Trial Outcomes & Findings for A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection (NCT NCT04978337)
NCT ID: NCT04978337
Last Updated: 2024-09-24
Results Overview
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores.
TERMINATED
PHASE2
5 participants
Baseline
2024-09-24
Participant Flow
Participant milestones
| Measure |
Placebo
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
|
Overall Study
STARTED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Baseline characteristics by cohort
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
51.8 years
STANDARD_DEVIATION 22.9 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 19.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
BULGARIA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
HUNGARY
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intent-to-Treat infected (ITT-i) analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (positive test by central laboratory analysis) were excluded.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline
Participant 1
|
—
|
1.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline
Participant 2
|
—
|
1.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline
Participant 3
|
—
|
1.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline
Participant 4
|
—
|
2.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline
Participants 5
|
2.25 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Day 3Population: ITT-I analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 3 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=1 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3
Participant 3
|
—
|
0.75 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3
Participant 5
|
1.75 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Day 8Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 8 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=3 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8
Participant 1
|
—
|
1.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8
Participant 2
|
—
|
1.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8
Participant 3
|
—
|
0.75 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8
Participant 5
|
0.5 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 14 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=3 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14
Participant 1
|
—
|
1.25 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14
Participant 2
|
—
|
1 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14
Participant 3
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14
Participant 5
|
0 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Day 21Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 21 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=3 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21
Participant 1
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21
Participant 2
|
—
|
1 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21
Participant 3
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21
Participant 5
|
0 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Day 28Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 28 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=3 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28
Participant 1
|
—
|
0.5 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28
Participant 2
|
—
|
0.75 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28
Participant 3
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28
Participant 5
|
0 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Day 35Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 35 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=3 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35
Participant 1
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35
Participant 2
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35
Participant 3
|
—
|
0 Scores on a scale
|
|
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35
Participant 5
|
0 Scores on a scale
|
—
|
SECONDARY outcome
Timeframe: Up to Day 35Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases \[such as COPD and asthma\]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure \[CHF\] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this outcome measure.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With Post-Baseline RSV-related Complications
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
New antibiotic use
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
New use or increased dose of systematic or inhaled corticosteroids and bronchodilators
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
Home oxygen supplementation
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
Unscheduled outpatient clinic visits
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
Emergency room visits
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
Hospitalization for respiratory infection
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance
|
0 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined as per division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild(transient or mild discomfort \[less than {\<} 48 hours\]; 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 (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4:life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Only Grade 2 abnormalities are reported in this outcome measure. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings
Decrease in hemoglobin (Grade 2)
|
0 Percentage of participants
|
25 Percentage of participants
|
|
Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings
Increase in glucose (Grade 2)
|
0 Percentage of participants
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
Various ECG variables assessed were heart rate: abnormally low (less than or equal to \[\<=\] 45 beats per minute \[bpm\]), abnormally high (greater than or equal to \[\>=\] 120 bpm); PR interval: abnormally high (\>=210 milliseconds \[msec\]); QRS interval: abnormally high (\>=120 msec); QTc: borderline prolonged: \>450 msec and \<=480 msec, prolonged: \>480 msec and \<=500 msec, pathologicaly prolonged: \>500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety analysis set included all participants who took at least 1 dose of study intervention.
Abnormal vital parameters included pulse rate: abnormally low \<=45 bpm, abnormally high \>=120 bpm; Systolic Blood Pressure (SBP): abnormally low \<=90 millimeter of mercury (mmHg), Grade 1 (mild): \>140 mmHg to \<160 mmHg, Grade 2 (moderate): \>=160 mmHg to \<180 mmHg, Grade 3 (severe): \>=180 mmHg; Diastolic BP: abnormally low \<=50 mmHg, Grade 1: \>90 mmHg to \<100 mmHg, Grade 2: \>=100 mmHg to \<110 mmHg, Grade 3: \>=110 mmHg; Respiratory rate: Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): \>25 breaths per minute, Grade 4 (potentially life threatening): intubation; Oxygen saturation: abnormally low: \<95%; Temperature: abnormally high \>38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=4 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 5, 8, 15, and 21Population: ITT-i analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Participants with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure and 'n' (number analyzed) represents number of participants evaluable at the specified timepoints.
RSV viral load (subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints and RSV subtypes (A or B) for which individual participants had data were reported.
Outcome measures
| Measure |
Placebo
n=1 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
n=3 Participants
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
RSV Viral Load Over Time
Participant 1: Baseline: RSV B
|
—
|
6.87 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 1: Day 3: RSV B
|
—
|
5.84 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 1: Day 8: RSV B
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 1: Day 15: RSV B
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 1: Day 21: RSV B
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 2: Baseline: RSV B
|
—
|
6.17 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 2: Day 3: RSV B
|
—
|
6.71 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 2: Day 8: RSV B
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 2: Day 15: RSV B
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 2: Day 21: RSV B
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 3: Baseline: RSV A
|
—
|
6.5 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 3: Day 3: RSV A
|
—
|
6.4 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 3: Day 5: RSV A
|
—
|
3.37 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 3: Day 8: RSV A
|
—
|
2.9 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 3: Day 15: RSV A
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 3: Day 21: RSV A
|
—
|
0 log10 copies per milliliter (mL)
|
|
RSV Viral Load Over Time
Participant 5: Baseline: RSV A
|
7.57 log10 copies per milliliter (mL)
|
—
|
|
RSV Viral Load Over Time
Participant 5: Day 3: RSV A
|
4.94 log10 copies per milliliter (mL)
|
—
|
|
RSV Viral Load Over Time
Participant 5: Day 5: RSV A
|
0 log10 copies per milliliter (mL)
|
—
|
|
RSV Viral Load Over Time
Participant 5: Day 8: RSV A
|
0 log10 copies per milliliter (mL)
|
—
|
|
RSV Viral Load Over Time
Participant 5: Day 15: RSV A
|
0 log10 copies per milliliter (mL)
|
—
|
|
RSV Viral Load Over Time
Participant 5: Day 21: RSV A
|
0 log10 copies per milliliter (mL)
|
—
|
SECONDARY outcome
Timeframe: Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8Population: Pharmacokinetic (PK) analysis set included all participants who were randomized and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Here, 'N' (number of participants analyzed) signifies number of participants with available data for this outcome measure.
Plasma concentration of rilematovir was reported. This outcome measure was planned to be analyzed for specified arm only. In this outcome measure, only those timepoints for which individual participants had data were reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participant received oral dose of placebo matching to rilematovir twice daily for 7 days.
|
Rilematovir 250 mg Bid
Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
|
|---|---|---|
|
Plasma Concentration of Rilematovir
Participant 1: Day 3 (Pre-dose)
|
658 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 1: Day 3 (1 hour post dose)
|
682 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 1: Follow-up-Day 8
|
9.63 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 2: Day 3 (pre-dose)
|
15.9 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 2: Day 3 (1 hour post dose)
|
465 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 2: Follow-up-Day 8
|
494 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 3: Day 1 (1 hour post dose)
|
257 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 3: Day 3 (pre-dose)
|
2400 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 3: Day 3 (1 hour post dose)
|
2960 Nanograms per milliliter (ng/mL)
|
—
|
|
Plasma Concentration of Rilematovir
Participant 3: Follow-up-Day 8
|
3130 Nanograms per milliliter (ng/mL)
|
—
|
Adverse Events
Placebo
Rilematovir 250 mg Bid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER