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JNJ-53718678 4.5 mg/kgWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1288 JNJ-53718678 2.5 mg/kg Wiki 1.00
drug2007 RSV Mobile Application Wiki 1.00
drug1290 JNJ-53718678 3 mg/kg Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D014777 Virus Diseases NIH 0.12

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

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.

NCT04068792 Respiratory Syncytial Viruses Other: RSV Mobile Application Drug: Placebo Drug: JNJ-53718678 2.5 mg/kg Drug: JNJ-53718678 3 mg/kg Drug: JNJ-53718678 4.5 mg/kg
MeSH:Virus Diseases

Primary Outcomes

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 stage

Secondary Outcomes

Description: 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 stage

Description: 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 stage

Description: 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 1

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

Description: 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 stage

No related HPO nodes (Using clinical trials)