Respiratory Syncytial Virus Infections
Conditions
Brief summary
The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams \[mg\] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
Detailed description
This study will be performed to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV. The study will include both participants who are otherwise healthy (ie, without underlying condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, other chronic diseases), with the exception of immunocompromised participants, presenting for medical care but not requiring hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will include adverse events, laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities.
Interventions
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
DRUGJNJ-53718678 80 mg
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
DRUGPlacebo
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection * Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test * Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile * A male participant must agree to the use of acceptable contraceptive measures * With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening
Exclusion criteria
* Hospitalized participants or participants expected to be hospitalized within 24 hours of screening * History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments * Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study * Participants who are considered by the investigator to be immunocompromised within the past 12 months * Participant has known or suspected chronic or acute hepatitis B or C infection * Women who are pregnant or breastfeeding * Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia \[QTcF\] interval greater than \[\>\] 500 millisecond \[ms\]) not consistent with the underlying condition in the study population, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Undetectable RSV Viral Load at Day 21 | Day 21 | Percentage of participants with undetectable RSV viral load at Day 21 were reported. |
| Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 | Baseline through Day 5 | Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs. |
| Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8 | Baseline through Day 8 | Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs. |
| Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14 | Baseline through Day 14 | Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs. |
| Change From Baseline in RSV Viral Load at Day 3 | Baseline to Day 3 | Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| Change From Baseline in RSV Viral Load at Day 5 | Baseline to Day 5 | Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| Change From Baseline in RSV Viral Load at Day 8 | Baseline to Day 8 | Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| Change From Baseline in RSV Viral Load at Day 14 | Baseline to Day 14 | Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| Change From Baseline in RSV Viral Load at Day 21 | Baseline to Day 21 | Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| RSV Viral Load at Baseline | Baseline | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| RSV Viral Load at Day 3 | Day 3 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| RSV Viral Load at Day 5 | Day 5 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| RSV Viral Load at Day 8 | Day 8 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| RSV Viral Load at Day 14 | Day 14 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| RSV Viral Load at Day 21 | Day 21 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. |
| Time to Undetectable RSV Viral Load | Up to Day 21 | The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments. |
| Percentage of Participants With Undetectable RSV Viral Load at Day 3 | Day 3 | Percentage of participants with undetectable RSV viral load at Day 3 were reported. |
| Percentage of Participants With Undetectable RSV Viral Load at Day 5 | Day 5 | Percentage of participants with undetectable RSV viral load at Day 5 were reported. |
| Percentage of Participants With Undetectable RSV Viral Load at Day 8 | Day 8 | Percentage of participants with undetectable RSV viral load at Day 8 were reported. |
| Percentage of Participants With Undetectable RSV Viral Load at Day 14 | Day 14 | Percentage of participants with undetectable RSV viral load at Day 14 were reported. |
| Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 | Baseline through Day 3 | Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Up to Day 28 | Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (\< 48 hours); no medical intervention/therapy required), Grade 2= moderate (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), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). |
| Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Up to Day 28 | Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (\<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - \< 100 mmHg, Grade 2 (moderate)- greater than or equal to (\>=)100 mmHg to \< 110 mmHg, Grade 3 (severe)- \>=110 mmHg; DBP: Abnormally low- \<=90 mmHg, Grade 1 (mild)- 140 mmHg - \< 160 mmHg, Grade 2 (moderate)- \>=160 mmHg to \< 180 mmHg, Grade 3 (severe)- \>=180 mmHg. |
| Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Up to Day 28 | The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval (\[450 milliseconds {ms}, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval (\[450 ms, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]). |
| Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Baseline, Days 3, 8, 14, and 21 | Peripheral capillary oxygen saturation was measured by the investigator over time. |
| Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Days 3, 8, 14 and 21 | Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator. |
| Pulse Rate Over Time | Baseline, Days 3, 8, 14 and 21 | Pulse rate was measured by the investigator over time. |
| Change From Baseline in Pulse Rate | Baseline to Days 3, 8, 14 and 21 | Change from baseline in pulse rate was calculated and reported by the investigator. |
| Respiratory Rate Over Time | Baseline, Days 3, 8, 14 and 21 | Respiratory rate was measured by the investigator over time. |
| Change From Baseline in Respiratory Rate | Baseline to Days 3, 8, 14 and 21 | Change from baseline in respiratory rate was calculated and reported by the investigator. |
| Body Temperature Over Time | Baseline, Days 3, 8, 14 and 21 | Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device. |
| Change From Baseline in Body Temperature | Baseline to Days 3, 5, 8, 14 and 21 | Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device. |
| Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose | 0 to 24 hours post dose on Days 1 and 7 | AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose. |
| Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Baseline, Days 3, 5, 8, 14 and 21 | The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain. |
| Duration of Signs and Symptoms of RSV Assessed by RI-PRO | Baseline up to Day 21 | Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms). |
| Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire | Up to Day 21 | Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms). |
| Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Up to Day 21 | Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours. |
| Predose Plasma Concentration (Ctrough) of JNJ-53718678 | Predose on Days 1 and 7 | Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model. |
| Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Days 1 and 7 | Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model. |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to Day 28 | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Japan, Mexico, Poland, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment A: JNJ-53718678 500 mg Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | 24 |
| Treatment B: JNJ-53718678 80 mg + Placebo Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | 24 |
| Treatment C: Placebo Participants received matching placebo as an oral solution once daily for 7 days. | 24 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Treatment A: JNJ-53718678 500 mg | Treatment C: Placebo | Total | Treatment B: JNJ-53718678 80 mg + Placebo |
|---|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 17.89 | 58.9 years STANDARD_DEVIATION 14.16 | 53 years STANDARD_DEVIATION 16.92 | 48.4 years STANDARD_DEVIATION 17.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 23 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 15 Participants | 48 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 19 Participants | 60 Participants | 20 Participants |
| Region of Enrollment Argentina | 4 Participants | 5 Participants | 12 Participants | 3 Participants |
| Region of Enrollment Belgium | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Brazil | 1 Participants | 1 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Bulgaria | 2 Participants | 2 Participants | 7 Participants | 3 Participants |
| Region of Enrollment Canada | 4 Participants | 3 Participants | 10 Participants | 3 Participants |
| Region of Enrollment France | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Germany | 3 Participants | 3 Participants | 6 Participants | 0 Participants |
| Region of Enrollment Mexico | 2 Participants | 2 Participants | 6 Participants | 2 Participants |
| Region of Enrollment Poland | 3 Participants | 2 Participants | 8 Participants | 3 Participants |
| Region of Enrollment Russia | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Spain | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Sweden | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Taiwan, Province Of China | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Ukraine | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 37 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 35 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 6 / 24 | 13 / 24 | 11 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Time frame: Baseline through Day 3
Population: The intent-to-treat-infected (ITT-i) population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 | 207.3 Log10 copies*hr/mL | Standard Deviation 89.55 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 | 246.3 Log10 copies*hr/mL | Standard Deviation 67.39 |
| Treatment C: Placebo | Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 | 203.4 Log10 copies*hr/mL | Standard Deviation 87.63 |
Primary
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Time frame: Baseline through Day 14
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14 | 534.4 Log10 copies*hr/mL | Standard Deviation 379.92 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14 | 747.1 Log10 copies*hr/mL | Standard Deviation 352.25 |
| Treatment C: Placebo | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14 | 619.9 Log10 copies*hr/mL | Standard Deviation 394.15 |
Primary
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Time frame: Baseline through Day 5
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 | 344.5 Log10 copies*hr/mL | Standard Deviation 189.4 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 | 424.2 Log10 copies*hr/mL | Standard Deviation 145.73 |
| Treatment C: Placebo | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 | 340.4 Log10 copies*hr/mL | Standard Deviation 148.3 |
Primary
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Time frame: Baseline through Day 8
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8 | 470.7 Log10 copies*hr/mL | Standard Deviation 305.38 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8 | 612.3 Log10 copies*hr/mL | Standard Deviation 253.29 |
| Treatment C: Placebo | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8 | 486.1 Log10 copies*hr/mL | Standard Deviation 254.15 |
Primary
Change From Baseline in RSV Viral Load at Day 14
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Baseline to Day 14
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in RSV Viral Load at Day 14 | -5.135 Log10 copies/mL | Standard Deviation 1.6444 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in RSV Viral Load at Day 14 | -5.777 Log10 copies/mL | Standard Deviation 1.6183 |
| Treatment C: Placebo | Change From Baseline in RSV Viral Load at Day 14 | -4.858 Log10 copies/mL | Standard Deviation 1.7419 |
Primary
Change From Baseline in RSV Viral Load at Day 21
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Baseline to Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in RSV Viral Load at Day 21 | -5.433 Log10 copies/mL | Standard Deviation 2.1416 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in RSV Viral Load at Day 21 | -5.898 Log10 copies/mL | Standard Deviation 1.6421 |
| Treatment C: Placebo | Change From Baseline in RSV Viral Load at Day 21 | -5.129 Log10 copies/mL | Standard Deviation 1.6513 |
Primary
Change From Baseline in RSV Viral Load at Day 3
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Baseline to Day 3
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in RSV Viral Load at Day 3 | -2.210 Log10 copies/mL | Standard Deviation 1.7185 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in RSV Viral Load at Day 3 | -1.436 Log10 copies/mL | Standard Deviation 1.6165 |
| Treatment C: Placebo | Change From Baseline in RSV Viral Load at Day 3 | -2.221 Log10 copies/mL | Standard Deviation 1.7093 |
Primary
Change From Baseline in RSV Viral Load at Day 5
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Baseline to Day 5
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in RSV Viral Load at Day 5 | -3.156 Log10 copies/mL | Standard Deviation 2.2887 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in RSV Viral Load at Day 5 | -2.324 Log10 copies/mL | Standard Deviation 1.6727 |
| Treatment C: Placebo | Change From Baseline in RSV Viral Load at Day 5 | -3.031 Log10 copies/mL | Standard Deviation 1.501 |
Primary
Change From Baseline in RSV Viral Load at Day 8
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Baseline to Day 8
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in RSV Viral Load at Day 8 | -4.960 Log10 copies/mL | Standard Deviation 1.7804 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in RSV Viral Load at Day 8 | -3.983 Log10 copies/mL | Standard Deviation 1.3928 |
| Treatment C: Placebo | Change From Baseline in RSV Viral Load at Day 8 | -3.953 Log10 copies/mL | Standard Deviation 1.5674 |
Primary
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Time frame: Day 14
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Percentage of Participants With Undetectable RSV Viral Load at Day 14 | 89.5 Percentage of participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 14 | 88.9 Percentage of participants |
| Treatment C: Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 14 | 78.9 Percentage of participants |
Primary
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
Time frame: Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Percentage of Participants With Undetectable RSV Viral Load at Day 21 | 95.0 Percentage of participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 21 | 94.7 Percentage of participants |
| Treatment C: Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 21 | 90.0 Percentage of participants |
Primary
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Time frame: Day 3
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Percentage of Participants With Undetectable RSV Viral Load at Day 3 | 28.6 Percentage of participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 3 | 5.0 Percentage of participants |
| Treatment C: Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 3 | 20.0 Percentage of participants |
Primary
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Time frame: Day 5
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Percentage of Participants With Undetectable RSV Viral Load at Day 5 | 40.0 Percentage of participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 5 | 14.3 Percentage of participants |
| Treatment C: Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 5 | 35.0 Percentage of participants |
Primary
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Time frame: Day 8
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Percentage of Participants With Undetectable RSV Viral Load at Day 8 | 83.3 Percentage of participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 8 | 45.0 Percentage of participants |
| Treatment C: Placebo | Percentage of Participants With Undetectable RSV Viral Load at Day 8 | 52.4 Percentage of participants |
Primary
RSV Viral Load at Baseline
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Baseline
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | RSV Viral Load at Baseline | 5.523 Log10 copies/mL | Standard Deviation 1.7911 |
| Treatment B: JNJ-53718678 80 mg + Placebo | RSV Viral Load at Baseline | 5.851 Log10 copies/mL | Standard Deviation 1.6777 |
| Treatment C: Placebo | RSV Viral Load at Baseline | 5.285 Log10 copies/mL | Standard Deviation 1.7158 |
Primary
RSV Viral Load at Day 14
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Day 14
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | RSV Viral Load at Day 14 | 0.421 Log10 copies/mL | Standard Deviation 1.2601 |
| Treatment B: JNJ-53718678 80 mg + Placebo | RSV Viral Load at Day 14 | 0.290 Log10 copies/mL | Standard Deviation 0.8579 |
| Treatment C: Placebo | RSV Viral Load at Day 14 | 0.492 Log10 copies/mL | Standard Deviation 0.991 |
Primary
RSV Viral Load at Day 21
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | RSV Viral Load at Day 21 | 0.108 Log10 copies/mL | Standard Deviation 0.4808 |
| Treatment B: JNJ-53718678 80 mg + Placebo | RSV Viral Load at Day 21 | 0.113 Log10 copies/mL | Standard Deviation 0.4932 |
| Treatment C: Placebo | RSV Viral Load at Day 21 | 0.253 Log10 copies/mL | Standard Deviation 0.7866 |
Primary
RSV Viral Load at Day 3
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Day 3
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | RSV Viral Load at Day 3 | 3.267 Log10 copies/mL | Standard Deviation 2.549 |
| Treatment B: JNJ-53718678 80 mg + Placebo | RSV Viral Load at Day 3 | 4.448 Log10 copies/mL | Standard Deviation 1.9513 |
| Treatment C: Placebo | RSV Viral Load at Day 3 | 3.160 Log10 copies/mL | Standard Deviation 2.2603 |
Primary
RSV Viral Load at Day 5
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Day 5
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | RSV Viral Load at Day 5 | 2.384 Log10 copies/mL | Standard Deviation 2.4214 |
| Treatment B: JNJ-53718678 80 mg + Placebo | RSV Viral Load at Day 5 | 3.528 Log10 copies/mL | Standard Deviation 1.9824 |
| Treatment C: Placebo | RSV Viral Load at Day 5 | 2.351 Log10 copies/mL | Standard Deviation 2.1302 |
Primary
RSV Viral Load at Day 8
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time frame: Day 8
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | RSV Viral Load at Day 8 | 0.661 Log10 copies/mL | Standard Deviation 1.5572 |
| Treatment B: JNJ-53718678 80 mg + Placebo | RSV Viral Load at Day 8 | 1.804 Log10 copies/mL | Standard Deviation 1.7888 |
| Treatment C: Placebo | RSV Viral Load at Day 8 | 1.398 Log10 copies/mL | Standard Deviation 1.5958 |
Primary
Time to Undetectable RSV Viral Load
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Time frame: Up to Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Time to Undetectable RSV Viral Load | 7.0 Days | 90% Confidence Interval 5.92 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Time to Undetectable RSV Viral Load | 8.0 Days | 90% Confidence Interval 6.86 |
| Treatment C: Placebo | Time to Undetectable RSV Viral Load | 9.7 Days | 90% Confidence Interval 7.03 |
Secondary
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.
Time frame: 0 to 24 hours post dose on Days 1 and 7
Population: Pharmacokinetic (PK) analysis set included all participants who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose | Day 1 | 29800 nanograms*hours per milliliter (ng*h/mL) | Standard Deviation 9180 |
| Treatment A: JNJ-53718678 500 mg | Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose | Day 7 | 41200 nanograms*hours per milliliter (ng*h/mL) | Standard Deviation 15300 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose | Day 1 | 4530 nanograms*hours per milliliter (ng*h/mL) | Standard Deviation 1560 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose | Day 7 | 5470 nanograms*hours per milliliter (ng*h/mL) | Standard Deviation 1620 |
Secondary
Body Temperature Over Time
Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Time frame: Baseline, Days 3, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Body Temperature Over Time | Day 14 | 36.37 degree Celsius | Standard Deviation 0.389 |
| Treatment A: JNJ-53718678 500 mg | Body Temperature Over Time | Day 8 | 36.26 degree Celsius | Standard Deviation 0.396 |
| Treatment A: JNJ-53718678 500 mg | Body Temperature Over Time | Baseline | 36.83 degree Celsius | Standard Deviation 0.622 |
| Treatment A: JNJ-53718678 500 mg | Body Temperature Over Time | Day 3 | 36.57 degree Celsius | Standard Deviation 0.572 |
| Treatment A: JNJ-53718678 500 mg | Body Temperature Over Time | Day 21 | 36.32 degree Celsius | Standard Deviation 0.38 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Body Temperature Over Time | Day 8 | 36.44 degree Celsius | Standard Deviation 0.527 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Body Temperature Over Time | Baseline | 36.73 degree Celsius | Standard Deviation 0.601 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Body Temperature Over Time | Day 3 | 36.65 degree Celsius | Standard Deviation 0.574 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Body Temperature Over Time | Day 14 | 36.38 degree Celsius | Standard Deviation 0.346 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Body Temperature Over Time | Day 21 | 36.40 degree Celsius | Standard Deviation 0.38 |
| Treatment C: Placebo | Body Temperature Over Time | Day 21 | 36.46 degree Celsius | Standard Deviation 0.299 |
| Treatment C: Placebo | Body Temperature Over Time | Day 14 | 36.50 degree Celsius | Standard Deviation 0.291 |
| Treatment C: Placebo | Body Temperature Over Time | Baseline | 36.75 degree Celsius | Standard Deviation 0.561 |
| Treatment C: Placebo | Body Temperature Over Time | Day 8 | 36.55 degree Celsius | Standard Deviation 0.404 |
| Treatment C: Placebo | Body Temperature Over Time | Day 3 | 36.69 degree Celsius | Standard Deviation 0.446 |
Secondary
Change From Baseline in Body Temperature
Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Time frame: Baseline to Days 3, 5, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Body Temperature | Baseline to Day 14 | -0.48 degree Celsius | Standard Deviation 0.402 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Body Temperature | Baseline to Day 8 | -0.55 degree Celsius | Standard Deviation 0.465 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Body Temperature | Baseline to Day 3 | -0.27 degree Celsius | Standard Deviation 0.39 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Body Temperature | Baseline to Day 5 | -0.63 degree Celsius | Standard Deviation 0.667 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Body Temperature | Baseline to Day 21 | -0.52 degree Celsius | Standard Deviation 0.537 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Body Temperature | Baseline to Day 8 | -0.29 degree Celsius | Standard Deviation 0.652 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Body Temperature | Baseline to Day 3 | -0.11 degree Celsius | Standard Deviation 0.621 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Body Temperature | Baseline to Day 5 | -0.41 degree Celsius | Standard Deviation 0.645 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Body Temperature | Baseline to Day 14 | -0.40 degree Celsius | Standard Deviation 0.624 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Body Temperature | Baseline to Day 21 | -0.37 degree Celsius | Standard Deviation 0.615 |
| Treatment C: Placebo | Change From Baseline in Body Temperature | Baseline to Day 21 | -0.24 degree Celsius | Standard Deviation 0.503 |
| Treatment C: Placebo | Change From Baseline in Body Temperature | Baseline to Day 14 | -0.20 degree Celsius | Standard Deviation 0.411 |
| Treatment C: Placebo | Change From Baseline in Body Temperature | Baseline to Day 3 | -0.01 degree Celsius | Standard Deviation 0.595 |
| Treatment C: Placebo | Change From Baseline in Body Temperature | Baseline to Day 8 | -0.11 degree Celsius | Standard Deviation 0.477 |
| Treatment C: Placebo | Change From Baseline in Body Temperature | Baseline to Day 5 | -0.17 degree Celsius | Standard Deviation 0.65 |
Secondary
Change From Baseline in Peripheral Capillary Oxygen Saturation
Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.
Time frame: Baseline to Days 3, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 3 | 0.5 % of SpO2 | Standard Deviation 2.21 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 8 | 1.3 % of SpO2 | Standard Deviation 2.72 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 14 | 1.2 % of SpO2 | Standard Deviation 2.1 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 21 | 1.3 % of SpO2 | Standard Deviation 3.11 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 21 | 1.2 % of SpO2 | Standard Deviation 2.22 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 3 | 0.9 % of SpO2 | Standard Deviation 1.73 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 14 | 0.7 % of SpO2 | Standard Deviation 1.73 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 8 | 0.5 % of SpO2 | Standard Deviation 1.29 |
| Treatment C: Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 21 | 1.1 % of SpO2 | Standard Deviation 2.21 |
| Treatment C: Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 8 | 1.1 % of SpO2 | Standard Deviation 2.07 |
| Treatment C: Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 14 | 1.2 % of SpO2 | Standard Deviation 2.09 |
| Treatment C: Placebo | Change From Baseline in Peripheral Capillary Oxygen Saturation | Baseline to Day 3 | 0.2 % of SpO2 | Standard Deviation 2.44 |
Secondary
Change From Baseline in Pulse Rate
Change from baseline in pulse rate was calculated and reported by the investigator.
Time frame: Baseline to Days 3, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Pulse Rate | Baseline to Day 3 | 0.0 Beats/min | Standard Deviation 10.27 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Pulse Rate | Baseline to Day 8 | -5.4 Beats/min | Standard Deviation 13.17 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Pulse Rate | Baseline to Day 14 | -4.3 Beats/min | Standard Deviation 13.16 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Pulse Rate | Baseline to Day 21 | -6.9 Beats/min | Standard Deviation 9.11 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Pulse Rate | Baseline to Day 21 | -6.8 Beats/min | Standard Deviation 12.11 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Pulse Rate | Baseline to Day 3 | -1.4 Beats/min | Standard Deviation 10.17 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Pulse Rate | Baseline to Day 14 | -7.4 Beats/min | Standard Deviation 13.76 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Pulse Rate | Baseline to Day 8 | -3.5 Beats/min | Standard Deviation 14.03 |
| Treatment C: Placebo | Change From Baseline in Pulse Rate | Baseline to Day 21 | -6.9 Beats/min | Standard Deviation 12.85 |
| Treatment C: Placebo | Change From Baseline in Pulse Rate | Baseline to Day 8 | -6.4 Beats/min | Standard Deviation 11.61 |
| Treatment C: Placebo | Change From Baseline in Pulse Rate | Baseline to Day 14 | -5.3 Beats/min | Standard Deviation 10.29 |
| Treatment C: Placebo | Change From Baseline in Pulse Rate | Baseline to Day 3 | 0.2 Beats/min | Standard Deviation 11.8 |
Secondary
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate was calculated and reported by the investigator.
