Trial · NCT03656510
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
NCT03656510, Phase 2, Terminated, Janssen Research & Development, LLC; results first posted 2023-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection. Trials, record NCT03656510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03656510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
- NCT number
- NCT03656510
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 246 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- JNJ-53718678, Placebo
- First posted
- 2018-09-04
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2016-003642-93
- Results first posted
- 2023-09-21
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5]) | Baseline through Day 5 | RSV viral load AUC from immediately prior to first dose of study drug through Day 5 was determined. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure. |
| Secondary | RSV Viral Load Over Time | Baseline, Days 3, 5, 8, 14, and 21 | RSV viral load actual values over time were measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure. |
| Secondary | Change From Baseline in RSV Viral Load Over Time | Baseline up to Days 3, 5, 8, 14, and 21 | Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure. |
| Secondary | Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14 | Baseline through Days 3, 8, and 14 | LS mean RSV viral load on Days 3, 8, and 14 was reported. LS mean viral load (log10 copies/mL) was estimated per time point. The difference in RSV viral Load AUC (log10 copies\*day/mL) from immediately prior to first dose of study drug (baseline) through Day 3, 8 and 14 was determined from the model estimating the LS Mean Viral Load per time point, and is presented in the statistical analysis. The RSV viral load was measured by qRT-PCR assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, and analyzed for this outcome measure at Days 3 and 8, however combined Cohort 1 and Cohort 2 data were not analyzed for this outcome measure at Day 14, due to the premature study termination. |
| Secondary | Time to Undetectable RSV Viral Load | Up to Day 21 | Time to undetectable RSV viral load (as measured by qRT-PCR) was defined as the time in hours from first dose of study drug to first post-baseline timepoint at which the virus was undetectable and after which there were no more detectable virus assessments. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure. |
| Secondary | Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study | Baseline, Days 3, 5, 8, 14 and 21 | Percentage of participants with undetectable RSV viral load (as measured by qRT-PCR) at each timepoint throughout the study was reported. As planned, combined data for both the cohorts were collected, analyzed and reported for this outcome measure. |
| Secondary | Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores | Baseline up to Days 3, 5, 8, 14 and 21 | PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). PRESORS overall RSV symptoms summary parameter consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom. |
| Secondary | Change From Baseline in Clinician PRESORS Score | Baseline, up to Days 3, 5, 8, 14 and 21 | Change from baseline in clinician PRESORS scores (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) was assessed. Clinician PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease and consisted of 10-items, each item score ranges from 0 to 3. Overall RSV symptoms summary parameter was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom. |
| Secondary | Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO) | Up to Day 21 | Time to resolution is defined as time from first dose of study drug until the first time of resolution of all RSV symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours. |
| Secondary | Time to Improvement on Overall Health | Up to Day 21 | Time to improvement based on general questions on overall health was assessed. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'. |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5]) | Baseline through Day 5 | Intent-to-Treat-infected (ITT-i) analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV RNA viral load of greater than or equal to (\>=) 1 log10 copies/mL above the lower limit of quantification (LLOQ) of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. | log10 copies*day per milliliter (mL) | MEAN |
| SECONDARY | RSV Viral Load Over Time | Baseline, Days 3, 5, 8, 14, and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints. | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in RSV Viral Load Over Time | Baseline up to Days 3, 5, 8, 14, and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints. | log10 copies/mL | MEAN |
| SECONDARY | Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14 | Baseline through Days 3, 8, and 14 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints. | log10 copies*day/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Undetectable RSV Viral Load | Up to Day 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. | Hours | MEDIAN |
| SECONDARY | Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study | Baseline, Days 3, 5, 8, 14 and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores | Baseline up to Days 3, 5, 8, 14 and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinician PRESORS Score | Baseline, up to Days 3, 5, 8, 14 and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'n' (number analyzed) represents number of participants who were evaluable at specified timepoints. | Units on a scale | MEAN |
| SECONDARY | Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO) | Up to Day 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. | Hours | MEDIAN |
| SECONDARY | Time to Improvement on Overall Health | Up to Day 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV RNA viral load of \>=1 log10 copies/mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Hours | MEDIAN |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group1,367
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5]) | Cohorts 1 and 2: Placebo | 22.74 | 95% Confidence Interval 21.677 to 23.800 | log10 copies*day per milliliter (mL) | |
| Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5]) | Cohorts 1 and 2: JNJ-53718678 Low Dose | 21.48 | 95% Confidence Interval 20.402 to 22.566 | log10 copies*day per milliliter (mL) | |
| Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5]) | Cohorts 1 and 2: JNJ-53718678 High Dose | 21.51 | 95% Confidence Interval 20.374 to 22.650 | log10 copies*day per milliliter (mL) | |
| RSV Viral Load Over Time | Cohorts 1 and 2: Placebo | Baseline | 6.913 | Standard Deviation 1.3449 | log10 copies/mL |
| RSV Viral Load Over Time | Cohorts 1 and 2: JNJ-53718678 Low Dose | Baseline | 7.113 | Standard Deviation 1.3667 | log10 copies/mL |
| RSV Viral Load Over Time | Cohorts 1 and 2: JNJ-53718678 High Dose | Baseline | 7.004 | Standard Deviation 1.4709 | log10 copies/mL |
| RSV Viral Load Over Time | Cohorts 1 and 2: Placebo | Day 3 | 5.398 | Standard Deviation 1.5834 | log10 copies/mL |
| RSV Viral Load Over Time | Cohorts 1 and 2: JNJ-53718678 Low Dose | Day 3 | 5.432 | Standard Deviation 1.8952 | log10 copies/mL |
| RSV Viral Load Over Time | Cohorts 1 and 2: JNJ-53718678 High Dose | Day 3 | 5.271 | Standard Deviation 1.7710 | log10 copies/mL |
| RSV Viral Load Over Time | Cohorts 1 and 2: Placebo | Day 5 | 4.146 | Standard Deviation 1.8508 | log10 copies/mL |
1 to 10 of 1,367Source ClinicalTrials.gov
See all 1,367 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Placebo | 50 | |
| Overall Study | STARTED | Cohort 1: JNJ-53718678 Low Dose | 49 | |
| Overall Study | STARTED | Cohort 1: JNJ-53718678 High Dose | 48 | |
| Overall Study | STARTED | Cohort 2: Placebo | 34 | |
| Overall Study | STARTED | Cohort 2: JNJ-53718678 Low Dose | 34 | |
| Overall Study | STARTED | Cohort 2: JNJ-53718678 High Dose | 31 | |
| Overall Study | COMPLETED | Cohort 1: Placebo | 48 | |
| Overall Study | COMPLETED | Cohort 1: JNJ-53718678 Low Dose | 48 | |
| Overall Study | COMPLETED | Cohort 1: JNJ-53718678 High Dose | 48 | |
| Overall Study | COMPLETED | Cohort 2: Placebo | 33 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events726
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Placebo | 0 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: JNJ-53718678 Low Dose | 2 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: JNJ-53718678 High Dose | 1 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Placebo | 0 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: JNJ-53718678 Low Dose | 0 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: JNJ-53718678 High Dose | 0 | 31 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1: Placebo | 0 | 50 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1: JNJ-53718678 Low Dose | 0 | 49 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1: JNJ-53718678 High Dose | 1 | 48 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 2: Placebo | 0 | 34 |
1 to 10 of 726Source ClinicalTrials.gov
See all 726 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Placebo | 0 | 50 |
| Total, all-cause mortality | Cohort 1: JNJ-53718678 Low Dose | 0 | 49 |
| Total, all-cause mortality | Cohort 1: JNJ-53718678 High Dose | 0 | 48 |
| Total, all-cause mortality | Cohort 2: Placebo | 0 | 34 |
| Total, all-cause mortality | Cohort 2: JNJ-53718678 Low Dose | 0 | 34 |
| Total, all-cause mortality | Cohort 2: JNJ-53718678 High Dose | 0 | 31 |
| Total, other adverse events | Cohort 1: Placebo | 28 | 50 |
| Total, other adverse events | Cohort 1: JNJ-53718678 Low Dose | 29 | 49 |
| Total, other adverse events | Cohort 1: JNJ-53718678 High Dose | 30 | 48 |
| Total, other adverse events | Cohort 2: Placebo | 14 | 34 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38649595 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03656510
GET https://conductscience.org/api/trials/v1/NCT03656510/registered?page=2