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

January 31, 2025 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8001DDU
        • Hospital Interzonal General de Agudos Dr. Jose Penna
      • Bahia Blanca, Argentina, 8000
        • Hospital Espanol De Bahia Blanca
      • Barrio Parque Velez Sarfield, Argentina, X5016KEH
        • Hospital Privado - Centro Medico de Cordoba
      • Caba, Argentina, C1426ABP
        • Fundación Respirar
      • Ciudad De La Plata, Argentina, B1900AX
        • Hospital Italiano de La Plata
      • Ciudadela, Argentina, 1702
        • HIGA Prof. Dr. Ramón Carrillo
      • Cordoba, Argentina, X5004BAL
        • Hospital Italiano de Córdoba
      • Cordoba, Argentina, 5000
        • Hospital Rawson
      • Cordoba, Argentina, X5004CDT
        • Hospital Cordoba
      • General Roca, Argentina, 8332
        • Sanatorio Juan XXIII
      • Rosario, Argentina, S2000DEJ
        • Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
      • San Miguel de Tucuman, Argentina, T4000IHE
        • Clinica Mayo de UMCB
  • Australia
      • Blacktown, Australia, 2060
        • Paratus Clinical Blacktown Clinic
      • Geelong, Australia, 3220
        • Barwon Health - University Hospital Geelong
      • Kanwal, Australia, 2059
        • Paratus Clinical Kanwal Clinic
      • Kippa Ring, Australia, 4021
        • Paratus Clinical Kippa Ring Clinic
      • South Brisbane, Australia, 4101
        • Mater Hospital Brisbane
      • Sydney, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Bruxelles, Belgium, 1000
        • CHU Saint-Pierre
      • Ham, Belgium, 3945
        • Jaak Mortelmans
      • Massemen, Belgium, 9230
        • BVBA Dr. Luc Capiau
      • Tessenderlo, Belgium, 3980
        • Testumed
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte
      • Botucatu, Brazil, 18618-970
        • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
      • Florianopolis, Brazil, 88036-800
        • Universidade Federal de Santa Catarina
      • Natal, Brazil, 59025-050
        • Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
      • Passo Fundo, Brazil, 99010-080
        • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
      • Porto Alegre, Brazil, 90610-000
        • Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS
      • Salvador, Brazil, 40110-060
        • Universidade Federal da Bahia - Hospital Professor Edgard Santos
      • Sao Paulo, Brazil, 01421-000
        • Hospital Alemao Oswaldo Cruz
      • Sao Paulo, Brazil, 04231-030
        • Hospital Heliopolis
      • São Paulo, Brazil, 01308 901
        • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
        • MHAT 'Sv. Ivan Rilski' Kozloduy EOOD
      • Pernik, Bulgaria, 2000
        • Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
      • Ruse, Bulgaria, 7002
        • SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
      • Smolyan, Bulgaria, 4703
        • MHAT 'Dr. Bratan Shukerov'
      • Sofia, Bulgaria, 1431
        • Diagnostic Consultation Centre 'Alexandrovska' EOOD
      • Troyan, Bulgaria, 5600
        • Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Ltd
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr Anil K Gupta Medicine Professional Corporation
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Clinique Force Medic (GCP Trials)
  • France
      • Agen cedex 9, France, 47923
        • Centre Hospitalier d'Agen
      • Angers, France, 49000
        • Cabinet du Dr Remaud
      • Murs Erigne, France, 49610
        • Maison Medicale Rive Sud
      • Nantes, France, 44093
        • CHU Nantes - Hotel Dieu
      • Nantes, France, 44300
        • Cabinet du Dr Boye
      • Paris, France, 75020
        • Cabinet du Dr Baranes
  • Germany
      • Berlin, Germany, 12203
        • MECS GmbH
      • Frankfurt, Germany, 60596
        • IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
      • Hannover, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH
      • Luebeck, Germany, 23554
        • Hausarztpraxis am Lindenplatz
  • Japan
      • Fukui-shi, Japan, 910-0067
        • Fukui General Clinic
      • Kawasaki, Japan, 210-0852
        • Koukan Clinic
      • Kitakyusyu, Japan, 800-0057
        • Shinkomonji hospital
      • Koganei-Shi, Japan, 184-0004
        • Musashikoganei Clinic
      • Kumamoto-shi, Japan, 862-0976
        • Medical Square Kuhonji Clinic
      • Osaka, Japan, 598-8577
        • Rinku General Medical Center
      • Shinagawa-ku, Japan, 140-8522
        • Tokyo Shinagawa Hospital
      • Tokorozawa-shi, Japan, 359-1141
        • Saino Clinic
      • Toyota, Japan, 470-0396
        • Toyota Kosei Hospital
      • Yukuhashi, Japan, 824-0026
        • Shin Yukuhashi Hospital
  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Hospital
      • Incheon, Korea, Republic of, 22322
        • Inha University Hospital
      • Seoul, Korea, Republic of, 07441
        • KangNam Sacred Heart Hospital
      • Seoul, Korea, Republic of, 7061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Hospital Cardiologica Aguascalientes
      • Guadalajara, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Guadalajara, Mexico, 44130
        • Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
      • Mexico, Mexico, 03100
        • RM Pharma Specialists
      • Monterrey, Mexico, 64460
        • Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
  • Poland
      • Kielce, Poland, 25-751
        • Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis
      • Krakow, Poland, 30 033
        • Centrum Medyczne All Med
      • Krakow, Poland, 31 559
        • Diamond Clinic
      • Lodz, Poland, 90-141
        • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni
      • Ostrow Wielkopolski, Poland, 63-400
        • Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna
      • Wroclaw, Poland, 51-162
        • Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
  • Russian Federation
      • Krasnogorsk, Russian Federation, 143408
        • Krasnogorsk city hospital #1
      • Saint-Petersburg, Russian Federation, 196143
        • Eco-safety Ltd
      • Saint-Petersburg, Russian Federation, 193312
        • City Polyclinic #25 of the Nevsky District of SPB
      • Saint-Petersburg, Russian Federation, 194354
        • LLC 'Medical centr 'Reavita Med Spb'
      • St. Petersburg, Russian Federation, 197376
        • Research Institute of Influenza
  • South Africa
      • Johannesburg, South Africa, 1818
        • Soweto Clinical Trial Centre
      • Johannesburg, South Africa, 2001
        • Newtown Clinical Research
      • Pretoria, South Africa, 0002
        • Emmed Research
      • Welkom, South Africa, 9460
        • Welkom Clinical Trial Centre
  • Spain
      • Alicante, Spain, 3010
        • Hosp. Gral. Univ. de Alicante
      • Elche, Spain, 3203
        • Hosp. Gral. Univ. de Elche
      • Granada, Spain, 18014
        • Hosp. Univ. Virgen de Las Nieves
      • Madrid, Spain, 28006
        • Hosp. Univ. de La Princesa
      • Santiago de Compostela, Spain, 15706
        • Hosp. Clinico Univ. de Santiago
      • Vigo, Spain, 36213
        • Hosp. Alvaro Cunqueiro
  • Sweden
      • Malmö, Sweden, 20502
        • Skånes universitetssjukhus
      • Umeå, Sweden, 90185
        • Norrlands universitetssjukhus
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • New Taipei, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung City, Taiwan, 437
        • Kuang Tien General Hospital- Dajia
      • Taipei, Taiwan, 11696
        • Taipei Municipal Wanfang Hospital
      • Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
  • Ukraine
      • Kharkiv, Ukraine, 61103
        • Medical Center of LL Company 'Scientific Medical Center-Your Doctor'
      • Kharkiv, Ukraine, 61106
        • Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
      • Kherson, Ukraine, 73000
        • Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ukraine, 04050
        • Policlinic of State Joint Stock Holding Company 'Artem'
      • Vinnytsia, Ukraine, 21001
        • Private Small Enterprise Medical Center Pulse
      • Vinnytsya, Ukraine, 21009
        • Medical Center Ltd 'Health Clinic', Department Of General Therapy
      • Vinnytsya, Ukraine, 21021
        • Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University
  • United States
    • California
      • Cerritos, California, United States, 90703
        • Core Healthcare Group
      • Chula Vista, California, United States, 919111
        • eStudySite
      • Garden Grove, California, United States, 92844
        • SC Clinical Research Inc
    • Florida
      • Eustis, Florida, United States, 32726
        • Lake Internal Medicine Associates
      • Miami, Florida, United States, 33174
        • Florida Research Center Inc.
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Family Medicine
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • AllinaHealth - Abbott Northwestern Hospital (13520)
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Onsite Clinical Solutions
    • Oklahoma
      • Lindsay, Oklahoma, United States, 73052
        • Unity Clinical Research
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Spectrum Medical Research
      • Spartanburg, South Carolina, United States, 29301
        • Fusion Clinical Research of Spartanburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.
Drug: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
Experimental: Treatment B: JNJ-53718678 80 mg + Placebo
Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Drug: 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.
Drug: 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.
Placebo Comparator: Treatment C: Placebo
Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Time Frame: 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
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Time Frame: 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
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Time Frame: 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
Change From Baseline in RSV Viral Load at Day 3
Time Frame: 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.
Baseline to Day 3
Change From Baseline in RSV Viral Load at Day 5
Time Frame: 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.
Baseline to Day 5
Change From Baseline in RSV Viral Load at Day 8
Time Frame: 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.
Baseline to Day 8
Change From Baseline in RSV Viral Load at Day 14
Time Frame: 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.
Baseline to Day 14
Change From Baseline in RSV Viral Load at Day 21
Time Frame: 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.
Baseline to Day 21
RSV Viral Load at Baseline
Time Frame: Baseline
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Baseline
RSV Viral Load at Day 3
Time Frame: Day 3
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Day 3
RSV Viral Load at Day 5
Time Frame: Day 5
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Day 5
RSV Viral Load at Day 8
Time Frame: Day 8
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Day 8
RSV Viral Load at Day 14
Time Frame: Day 14
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Day 14
RSV Viral Load at Day 21
Time Frame: Day 21
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Day 21
Time to Undetectable RSV Viral Load
Time Frame: Up to Day 21
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Up to Day 21
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Time Frame: Day 3
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Day 3
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Time Frame: Day 5
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Day 5
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Time Frame: Day 8
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Day 8
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Time Frame: Day 14
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Day 14
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Time Frame: Day 21
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
Day 21

Secondary Outcome Measures

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108419
  • 2017-003252-24 (EudraCT Number)
  • 53718678RSV2004 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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