate nasal swab specimens. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of subjects who were analyzed at specified timepoints.
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End point type |
Primary
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End point timeframe |
Baseline up to Day 21
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics was done, no inferential statistical analyses was performed. |
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No statistical analyses for this end point |
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End point title |
RSV Viral Load Over Time [3] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
RSV viral load over time was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of subjects who were analyzed at specified timepoints.
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End point type |
Primary
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End point timeframe |
Baseline up to Day 21
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics was done, no inferential statistical analyses was performed. |
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No statistical analyses for this end point |
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End point title |
Time to Undetectable RSV Viral Load [4] | ||||||||||||||||
End point description |
The time to undetectable nasal RSV RNA viral load was defined as the time to the first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
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End point type |
Primary
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End point timeframe |
Up to Day 21
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics was done, no inferential statistical analyses was performed. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Undetectable RSV Viral Load [5] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The number of subjects with undetectable RSV viral load over time were reported. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, n (subjects analyzed) signifies the number of subjects analyzed at specified timepoints.
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End point type |
Primary
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End point timeframe |
Baseline up to Day 21
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics was done, no inferential statistical analyses was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability | ||||||||||||
End point description |
An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. The safety population included randomized subjects who received at least one dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Clinically Significant Laboratory Abnormalities | ||||||||||||
End point description |
Number of subjects with clinically significant laboratory (serum chemistry, hematology and urinalyses) abnormalities were reported. The safety population included randomized subjects who received at least one dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Treatment Emergent Vital Sign Abnormalities | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The subjects were analyzed for abnormalities in vital sign parameters like diastolic blood pressure (DBP), oxygen saturation, pulse rate, respiratory rate (RR), systolic blood pressure (SBP) and temperature. The classification was based on division of microbiology and infectious diseases (DMID) scale. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, n (subjects analyzed) signifies the number of subjects analyzed at specified categories.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Worst Treatment Emergent Electrocardiograms (ECGs) Abnormalities | ||||||||||||||||||||||||||||||||
End point description |
The number of subjects with ECG abnormalities were reported. The ECG variables that were analyzed are heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. The safety population included randomized subjects who received at least one dose of study drug. Here, 'n' (subjects analyzed) signifies number of subjects analyzed for specified categories.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Abnormalities in Physical Examination | ||||||||||||
End point description |
A physical examination (including height [only at screening] and body weight measurements) and skin examination were performed. A skin examination included an examination of the mucous membranes, but not a vaginal or rectal examination. The safety population included randomized subjects who received at least one dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to Day 28
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Notes [6] - Clinically relevant treatment emergent abnormalities were reported as adverse events. [7] - Clinically relevant treatment emergent abnormalities were reported as adverse events. [8] - Clinically relevant treatment emergent abnormalities were reported as adverse events. |
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No statistical analyses for this end point |
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End point title |
Time to Resolution of Selected RSV Symptoms as Assessed by RI-PRO | ||||||||||||||||
End point description |
Resolution of RSV symptoms was defined as a score of ‘Not at all’ (score = 0) or ‘A little bit’ (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. RI-PRO is a 32 items questionnaire computed in six domain scores, representing symptom severity. Selected RSV symptoms include symptoms in the following domains: Nose, Throat, Chest/respiratory and Body/systemic. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
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End point type |
Secondary
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End point timeframe |
Up to Day 21
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No statistical analyses for this end point |
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End point title |
Time to Return to Usual Activity/Health Based on RI-PRO | ||||||||||||||||||||||||
End point description |
Time from the first dose of study drug until the time of 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. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
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End point type |
Secondary
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End point timeframe |
Up to Day 21
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No statistical analyses for this end point |
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End point title |
Peripheral Capillary Oxygen Saturation (SpO2) Over Time | ||||||||||||||||||||||||||||||||||||
End point description |
Oxygen saturation was measured by the investigator over time. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Baseline, Days 3, 8, 14 and 21
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Peripheral Capillary Oxygen saturation | ||||||||||||||||||||||||||||||||
End point description |
Change from baseline in oxygen saturation levels was calculated by the investigator. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Days 3, 8, 14 and 21
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No statistical analyses for this end point |
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End point title |
Pulse Rate Over Time | ||||||||||||||||||||||||||||||||||||
End point description |
Pulse rate was measured by the investigator over time. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Baseline, Days 3, 8, 14 and 21
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Pulse Rate | ||||||||||||||||||||||||||||||||
End point description |
Change from baseline in pulse rate was calculated by the investigator. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Days 3, 8, 14 and 21
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No statistical analyses for this end point |
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End point title |
Respiratory Rate Over Time | ||||||||||||||||||||||||||||||||||||
End point description |
Respiratory rate was measured by the investigator over time. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Baseline, Days 3, 8, 14 and 21
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Respiratory Rate | ||||||||||||||||||||||||||||||||
End point description |
Change from baseline in respiratory rate was calculated by the investigator. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Days 3, 8, 14 and 21
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No statistical analyses for this end point |
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End point title |
Body Temperature Over Time | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Body temperature was measured over time. Subjects were provided a thermometer and asked to record body temperature in the electronic device on the non-visit days. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Baseline up to Day 21
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Body Temperature | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from baseline in body temperature was calculated. Subjects were provided a thermometer and asked to record body temperature in the electronic device on the non-visit days. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Day 2 up to Day 21
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No statistical analyses for this end point |
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End point title |
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post dose [9] | ||||||||||||||||||
End point description |
AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose. Pharmacokinetic analysis set included all subjects who received JNJ-53718678 and for whom at least one pharmacokinetic (PK) concentration was reported. Here 'N' (number of subjects analyzed) signifies number of subjects analyzed for this endpoint and 'n' (number analyzed) signifies number of subjects analyzed for this endpoint at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Days 1 and 7 up to 24 hours post dose
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Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoint was planned to be analyzed for specified arms only. |
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No statistical analyses for this end point |
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End point title |
Predose Plasma Concentration (Ctrough) of JNJ-53718678 [10] | ||||||||||||||||||
End point description |
Ctrough is the trough observed plasma concentration of JNJ-53718678. Pharmacokinetic analysis set included all subjects who received JNJ-53718678 and for whom at least one pharmacokinetic (PK) concentration was reported. Here 'N' (number of subjects analyzed) signifies number of subjects analyzed for this endpoint and 'n' (number analyzed) signifies number of subjects analyzed for this endpoint at specified timepoints.
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End point type |
Secondary
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End point timeframe |
Days 1 and 7
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Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoint was planned to be analyzed for specified arms only. |
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No statistical analyses for this end point |
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End point title |
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 [11] | ||||||||||||||||||
End point description |
Cmax is the maximum observed plasma concentration of JNJ-53718678. Pharmacokinetic analysis set included all subjects who received JNJ-53718678 and for whom at least one pharmacokinetic (PK) concentration was reported. Here 'N' (number of subjects analyzed) signifies number of subjects analyzed for this endpoint and 'n' (number analyzed) signifies number of subjects analyzed for this endpoint at specified timepoints.
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End point type |
Secondary
|
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End point timeframe |
Days 1 and 7
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Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoint was planned to be analyzed for specified arms only. |
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No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
Up to 29 days
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Adverse event reporting additional description |
Safety analysis set included all randomized subjects who received at least one dose of study drug.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
|
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Reporting group title |
Placebo
|
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Reporting group description |
Subjects received matching placebo as an oral solution once daily for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-53718678 80 mg
|
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Reporting group description |
Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-53718678 500 mg
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Reporting group description |
Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
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Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
24 Apr 2019 |
The amendment 1 included the following changes: some other minor editorial changes, corrections, and clarifications: replaced the RI-PRO questionnaire by the RiiQ questionnaire for the assessment of the duration and severity of signs and symptoms of RSV infection as reported by
the subject, for all newly enrolled subjects after approval of the amendment. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The RiiQ Scale that replaced RI-PRO questionnaire was only evaluated in the 5 subjects who were enrolled after implementation of protocol amendment 1. This sample size was too small to draw conclusions on comparison between RiiQ and RI-PRO results. |