Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV) (FREESIA)

January 31, 2025 updated by: Janssen Sciences Ireland UC

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

Study Overview

Status

Status

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

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

RSV is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. Immunocompromised (IC) participants have a reduced ability to combat infection due to an impaired or weakened immune system. Within the IC population, HSCT recipients are generally regarded as having a particularly high risk for more severe disease caused by RSV, representing a substantial unmet need for antiviral treatment of RSV infections in this participant population. JNJ-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (RSV)-specific fusion inhibitor. The study will include a Screening Period (Day -2 to Day 1), a Treatment Period (Day 1 to Day 21), and a Follow-up Period (1 year). Assessments like chest X-ray, pulse/heart rate, respiratory rate, electrocardiogram (ECG), etc will be performed. Safety and efficacy will be assessed through the study. The total study duration for each participant will be approximately 49 days.

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.
3

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

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

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, 8000
        • Hospital Espanol De Bahia Blanca
      • Ciudad De La Plata, Argentina, B1900AX
        • Hospital Italiano de La Plata
      • Cordoba, Argentina, X5000JHQ
        • Sanatorio Allende
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado-Universitario de Cordoba
      • San Miguel de Tucuman, Argentina, T4000IHE
        • Clinica Mayo de UMCB
  • Australia
      • Melbourne, Australia, 3000
        • Peter MacCallum Cancer Centre
      • Melbourne, Australia, 3050
        • Royal Melbourne Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1000
        • Jules Bordet Institute
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liege, Belgium, 4000
        • CHU de Liege
      • Limburg, Belgium, 3500
        • Jessa Ziekenhuis
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundacao Pio XII
      • Belo Horizonte, Brazil, 30130-100
        • Universidade Federal De Minas Gerais - Hospital das Clínicas
      • Florianopolis, Brazil, 88034-000
        • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
      • Fortaleza, Brazil, 60430-380
        • Universidade Federal do Ceara Hospital Universitario Walter Cantidio
      • Jau, Brazil, 17210 080
        • Fundacao Doutor Amaral Carvalho
      • Porto Alegre, Brazil, 90035-003
        • Hospital das Clinicas de Porto Alegre
      • Sao Jose do Rio Preto, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
      • Sao Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia
      • Sao Paulo, Brazil, 01508-010
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brazil, 01308 901
        • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT 'Sveti Georgi'-Plovdiv
      • Sofia, Bulgaria, 1756
        • Specialized Hospital for Active Treatment of Haematologic Diseases
      • Varna, Bulgaria, 9010
        • Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
  • France
      • Clamart, France, 92190
        • Hôpital d'instruction des armées Percy
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer Toulouse - Oncopole
  • Israel
      • Haifa, Israel, 3525408
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Ramat Gan, Israel, 5266202
        • Sheba medical center
      • Tel Aviv, Israel, 64239
        • Sourasky (Ichilov) Medical Center
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
      • Roma, Italy, 168
        • Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
  • Japan
      • Akita, Japan, 010-8543
        • Akita University Hospital
      • Chiba, Japan, 260 8677
        • Chiba University Hospital
      • Isehara, Japan, 259-1193
        • Tokai University Hospital
      • Nagano, Japan, 380-8582
        • Japanese Red Cross Society Nagano Hospital
      • Okayama, Japan, 700 8558
        • Okayama University Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
  • Malaysia
      • Ampang Jaya, Malaysia, 68000
        • Hospital Ampang
      • Georgetown, Malaysia, 10190
        • Penang General Hospital
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Petaling Jaya, Malaysia, 47500
        • Sunway Medical Centre
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
  • Spain
      • Barcelona, Spain, 8041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Sevilla, Spain, 41013
        • Hosp. Virgen Del Rocio
  • Sweden
      • Malmö, Sweden, 20502
        • Skånes universitetssjukhus
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Trust
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital - Hematology/oncology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health Cancer Institute
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott and White Research Institute
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center - University of Texas

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

13 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen
  • Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)
  • Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization
  • New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing
  • Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent (%) on room air

Exclusion Criteria:

  • Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator
  • Requires supplemental oxygen at Screening or any time between Screening and randomization
  • Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required)
  • Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined 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: Adult cohort: JNJ-53718678 or Placebo
Participants greater than or equal to (>=) 18 to less than or equal to (<=) 75 years of age will receive 250 milligram (mg) JNJ-53718678 twice daily (bid) for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg once daily (qd) for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.
Drug: Placebo
Matching placebo will be administered orally.
Drug: JNJ-53718678 250 mg
JNJ-53718678 250 mg will be administered orally.
Drug: JNJ-53718678 125 mg
JNJ-53718678 125 mg will be administered orally.
Experimental: Adolescent cohort: JNJ-53718678 or Placebo
Participants >=13 to <18 years of age will receive 250 mg JNJ-53718678 bid for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg qd for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.
Drug: Placebo
Matching placebo will be administered orally.
Drug: JNJ-53718678 250 mg
JNJ-53718678 250 mg will be administered orally.
Drug: JNJ-53718678 125 mg
JNJ-53718678 125 mg will be administered orally.

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
Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
Time Frame: Up to Day 28
Percentage of participants who developed RSV LRTI was assessed. RSV LRTI was defined as the development of a lower respiratory sign or symptom (including decrease in oxygen saturation or increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, worsening cough) and positive RSV test from lower respiratory tract sample (example [eg], sputum, induced sputum, bronchoalveolar lavage (BAL), lung biopsy, or autopsy specimen) within +-4 days of a new chest image finding, compared to baseline, consistent with a LRTI; OR positive RSV test from lower respiratory tract sample (eg, sputum, induced sputum, BAL, lung biopsy, or autopsy specimen) only; OR positive RSV test from upper respiratory tract sample within ±4 days of a new chest image finding, compared to baseline, consistent with a RSV LRTI as determined by the Endpoint Adjudication Committee (EAC).
Up to Day 28

