Trial Outcomes & Findings for A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus (NCT NCT03379675)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Baseline through Day 3

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment A: JNJ-53718678 500 mg Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	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.	Treatment C: Placebo Participants received matching placebo as an oral solution once daily for 7 days.
Overall Study STARTED	24	24	24
Overall Study COMPLETED	20	22	22
Overall Study NOT COMPLETED	4	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment A: JNJ-53718678 500 mg Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	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.	Treatment C: Placebo Participants received matching placebo as an oral solution once daily for 7 days.
Overall Study Lost to Follow-up	0	1	0
Overall Study Adverse Event	2	0	0
Overall Study Withdrawal by Subject	2	1	2

Baseline Characteristics

A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment A: JNJ-53718678 500 mg n=24 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=24 Participants 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.	Treatment C: Placebo n=24 Participants Participants received matching placebo as an oral solution once daily for 7 days.	Total n=72 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 17.89 • n=5 Participants	48.4 years STANDARD_DEVIATION 17.39 • n=7 Participants	58.9 years STANDARD_DEVIATION 14.16 • n=5 Participants	53 years STANDARD_DEVIATION 16.92 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	60 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Argentina	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Brazil	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Bulgaria	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment Canada	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment France	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Germany	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Mexico	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Poland	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment Russia	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Taiwan, Province Of China	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Ukraine	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Sweden	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
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	246.3 Log10 copies*hr/mL Standard Deviation 67.39	203.4 Log10 copies*hr/mL Standard Deviation 87.63

PRIMARY outcome

Timeframe: 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.

Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
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 189.40	424.2 Log10 copies*hr/mL Standard Deviation 145.73	340.4 Log10 copies*hr/mL Standard Deviation 148.30

PRIMARY outcome

Timeframe: 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.

Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
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	612.3 Log10 copies*hr/mL Standard Deviation 253.29	486.1 Log10 copies*hr/mL Standard Deviation 254.15

PRIMARY outcome

Timeframe: 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.

Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=19 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
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	747.1 Log10 copies*hr/mL Standard Deviation 352.25	619.9 Log10 copies*hr/mL Standard Deviation 394.15

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in RSV Viral Load at Day 3	-2.210 Log10 copies/mL Standard Deviation 1.7185	-1.436 Log10 copies/mL Standard Deviation 1.6165	-2.221 Log10 copies/mL Standard Deviation 1.7093

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in RSV Viral Load at Day 5	-3.156 Log10 copies/mL Standard Deviation 2.2887	-2.324 Log10 copies/mL Standard Deviation 1.6727	-3.031 Log10 copies/mL Standard Deviation 1.5010

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in RSV Viral Load at Day 8	-4.960 Log10 copies/mL Standard Deviation 1.7804	-3.983 Log10 copies/mL Standard Deviation 1.3928	-3.953 Log10 copies/mL Standard Deviation 1.5674

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in RSV Viral Load at Day 14	-5.135 Log10 copies/mL Standard Deviation 1.6444	-5.777 Log10 copies/mL Standard Deviation 1.6183	-4.858 Log10 copies/mL Standard Deviation 1.7419

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in RSV Viral Load at Day 21	-5.433 Log10 copies/mL Standard Deviation 2.1416	-5.898 Log10 copies/mL Standard Deviation 1.6421	-5.129 Log10 copies/mL Standard Deviation 1.6513

PRIMARY outcome

Timeframe: 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.

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
RSV Viral Load at Baseline	5.523 Log10 copies/mL Standard Deviation 1.7911	5.851 Log10 copies/mL Standard Deviation 1.6777	5.285 Log10 copies/mL Standard Deviation 1.7158

PRIMARY outcome

Timeframe: 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.

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
RSV Viral Load at Day 3	3.267 Log10 copies/mL Standard Deviation 2.5490	4.448 Log10 copies/mL Standard Deviation 1.9513	3.160 Log10 copies/mL Standard Deviation 2.2603

PRIMARY outcome

Timeframe: 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.

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
RSV Viral Load at Day 5	2.384 Log10 copies/mL Standard Deviation 2.4214	3.528 Log10 copies/mL Standard Deviation 1.9824	2.351 Log10 copies/mL Standard Deviation 2.1302

PRIMARY outcome

Timeframe: 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.

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=18 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
RSV Viral Load at Day 8	0.661 Log10 copies/mL Standard Deviation 1.5572	1.804 Log10 copies/mL Standard Deviation 1.7888	1.398 Log10 copies/mL Standard Deviation 1.5958

PRIMARY outcome

Timeframe: 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.

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=19 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=18 Participants 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.	Treatment C: Placebo n=19 Participants Participants received matching placebo as an oral solution once daily for 7 days.
RSV Viral Load at Day 14	0.421 Log10 copies/mL Standard Deviation 1.2601	0.290 Log10 copies/mL Standard Deviation 0.8579	0.492 Log10 copies/mL Standard Deviation 0.9910

PRIMARY outcome

Timeframe: 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.

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=19 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
RSV Viral Load at Day 21	0.108 Log10 copies/mL Standard Deviation 0.4808	0.113 Log10 copies/mL Standard Deviation 0.4932	0.253 Log10 copies/mL Standard Deviation 0.7866

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Time to Undetectable RSV Viral Load	7.0 Days 90% Confidence Interval 5.92 • Interval 5.92 to 9.9	8.0 Days 90% Confidence Interval 6.86 • Interval 6.86 to 12.8	9.7 Days 90% Confidence Interval 7.03 • Interval 7.03 to 11.74

PRIMARY outcome

Timeframe: 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.

Percentage of participants with undetectable RSV viral load at Day 3 were reported.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Percentage of Participants With Undetectable RSV Viral Load at Day 3	28.6 Percentage of participants	5.0 Percentage of participants	20.0 Percentage of participants

PRIMARY outcome

Timeframe: 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.

Percentage of participants with undetectable RSV viral load at Day 5 were reported.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Percentage of Participants With Undetectable RSV Viral Load at Day 5	40.0 Percentage of participants	14.3 Percentage of participants	35.0 Percentage of participants

PRIMARY outcome

Timeframe: 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.

Percentage of participants with undetectable RSV viral load at Day 8 were reported.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=18 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Percentage of Participants With Undetectable RSV Viral Load at Day 8	83.3 Percentage of participants	45.0 Percentage of participants	52.4 Percentage of participants

PRIMARY outcome

Timeframe: 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.

Percentage of participants with undetectable RSV viral load at Day 14 were reported.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=19 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=18 Participants 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.	Treatment C: Placebo n=19 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Percentage of Participants With Undetectable RSV Viral Load at Day 14	89.5 Percentage of participants	88.9 Percentage of participants	78.9 Percentage of participants

PRIMARY outcome

Timeframe: 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.

Percentage of participants with undetectable RSV viral load at Day 21 were reported.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=19 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=18 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Percentage of Participants With Undetectable RSV Viral Load at Day 21	95.0 Percentage of participants	94.7 Percentage of participants	90.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=24 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=24 Participants 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.	Treatment C: Placebo n=24 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability	9 Participants	18 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=24 Participants 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.	Treatment C: Placebo n=23 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hypophosphatemia (Grade 1)	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hypomagnesemia (Grade 1)	0 Participants	0 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Alkaline Phosphatase (Grade 1)	1 Participants	0 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Alanine Aminotransferase (Grade 1)	1 Participants	0 Participants	2 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Alanine Aminotransferase (Grade 2)	0 Participants	2 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Aspartate Aminotransferase (Grade 1)	1 Participants	1 Participants	2 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hyperbilirubinemia (Grade 1)	1 Participants	0 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hyperglycemia (Grade 1)	4 Participants	2 Participants	4 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hyperglycemia (Grade 2)	0 Participants	3 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hypoglycemia (Grade 1)	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hyperkalemia (Grade 1)	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hypernatremia (Grade 1)	0 Participants	0 Participants	2 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hyperuricemia (Grade 1)	2 Participants	3 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Hyperuricemia (Grade 2)	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Serum chemistry: Renal Function Creatinine (Grade 1)	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hematology: Leukocytes High (Grade 3)	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hematology: Coagulation Prothrombin Time (Grade 1)	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hematology: Coagulation Prothrombin Time (Grade 2)	0 Participants	0 Participants	2 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Urinalysis: Dipstick Protein (Grade 1)	0 Participants	0 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Urinalysis: Urine (Grade 1)	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Urinalysis Urine (Grade 2)	1 Participants	1 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hematology: Hemoglobin (Grade 1)	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hematology: Leukocytes High (Grade 1)	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities Hematology: Leukocytes High (Grade 2)	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=24 Participants 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.	Treatment C: Placebo n=23 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Abnormally low DBP	0 Participants	0 Participants	2 Participants
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Mild increased DBP	0 Participants	3 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Moderate increased DBP	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Abnormally low SBP	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Mild increased SBP	1 Participants	5 Participants	3 Participants
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Moderate increased SBP	0 Participants	0 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities Severe increased SBP	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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 \[more than 500 ms\]).

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=24 Participants 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.	Treatment C: Placebo n=23 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities Abnormally low heart rate	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities Abnormally high PR interval	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities Abnormally high QRS interval	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities QTcB Increase between 30 and 60 ms (Bazett)	3 Participants	1 Participants	0 Participants
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities QTcF Increase between 30 and 60 ms (Fridericia)	3 Participants	0 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities Borderline prolonged QTcB	5 Participants	2 Participants	1 Participants
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities Borderline prolonged QTcF	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Peripheral capillary oxygen saturation was measured by the investigator over time.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Baseline	95.6 Percentage of SpO2 (%) Standard Deviation 2.72	96.0 Percentage of SpO2 (%) Standard Deviation 2.60	95.8 Percentage of SpO2 (%) Standard Deviation 2.74
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 3	95.8 Percentage of SpO2 (%) Standard Deviation 2.62	96.8 Percentage of SpO2 (%) Standard Deviation 2.17	95.7 Percentage of SpO2 (%) Standard Deviation 3.57
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 8	97.2 Percentage of SpO2 (%) Standard Deviation 1.69	96.5 Percentage of SpO2 (%) Standard Deviation 2.23	96.9 Percentage of SpO2 (%) Standard Deviation 2.26
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 14	97.4 Percentage of SpO2 (%) Standard Deviation 0.99	96.6 Percentage of SpO2 (%) Standard Deviation 2.14	96.7 Percentage of SpO2 (%) Standard Deviation 1.81
Peripheral Capillary Oxygen Saturation (SpO2) Over Time Day 21	97.1 Percentage of SpO2 (%) Standard Deviation 1.23	97.1 Percentage of SpO2 (%) Standard Deviation 1.47	96.6 Percentage of SpO2 (%) Standard Deviation 2.41

SECONDARY outcome

Timeframe: 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.

Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in Peripheral Capillary Oxygen Saturation Baseline to Day 3	0.5 % of SpO2 Standard Deviation 2.21	0.9 % of SpO2 Standard Deviation 1.73	0.2 % of SpO2 Standard Deviation 2.44
Change From Baseline in Peripheral Capillary Oxygen Saturation Baseline to Day 8	1.3 % of SpO2 Standard Deviation 2.72	0.5 % of SpO2 Standard Deviation 1.29	1.1 % of SpO2 Standard Deviation 2.07
Change From Baseline in Peripheral Capillary Oxygen Saturation Baseline to Day 14	1.2 % of SpO2 Standard Deviation 2.10	0.7 % of SpO2 Standard Deviation 1.73	1.2 % of SpO2 Standard Deviation 2.09
Change From Baseline in Peripheral Capillary Oxygen Saturation Baseline to Day 21	1.3 % of SpO2 Standard Deviation 3.11	1.2 % of SpO2 Standard Deviation 2.22	1.1 % of SpO2 Standard Deviation 2.21

SECONDARY outcome

Timeframe: 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.

Pulse rate was measured by the investigator over time.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Pulse Rate Over Time Baseline	76.9 Beats/min Standard Deviation 10.86	78.0 Beats/min Standard Deviation 12.16	77.8 Beats/min Standard Deviation 13.05
Pulse Rate Over Time Day 3	76.4 Beats/min Standard Deviation 11.88	76.6 Beats/min Standard Deviation 13.20	78.7 Beats/min Standard Deviation 15.64
Pulse Rate Over Time Day 8	70.7 Beats/min Standard Deviation 8.22	74.5 Beats/min Standard Deviation 12.74	71.8 Beats/min Standard Deviation 10.58
Pulse Rate Over Time Day 14	73.0 Beats/min Standard Deviation 12.62	71.4 Beats/min Standard Deviation 13.09	73.3 Beats/min Standard Deviation 6.27
Pulse Rate Over Time Day 21	69.4 Beats/min Standard Deviation 7.13	71.9 Beats/min Standard Deviation 9.76	71.7 Beats/min Standard Deviation 10.00

SECONDARY outcome

Timeframe: 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.

Change from baseline in pulse rate was calculated and reported by the investigator.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in Pulse Rate Baseline to Day 3	0.0 Beats/min Standard Deviation 10.27	-1.4 Beats/min Standard Deviation 10.17	0.2 Beats/min Standard Deviation 11.80
Change From Baseline in Pulse Rate Baseline to Day 8	-5.4 Beats/min Standard Deviation 13.17	-3.5 Beats/min Standard Deviation 14.03	-6.4 Beats/min Standard Deviation 11.61
Change From Baseline in Pulse Rate Baseline to Day 14	-4.3 Beats/min Standard Deviation 13.16	-7.4 Beats/min Standard Deviation 13.76	-5.3 Beats/min Standard Deviation 10.29
Change From Baseline in Pulse Rate Baseline to Day 21	-6.9 Beats/min Standard Deviation 9.11	-6.8 Beats/min Standard Deviation 12.11	-6.9 Beats/min Standard Deviation 12.85

SECONDARY outcome

Timeframe: 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.

Respiratory rate was measured by the investigator over time.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Respiratory Rate Over Time Baseline	18.2 Breaths/min Standard Deviation 3.55	18.0 Breaths/min Standard Deviation 3.08	19.2 Breaths/min Standard Deviation 3.52
Respiratory Rate Over Time Day 3	17.1 Breaths/min Standard Deviation 2.64	16.7 Breaths/min Standard Deviation 3.02	18.3 Breaths/min Standard Deviation 3.06
Respiratory Rate Over Time Day 8	16.9 Breaths/min Standard Deviation 1.82	17.4 Breaths/min Standard Deviation 4.15	18.0 Breaths/min Standard Deviation 2.48
Respiratory Rate Over Time Day 14	16.6 Breaths/min Standard Deviation 2.11	16.4 Breaths/min Standard Deviation 3.10	18.1 Breaths/min Standard Deviation 2.44
Respiratory Rate Over Time Day 21	16.6 Breaths/min Standard Deviation 2.23	15.7 Breaths/min Standard Deviation 3.41	17.6 Breaths/min Standard Deviation 2.82

SECONDARY outcome

Timeframe: 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.

Change from baseline in respiratory rate was calculated and reported by the investigator.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in Respiratory Rate Baseline to Day 3	-0.9 Breaths/min Standard Deviation 2.10	-1.3 Breaths/min Standard Deviation 3.52	-0.8 Breaths/min Standard Deviation 2.25
Change From Baseline in Respiratory Rate Baseline to Day 8	-1.4 Breaths/min Standard Deviation 2.34	-0.6 Breaths/min Standard Deviation 4.17	-1.1 Breaths/min Standard Deviation 3.51
Change From Baseline in Respiratory Rate Baseline to Day 14	-1.8 Breaths/min Standard Deviation 2.83	-1.7 Breaths/min Standard Deviation 3.59	-1.3 Breaths/min Standard Deviation 3.33
Change From Baseline in Respiratory Rate Baseline to Day 21	-1.8 Breaths/min Standard Deviation 2.73	-2.4 Breaths/min Standard Deviation 4.34	-1.8 Breaths/min Standard Deviation 3.33

SECONDARY outcome

Timeframe: 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.

Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Body Temperature Over Time Baseline	36.83 degree Celsius Standard Deviation 0.622	36.73 degree Celsius Standard Deviation 0.601	36.75 degree Celsius Standard Deviation 0.561
Body Temperature Over Time Day 3	36.57 degree Celsius Standard Deviation 0.572	36.65 degree Celsius Standard Deviation 0.574	36.69 degree Celsius Standard Deviation 0.446
Body Temperature Over Time Day 8	36.26 degree Celsius Standard Deviation 0.396	36.44 degree Celsius Standard Deviation 0.527	36.55 degree Celsius Standard Deviation 0.404
Body Temperature Over Time Day 14	36.37 degree Celsius Standard Deviation 0.389	36.38 degree Celsius Standard Deviation 0.346	36.50 degree Celsius Standard Deviation 0.291
Body Temperature Over Time Day 21	36.32 degree Celsius Standard Deviation 0.380	36.40 degree Celsius Standard Deviation 0.380	36.46 degree Celsius Standard Deviation 0.299

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=21 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Change From Baseline in Body Temperature Baseline to Day 21	-0.52 degree Celsius Standard Deviation 0.537	-0.37 degree Celsius Standard Deviation 0.615	-0.24 degree Celsius Standard Deviation 0.503
Change From Baseline in Body Temperature Baseline to Day 3	-0.27 degree Celsius Standard Deviation 0.390	-0.11 degree Celsius Standard Deviation 0.621	-0.01 degree Celsius Standard Deviation 0.595
Change From Baseline in Body Temperature Baseline to Day 5	-0.63 degree Celsius Standard Deviation 0.667	-0.41 degree Celsius Standard Deviation 0.645	-0.17 degree Celsius Standard Deviation 0.650
Change From Baseline in Body Temperature Baseline to Day 8	-0.55 degree Celsius Standard Deviation 0.465	-0.29 degree Celsius Standard Deviation 0.652	-0.11 degree Celsius Standard Deviation 0.477
Change From Baseline in Body Temperature Baseline to Day 14	-0.48 degree Celsius Standard Deviation 0.402	-0.40 degree Celsius Standard Deviation 0.624	-0.20 degree Celsius Standard Deviation 0.411

SECONDARY outcome

Timeframe: 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.

AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=16 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=18 Participants 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.	Treatment C: Placebo Participants received matching placebo as an oral solution once daily for 7 days.
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose Day 1	29800 nanogramshours per milliliter (ngh/mL) Standard Deviation 9180	4530 nanogramshours per milliliter (ngh/mL) Standard Deviation 1560	—
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose Day 7	41200 nanogramshours per milliliter (ngh/mL) Standard Deviation 15300	5470 nanogramshours per milliliter (ngh/mL) Standard Deviation 1620	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=21 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
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	0.45 Scale on a score Standard Deviation 0.557	0.68 Scale on a score Standard Deviation 0.630
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	2.16 Scale on a score Standard Deviation 0.816	1.91 Scale on a score Standard Deviation 0.9990
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	1.01 Scale on a score Standard Deviation 0.720	1.25 Scale on a score Standard Deviation 0.182
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	0.63 Scale on a score Standard Deviation 0.591	0.94 Scale on a score Standard Deviation 0.649
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	0.20 Scale on a score Standard Deviation 0.504	0.38 Scale on a score Standard Deviation 0.580
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	0.18 Scale on a score Standard Deviation 0.532	0.48 Scale on a score Standard Deviation 0.607
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	2.02 Scale on a score Standard Deviation 1.197	1.36 Scale on a score Standard Deviation 1.186
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	0.78 Scale on a score Standard Deviation 0.741	0.67 Scale on a score Standard Deviation 0.720
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	0.44 Scale on a score Standard Deviation 0.485	0.33 Scale on a score Standard Deviation 0.471
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	0.22 Scale on a score Standard Deviation 0.355	0.25 Scale on a score Standard Deviation 0.417
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 0.000	0.02 Scale on a score Standard Deviation 0.076	0.18 Scale on a score Standard Deviation 0.393
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	0.00 Scale on a score Standard Deviation 0.00	0.19 Scale on a score Standard Deviation 0.388
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	0.80 Scale on a score Standard Deviation 0.847	1.17 Scale on a score Standard Deviation 0.821
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	0.26 Scale on a score Standard Deviation 0.421	0.65 Scale on a score Standard Deviation 0.662
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	0.14 Scale on a score Standard Deviation 0.339	0.50 Scale on a score Standard Deviation 0.798
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	0.08 Scale on a score Standard Deviation 0.296	0.35 Scale on a score Standard Deviation 0.629
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	0.04 Scale on a score Standard Deviation 0.153	0.29 Scale on a score Standard Deviation 0.406
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 0.00	0.00 Scale on a score Standard Deviation 0.00	0.39 Scale on a score Standard Deviation 0.529
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	1.96 Scale on a score Standard Deviation 0.815	1.74 Scale on a score Standard Deviation 0.659
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	1.37 Scale on a score Standard Deviation 0.750	1.37 Scale on a score Standard Deviation 0.715
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	0.95 Scale on a score Standard Deviation 0.767	1.12 Scale on a score Standard Deviation 0.648
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	0.72 Scale on a score Standard Deviation 0.632	0.81 Scale on a score Standard Deviation 0.616
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	0.31 Scale on a score Standard Deviation 0.566	0.53 Scale on a score Standard Deviation 0.599
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	0.32 Scale on a score Standard Deviation 0.666	0.60 Scale on a score Standard Deviation 0.523
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	0.38 Scale on a score Standard Deviation 0.666	0.26 Scale on a score Standard Deviation 0.426
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	0.47 Scale on a score Standard Deviation 0.712	0.50 Scale on a score Standard Deviation 0.692
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	0.36 Scale on a score Standard Deviation 0.385	0.48 Scale on a score Standard Deviation 0.559
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	0.19 Scale on a score Standard Deviation 0.249	0.28 Scale on a score Standard Deviation 0.423
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	0.01 Scale on a score Standard Deviation 0.057	0.07 Scale on a score Standard Deviation 0.212
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	0.00 Scale on a score Standard Deviation 0.00	0.17 Scale on a score Standard Deviation 0.268
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	1.50 Scale on a score Standard Deviation 0.649	1.34 Scale on a score Standard Deviation 0.770
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	0.55 Scale on a score Standard Deviation 0.435	0.82 Scale on a score Standard Deviation 0.633
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	0.37 Scale on a score Standard Deviation 0.442	0.61 Scale on a score Standard Deviation 0.463
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	0.27 Scale on a score Standard Deviation 0.296	0.36 Scale on a score Standard Deviation 0.471
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	0.10 Scale on a score Standard Deviation 0.186	0.36 Scale on a score Standard Deviation 0.480
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 0.300	0.09 Scale on a score Standard Deviation 0.147	0.27 Scale on a score Standard Deviation 0.384

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=20 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo n=20 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Duration of Signs and Symptoms of RSV Assessed by RI-PRO	7.9 days Interval 6.9 to 18.92	7.4 days Interval 5.05 to 9.52	15.9 days Interval 6.4 to Here, NA signifies that upper bound of the 90% confidence interval could not be calculated due to the low number of participants and censoring.

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=22 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire	7.1 Days Interval 5.03 to 11.43	7.6 Days Interval 5.93 to 8.32	9.6 Days Interval 5.95 to 14.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=23 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=21 Participants 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.	Treatment C: Placebo n=22 Participants Participants received matching placebo as an oral solution once daily for 7 days.
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 • Interval 2.99 to 8.33	3.0 days 90% Confidence Interval 1.39 • Interval 1.39 to 7.88	5.6 days 90% Confidence Interval 4.62 • Interval 4.62 to 10.62
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 • Interval 5.51 to 11.87	8.6 days 90% Confidence Interval 5.57 • Interval 5.57 to 10.81	9.1 days 90% Confidence Interval 5.62 • Interval 5.62 to 10.64

SECONDARY outcome

Timeframe: 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.

Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=16 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=18 Participants 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.	Treatment C: Placebo Participants received matching placebo as an oral solution once daily for 7 days.
Predose Plasma Concentration (Ctrough) of JNJ-53718678 Day 1	514 nanograms per milliliter (ng/mL) Standard Deviation 249	68.2 nanograms per milliliter (ng/mL) Standard Deviation 36.2	—
Predose Plasma Concentration (Ctrough) of JNJ-53718678 Day 7	774 nanograms per milliliter (ng/mL) Standard Deviation 451	84.4 nanograms per milliliter (ng/mL) Standard Deviation 39.4	—

SECONDARY outcome

Timeframe: 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.

Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.

Outcome measures

Outcome measures
Measure	Treatment A: JNJ-53718678 500 mg n=17 Participants Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=20 Participants 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.	Treatment C: Placebo Participants received matching placebo as an oral solution once daily for 7 days.
Maximum Plasma Concentration (Cmax) of JNJ-53718678 Day 1	2870 ng/mL Standard Deviation 802	490 ng/mL Standard Deviation 150	—
Maximum Plasma Concentration (Cmax) of JNJ-53718678 Day 7	3540 ng/mL Standard Deviation 1050	552 ng/mL Standard Deviation 131	—

Adverse Events

Treatment A: JNJ-53718678 500 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Treatment B: JNJ-53718678 80 mg + Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Treatment C: Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment A: JNJ-53718678 500 mg n=24 participants at risk Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days.	Treatment B: JNJ-53718678 80 mg + Placebo n=24 participants at risk 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.	Treatment C: Placebo n=24 participants at risk Participants received matching placebo as an oral solution once daily for 7 days.
Gastrointestinal disorders Diarrhoea	20.8% 5/24 • Number of events 5 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	37.5% 9/24 • Number of events 14 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	37.5% 9/24 • Number of events 10 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Gastrointestinal disorders Vomiting	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	12.5% 3/24 • Number of events 3 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	4.2% 1/24 • Number of events 1 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Infections and infestations Urinary Tract Infection	4.2% 1/24 • Number of events 1 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	8.3% 2/24 • Number of events 2 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Nervous system disorders Dizziness	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	8.3% 2/24 • Number of events 2 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Nervous system disorders Headache	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	8.3% 2/24 • Number of events 2 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	12.5% 3/24 • Number of events 3 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	12.5% 3/24 • Number of events 3 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	4.2% 1/24 • Number of events 1 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	8.3% 2/24 • Number of events 3 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	8.3% 2/24 • Number of events 2 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.	4.2% 1/24 • Number of events 1 • Up to Day 28 The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated.

Additional Information

Senior Director

Janssen Research and Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER