Respiratory Syncytial Virus Infections
Conditions
Brief summary
The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.
Detailed description
RSV is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. Immunocompromised (IC) participants have a reduced ability to combat infection due to an impaired or weakened immune system. Within the IC population, HSCT recipients are generally regarded as having a particularly high risk for more severe disease caused by RSV, representing a substantial unmet need for antiviral treatment of RSV infections in this participant population. JNJ-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (RSV)-specific fusion inhibitor. The study will include a Screening Period (Day -2 to Day 1), a Treatment Period (Day 1 to Day 21), and a Follow-up Period (1 year). Assessments like chest X-ray, pulse/heart rate, respiratory rate, electrocardiogram (ECG), etc will be performed. Safety and efficacy will be assessed through the study. The total study duration for each participant will be approximately 49 days.
Interventions
DRUGJNJ-53718678 250 mg
JNJ-53718678 250 mg will be administered orally.
DRUGPlacebo
Matching placebo will be administered orally.
DRUGJNJ-53718678 125 mg
JNJ-53718678 125 mg will be administered orally.
Sponsors
Janssen Sciences Ireland UC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen * Absolute lymphocyte count (ALC) less than (\<) 1,000 cells/microliter (mL) * Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization * New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing * Peripheral capillary oxygen saturation (SpO2) greater than or equal to (\>=) 92 percent (%) on room air
Exclusion criteria
* Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator * Requires supplemental oxygen at Screening or any time between Screening and randomization * Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required) * Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) | Up to Day 28 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Over Time | Baseline (Day 1), Days 15, 28, and 35 | Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported. |
| Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Baseline (Day 1), Days 15, 28, and 35 | 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. |
| Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC) | Up to Day 28 | 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). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 49 | 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. |
| Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings | Up to Day 49 | 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). |
| Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Up to Day 49 | 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.) |
| Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings | Up to Day 49 | 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). |
| 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 | Up to Day 49 | 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. |
| Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality) | Up to Day 49 | 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. |
| 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 | Up to Day 49 | 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. |
| Percentage of Participants Who Progressed to Death (All-cause Mortality) | Up to Day 49 | Percentage of participants who progressed to death (all-cause mortality) was assessed. |
| 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 | Up to Day 49 | 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. |
| Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) | Up to Day 49 | Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed. |
| Respiratory Rate Over Time | Baseline (Day 1), Days 15, 28, and 35 | Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported. |
| Percentage of Participants With Treatment-emergent Oxygen Supplementation | Up to Day 49 | 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. |
| Body Temperature Over Time | Baseline (Day 1), Days 15, 28, and 35 | Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported. |
| Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline) | Up to Day 49 | Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed. |
| Percentage of Participants Who Were Re-hospitalized | Up to Day 49 | 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. |
| Duration of Hospital Stay | Up to Day 49 | Duration (in days) of hospital stay was assessed. |
| Duration of Intensive Care Unit (ICU) Stay | Up to Day 49 | 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. |
| Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class | Up to Day 49 | 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. |
| Number of Participants With Respiratory Related AEs | Up to Day 49 | Number of participants with respiratory related AEs (respiratory infections) was assessed. |
| Number of Participants With Thoracic-related AEs | Up to Day 49 | Number of participants with thoracic-related AEs was assessed. |
| Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment | Up to Day 49 | 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. |
| Plasma Concentration of JNJ-53718678 | Days 1, 3, 8, 15 and 22 | Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported. |
| RSV Viral Load Over Time | Baseline (Day 1), Days 15, 28, and 35 | 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. |
| Number of Supplemental Oxygen Free Days | Through Day 28 | 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. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, France, Israel, Italy, Japan, Malaysia, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | JNJ-53718678 |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 13.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment BRAZIL | 1 Participants |
| Region of Enrollment FRANCE | 1 Participants |
| Region of Enrollment ISRAEL | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) | 0 Percentage of participants |
Secondary
Body Temperature Over Time
Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Body Temperature Over Time | Participant 1: Baseline | 36.3 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 2: Baseline | 36.8 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 2: Day 15 | 36.8 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 2: Day 28 | 36.5 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 2: Day 35 | 36.7 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 3: Baseline | 35.9 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 3: Day 15 | 36.1 Degree Celsius |
| JNJ-53718678 | Body Temperature Over Time | Participant 3: Day 28 | 36.2 Degree Celsius |
Secondary
Duration of Hospital Stay
Duration (in days) of hospital stay was assessed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Duration of Hospital Stay | 4 Days |
Secondary
Duration of Intensive Care Unit (ICU) Stay
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| JNJ-53718678 | Duration of Intensive Care Unit (ICU) Stay | 0 Hours |
Secondary
Heart Rate Over Time
Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Heart Rate Over Time | Participant 1: Baseline | 83 Beats per minute |
| JNJ-53718678 | Heart Rate Over Time | Participant 2: Baseline | 72 Beats per minute |
| JNJ-53718678 | Heart Rate Over Time | Participant 2: Day 15 | 79 Beats per minute |
| JNJ-53718678 | Heart Rate Over Time | Participant 2: Day 35 | 70 Beats per minute |
| JNJ-53718678 | Heart Rate Over Time | Participant 3: Baseline | 70 Beats per minute |
| JNJ-53718678 | Heart Rate Over Time | Participant 3: Day 15 | 73 Beats per minute |
| JNJ-53718678 | Heart Rate Over Time | Participant 3: Day 28 | 78 Beats per minute |
Secondary
Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
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.
Time frame: 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.
Secondary
Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
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.
Time frame: 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'.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JNJ-53718678 | 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
Number of Participants With Respiratory Related AEs
Number of participants with respiratory related AEs (respiratory infections) was assessed.
Time frame: 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'.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JNJ-53718678 | Number of Participants With Respiratory Related AEs | 0 Participants |
Secondary
Number of Participants With Thoracic-related AEs
Number of participants with thoracic-related AEs was assessed.
Time frame: 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'.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JNJ-53718678 | Number of Participants With Thoracic-related AEs | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: 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'.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JNJ-53718678 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
Secondary
Number of Supplemental Oxygen Free Days
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Number of Supplemental Oxygen Free Days | Participant 3 | 28 Days |
| JNJ-53718678 | Number of Supplemental Oxygen Free Days | Participant 1 | 25 Days |
| JNJ-53718678 | Number of Supplemental Oxygen Free Days | Participant 2 | 28 Days |
Secondary
Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline) | 0 Percentage of participants |
Secondary
Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC) | 0 Percentage of participants |
Secondary
Percentage of Participants Who Progressed to Death (All-cause Mortality)
Percentage of participants who progressed to death (all-cause mortality) was assessed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants Who Progressed to Death (All-cause Mortality) | 0 Percentage of participants |
Secondary
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
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.
Time frame: 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.
Secondary
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) | 0 Percentage of participants |
Secondary
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
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.
Time frame: 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.
Secondary
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | 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
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
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.
Time frame: 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.
Secondary
Percentage of Participants Who Were Re-hospitalized
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants Who Were Re-hospitalized | 33.33 Percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
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.)
Time frame: 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'.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Heart rate | 0 Percentage of participants |
| JNJ-53718678 | Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | PR interval | 0 Percentage of participants |
| JNJ-53718678 | Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | QRS interval | 0 Percentage of participants |
| JNJ-53718678 | Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | QTcF | 0 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
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).
Time frame: 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'.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings | Platelet count decreased | 33.33 Percentage of participants |
| JNJ-53718678 | Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings | Glucose increase | 33.33 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
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).
Time frame: 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'.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings | Respiratory rate: Grade 2 | 66.67 Percentage of participants |
| JNJ-53718678 | Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings | DBP: Grade 1 | 33.3 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Oxygen Supplementation
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JNJ-53718678 | Percentage of Participants With Treatment-emergent Oxygen Supplementation | 0 Percentage of participants |
Secondary
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 1: Baseline | 96 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 2: Baseline | 98 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 2: Day 15 | 97 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 2: Day 28 | 100 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 2: Day 35 | 96 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 3: Baseline | 96 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 3: Day 15 | 97 Percentage (%) of Spo2 |
| JNJ-53718678 | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Participant 3: Day 28 | 95 Percentage (%) of Spo2 |
Secondary
Plasma Concentration of JNJ-53718678
Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 1: Day 1 | 1380 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 2: Day 1 | 653 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 2: Day 8 | 1780 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 2: Day 15 | 1680 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 2: Day 22 | 802 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 3: Day 1 | 155 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 3: Day 3 | 1680 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 3: Day 8 | 2290 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 3: Day 15 | 2510 Nanograms per milliliter (ng/mL) |
| JNJ-53718678 | Plasma Concentration of JNJ-53718678 | Participant 3: Day 22 | 812 Nanograms per milliliter (ng/mL) |
Secondary
Respiratory Rate Over Time
Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | Respiratory Rate Over Time | Participant 1: Day 28 | 20 Breaths per minute |
| JNJ-53718678 | Respiratory Rate Over Time | Participant 1: Day 15 | 20 Breaths per minute |
| JNJ-53718678 | Respiratory Rate Over Time | Participant 1: Day 35 | 20 Breaths per minute |
| JNJ-53718678 | Respiratory Rate Over Time | Participant 2: Baseline | 16 Breaths per minute |
| JNJ-53718678 | Respiratory Rate Over Time | Participant 2: Day 15 | 20 Breaths per minute |
| JNJ-53718678 | Respiratory Rate Over Time | Participant 2: Day 28 | 16 Breaths per minute |
Secondary
RSV Viral Load Over Time
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JNJ-53718678 | RSV Viral Load Over Time | Participant 1: RSV B: Baseline | 3.85 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 1: RSV B: Day 28 | 0 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 2: RSV B: Baseline | 8.01 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 2: RSV B: Day 15 | 5.95 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 2: RSV B: Day 28 | 5.16 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 2: RSV B: Day 35 | 5.63 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 3: RSV B: Baseline | 8.73 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 3: RSV B: Day 15 | 5.36 log10 copies per milliliter (mL) |
| JNJ-53718678 | RSV Viral Load Over Time | Participant 3: RSV B: Day 28 | 0 log10 copies per milliliter (mL) |