Respiratory Syncytial Virus MedDRA version: 20.0 Level: HLT Classification code 10038717 Term: Respiratory syncytial viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: JNJ-53718678
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: JNJ-53718678
Current Sponsor code: JNJ-53718678
Concentration unit: mg/ml milligram(s)/milli
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Male or female. 2. 18 to 75 years of age, inclusive. Subjects =13 and =65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator. 2. Requires supplemental oxygen at Screening or any time between Screening and randomization. 3. 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). 4. Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator. 5. Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients. 6. Bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of JNJ-53718678 on the development of RSV lower tract respiratory infections (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper respiratory tract infection (URTI).;Secondary Objective: To evaluate: 1. The effect of JNJ-53718678 on the development of RSV-associated lower respiratory tract complications (LRTC) in adult and adolescent HSCT recipients with RSV URTI. 2. The safety and tolerability of JNJ-53718678. 3. The impact of JNJ-53718678 on progression to respiratory failure and on all-cause mortality. 4. The impact of JNJ-53718678 on the clinical course of RSV infection. 5. The PK of JNJ-53718678. 6. The relationship between the PK of JNJ-53718678 and the PD after repeated dosing of JNJ-53718678. 7. The antiviral effect of JNJ-53718678 as measured by RSV viral load in bilateral mid-turbinate nasal swab samples by quantitative reverse transcription polymerase chain reaction (qRT PCR) assay. 8. The impact of RSV and its treatment on health-related quality of life (HRQOL). 9. The emergence of mutations in the viral genome potentially associated with resistance to JNJ-53718678.;Primary end point(s): The proportion of participants who develop RSV LRTI per the Endpoint Adjudication Committee (EAC)’s assessment through Visit Day 28. ;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of participants who develop RSV-associated LRTC per the EAC’s assessment through Visit Day 28. 2. Safety and tolerability, as assessed by AEs, clinical laboratory testing, ECGs, vital signs, throughout the study. 3. The proportion of participants progressing to respiratory failure and all-cause mortality. 4. Clinical course-related endpoints: -Number of supplemental O2 free days through Day 28 -Incidence of O2 requirement, total length and type (eg, supplemental oxygen, noninvasive pressure ventilation, invasive mechanical ventilation [tracheal tube, laryngeal mask, or tracheostomy]) -Respiratory rate, heart rate, body temperature, and peripheral capillary oxygen saturation (SpO2) over time as measured by the investigator during scheduled visits -Proportion of participants hospitalized (of participants who were not hospitalized at baseline), proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) -Total length of hospital stay (time in hospital before first dosing) and total time in the intensive care unit (ICU) (time in ICU before first dosing) -Incidence of Grade 3 and Grade 4 adverse events (AEs) in the Infections and Infestations System Organ Class -Incidence of respiratory and thoracic-related AEs -Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC’s assessment -Time to resolution of symptoms, assessed through an instrument for patient-reported symptoms (Respiratory Infection Intensity and Impact Questionnaire [RiiQ] Symptom Scale) -Change from baseline through Day 28 in severity of symptoms reported by subjects in the RiiQ Symptom Scale -Time to resolution of respiratory illness, through the Patient Global Impre | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International N.V.
Outcome results
None listed