Trial · NCT04583280
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
NCT04583280, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2023-04-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV). Trials, record NCT04583280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04583280
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
- NCT number
- NCT04583280
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 28 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Respiratory Tract Infections
- Interventions
- Rilematovir, Rilematovir X mg/kg, Placebo
- First posted
- 2020-10-12
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2020-002023-11
- Results first posted
- 2023-04-10
- Limitations and caveats
As the study was terminated early, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety, and selected PK and efficacy parameters only.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Baseline to Day 8 | RRS was an ordinal scale to assess a participant's clinical status. The RRS provided 7 mutually exclusive categories ordered from best (1) to worst (7) where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=worst (death). Higher category indicates worse condition. With or without signs/symptoms was defined as the key RSV signs/symptoms (breathing problems, retractions, tachypnea, cough, wheezing/breathing sounds, and tachycardia) resolved (absent or mild) or not resolved assessed by parent/caregiver. |
| Secondary | Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8 | Day 8 | Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had Key RSV signs/symptoms resolved to absent or mild as per ClinRO signs/symptoms. Clinically resolved Key RSV signs/symptoms were assessed based on clinician's observations as resolved if participant had no retractions, tachypnea, tachycardia, breathing problems (nasal flaring, head bobbing, grunting); cough (resolved if little or no coughing or occasional strong cough or sometimes productive) and wheezing (resolved if no wheezing or terminal expiratory wheezing or only with stethoscope). |
| Secondary | Time From First Study Dose to Resolution of Key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours | Up to Day 21 | Time (in hours) from first dose of study intervention to first resolution of key RSV signs/symptoms was evaluated based on ObsRO assessment after free of supplementation (O2/feeding/hydration) for at least 24 hours. Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had key RSV signs/symptoms resolved to absent or mild as per ObsRO signs/symptoms. Resolution of key signs/symptoms assessment was based on observations of child's parent/caregiver as resolved if no retractions, tachypnea, tachycardia, breathing problems (gasping for air nostrils, flaring when breathing, head bobbed back and forth when breathing), no breathing sound; cough (no coughing, little coughing without problems). Kaplan-Meier method was used for estimation. |
| Secondary | Number of Participants With Post-baseline RSV-related Complications | Up to Day 35 | RSV related complications included respiratory complications (respiratory failure, apnoeic attacks, bronchiolitis, bronchial obstruction, pneumonia and asthmatic crisis), infectious complications (otitis media, bacterial respiratory tract infections and sepsis), cardiovascular complications (arrhythmia, cardiogenic shock, hemodynamic instability, congestive cardiac failure), acid-base or electrolyte complications (metabolic acidosis, metabolic alkalosis, hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoglycemia and hyperglycemia). Participants were counted only once, regardless of the number of complications they actually experienced. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 35 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE with an onset after the initiation study drug (Day 1) up to end of study (Day 35). AEs included both serious and non-serious AEs. |
| Secondary | Number of Participants With Abnormalities in Clinical Laboratory Values | Up to Day 35 | Number of participants with abnormally low (AL) and abnormally high (AH) values of bicarbonate, direct bilirubin, urea nitrogen, basophils, eosinophils, erythrocyte (Ery). mean corpuscular hemoglobin (HGB) concentration (conc), Ery. mean corpuscular hemoglobin, erythrocytes, leukocytes, lymphocytes, monocytes, neutrophils and reticulocytes were reported based on the investigator's discretion. |
| Secondary | Number of Participants With Abnormalities in Electrocardiograms (ECGs) | Up to Day 35 | Number of participants with abnormally low and abnormally high values of ECG parameters (PR interval and RR interval) as assessed based on the investigator's discretion were reported. |
| Secondary | Number of Participants With Abnormalities in Vital Signs | Up to Day 35 | Number of participants with abnormally low and abnormally high values of vital signs from baseline were assessed based on investigator's discretion. Vital signs included systolic blood pressure (SBP) (millimeter of mercury \[mmHg\]), diastolic blood pressure (DBP) (mmHg), pulse rate (beats per minute), respiratory rate (breaths per minute), temperature (degree Celsius) and oxygen saturation (in percentage). |
| Secondary | Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir | Up to Day 35 | Percentage of participants requiring ICU stay was analyzed and reported. |