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
Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
Time Frame: Up to Day 28
Percentage of participants who developed RSV-associated LRTC was assessed. RSV-associated LRTC defined as development of lower respiratory sign/symptom (includes decrease in oxygen saturation/increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, and worsening cough) and met 1 of following subcategories determined by EAC: a) RSV LRTI, b) secondary bacterial LRTI (positive specimen for clinically significant bacterium within 4 days of new chest image finding, compared to baseline, consistent with LRTI), c) secondary LRTI due to unusual pathogens (positive specimen for clinically significant unusual organism within 4 days of new chest image finding, compared to baseline, consistent with LRTI), d) secondary LRTC of unknown etiology (new chest image finding than baseline, consistent with LRTI, inflammatory process/ some other clinically significant pulmonary process which were absent within 4 days of new chest image finding).
Up to Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Day 49
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the intervention. Any AE which occurred post first dose administration of study drug up to the end of study (EOS) (that is, Day 49) was considered as treatment-emergent.
Up to Day 49
Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
Time Frame: Up to Day 49
Percentage of participants with greater than or equal to (>=) Grade 3 treatment-emergent laboratory abnormalities (platelet count decreased, glucose increase) was assessed in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to end of study (that is, Day 49).
Up to Day 49
Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
Time Frame: Up to Day 49
Percentage of participants with clinically significant abnormalities in ECG findings was assessed in this outcome measure. Various ECG variables assessed were heart rate: abnormally low (<= 45 beats per minute [bpm]), abnormally high (>= 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec), QT interval and corrected QT (QTcF; according to Fridericia's formula) interval (>450 msec, >480 msec, or >500 msec, increases from baseline >30 msec or >60 msec.)
Up to Day 49
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Time Frame: Up to Day 49
Percentage of participants with abnormal vital signs findings was assessed. Abnormal vital parameters included pulse rate: abnormally low <=45 bpm, abnormally high >=120 bpm; Systolic Blood Pressure (SBP): abnormally low <=90 Millimeter of mercury (mmHg), Grade 1 (mild): > 90 mmHg - < 100 mmHg, Grade 2 (moderate): >= 100 mmHg to <110 mmHg, Grade 3 (severe): >=110 mmHg; Diastolic BP: abnormally low <=50 mmHg, Grade 1: >90 mmHg to <100 mmHg, Grade 2: >=100 mmHg to <110 mmHg, Grade 3: >=110 mmHg; Respiratory rate- Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): >25 breaths per minute, Grade 4 (potentially life threatening): intubation; Temperature: abnormally high >38.0 degree celsius. Vital signs abnormalities reported for at least 1 participant were reported in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to EOS (that is, Day 49).
Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Time Frame: Up to Day 49
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
Time Frame: Up to Day 49
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death (all-cause mortality) was assessed.
Up to Day 49
Percentage of Participants Who Progressed to Death (All-cause Mortality) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Time Frame: Up to Day 49
Percentage of participants who progressed to death (all-cause mortality) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Up to Day 49
Percentage of Participants Who Progressed to Death (All-cause Mortality)
Time Frame: Up to Day 49
Percentage of participants who progressed to death (all-cause mortality) was assessed.
Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment
Time Frame: Up to Day 49
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Up to Day 49
Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
Time Frame: Up to Day 49
Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.
Up to Day 49
Number of Supplemental Oxygen Free Days
Time Frame: Through Day 28
Number of supplemental oxygen free days was assessed. The number of supplemental oxygen free days was the number of days the participants did not receive/require supplemental oxygen during the first 28 days post treatment.
Through Day 28
Percentage of Participants With Treatment-emergent Oxygen Supplementation
Time Frame: Up to Day 49
Percentage of participants who required treatment-emergent oxygen supplementation (e.g., supplemental oxygen, noninvasive pressure ventilation, invasive mechanical ventilation [tracheal tube, laryngeal mask or tracheostomy]). Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.
Up to Day 49
Respiratory Rate Over Time
Time Frame: Baseline (Day 1), Days 15, 28, and 35
Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Baseline (Day 1), Days 15, 28, and 35
Heart Rate Over Time
Time Frame: Baseline (Day 1), Days 15, 28, and 35
Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Baseline (Day 1), Days 15, 28, and 35
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Time Frame: Baseline (Day 1), Days 15, 28, and 35
Peripheral capillary oxygen saturation (SpO2) over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
Baseline (Day 1), Days 15, 28, and 35
Body Temperature Over Time
Time Frame: Baseline (Day 1), Days 15, 28, and 35
Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
Baseline (Day 1), Days 15, 28, and 35
Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
Time Frame: Up to Day 49
Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.
Up to Day 49
Percentage of Participants Who Were Re-hospitalized
Time Frame: Up to Day 49
Percentage of participants who were re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline and required hospitalization and were discharged during the study) was assessed in this outcome measure.
Up to Day 49
Duration of Hospital Stay
Time Frame: Up to Day 49
Duration (in days) of hospital stay was assessed.
Up to Day 49
Duration of Intensive Care Unit (ICU) Stay
Time Frame: Up to Day 49
Duration of ICU stay was assessed. Duration (in hours) was defined as total number of hours a participant was in ICU from first dose of study drug until study termination.
Up to Day 49
Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
Time Frame: Up to Day 49
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily had a causal relationship with the intervention. Participants with Grade 3 or Grade 4 TEAE were assessed in this outcome measure. Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.
Up to Day 49
Number of Participants With Respiratory Related AEs
Time Frame: Up to Day 49
Number of participants with respiratory related AEs (respiratory infections) was assessed.
Up to Day 49
Number of Participants With Thoracic-related AEs
Time Frame: Up to Day 49
Number of participants with thoracic-related AEs was assessed.
Up to Day 49
Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
Time Frame: Up to Day 49
Number of participants with antibiotic use among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.
Up to Day 49
Plasma Concentration of JNJ-53718678
Time Frame: Days 1, 3, 8, 15 and 22
Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
Days 1, 3, 8, 15 and 22
RSV Viral Load Over Time
Time Frame: Baseline (Day 1), Days 15, 28, and 35
RSV viral load (RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints in which individual participant had data were reported.
Baseline (Day 1), Days 15, 28, and 35

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 Sciences Ireland UC

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 Sciences Ireland UC Clinical Trial, Janssen Sciences Ireland UC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
December 26, 2019

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.
February 4, 2022

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.
February 4, 2022

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).
August 13, 2019

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.
August 13, 2019

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.
August 14, 2019

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

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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.
  • CR108662
  • 53718678RSV2005 (Other Identifier: Janssen Sciences Ireland UC)
  • 2019-001551-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

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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