Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | COMPLETED | 22 | — | — | Oct 10, 2019 | May 15, 2021 | Feb 4, 2025 | 10 | Argentina, Belgium +3 |
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.
| Arm | Type | Description |
|---|---|---|
| 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). |
| 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. |
| Name | Type | Description |
|---|---|---|
| RSV Mobile Application | OTHER | 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. |
| Placebo | DRUG | 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/kg | DRUG | JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days. |
| JNJ-53718678 3 mg/kg | DRUG | JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days. |
| JNJ-53718678 4.5 mg/kg | DRUG | JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days. |
Inclusion Criteria: 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/caregiv...