NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210527

Registered date:26/12/2021

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedRespiratory Syncytial Virus
Date of first enrollment08/04/2022
Target sample size180
Countries of recruitmentArgentina,Japan,Bulgaria,Japan,Canada,Japan,German,Japan,Spain,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,Sweden,Japan,Thailan,Japan,Ukraine,Japan,United States Of Americ,Japan,South Africa,Japan
Study typeInterventional
Intervention(s)Rilematovir:Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily(bid) for 7 days. Placebo:Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.

Outcome(s)

Primary OutcomeTime to Resolution of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ Symptom Scale):From initiation of study treatment up to Day 35:Time to resolution of RSV LRTD symptoms(that is, cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale. Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe.
Secondary Outcome-Percentage of Participants with Post-Baseline RSV-related Complications:From initiation of study treatment up toDay 35:Percentage of participants withpostbaseline RSV-related pulmonary andextrapulmonary complications will bereported. -Percentage of Participants with New Antibiotic Use, or New or Increased Use in Bronchodilator/Nebulizer, Systemic Corticosteroids, or Home Oxygen Supplementation:From initiation of study treatment up toDay 35:Percentage of participants with newantibiotic use, or new or increased use inbronchodilator/nebulizer, systemiccorticosteroids, or home oxygensupplementation will be reported. -Percentage of Participants with Unscheduled Outpatient Clinic Visits,Emergency Room Visits or Hospitalization for Respiratory Infection:From initiation of study treatment up to Day 35:Percentage of participants with unscheduled outpatient clinic visits,emergency room visits or hospitalization for respiratory infection will be reported. -Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance:From initiation of study treatment up to Day 35:Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary & extra pulmonary) and/or needing RSVrelated medical attendance will be reported. -Percentage of Participants with Adverse Events (AEs) as Measure of Safety and Tolerability:From initiation of study treatment up to Day 35:AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. -Percentage of Participants with Abnormalities in Clinical Laboratory Tests:From initiation of study treatment up to Day 35:Percentage of participants with abnormalities in clinical laboratory parameters (including hematology, chemistry and urinalysis) will be reported. -Percentage of Participants with Abnormalities in Electrocardiograms (ECGs):From initiation of study treatment up to Day 14:Percentage of participants with abnormalities in ECGs will be reported. -Percentage of Participants with Abnormalities in Physical Examination:From initiation of study treatment up to Day 35:Percentage of participants with abnormalities in physical examination will be reported. -Percentage of Participants with Abnormalities in Vital Signs:From initiation of study treatment up to Day 35:Percentage of participants with abnormalities in vital signs will be reported. -Change from Baseline Over Time in Severity of the RSV LRTD Symptoms as Assessed by the Participant Using the RiiQ Symptom Scale Score:Baseline up to Day 35:Change from baseline over time in severity of the RSV LRTD symptoms as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale. Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. -Time to Resolution of LRTD Symptoms and 2 Systemic symptoms as Assessed by RiiQ Symptom Scale Score:From initiation of study treatment up toDay 35:Time to resolution of LRTD symptoms and 2 systemic symptoms (feeling feverish and fatigue) as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale. Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild,2=Moderate, and 3=Severe. -Time to Resolution of the Overall RSV Symptoms (Upper Respiratory Tract Disease [URTD], LRTD, and 2 Systemic Symptoms) as Assessed by RiiQ Symptom Scale Score:From initiation of study treatment up to Day 35:Time to resolution of the overall RSV symptoms (URTD [sore throat and nasal congestion], LRTD, and 2 systemic symptoms [feeling feverish and fatigue]) as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale. Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. -Time to Resolution of all RSV Symptoms as Assessed by RiiQ Symptom Scale Score:From initiation of study treatment up to Day 35:Time to resolution of all RSV symptoms as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale and it can be scored as a mean of all scores (total symptom scale score) or 2 subscales scores that is respiratory symptoms and systemic symptoms. Respiratory symptoms subscale score is the mean of 6 symptoms, that is, 2 URTD symptoms (nasal congestion and sore throat) and 4 LRTD symptoms (cough, wheezing, shortness of breath, and coughing up phlegm/sputum) whereas systemic symptom subscale score is the mean of 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. -Time to Resolution of each Separate RSV LRTD Symptom as Assessed by RiiQ Symptom Scale Score:From initiation of study treatment up to Day 35:Time to resolution of each separate RSV LRTD symptom as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale. Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. -Time to Resolution of Respiratory Infection Symptoms as Assessed by Patient Global Impression of RSV Severity (PGI-S) Scale Score:From initiation of study treatment up to Day 35:Time to resolution of respiratory infection symptoms as assessed by PGI-S scale score will be reported. PGI-S is a single item patient-reported outcome (PRO)aimed to capture how severe the participants respiratory infection symptoms at their worst scored that day. PGI-S is a 5- point ordinal response scale ranging from no symptoms today (0), mild (1), moderate (2), severe (3), and very severe (4). -Time to Return to Pre-existing Health (Status) for all RSV Symptoms as Assessed by RiiQ Symptom Scale Score:From initiation of study treatment up to Day 35:Time to return to pre-existing health (status) for all RSV symptoms as assessed by RiiQ symptom scale score will be reported. RiiQ is a 4-point scale. Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. -Time to Improvement in RSV Disease as Assessed by Patient Global Impression of Change (PGI-C) Scale Score:From initiation of study treatment up to Day 35:Time to improvement in RSV disease as assessed by PGI-C scale will be reported.PGI-C is a single item patient-reported outcome (PRO) aimed to capture the participants perceptions of improvement or deterioration in the severity of RSV symptoms compared to before the participant started taking the study intervention. PGI-C is a 7-point ordinal response scale ranging from much better (3), somewhat better (2), a little better (1), about the same (0), a little worse (-1),somewhat worse (-2), and much worse (-3). -Change from Baseline Over Time for the Health-Related Quality of Life (HRQOL) as Assessed by 5 Level EuroQol 5 Dimension(EQ-5D-5L):Baseline up to Day 35:EQ-5D-5L includes 6 questions that provide a profile on 5 HRQOL domains: mobility,self-care, usual activities, pain/discomfort,and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3:moderate problems, Level 4: severe problems and Level 5: extreme problems. It also contains a visual analog scale (VAS)of `how good or bad is your health today` on a scale ranging from 0 (the best health you can imagine) to 100 (the worst health youcan imagine). Please see the attached file for the rest.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 85age old
GenderBoth
Include criteria- Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus(RSV) infection - Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least `moderate` if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms preexisted - Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction [PCR] or other) on a bilateral nasal mid-turbinate swab sample - Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a.age greater than or equal to (>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma - Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms - Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than [<] 24 hours are not considered as hospitalization)
Exclude criteria- Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation - Presence of clinically significant heart arrhythmias,uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia - Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection - Immunocompromised conditions - Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition

Related Information

Contact

Public contact
Name Medical Information Center
Address 3-5-2 Nishikanda Chiyoda-ku Tokyo Tokyo Japan 101-0065
Telephone +81-120-183-275
E-mail DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation Janssen Pharmaceutical K.K.
Scientific contact
Name Takahiro Nakama
Address 3-5-2 Nishikanda Chiyoda-ku Tokyo Tokyo Japan 101-0065
Telephone +81-120-183-275
E-mail DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation Janssen Pharmaceutical K.K.