Time frame: Baseline to Days 3, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Respiratory Rate | Baseline to Day 3 | -0.9 Breaths/min | Standard Deviation 2.1 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Respiratory Rate | Baseline to Day 8 | -1.4 Breaths/min | Standard Deviation 2.34 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Respiratory Rate | Baseline to Day 14 | -1.8 Breaths/min | Standard Deviation 2.83 |
| Treatment A: JNJ-53718678 500 mg | Change From Baseline in Respiratory Rate | Baseline to Day 21 | -1.8 Breaths/min | Standard Deviation 2.73 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 21 | -2.4 Breaths/min | Standard Deviation 4.34 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 3 | -1.3 Breaths/min | Standard Deviation 3.52 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 14 | -1.7 Breaths/min | Standard Deviation 3.59 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 8 | -0.6 Breaths/min | Standard Deviation 4.17 |
| Treatment C: Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 21 | -1.8 Breaths/min | Standard Deviation 3.33 |
| Treatment C: Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 8 | -1.1 Breaths/min | Standard Deviation 3.51 |
| Treatment C: Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 14 | -1.3 Breaths/min | Standard Deviation 3.33 |
| Treatment C: Placebo | Change From Baseline in Respiratory Rate | Baseline to Day 3 | -0.8 Breaths/min | Standard Deviation 2.25 |
Secondary
Duration of Signs and Symptoms of RSV Assessed by RI-PRO
Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Time frame: Baseline up to Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Duration of Signs and Symptoms of RSV Assessed by RI-PRO | 7.9 days |
| Treatment B: JNJ-53718678 80 mg + Placebo | Duration of Signs and Symptoms of RSV Assessed by RI-PRO | 7.4 days |
| Treatment C: Placebo | Duration of Signs and Symptoms of RSV Assessed by RI-PRO | 15.9 days |
Secondary
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
Time frame: Days 1 and 7
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) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Day 1 | 2870 ng/mL | Standard Deviation 802 |
| Treatment A: JNJ-53718678 500 mg | Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Day 7 | 3540 ng/mL | Standard Deviation 1050 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Day 1 | 490 ng/mL | Standard Deviation 150 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Day 7 | 552 ng/mL | Standard Deviation 131 |
Secondary
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to Day 28
Population: The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | 9 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | 18 Participants |
| Treatment C: Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | 15 Participants |
Secondary
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (\< 48 hours); no medical intervention/therapy required), Grade 2= moderate (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), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).
Time frame: Up to Day 28
Population: The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants who were valuable for this outcome measure. Here, n (number analysed) is defined as number of participants analyzed for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypomagnesemia (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis: Urine (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Hemoglobin (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperglycemia (Grade 2) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis: Dipstick Protein (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Aspartate Aminotransferase (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Coagulation Prothrombin Time (Grade 2) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 2) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypophosphatemia (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Coagulation Prothrombin Time (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 3) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperglycemia (Grade 1) | 4 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alanine Aminotransferase (Grade 2) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hypernatremia (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperkalemia (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alanine Aminotransferase (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperuricemia (Grade 1) | 2 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypoglycemia (Grade 1) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alkaline Phosphatase (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperuricemia (Grade 2) | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperbilirubinemia (Grade 1) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis Urine (Grade 2) | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Renal Function Creatinine (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis: Dipstick Protein (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypoglycemia (Grade 1) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperkalemia (Grade 1) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypomagnesemia (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypophosphatemia (Grade 1) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hypernatremia (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperuricemia (Grade 1) | 3 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperuricemia (Grade 2) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Renal Function Creatinine (Grade 1) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Hemoglobin (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 2) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 3) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Coagulation Prothrombin Time (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Coagulation Prothrombin Time (Grade 2) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperglycemia (Grade 2) | 3 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis: Urine (Grade 1) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis Urine (Grade 2) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alkaline Phosphatase (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alanine Aminotransferase (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alanine Aminotransferase (Grade 2) | 2 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Aspartate Aminotransferase (Grade 1) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperbilirubinemia (Grade 1) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperglycemia (Grade 1) | 2 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Aspartate Aminotransferase (Grade 1) | 2 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis: Urine (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperuricemia (Grade 2) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperkalemia (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis Urine (Grade 2) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperuricemia (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperglycemia (Grade 1) | 4 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alkaline Phosphatase (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hypernatremia (Grade 1) | 2 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperbilirubinemia (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alanine Aminotransferase (Grade 1) | 2 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypophosphatemia (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypoglycemia (Grade 1) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 3) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 2) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Alanine Aminotransferase (Grade 2) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Coagulation Prothrombin Time (Grade 1) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Leukocytes High (Grade 1) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hypomagnesemia (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Coagulation Prothrombin Time (Grade 2) | 2 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Hematology: Hemoglobin (Grade 1) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Hyperglycemia (Grade 2) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Urinalysis: Dipstick Protein (Grade 1) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Serum chemistry: Renal Function Creatinine (Grade 1) | 0 Participants |
Secondary
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval (\[450 milliseconds {ms}, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval (\[450 ms, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]).
Time frame: Up to Day 28
Population: The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally high PR interval | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | QTcF Increase between 30 and 60 ms (Fridericia) | 3 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | QTcB Increase between 30 and 60 ms (Bazett) | 3 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally low heart rate | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Borderline prolonged QTcF | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Borderline prolonged QTcB | 5 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally high QRS interval | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | QTcB Increase between 30 and 60 ms (Bazett) | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally low heart rate | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally high PR interval | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally high QRS interval | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | QTcF Increase between 30 and 60 ms (Fridericia) | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Borderline prolonged QTcB | 2 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Borderline prolonged QTcF | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | QTcF Increase between 30 and 60 ms (Fridericia) | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally high PR interval | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Borderline prolonged QTcF | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Borderline prolonged QTcB | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | QTcB Increase between 30 and 60 ms (Bazett) | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally high QRS interval | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | Abnormally low heart rate | 1 Participants |
Secondary
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (\<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - \< 100 mmHg, Grade 2 (moderate)- greater than or equal to (\>=)100 mmHg to \< 110 mmHg, Grade 3 (severe)- \>=110 mmHg; DBP: Abnormally low- \<=90 mmHg, Grade 1 (mild)- 140 mmHg - \< 160 mmHg, Grade 2 (moderate)- \>=160 mmHg to \< 180 mmHg, Grade 3 (severe)- \>=180 mmHg.
Time frame: Up to Day 28
Population: The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Mild increased DBP | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Mild increased SBP | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Abnormally low SBP | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Abnormally low DBP | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Severe increased SBP | 1 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Moderate increased SBP | 0 Participants |
| Treatment A: JNJ-53718678 500 mg | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Moderate increased DBP | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Abnormally low SBP | 1 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Abnormally low DBP | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Mild increased DBP | 3 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Moderate increased DBP | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Mild increased SBP | 5 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Moderate increased SBP | 0 Participants |
| Treatment B: JNJ-53718678 80 mg + Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Severe increased SBP | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Mild increased SBP | 3 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Mild increased DBP | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Severe increased SBP | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Moderate increased SBP | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Abnormally low SBP | 1 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Moderate increased DBP | 0 Participants |
| Treatment C: Placebo | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Abnormally low DBP | 2 Participants |
Secondary
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Peripheral capillary oxygen saturation was measured by the investigator over time.
Time frame: Baseline, Days 3, 8, 14, and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 14 | 97.4 Percentage of SpO2 (%) | Standard Deviation 0.99 |
| Treatment A: JNJ-53718678 500 mg | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 8 | 97.2 Percentage of SpO2 (%) | Standard Deviation 1.69 |
| Treatment A: JNJ-53718678 500 mg | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Baseline | 95.6 Percentage of SpO2 (%) | Standard Deviation 2.72 |
| Treatment A: JNJ-53718678 500 mg | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 3 | 95.8 Percentage of SpO2 (%) | Standard Deviation 2.62 |
| Treatment A: JNJ-53718678 500 mg | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 21 | 97.1 Percentage of SpO2 (%) | Standard Deviation 1.23 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 8 | 96.5 Percentage of SpO2 (%) | Standard Deviation 2.23 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Baseline | 96.0 Percentage of SpO2 (%) | Standard Deviation 2.6 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 3 | 96.8 Percentage of SpO2 (%) | Standard Deviation 2.17 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 14 | 96.6 Percentage of SpO2 (%) | Standard Deviation 2.14 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 21 | 97.1 Percentage of SpO2 (%) | Standard Deviation 1.47 |
| Treatment C: Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 21 | 96.6 Percentage of SpO2 (%) | Standard Deviation 2.41 |
| Treatment C: Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 14 | 96.7 Percentage of SpO2 (%) | Standard Deviation 1.81 |
| Treatment C: Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Baseline | 95.8 Percentage of SpO2 (%) | Standard Deviation 2.74 |
| Treatment C: Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 8 | 96.9 Percentage of SpO2 (%) | Standard Deviation 2.26 |
| Treatment C: Placebo | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Day 3 | 95.7 Percentage of SpO2 (%) | Standard Deviation 3.57 |
Secondary
Predose Plasma Concentration (Ctrough) of JNJ-53718678
Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
Time frame: Predose on Days 1 and 7
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) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Predose Plasma Concentration (Ctrough) of JNJ-53718678 | Day 1 | 514 nanograms per milliliter (ng/mL) | Standard Deviation 249 |
| Treatment A: JNJ-53718678 500 mg | Predose Plasma Concentration (Ctrough) of JNJ-53718678 | Day 7 | 774 nanograms per milliliter (ng/mL) | Standard Deviation 451 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Predose Plasma Concentration (Ctrough) of JNJ-53718678 | Day 1 | 68.2 nanograms per milliliter (ng/mL) | Standard Deviation 36.2 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Predose Plasma Concentration (Ctrough) of JNJ-53718678 | Day 7 | 84.4 nanograms per milliliter (ng/mL) | Standard Deviation 39.4 |
Secondary
Pulse Rate Over Time
Pulse rate was measured by the investigator over time.
Time frame: Baseline, Days 3, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Pulse Rate Over Time | Day 14 | 73.0 Beats/min | Standard Deviation 12.62 |
| Treatment A: JNJ-53718678 500 mg | Pulse Rate Over Time | Day 8 | 70.7 Beats/min | Standard Deviation 8.22 |
| Treatment A: JNJ-53718678 500 mg | Pulse Rate Over Time | Baseline | 76.9 Beats/min | Standard Deviation 10.86 |
| Treatment A: JNJ-53718678 500 mg | Pulse Rate Over Time | Day 3 | 76.4 Beats/min | Standard Deviation 11.88 |
| Treatment A: JNJ-53718678 500 mg | Pulse Rate Over Time | Day 21 | 69.4 Beats/min | Standard Deviation 7.13 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Pulse Rate Over Time | Day 8 | 74.5 Beats/min | Standard Deviation 12.74 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Pulse Rate Over Time | Baseline | 78.0 Beats/min | Standard Deviation 12.16 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Pulse Rate Over Time | Day 3 | 76.6 Beats/min | Standard Deviation 13.2 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Pulse Rate Over Time | Day 14 | 71.4 Beats/min | Standard Deviation 13.09 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Pulse Rate Over Time | Day 21 | 71.9 Beats/min | Standard Deviation 9.76 |
| Treatment C: Placebo | Pulse Rate Over Time | Day 21 | 71.7 Beats/min | Standard Deviation 10 |
| Treatment C: Placebo | Pulse Rate Over Time | Day 14 | 73.3 Beats/min | Standard Deviation 6.27 |
| Treatment C: Placebo | Pulse Rate Over Time | Baseline | 77.8 Beats/min | Standard Deviation 13.05 |
| Treatment C: Placebo | Pulse Rate Over Time | Day 8 | 71.8 Beats/min | Standard Deviation 10.58 |
| Treatment C: Placebo | Pulse Rate Over Time | Day 3 | 78.7 Beats/min | Standard Deviation 15.64 |
Secondary
Respiratory Rate Over Time
Respiratory rate was measured by the investigator over time.
Time frame: Baseline, Days 3, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Respiratory Rate Over Time | Day 8 | 16.9 Breaths/min | Standard Deviation 1.82 |
| Treatment A: JNJ-53718678 500 mg | Respiratory Rate Over Time | Day 14 | 16.6 Breaths/min | Standard Deviation 2.11 |
| Treatment A: JNJ-53718678 500 mg | Respiratory Rate Over Time | Day 3 | 17.1 Breaths/min | Standard Deviation 2.64 |
| Treatment A: JNJ-53718678 500 mg | Respiratory Rate Over Time | Baseline | 18.2 Breaths/min | Standard Deviation 3.55 |
| Treatment A: JNJ-53718678 500 mg | Respiratory Rate Over Time | Day 21 | 16.6 Breaths/min | Standard Deviation 2.23 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Respiratory Rate Over Time | Day 8 | 17.4 Breaths/min | Standard Deviation 4.15 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Respiratory Rate Over Time | Day 3 | 16.7 Breaths/min | Standard Deviation 3.02 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Respiratory Rate Over Time | Baseline | 18.0 Breaths/min | Standard Deviation 3.08 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Respiratory Rate Over Time | Day 14 | 16.4 Breaths/min | Standard Deviation 3.1 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Respiratory Rate Over Time | Day 21 | 15.7 Breaths/min | Standard Deviation 3.41 |
| Treatment C: Placebo | Respiratory Rate Over Time | Day 21 | 17.6 Breaths/min | Standard Deviation 2.82 |
| Treatment C: Placebo | Respiratory Rate Over Time | Day 14 | 18.1 Breaths/min | Standard Deviation 2.44 |
| Treatment C: Placebo | Respiratory Rate Over Time | Day 3 | 18.3 Breaths/min | Standard Deviation 3.06 |
| Treatment C: Placebo | Respiratory Rate Over Time | Day 8 | 18.0 Breaths/min | Standard Deviation 2.48 |
| Treatment C: Placebo | Respiratory Rate Over Time | Baseline | 19.2 Breaths/min | Standard Deviation 3.52 |
Secondary
Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.
Time frame: Baseline, Days 3, 5, 8, 14 and 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Baseline | 0.97 Scale on a score | Standard Deviation 1.115 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 14 | 0.18 Scale on a score | Standard Deviation 0.281 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Baseline | 0.17 Scale on a score | Standard Deviation 0.398 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 3 | 0.77 Scale on a score | Standard Deviation 0.802 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Baseline | 2.32 Scale on a score | Standard Deviation 0.912 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 21 | 0.28 Scale on a score | Standard Deviation 0.607 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 5 | 0.46 Scale on a score | Standard Deviation 0.742 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 21 | 0.45 Scale on a score | Standard Deviation 0.674 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 14 | 0.40 Scale on a score | Standard Deviation 0.494 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 8 | 0.13 Scale on a score | Standard Deviation 0.251 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 5 | 1.11 Scale on a score | Standard Deviation 0.614 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 8 | 0.69 Scale on a score | Standard Deviation 0.579 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 14 | 0.07 Scale on a score | Standard Deviation 0.244 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 3 | 1.02 Scale on a score | Standard Deviation 0.748 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 5 | 1.02 Scale on a score | Standard Deviation 0.542 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 21 | 0.00 Scale on a score | Standard Deviation 0 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Baseline | 1.46 Scale on a score | Standard Deviation 1.142 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 3 | 1.46 Scale on a score | Standard Deviation 0.704 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Baseline | 1.86 Scale on a score | Standard Deviation 0.804 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 3 | 1.84 Scale on a score | Standard Deviation 0.983 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Baseline | 1.47 Scale on a score | Standard Deviation 0.925 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 3 | 1.02 Scale on a score | Standard Deviation 0.828 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 8 | 0.20 Scale on a score | Standard Deviation 0.368 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 21 | 0.02 Scale on a score | Standard Deviation 0.067 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 5 | 0.74 Scale on a score | Standard Deviation 0.813 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 8 | 0.88 Scale on a score | Standard Deviation 0.676 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 14 | 0.08 Scale on a score | Standard Deviation 0.354 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 8 | 0.13 Scale on a score | Standard Deviation 0.274 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 21 | 0.17 Scale on a score | Standard Deviation 0.3 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 8 | 0.24 Scale on a score | Standard Deviation 0.425 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 14 | 0.00 Scale on a score | Standard Deviation 0 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 5 | 0.54 Scale on a score | Standard Deviation 0.429 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 5 | 0.40 Scale on a score | Standard Deviation 0.648 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 21 | 0.02 Scale on a score | Standard Deviation 0.089 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 14 | 0.43 Scale on a score | Standard Deviation 0.561 |
| Treatment A: JNJ-53718678 500 mg | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 3 | 0.72 Scale on a score | Standard Deviation 0.986 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 3 | 0.55 Scale on a score | Standard Deviation 0.435 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Baseline | 2.16 Scale on a score | Standard Deviation 0.816 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 3 | 1.01 Scale on a score | Standard Deviation 0.72 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 5 | 0.63 Scale on a score | Standard Deviation 0.591 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 8 | 0.45 Scale on a score | Standard Deviation 0.557 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 14 | 0.20 Scale on a score | Standard Deviation 0.504 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 21 | 0.18 Scale on a score | Standard Deviation 0.532 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Baseline | 2.02 Scale on a score | Standard Deviation 1.197 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 3 | 0.78 Scale on a score | Standard Deviation 0.741 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 5 | 0.44 Scale on a score | Standard Deviation 0.485 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 8 | 0.22 Scale on a score | Standard Deviation 0.355 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 14 | 0.02 Scale on a score | Standard Deviation 0.076 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 21 | 0.00 Scale on a score | Standard Deviation 0 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Baseline | 0.80 Scale on a score | Standard Deviation 0.847 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 3 | 0.26 Scale on a score | Standard Deviation 0.421 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 5 | 0.14 Scale on a score | Standard Deviation 0.339 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 8 | 0.08 Scale on a score | Standard Deviation 0.296 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 14 | 0.04 Scale on a score | Standard Deviation 0.153 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 21 | 0.00 Scale on a score | Standard Deviation 0 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Baseline | 1.96 Scale on a score | Standard Deviation 0.815 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 3 | 1.37 Scale on a score | Standard Deviation 0.75 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 5 | 0.95 Scale on a score | Standard Deviation 0.767 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 8 | 0.72 Scale on a score | Standard Deviation 0.632 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 14 | 0.31 Scale on a score | Standard Deviation 0.566 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 21 | 0.32 Scale on a score | Standard Deviation 0.666 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Baseline | 0.38 Scale on a score | Standard Deviation 0.666 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 3 | 0.47 Scale on a score | Standard Deviation 0.712 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 5 | 0.36 Scale on a score | Standard Deviation 0.385 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 8 | 0.19 Scale on a score | Standard Deviation 0.249 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 14 | 0.01 Scale on a score | Standard Deviation 0.057 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 21 | 0.00 Scale on a score | Standard Deviation 0 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Baseline | 1.50 Scale on a score | Standard Deviation 0.649 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 5 | 0.37 Scale on a score | Standard Deviation 0.442 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 8 | 0.27 Scale on a score | Standard Deviation 0.296 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 14 | 0.10 Scale on a score | Standard Deviation 0.186 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 21 | 0.09 Scale on a score | Standard Deviation 0.147 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Baseline | 1.17 Scale on a score | Standard Deviation 0.821 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 14 | 0.36 Scale on a score | Standard Deviation 0.48 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Baseline | 0.26 Scale on a score | Standard Deviation 0.426 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 21 | 0.19 Scale on a score | Standard Deviation 0.388 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 5 | 0.61 Scale on a score | Standard Deviation 0.463 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 3 | 0.50 Scale on a score | Standard Deviation 0.692 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 14 | 0.18 Scale on a score | Standard Deviation 0.393 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 5 | 0.94 Scale on a score | Standard Deviation 0.649 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 5 | 0.48 Scale on a score | Standard Deviation 0.559 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 8 | 0.25 Scale on a score | Standard Deviation 0.417 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Baseline | 1.91 Scale on a score | Standard Deviation 0.999 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 8 | 0.28 Scale on a score | Standard Deviation 0.423 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 5 | 0.33 Scale on a score | Standard Deviation 0.471 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 8 | 0.36 Scale on a score | Standard Deviation 0.471 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 14 | 0.07 Scale on a score | Standard Deviation 0.212 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Day 3 | 0.67 Scale on a score | Standard Deviation 0.72 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 3 | 1.25 Scale on a score | Standard Deviation 0.182 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Gastrointestinal: Day 21 | 0.17 Scale on a score | Standard Deviation 0.268 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Throat: Baseline | 1.36 Scale on a score | Standard Deviation 1.186 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 21 | 0.27 Scale on a score | Standard Deviation 0.384 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Baseline | 1.74 Scale on a score | Standard Deviation 0.659 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 21 | 0.39 Scale on a score | Standard Deviation 0.529 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Baseline | 1.34 Scale on a score | Standard Deviation 0.77 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 3 | 1.37 Scale on a score | Standard Deviation 0.715 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 14 | 0.29 Scale on a score | Standard Deviation 0.406 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 21 | 0.48 Scale on a score | Standard Deviation 0.607 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 5 | 1.12 Scale on a score | Standard Deviation 0.648 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 8 | 0.35 Scale on a score | Standard Deviation 0.629 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 14 | 0.38 Scale on a score | Standard Deviation 0.58 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 8 | 0.81 Scale on a score | Standard Deviation 0.616 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 5 | 0.50 Scale on a score | Standard Deviation 0.798 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Body/Systemic: Day 3 | 0.82 Scale on a score | Standard Deviation 0.633 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 14 | 0.53 Scale on a score | Standard Deviation 0.599 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Eye: Day 3 | 0.65 Scale on a score | Standard Deviation 0.662 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Nose: Day 8 | 0.68 Scale on a score | Standard Deviation 0.63 |
| Treatment C: Placebo | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | Chest/Respiratory: Day 21 | 0.60 Scale on a score | Standard Deviation 0.523 |
Secondary
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Time frame: Up to Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire | 7.1 Days |
| Treatment B: JNJ-53718678 80 mg + Placebo | Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire | 7.6 Days |
| Treatment C: Placebo | Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire | 9.6 Days |
Secondary
Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.
Time frame: Up to Day 21
Population: The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time to return to usual activity | 6.0 days | 90% Confidence Interval 2.99 |
| Treatment A: JNJ-53718678 500 mg | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time to return to usual health | 8.3 days | 90% Confidence Interval 5.51 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time to return to usual activity | 3.0 days | 90% Confidence Interval 1.39 |
| Treatment B: JNJ-53718678 80 mg + Placebo | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time to return to usual health | 8.6 days | 90% Confidence Interval 5.57 |
| Treatment C: Placebo | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time to return to usual activity | 5.6 days | 90% Confidence Interval 4.62 |
| Treatment C: Placebo | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time to return to usual health | 9.1 days | 90% Confidence Interval 5.62 |