| Secondary | Duration of ICU Stay | Up to Day 35 | Duration (in hours) of ICU stay was defined as total number of hours a participant experienced an ICU stay from first dose of rilematovir until study termination, calculated as the sum of all separate records of ICU stay. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Baseline to Day 8 | Intent to treat - infected (ITT-i) analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Due to the early termination of study, last day of RRS treatment (Day 8) was considered instead of the original planned day defined as when 50% participants would have been discharged. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8 | Day 8 | ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. | Percentage of participants | NUMBER |
| SECONDARY | Time From First Study Dose to Resolution of Key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours | Up to Day 21 | ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had RSV infection confirmed by central laboratory analysis. | Hours | MEDIAN |
| SECONDARY | Number of Participants With Post-baseline RSV-related Complications | Up to Day 35 | ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 35 | Safety analysis set included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Clinical Laboratory Values | Up to Day 35 | Safety analysis set included all participants who received at least 1 dose of study intervention. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants with available data at each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Electrocardiograms (ECGs) | Up to Day 35 | Safety analysis set included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Vital Signs | Up to Day 35 | Safety analysis set included all participants who received at least 1 dose of study intervention. Here, 'n' (number analyzed) signifies number of participants with available data at each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir | Up to Day 35 | ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (Overall number of participants analyzed) signifies participants with no ICU stay before first dose of rilematovir. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of ICU Stay | Up to Day 35 | ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (Overall number of participants analyzed) signifies participants who required ICU stay before first dose of rilematovir and continued after first dose plus participants who required ICU stay after first dose of drug without prior ICU stay. | hours | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group209
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Placebo | Home without symptoms | 25.0 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Rilematovir | Home without symptoms | 31.6 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Placebo | Home with symptoms | 50.0 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Rilematovir | Home with symptoms | 26.3 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Placebo | Ward without supplemental oxygen/feeding/hydration | 25.0 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Rilematovir | Ward without supplemental oxygen/feeding/hydration | 36.8 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Placebo | Ward with supplemental or feeding/hydration | 0 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Rilematovir | Ward with supplemental or feeding/hydration | 5.3 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Placebo | ICU without mechanical ventilation | 0 | Percentage of participants | |
| Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category | Rilematovir | ICU without mechanical ventilation | 0 | Percentage of participants |
1 to 10 of 209Source ClinicalTrials.gov
See all 209 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | STARTED | Rilematovir | 20 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Rilematovir | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rilematovir | 1 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutrophilia | Blood and lymphatic system disorders | Placebo | 0 | 8 | 0 |
| other | Neutrophilia | Blood and lymphatic system disorders | Rilematovir | 1 | 20 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo | 1 | 8 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Rilematovir | 1 | 20 | 1 |
| other | Ventricular Extrasystoles | Cardiac disorders | Placebo | 0 | 8 | 0 |
| other | Ventricular Extrasystoles | Cardiac disorders | Rilematovir | 2 | 20 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 8 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Rilematovir | 1 | 20 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 8 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Rilematovir | 1 | 20 | 1 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, all-cause mortality | Rilematovir | 0 | 20 |
| Total, other adverse events | Placebo | 5 | 8 |
| Total, other adverse events | Rilematovir | 10 | 20 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Rilematovir | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rilematovir vs Placebo: Number of Participants With Post-baseline RSV-related Complications | Trial comparisons |
| Rilematovir vs Placebo: Number of Participants With Medical Encounters and Treatments | Trial comparisons |
| Rilematovir vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Rilematovir vs Placebo: deaths from any cause | Trial comparisons |
| Rilematovir vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04583280
GET https://conductscience.org/api/trials/v1/NCT04583280/registered?page=2