Trial · NCT04068792
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5]) | Baseline (Day 1) up to 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 viral load of greater than or equal to (\>=) 1 log10 copies per milliliter (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 | MEAN |
| SECONDARY | RSV Viral Load Over Time | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>= 1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. | log10 copies per milliliter | MEAN |
| SECONDARY | Change From Baseline in RSV Viral Load Over Time | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>= 1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here, 'n' (number analyzed) included all participants who were analyzed at specified timepoints. | log10 copies per milliliter | MEAN |
| SECONDARY | RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through 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 a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. At Day 14, data was not collected due to low sample size. | log10 copies*hour per milliliter (h/mL) | MEAN |
| SECONDARY | Time to Undetectable RSV Viral Load | Up to 21 days | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. | hours | MEDIAN |
| SECONDARY | Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) | 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 a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. | Unit on scale | MEAN |
| SECONDARY | Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores | Baseline, Day 3, 5, 8, 14, 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. | units on scale | MEAN |
| SECONDARY | Change From Baseline in Clinician PRESORS Score | Baseline, Day 3, 5, 8, 14, 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV viral load of \>=1 log10 copies per mL above LLOQ of RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure; 'n' (number analyzed) included all participants who were analyzed at specified timepoints for specific category. | units on scale | MEAN |
| SECONDARY | Time to Resolution of RSV Symptoms | Up to 21 days | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. | Hours | MEDIAN |
| SECONDARY | Time to Improvement on Overall Health | Up to 21 days | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. | Hours | MEDIAN |
| SECONDARY | Percentage of Participants With Worsening or Improvement of RSV Disease | On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 | ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) | Up to 21 days | Data was not collected due to low number of participants. Hence, no results are reported. | ||
| SECONDARY | Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up | Up to Day 31 | The Safety set (SAF) included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 31 | The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormal Chemistry Laboratory Findings | Up to Day 31 | The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all participants who were analyzed at specified categories. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormal Urinalysis Laboratory Findings | Up to Day 31 | The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings | Up to Day 31 | The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Vital Sign Abnormalities | Up to Day 31 | The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all participants who were analyzed for specified categories. | percentage of participants | NUMBER |
| SECONDARY | Plasma Concentrations of JNJ-53718678 | Day 1 and Day 3 | No data was collected for PK analysis due to small sample size. Hence, no results are reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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