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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2055 | JNJ-53718678 3 mg/kg Wiki | 1.00 |
| drug2056 | JNJ-53718678 4.5 mg/kg Wiki | 1.00 |
| drug3237 | RSV Mobile Application Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.
Description: Respiratory Syncytial Virus (RSV) viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.
Measure: Part 2: RSV Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5 Time: On the day of diagnosis (Baseline) through Day 5 of interventional stageDescription: Total Respiratory Symptom Score over time will be captured by RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV positive participants that do not enter in the interventional stage.
Measure: Part 1: Total Respiratory Symptom Score Over Time Time: Up to 21 Days of observational stageDescription: Clinician PRESORS scores will be reported for hospitalized RSV positive participants. Clinician 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) by clinician.
Measure: Part 1: Change from Baseline in Clinician Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Scores Time: On the day of RSV diagnosis (Baseline) up to Discharge post-diagnosis (21 Days) of observational stageDescription: RSV Viral load during pre-diagnostic phase will be determined based on measurements of RSV viral load in nasal secretions by a qRT-PCR assay in mid-turbinate nasal swab specimens.
Measure: Part 1: RSV Viral Load Time: Pre-diagnostic phase: Within 24hrs of Observation Day 1Description: RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) will be measured by real-time qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure: Part 1: RSV Viral Load Kinetics from Day 1 to Day 8 Time: On the day of diagnosis (Baseline) through Day 8 of observational stageDescription: Change from baseline in Parent(s)/Caregiver(s) PRESORS scores (worsening or improvement) will be reported.
Measure: Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time Time: On the day of diagnosis (Baseline) up to 21 Days of the observational stageDescription: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in mid-turbinate nasal swab specimens.
Measure: Part 2: RSV Viral Load and Change from Baseline Over Time Time: On the day of diagnosis (Baseline) through Day 21 of interventional stageDescription: RSV viral load AUC will be determined by qRT-PCR assay in mid-turbinate nasal swab specimens.
Measure: Part 2: RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14 Time: On the day of diagnosis (Baseline) through Days 3, 8 and 14 of interventional stageDescription: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.
Measure: Part 2: Time to Undetectable RSV Viral Load Time: Up to 21 days of interventional stageDescription: Percentage of participants with undetectable RSV viral load will be reported.
Measure: Part 2: Percentage of Participants with Undetectable RSV Viral Load at each timepoint Time: Up to 21 days of interventional stageDescription: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. 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).
Measure: Part 2: Duration of Signs and Symptoms of RSV Disease Assessed by the PRESORS Time: Up to 21 days of interventional stageDescription: Severity of RSV disease will be assessed by PRESORS. 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).
Measure: Part 2: Severity of RSV Disease Assessed by PRESORS Time: Up to 21 days of interventional stageDescription: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. 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) daily by parent/caregiver.
Measure: Part 2: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Time: On the day of diagnosis (Baseline) up to 21 days of interventional stageDescription: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. 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) by clinician.
Measure: Part 2: Change from Baseline in Clinician PRESORS Scores Time: On the day of diagnosis (Baseline) up to 21 days of interventional stageDescription: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.
Measure: Part 2: Time to Resolution of RSV Symptoms Time: Up to 21 days of interventional stageDescription: Time to improvement based on general questions on overall health will be reported.
Measure: Part 2: Time to Improvement on Overall Health Time: Up to 21 days of interventional stageDescription: Percentage of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.
Measure: Part 2: Percentage of Participants with Improvement or Worsening of RSV Disease Time: Up to 21 days of interventional stageDescription: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.
Measure: Part 2: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) Time: Up to 21 days of interventional stageDescription: Percentage of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.
Measure: Part 2: Percentage of Participants with Vital Sign Abnormalities Time: Up to 28 days of interventional stageDescription: Percentage of participants who require (re)hospitalization during treatment and follow-up will be reported.
Measure: Part 2: Percentage of Participants who Require (re)Hospitalization During Treatment and Follow-up Time: Up to 28 days of interventional stageDescription: 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.
Measure: Part 2: Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability Time: Up to 28 days of interventional stageDescription: Percentage of participants with abnormal laboratory findings (hematology, biochemistry, urinalysis) will be reported.
Measure: Part 2: Percentage of Participants with Abnormal Laboratory Findings Time: Up to 28 days of interventional stageDescription: Percentage of participants with abnormal ECGs findings will be reported.
Measure: Part 2: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings Time: Up to 28 days of interventional stageDescription: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.
Measure: Part 2: Plasma Concentrations of JNJ-53718678 Time: Day 1 and Day 3 of interventional stageAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports