Respiratory Syncytial VirusesPhase 2NCT04068792
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
A Phase 2 study testing RSV Mobile Application, JNJ-53718678 2.5 mg/kg and JNJ-53718678 3 mg/kg in people with Respiratory Syncytial Viruses, run by Janssen Research & Development, LLC at 10 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 28 days to 4 months
- Conditions the study is for
- Respiratory Syncytial Viruses
- What is being tested?
- RSV Mobile Application, JNJ-53718678 2.5 mg/kg and JNJ-53718678 3 mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 10 Oct 2019to 15 May 2021
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Part 1: Observational Stage
- The infant is less than or equal to (<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study
- At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)
- The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Part 2: Interventional Stage
- The infant is 28 days and if prematurely born infant (that is [i.e.], less than [<] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age
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- The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay
- The participant weighs more than 2.4 kilogram (kg)
- The participant has an acute respiratory illness as evaluated by the investigator
- Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions
- The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection
Who cannot join
- Part 1: Observational Stage
- The participant has any physical abnormality which limits the ability to collect regular nasal specimens
- The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)
- Part 2: Interventional Stage
- The participant is <3 months postnatal age at screening and was born prematurely (i.e., <37 weeks and 0 days of gestation) or if the participant weights <2.4 kg
- The participant has a QT interval with Fridericia's correction (QTcF) greater than (>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening
- The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy
- The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Taiwan4 sites
Hsinchu MacKay Memorial Hospital
Hsinchu, 30071
National Taiwan University Hospital
Taipei, 10002
Department of Pediatrics, MacKay Memorial Hospital
Taipei, 10449
Chang Gung Memorial Hospital- Linkou
Taoyuan, 333
Panama3 sites
Cevaxin 24 de diciembre
Panama City, 000000
Cevaxin Avenida Mexico
Panama City, 000000
Cevaxin La Chorrera
Republica de Panama, 000000
Argentina1 site
Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes
San Miguel de Tucumán
United Kingdom1 site
St George's University Hospital NHS Foundation Trust
London, SW17 0QT
About this study
Official title: 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.
- Conditions
- Respiratory Syncytial Viruses
- Being tested
- RSV Mobile Application, Placebo, JNJ-53718678 2.5 mg/kg, JNJ-53718678 3 mg/kg, JNJ-53718678 4.5 mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV Mobile ApplicationOther
Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.
PlaceboDrug
Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.
JNJ-53718678 2.5 mg/kgDrug
JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.
JNJ-53718678 3 mg/kgDrug
JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.
JNJ-53718678 4.5 mg/kgDrug
JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Part 1-Observational Phase | Other | Participants will not receive any intervention in the observation phase. All infants will be closely monitored for early signs and symptoms of Respiratory Syncytial Virus (RSV) disease using a mobile RSV application on the parent/caregiver's mobile phone, upon an alert, the RSV will be tested, if RSV negative participants (RSV [-] diagnosed at site) will return to the pre-diagnostic phase and RSV positive participants (RSV [+] diagnosed at site) can be enrolled in the interventional stage of the study after obtaining informed consent for the interventional stage at that time. RSV (+) participants whose parent(s)/caregiver(s) do not consent for enrollment in the interventional stage and participants who are screening failures in the interventional stage will enter the post-diagnostic phase of the observational stage (hospitalized or outpatients). Receives: Other: RSV Mobile Application |
| Part 2-Interventional Phase | Experimental | Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to [>=] 28 days and less than [<] 3 months): 2.5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 3 mg/kg and for Age Group 3 (>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days. Receives: Drug: Placebo; Drug: JNJ-53718678 2.5 mg/kg; Drug: JNJ-53718678 3 mg/kg; Drug: JNJ-53718678 4.5 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
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.
Measured: Baseline (Day 1) up to Day 5
Secondary outcomes (19)
RSV Viral Load Over Time
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.
Measured: 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
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.
Measured: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14
RSV viral load AUC was determined by qRT-PCR assay in mid-turbinate nasal swab specimens.
Measured: Baseline through Days 3, 8, and 14
Time to Undetectable RSV Viral Load
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.
Measured: Up to 21 days
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Percentage of participants with undetectable RSV viral load at each time point throughout the study were reported.
Measured: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
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.
Measured: Baseline, Days 3, 5, 8, 14, and 21
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
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.
Measured: Baseline, Day 3, 5, 8, 14, 21
Change From Baseline in Clinician PRESORS Score
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.
Measured: Baseline, Day 3, 5, 8, 14, 21
Time to Resolution of RSV Symptoms
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.
Measured: Up to 21 days
Time to Improvement on Overall Health
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'.
Measured: Up to 21 days
Percentage of Participants With Worsening or Improvement of RSV Disease
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'.
Measured: On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)
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.
Measured: Up to 21 days
Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up
Percentage of participants who require (re)hospitalization during treatment and follow-up were reported.
Measured: Up to Day 31
Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
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.
Measured: Up to Day 31
Percentage of Participants With Abnormal Chemistry Laboratory Findings
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.
Measured: Up to Day 31
Percentage of Participants With Abnormal Urinalysis Laboratory Findings
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.
Measured: Up to Day 31
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
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).
Measured: Up to Day 31
Percentage of Participants With Vital Sign Abnormalities
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.
Measured: Up to Day 31
Plasma Concentrations of JNJ-53718678
No data was collected for pharmacokinetic (PK) analysis due to small sample size. Hence, no results are reported.
Measured: Day 1 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Oct 2019
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial VirusesStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068792
- Sponsor's protocol ID
- CR108647
- Other IDs
- 2019-001509-25, 53718678RSV2006, 2019
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2019
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu