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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379675
• Other study ID #: CR108419
• Secondary ID: 2017-003252-2453
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2018
• Est. completion date: December 26, 2019

Study information

• Verified date: June 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

Description:

This study will be performed to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV. The study will include both participants who are otherwise healthy (ie, without underlying condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, other chronic diseases), with the exception of immunocompromised participants, presenting for medical care but not requiring hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will include adverse events, laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 26, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection
• Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
• Before randomization, a woman must be not of childbearing potential defined as:

Premenarchal, Postmenopausal or Permanently sterile

• A male participant must agree to the use of acceptable contraceptive measures
• With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening

Exclusion Criteria:

• Hospitalized participants or participants expected to be hospitalized within 24 hours of screening
• History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments
• Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
• Participants who are considered by the investigator to be immunocompromised within the past 12 months
• Participant has known or suspected chronic or acute hepatitis B or C infection
• Women who are pregnant or breastfeeding
• Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500 millisecond [ms]) not consistent with the underlying condition in the study population, as judged by the investigator

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Drug:
• JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
• JNJ-53718678 80 mg
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
• Placebo
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Locations

Country	Name	City	State
Argentina	Hospital Español De Bahia Blanca	Bahia Blanca
Argentina	Hospital Interzonal General de Agudos Dr. Jose Penna	Bahia Blanca
Argentina	Hospital Privado - Centro Medico de Cordoba	Barrio Parque Velez Sarfield
Argentina	Fundación Respirar	Caba
Argentina	Hospital Italiano de La Plata	Ciudad De La Plata
Argentina	HIGA Prof. Dr. Ramón Carrillo	Ciudadela
Argentina	Hospital Cordoba	Cordoba
Argentina	Hospital Italiano de Cordoba	Cordoba
Argentina	Hospital Rawson	Cordoba
Argentina	Sanatorio Juan XXIII	General Roca
Argentina	Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)	Rosario
Argentina	Clinica Mayo de UMCB	San Miguel de Tucuman
Australia	Paratus Clinical Blacktown Clinic	Blacktown
Australia	Barwon Health - University Hospital Geelong	Geelong
Australia	Paratus Clinical Kanwal Clinic	Kanwal
Australia	Paratus Clinical Kippa Ring Clinic	Kippa Ring
Australia	Mater Hospital Brisbane	South Brisbane
Australia	Westmead Hospital	Sydney
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	Jaak Mortelmans	Ham
Belgium	BVBA Dr. Luc Capiau	Massemen
Belgium	Testumed	Tessenderlo
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	Faculdade de Medicina de Botucatu	Botucatu
Brazil	Universidade Federal de Santa Catarina/Clínica Médica	Florianopolis
Brazil	Centro de Estudos e Pesquisas em Moléstias Infecciosas	Natal
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo
Brazil	Hospital São Lucas - PUCRS	Porto Alegre
Brazil	Hospital Universitario Prof Edgard Santos	Salvador
Brazil	Hospital Alemão Oswaldo Cruz	Sao Paulo
Brazil	Hospital Heliopolis	Sao Paulo
Brazil	Hospital Sirio Libanes	São Paulo
Bulgaria	MHAT 'Sv. Ivan Rilski' Kozloduy EOOD	Kozloduy
Bulgaria	Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik	Pernik
Bulgaria	SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD	Ruse
Bulgaria	MHAT 'Dr. Bratan Shukerov'	Smolyan
Bulgaria	Diagnostic Consultation Centre 'Alexandrovska' EOOD	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD	Troyan
Canada	Aggarwal and associates Ltd	Brampton	Ontario
Canada	Milestone Research	London	Ontario
Canada	Clinique Force Medic (GCP Trials)	Montreal	Quebec
Canada	Dr Anil K Gupta Medicine Professional Corporation	Toronto	Ontario
France	Centre Hospitalier d'Agen	Agen cedex 9
France	Cabinet du Dr Remaud	Angers
France	Maison Medicale Rive Sud	Murs Erigne
France	Cabinet du Dr Boye	Nantes
France	CHU Nantes - Hotel Dieu	Nantes
France	Cabinet du Dr Baranes	Paris
Germany	MECS GmbH	Berlin
Germany	IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum	Frankfurt
Germany	Klinische Forschung Hannover-Mitte GmbH	Hannover
Germany	Hausarztpraxis am Lindenplatz	Luebeck
Japan	Fukui General Clinic	Fukui-shi
Japan	Koukan Clinic	Kawasaki
Japan	Shinkomonji hospital	Kitakyusyu
Japan	Musashikoganei Clinic	Koganei-Shi
Japan	Medical Square Kuhonji Clinic	Kumamoto-shi
Japan	Rinku General Medical Center	Osaka
Japan	Tokyo Shinagawa Hospital	Shinagawa-ku
Japan	Saino Clinic	Tokorozawa-shi
Japan	Toyota Kosei Hospital	Toyota
Japan	Shin Yukuhashi Hospital	Yukuhashi
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon-si
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA	Guadalajara
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
Mexico	RM Pharma Specialists	Mexico
Mexico	Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'	Monterrey
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis	Kielce
Poland	Centrum Medyczne 'ALL-MED'	Krakow
Poland	Diamond Clinic	Krakow
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni	Lodz
Poland	Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna	Ostrow Wielkopolski
Poland	Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy	Wroclaw
Russian Federation	Krasnogorsk city hospital #1	Krasnogorsk
Russian Federation	City Polyclinic #25 of the Nevsky District of SPB	Saint-Petersburg
Russian Federation	Eco-safety Ltd	Saint-Petersburg
Russian Federation	LLC 'Medical centr 'Reavita Med Spb'	Saint-Petersburg
Russian Federation	Research Institute of Influenza	St. Petersburg
South Africa	Newtown Clinical Research	Johannesburg
South Africa	Soweto Clinical Trial Centre	Johannesburg
South Africa	Emmed Research	Pretoria
South Africa	Welkom Clinical Trial Centre	Welkom
Spain	Hosp. Gral. Univ. de Alicante	Alicante
Spain	Hosp. Gral. Univ. de Elche	Elche
Spain	Hosp. Univ. Virgen de Las Nieves	Granada
Spain	Hosp. Univ. de La Princesa	Madrid
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Alvaro Cunqueiro	Vigo
Sweden	Skanes universitetssjukhus	Malmö
Sweden	Norrlands Universitetssjukhus	Umeå
Sweden	Akademiska Sjukhuset	Uppsala
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei
Taiwan	Kuang Tien General Hospital- Dajia	Taichung City
Taiwan	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Far Eastern Memorial Hospital	Taipei City
Ukraine	Medical Center of LL Company 'Scientific Medical Center-Your Doctor'	Kharkiv
Ukraine	Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education	Kharkiv
Ukraine	Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'	Kherson
Ukraine	Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'	Kyiv
Ukraine	Policlinic of State Joint Stock Holding Company 'Artem'	Kyiv
Ukraine	Private Small Enterprise Medical Center Pulse	Vinnytsia
Ukraine	Medical Center Ltd 'Health Clinic', Department Of General Therapy	Vinnytsya
Ukraine	Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University	Vinnytsya
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Core Healthcare Group	Cerritos	California
United States	Onsite Clinical Solutions	Charlotte	North Carolina
United States	eStudySite	Chula Vista	California
United States	Lake Internal Medicine Associates	Eustis	Florida
United States	Spectrum Medical Research	Gaffney	South Carolina
United States	SC Clinical Research Inc	Garden Grove	California
United States	Unity Clinical Research	Lindsay	Oklahoma
United States	Florida Research Center Inc.	Miami	Florida
United States	AllinaHealth - Abbott Northwestern Hospital (13520)	Minneapolis	Minnesota
United States	Family Medicine	Nampa	Idaho
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Fusion Clinical Research of Spartanburg	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  France,  Germany,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3	Area under the RSV VL-time curve (AUC) was determined as log10 copies*hour per milliliter (Log10 copies*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.	Baseline through Day 3
Primary	Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5	Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.	Baseline through Day 5
Primary	Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8	Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.	Baseline through Day 8
Primary	Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14	Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.	Baseline through Day 14
Primary	Change From Baseline in RSV Viral Load at Day 3	Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Baseline to Day 3
Primary	Change From Baseline in RSV Viral Load at Day 5	Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Baseline to Day 5
Primary	Change From Baseline in RSV Viral Load at Day 8	Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Baseline to Day 8
Primary	Change From Baseline in RSV Viral Load at Day 14	Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Baseline to Day 14
