Trial · NCT04068792
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Time to Improvement on Overall Health | Up to 21 days | Time to improvement based on general questions on overall health was reported. 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'. |
| 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 | Percentage of participants with worsening or improvement of RSV disease based on general questions on overall health was reported. Improvement is defined 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'. |
| Secondary | Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) | Up to 21 days | Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) was evaluated. It is the time from first dose of study drug until the time to return to pre-RSV disease level. |
| Secondary | Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up | Up to Day 31 | Percentage of participants who require (re)hospitalization during treatment and follow-up were reported. |
| Secondary | Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 31 | 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. |
| Secondary | Percentage of Participants With Abnormal Chemistry Laboratory Findings | Up to Day 31 | Percentage of participants with abnormal chemistry laboratory findings (alanine aminotransferase \[ALT; Grade 1 and 4\], aspartate aminotransferase \[AST; Grade 1\], and Hyperkalemia \[Grade 1 and 2\]) were reported based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable. |
| Secondary | Percentage of Participants With Abnormal Urinalysis Laboratory Findings | Up to Day 31 | Percentage of participants with abnormal urinalysis (Hematuria- Grade 1) laboratory finding was reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable. |
| Secondary | Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings | Up to Day 31 | Percentage of participants with abnormal ECGs findings were reported. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB) Interval (\[450 milliseconds {ms}, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), QTc according to Fridericia's formula (QTcF) Interval (\[450 ms, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), change from baseline for QTcB Interval (\[30; 60\] ms, and greater than \[\>\] 60 ms), and for QTcF Interval (\[30; 60\] ms, and \>60 ms). |
| Secondary | Percentage of Participants With Vital Sign Abnormalities | Up to Day 31 | Percentage of participants with vital signs (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\], pulse rate, respiratory rate, body temperature and peripheral capillary oxygen saturation \[SpO2\]) abnormalities (abnormally low \[ABL\] and abnormally high \[ABH\]) were reported. |
| Secondary | Plasma Concentrations of JNJ-53718678 | Day 1 and Day 3 | No data was collected for pharmacokinetic (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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