Trial · NCT03379675

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

NCT03379675, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2022-06-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03379675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03379675

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT03379675
Status: Completed
Phases: Phase 2
Enrollment: 72 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Respiratory Syncytial Virus Infections
Interventions: JNJ-53718678 500 mg, JNJ-53718678 80 mg, Placebo
First posted: 2017-12-20
Last updated: 2025-02-04
Other registries' IDs: eudract:2017-003252-24
Results first posted: 2022-06-28
Limitations and caveats: The Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale that replaced Respiratory Infection-Patient Reported Outcomes (RI-PRO) questionnaire was only evaluated in the 5 participants who were enrolled after implementation of protocol amendment 1. This sample size was too small to draw conclusions on comparison between RiiQ and RI-PRO results.

Source ClinicalTrials.gov

Registered outcomes40

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.

1 to 10 of 40Source ClinicalTrials.gov

See all 40 registered outcomes

Outcomes40

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	Baseline through Day 3	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.	Log10 copies*hr/mL	MEAN
PRIMARY	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	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.	Log10 copies*hr/mL	MEAN
PRIMARY	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	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.	Log10 copies*hr/mL	MEAN
PRIMARY	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	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.	Log10 copies*hr/mL	MEAN
PRIMARY	Change From Baseline in RSV Viral Load at Day 3	Baseline to Day 3	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.	Log10 copies/mL	MEAN
PRIMARY	Change From Baseline in RSV Viral Load at Day 5	Baseline to Day 5	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.	Log10 copies/mL	MEAN
PRIMARY	Change From Baseline in RSV Viral Load at Day 8	Baseline to Day 8	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.	Log10 copies/mL	MEAN
PRIMARY	Change From Baseline in RSV Viral Load at Day 14	Baseline to Day 14	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.	Log10 copies/mL	MEAN
PRIMARY	Change From Baseline in RSV Viral Load at Day 21	Baseline to Day 21	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.	Log10 copies/mL	MEAN
PRIMARY	RSV Viral Load at Baseline	Baseline	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.	Log10 copies/mL	MEAN

1 to 10 of 40Source ClinicalTrials.gov

See all 40 outcomes

Results by group423

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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	Treatment A: JNJ-53718678 500 mg	207.3	Standard Deviation 89.55	Log10 copies*hr/mL
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	Treatment B: JNJ-53718678 80 mg + Placebo	246.3	Standard Deviation 67.39	Log10 copies*hr/mL
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	Treatment C: Placebo	203.4	Standard Deviation 87.63	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5	Treatment A: JNJ-53718678 500 mg	344.5	Standard Deviation 189.40	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5	Treatment B: JNJ-53718678 80 mg + Placebo	424.2	Standard Deviation 145.73	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5	Treatment C: Placebo	340.4	Standard Deviation 148.30	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8	Treatment A: JNJ-53718678 500 mg	470.7	Standard Deviation 305.38	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8	Treatment B: JNJ-53718678 80 mg + Placebo	612.3	Standard Deviation 253.29	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8	Treatment C: Placebo	486.1	Standard Deviation 254.15	Log10 copies*hr/mL
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14	Treatment A: JNJ-53718678 500 mg	534.4	Standard Deviation 379.92	Log10 copies*hr/mL

1 to 10 of 423Source ClinicalTrials.gov

See all 423 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment A: JNJ-53718678 500 mg	24
Overall Study	STARTED	Treatment B: JNJ-53718678 80 mg + Placebo	24
Overall Study	STARTED	Treatment C: Placebo	24
Overall Study	COMPLETED	Treatment A: JNJ-53718678 500 mg	20
Overall Study	COMPLETED	Treatment B: JNJ-53718678 80 mg + Placebo	22
Overall Study	COMPLETED	Treatment C: Placebo	22
Overall Study	NOT COMPLETED	Treatment A: JNJ-53718678 500 mg	4
Overall Study	NOT COMPLETED	Treatment B: JNJ-53718678 80 mg + Placebo	2
Overall Study	NOT COMPLETED	Treatment C: Placebo	2

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Treatment A: JNJ-53718678 500 mg	5	24	5
other	Diarrhoea	Gastrointestinal disorders	Treatment B: JNJ-53718678 80 mg + Placebo	9	24	14
other	Diarrhoea	Gastrointestinal disorders	Treatment C: Placebo	9	24	10
other	Vomiting	Gastrointestinal disorders	Treatment A: JNJ-53718678 500 mg	0	24	0
other	Vomiting	Gastrointestinal disorders	Treatment B: JNJ-53718678 80 mg + Placebo	3	24	3
other	Vomiting	Gastrointestinal disorders	Treatment C: Placebo	1	24	1
other	Urinary Tract Infection	Infections and infestations	Treatment A: JNJ-53718678 500 mg	1	24	1
other	Urinary Tract Infection	Infections and infestations	Treatment B: JNJ-53718678 80 mg + Placebo	2	24	2
other	Urinary Tract Infection	Infections and infestations	Treatment C: Placebo	0	24	0
other	Dizziness	Nervous system disorders	Treatment A: JNJ-53718678 500 mg	0	24	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment A: JNJ-53718678 500 mg	0	24
Total, all-cause mortality	Treatment B: JNJ-53718678 80 mg + Placebo	0	24
Total, all-cause mortality	Treatment C: Placebo	0	24
Total, other adverse events	Treatment A: JNJ-53718678 500 mg	6	24
Total, other adverse events	Treatment B: JNJ-53718678 80 mg + Placebo	13	24
Total, other adverse events	Treatment C: Placebo	11	24
Total, serious adverse events	Treatment A: JNJ-53718678 500 mg	0	24
Total, serious adverse events	Treatment B: JNJ-53718678 80 mg + Placebo	0	24
Total, serious adverse events	Treatment C: Placebo	0	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37422079	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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