Primary	Change From Baseline in RSV Viral Load at Day 21	Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Baseline to Day 21
Primary	RSV Viral Load at Baseline	RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Baseline
Primary	RSV Viral Load at Day 3	RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Day 3
Primary	RSV Viral Load at Day 5	RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Day 5
Primary	RSV Viral Load at Day 8	RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Day 8
Primary	RSV Viral Load at Day 14	RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Day 14
Primary	RSV Viral Load at Day 21	RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.	Day 21
Primary	Time to Undetectable RSV Viral Load	The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.	Up to Day 21
Primary	Percentage of Participants With Undetectable RSV Viral Load at Day 3	Percentage of participants with undetectable RSV viral load at Day 3 were reported.	Day 3
Primary	Percentage of Participants With Undetectable RSV Viral Load at Day 5	Percentage of participants with undetectable RSV viral load at Day 5 were reported.	Day 5
Primary	Percentage of Participants With Undetectable RSV Viral Load at Day 8	Percentage of participants with undetectable RSV viral load at Day 8 were reported.	Day 8
Primary	Percentage of Participants With Undetectable RSV Viral Load at Day 14	Percentage of participants with undetectable RSV viral load at Day 14 were reported.	Day 14
Primary	Percentage of Participants With Undetectable RSV Viral Load at Day 21	Percentage of participants with undetectable RSV viral load at Day 21 were reported.	Day 21
Secondary	Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to Day 28
Secondary	Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities	Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).	Up to Day 28
Secondary	Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities	Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure [SBP] and diastolic blood pressure [DBP]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - < 100 mmHg, Grade 2 (moderate)- greater than or equal to (>=)100 mmHg to < 110 mmHg, Grade 3 (severe)- >=110 mmHg; DBP: Abnormally low- <=90 mmHg, Grade 1 (mild)- 140 mmHg - < 160 mmHg, Grade 2 (moderate)- >=160 mmHg to < 180 mmHg, Grade 3 (severe)- >=180 mmHg.	Up to Day 28
Secondary	Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities	The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval ([450 milliseconds {ms}, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]).	Up to Day 28
Secondary	Peripheral Capillary Oxygen Saturation (SpO2) Over Time	Peripheral capillary oxygen saturation was measured by the investigator over time.	Baseline, Days 3, 8, 14, and 21
Secondary	Change From Baseline in Peripheral Capillary Oxygen Saturation	Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.	Baseline to Days 3, 8, 14 and 21
Secondary	Pulse Rate Over Time	Pulse rate was measured by the investigator over time.	Baseline, Days 3, 8, 14 and 21
Secondary	Change From Baseline in Pulse Rate	Change from baseline in pulse rate was calculated and reported by the investigator.	Baseline to Days 3, 8, 14 and 21
Secondary	Respiratory Rate Over Time	Respiratory rate was measured by the investigator over time.	Baseline, Days 3, 8, 14 and 21
Secondary	Change From Baseline in Respiratory Rate	Change from baseline in respiratory rate was calculated and reported by the investigator.	Baseline to Days 3, 8, 14 and 21
Secondary	Body Temperature Over Time	Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.	Baseline, Days 3, 8, 14 and 21
Secondary	Change From Baseline in Body Temperature	Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.	Baseline to Days 3, 5, 8, 14 and 21
Secondary	Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose	AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.	0 to 24 hours post dose on Days 1 and 7
Secondary	Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire	The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.	Baseline, Days 3, 5, 8, 14 and 21
Secondary	Duration of Signs and Symptoms of RSV Assessed by RI-PRO	Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).	Baseline up to Day 21
Secondary	Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire	Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).	Up to Day 21
Secondary	Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire	Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.	Up to Day 21
Secondary	Predose Plasma Concentration (Ctrough) of JNJ-53718678	Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.	Predose on Days 1 and 7
Secondary	Maximum Plasma Concentration (Cmax) of JNJ-53718678	Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.	Days 1 and 7