Trial Outcomes & Findings for Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV) (NCT NCT04056611)

NCT ID: NCT04056611

Last Updated: 2025-02-04

Results Overview

Percentage of participants who developed RSV LRTI was assessed. RSV LRTI was defined as the development of a lower respiratory sign or symptom (including decrease in oxygen saturation or increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, worsening cough) and positive RSV test from lower respiratory tract sample (example \[eg\], sputum, induced sputum, bronchoalveolar lavage (BAL), lung biopsy, or autopsy specimen) within +-4 days of a new chest image finding, compared to baseline, consistent with a LRTI; OR positive RSV test from lower respiratory tract sample (eg, sputum, induced sputum, BAL, lung biopsy, or autopsy specimen) only; OR positive RSV test from upper respiratory tract sample within ±4 days of a new chest image finding, compared to baseline, consistent with a RSV LRTI as determined by the Endpoint Adjudication Committee (EAC).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to Day 28
• Results posted on: 2025-02-04

Participant Flow

Participants were randomized to receive either rilematovir or placebo. The dose was dependent upon coadministration without/with CYP3A4 inhibitors or posaconazole. Due to the limited participants randomized and due to chance, no participants were randomized to placebo.

Participant milestones

Measure	JNJ-53718678 Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	JNJ-53718678 Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Overall Study Physician Decision	1

Baseline Characteristics

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

Baseline characteristics by cohort

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Age, Continuous	47 years STANDARD_DEVIATION 13.89 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment BRAZIL	1 Participants n=5 Participants
Region of Enrollment FRANCE	1 Participants n=5 Participants
Region of Enrollment ISRAEL	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who developed RSV LRTI was assessed. RSV LRTI was defined as the development of a lower respiratory sign or symptom (including decrease in oxygen saturation or increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, worsening cough) and positive RSV test from lower respiratory tract sample (example [eg], sputum, induced sputum, bronchoalveolar lavage (BAL), lung biopsy, or autopsy specimen) within +-4 days of a new chest image finding, compared to baseline, consistent with a LRTI; OR positive RSV test from lower respiratory tract sample (eg, sputum, induced sputum, BAL, lung biopsy, or autopsy specimen) only; OR positive RSV test from upper respiratory tract sample within ±4 days of a new chest image finding, compared to baseline, consistent with a RSV LRTI as determined by the Endpoint Adjudication Committee (EAC).

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who developed RSV-associated LRTC was assessed. RSV-associated LRTC defined as development of lower respiratory sign/symptom (includes decrease in oxygen saturation/increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, and worsening cough) and met 1 of following subcategories determined by EAC: a) RSV LRTI, b) secondary bacterial LRTI (positive specimen for clinically significant bacterium within 4 days of new chest image finding, compared to baseline, consistent with LRTI), c) secondary LRTI due to unusual pathogens (positive specimen for clinically significant unusual organism within 4 days of new chest image finding, compared to baseline, consistent with LRTI), d) secondary LRTC of unknown etiology (new chest image finding than baseline, consistent with LRTI, inflammatory process/ some other clinically significant pulmonary process which were absent within 4 days of new chest image finding).

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the intervention. Any AE which occurred post first dose administration of study drug up to the end of study (EOS) (that is, Day 49) was considered as treatment-emergent.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	2 Participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Percentage of participants with greater than or equal to (>=) Grade 3 treatment-emergent laboratory abnormalities (platelet count decreased, glucose increase) was assessed in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to end of study (that is, Day 49).

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings Glucose increase	33.33 Percentage of participants
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings Platelet count decreased	33.33 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Percentage of participants with clinically significant abnormalities in ECG findings was assessed in this outcome measure. Various ECG variables assessed were heart rate: abnormally low (<= 45 beats per minute [bpm]), abnormally high (>= 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec), QT interval and corrected QT (QTcF; according to Fridericia's formula) interval (>450 msec, >480 msec, or >500 msec, increases from baseline >30 msec or >60 msec.)

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings QRS interval	0 Percentage of participants
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings Heart rate	0 Percentage of participants
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings PR interval	0 Percentage of participants
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings QTcF	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Percentage of participants with abnormal vital signs findings was assessed. 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): > 90 mmHg - < 100 mmHg, Grade 2 (moderate): >= 100 mmHg to <110 mmHg, Grade 3 (severe): >=110 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; Temperature: abnormally high >38.0 degree celsius. Vital signs abnormalities reported for at least 1 participant were reported in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to EOS (that is, Day 49).

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings Respiratory rate: Grade 2	66.67 Percentage of participants
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings DBP: Grade 1	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death (all-cause mortality) was assessed.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who progressed to death (all-cause mortality) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who progressed to death (all-cause mortality) was assessed.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Who Progressed to Death (All-cause Mortality)	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)	0 Percentage of participants

SECONDARY outcome

Timeframe: Through Day 28

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized. Here, "n" (number analyzed)" is defined as number of participants analyzed for each specified category.

Number of supplemental oxygen free days was assessed. The number of supplemental oxygen free days was the number of days the participants did not receive/require supplemental oxygen during the first 28 days post treatment.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Number of Supplemental Oxygen Free Days Participant 1	25 Days
Number of Supplemental Oxygen Free Days Participant 2	28 Days
Number of Supplemental Oxygen Free Days Participant 3	28 Days

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, and were analyzed as randomized.

Percentage of participants who required treatment-emergent oxygen supplementation (e.g., supplemental oxygen, noninvasive pressure ventilation, invasive mechanical ventilation [tracheal tube, laryngeal mask or tracheostomy]). Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants With Treatment-emergent Oxygen Supplementation	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 28, and 35

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represent number of participants with available data for each specified timepoint.

Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Outcome measures

Measure	JNJ-53718678 n=2 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Respiratory Rate Over Time Participant 1: Day 15	20 Breaths per minute
Respiratory Rate Over Time Participant 1: Day 28	20 Breaths per minute
Respiratory Rate Over Time Participant 1: Day 35	20 Breaths per minute
Respiratory Rate Over Time Participant 2: Baseline	16 Breaths per minute
Respiratory Rate Over Time Participant 2: Day 15	20 Breaths per minute
Respiratory Rate Over Time Participant 2: Day 28	16 Breaths per minute

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 28, and 35

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'. Here, 'n' (number analyzed) represent number of participants with available data for each specified timepoint.

Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Heart Rate Over Time Participant 1: Baseline	83 Beats per minute
Heart Rate Over Time Participant 2: Baseline	72 Beats per minute
Heart Rate Over Time Participant 2: Day 15	79 Beats per minute
Heart Rate Over Time Participant 2: Day 35	70 Beats per minute
Heart Rate Over Time Participant 3: Baseline	70 Beats per minute
Heart Rate Over Time Participant 3: Day 15	73 Beats per minute
Heart Rate Over Time Participant 3: Day 28	78 Beats per minute

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 28, and 35

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'. Here, 'n' (number analyzed) represent number of participants with available data for each specified timepoint.

Peripheral capillary oxygen saturation (SpO2) over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 1: Baseline	96 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 2: Baseline	98 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 2: Day 15	97 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 2: Day 28	100 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 2: Day 35	96 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 3: Baseline	96 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 3: Day 15	97 Percentage (%) of Spo2
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Participant 3: Day 28	95 Percentage (%) of Spo2

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 28, and 35

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'. Here, 'n' (number analyzed) represent number of participants with available data for each specified timepoint.

Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Body Temperature Over Time Participant 1: Baseline	36.3 Degree Celsius
Body Temperature Over Time Participant 2: Baseline	36.8 Degree Celsius
Body Temperature Over Time Participant 2: Day 15	36.8 Degree Celsius
Body Temperature Over Time Participant 2: Day 28	36.5 Degree Celsius
Body Temperature Over Time Participant 2: Day 35	36.7 Degree Celsius
Body Temperature Over Time Participant 3: Baseline	35.9 Degree Celsius
Body Temperature Over Time Participant 3: Day 15	36.1 Degree Celsius
Body Temperature Over Time Participant 3: Day 28	36.2 Degree Celsius

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Percentage of participants who were re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline and required hospitalization and were discharged during the study) was assessed in this outcome measure.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Percentage of Participants Who Were Re-hospitalized	33.33 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Duration (in days) of hospital stay was assessed.

Outcome measures

Measure	JNJ-53718678 n=1 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Duration of Hospital Stay	4 Days

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Duration of ICU stay was assessed. Duration (in hours) was defined as total number of hours a participant was in ICU from first dose of study drug until study termination.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Duration of Intensive Care Unit (ICU) Stay	0 Hours Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily had a causal relationship with the intervention. Participants with Grade 3 or Grade 4 TEAE were assessed in this outcome measure. Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class	1 Participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Number of participants with respiratory related AEs (respiratory infections) was assessed.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Number of Participants With Respiratory Related AEs	0 Participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Number of participants with thoracic-related AEs was assessed.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Number of Participants With Thoracic-related AEs	0 Participants

SECONDARY outcome

Timeframe: Up to Day 49

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized.

Number of participants with antibiotic use among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 3, 8, 15 and 22

Population: PK analysis set included all participants who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) represents number of participants with available data for each specified timepoint.

Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Plasma Concentration of JNJ-53718678 Participant 3: Day 22	812 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 1: Day 1	1380 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 2: Day 1	653 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 2: Day 8	1780 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 2: Day 15	1680 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 2: Day 22	802 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 3: Day 1	155 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 3: Day 3	1680 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 3: Day 8	2290 Nanograms per milliliter (ng/mL)
Plasma Concentration of JNJ-53718678 Participant 3: Day 15	2510 Nanograms per milliliter (ng/mL)

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 28, and 35

Population: Efficacy analysis set included all participants who were randomized, treated (took at least 1 dose), and had a RSV infection confirmed by central laboratory analysis, excluding participants infected with a co-pathogen at baseline not identified during screening, analyzed as randomized. Here, 'n' (number analyzed) represents number of participants with available data for each specified timepoint.

RSV viral load (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 in which individual participant had data were reported.

Outcome measures

Measure	JNJ-53718678 n=3 Participants Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
RSV Viral Load Over Time Participant 1: RSV B: Baseline	3.85 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 1: RSV B: Day 28	0 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 2: RSV B: Baseline	8.01 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 2: RSV B: Day 15	5.95 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 2: RSV B: Day 28	5.16 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 2: RSV B: Day 35	5.63 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 3: RSV B: Baseline	8.73 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 3: RSV B: Day 15	5.36 log10 copies per milliliter (mL)
RSV Viral Load Over Time Participant 3: RSV B: Day 28	0 log10 copies per milliliter (mL)

Adverse Events

JNJ-53718678

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	JNJ-53718678 n=3 participants at risk Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Infections and infestations Sepsis	33.3% 1/3 • Up to Day 49 The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Other adverse events

Measure	JNJ-53718678 n=3 participants at risk Participants with age greater than or equal to (\>=) 18 to less than or equal to (\<=) 75 years received rilematovir 125 milligrams (mg) twice daily (bid) for 21 days.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Up to Day 49 The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.
Infections and infestations Cytomegalovirus Infection Reactivation	33.3% 1/3 • Up to Day 49 The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.
Nervous system disorders Dysgeusia	33.3% 1/3 • Up to Day 49 The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.
Vascular disorders Hot Flush	33.3% 1/3 • Up to Day 49 The safety analysis set included all randomized participants who took at least 1 dose of study intervention and were analyzed 'as treated'.

Additional Information

Senior Director Medical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

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 withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER