Trial · NCT04068792
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
NCT04068792, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2022-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease. Trials, record NCT04068792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04068792
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
- NCT number
- NCT04068792
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Respiratory Syncytial Viruses
- Interventions
- RSV Mobile Application, Placebo, JNJ-53718678 2.5 mg/kg, JNJ-53718678 3 mg/kg, JNJ-53718678 4.5 mg/kg
- First posted
- 2019-08-28
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2019-001509-25
- Results first posted
- 2022-06-08
- Limitations and caveats
- The required number of participants in the interventional phase was not reached, and hence, limiting the interpretability of the data.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. |
| Secondary | RSV Viral Load Over Time | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21 | RSV viral load actual values over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. |
| 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 | 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. |
| 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 | RSV viral load AUC was determined by qRT-PCR assay in mid-turbinate nasal swab specimens. |
| Secondary | Time to Undetectable RSV Viral Load | Up to 21 days | Time to undetectable RSV viral load is defined as the time in hours from initiation of study treatment until the first post-baseline time point at which the virus is confirmed undetectable. A confirmed undetectable sample is defined as the first of at least two consecutive samples that are undetectable. The last obtained sample for a participant, if undetectable, is considered confirmed. |
| 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 | Percentage of participants with undetectable RSV viral load at each time point throughout the study were reported. |
| 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 | The severity of signs and symptoms of RSV infection (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration) were assessed by the PRESORS. PRESORS is a questionnaire by parent(s)/caregiver(s) recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each 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 Parent(s)/Caregiver(s) PRESORS Scores | Baseline, Day 3, 5, 8, 14, 21 | PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score 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, Day 3, 5, 8, 14, 21 | Change from baseline in clinician (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) PRESORS scores was reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 10-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 | Time to Resolution of RSV Symptoms | Up to 21 days | Time to resolution 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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-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 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group266
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-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5]) | Placebo | 26.13 | 90% Confidence Interval 23.701 | log10 copies*day per milliliter | |
| Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5]) | JNJ-53718678 | 25.10 | 90% Confidence Interval 22.497 | log10 copies*day per milliliter | |
| RSV Viral Load Over Time | Placebo | Baseline | 7.744 | Standard Deviation 1.1991 | log10 copies per milliliter |
| RSV Viral Load Over Time | JNJ-53718678 | Baseline | 7.477 | Standard Deviation 1.4111 | log10 copies per milliliter |
| RSV Viral Load Over Time | Placebo | Day 2 | 7.748 | Standard Deviation 1.2387 | log10 copies per milliliter |
| RSV Viral Load Over Time | JNJ-53718678 | Day 2 | 6.613 | Standard Deviation 3.2426 | log10 copies per milliliter |
| RSV Viral Load Over Time | Placebo | Day 3 | 6.415 | Standard Deviation 2.3924 | log10 copies per milliliter |
| RSV Viral Load Over Time | JNJ-53718678 | Day 3 | 6.277 | Standard Deviation 2.8027 | log10 copies per milliliter |
| RSV Viral Load Over Time | Placebo | Day 4 | 5.600 | Standard Deviation 2.2868 | log10 copies per milliliter |
| RSV Viral Load Over Time | JNJ-53718678 | Day 4 | 5.683 | Standard Deviation 3.2009 | log10 copies per milliliter |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | STARTED | JNJ-53718678 | 11 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | COMPLETED | JNJ-53718678 | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | JNJ-53718678 | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Tachycardia | Cardiac disorders | Placebo | 0 | 11 | |
| other | Tachycardia | Cardiac disorders | JNJ-53718678 | 1 | 11 | |
| other | Gastroenteritis | Infections and infestations | Placebo | 1 | 11 | |
| other | Gastroenteritis | Infections and infestations | JNJ-53718678 | 0 | 11 | |
| other | Urinary Tract Infection | Infections and infestations | Placebo | 0 | 11 | |
| other | Urinary Tract Infection | Infections and infestations | JNJ-53718678 | 1 | 11 | |
| other | Dermatitis Atopic | Skin and subcutaneous tissue disorders | Placebo | 1 | 11 | |
| other | Dermatitis Atopic | Skin and subcutaneous tissue disorders | JNJ-53718678 | 0 | 11 | |
| other | Dermatitis Diaper | Skin and subcutaneous tissue disorders | Placebo | 1 | 11 | |
| other | Dermatitis Diaper | Skin and subcutaneous tissue disorders | JNJ-53718678 | 0 | 11 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, all-cause mortality | JNJ-53718678 | 0 | 11 |
| Total, other adverse events | Placebo | 3 | 11 |
| Total, other adverse events | JNJ-53718678 | 2 | 11 |
| Total, serious adverse events | Placebo | 1 | 11 |
| Total, serious adverse events | JNJ-53718678 | 1 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| JNJ-53718678 vs Placebo: deaths from any cause | Trial comparisons |
| JNJ-53718678 vs Placebo: serious adverse events | Trial comparisons |
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/NCT04068792
GET https://conductscience.org/api/trials/v1/NCT04068792/results?page=2