Respiratory Syncytial Virus MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: rilematovir
Product Code: JNJ-53718678
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rilematovir
Current Sponsor code: JNJ-53718678
Other descriptive name: rilematovir
Con
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 85 years of age. 2. Presentation to the healthcare facility with symptoms suggestive of a diagnosis of acute RSV infection and have at least any 2 symptoms of LRTD. 3. Tested positive for RSV infection using a molecular-based diagnostic assay or on a respiratory tract sample. 4. Participants must have at least one high-risk condition that predispose them to RSV-related disease progression. 5. Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms. 6. Not be hospitalized during screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. History of or concurrent disease or clinically significant findings during screening or medical history, physical examination, laboratory testing, vital signs, ECG recording, for which, in the opinion of the investigator, participation would not be in the best interest of the participant. 2. Any condition that could prevent, limit, or confound the protocol-specified assessments. 3. Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation. 4. Participants who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition or medical therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.;Secondary Objective: - To evaluate the effect of rilematovir as compared to placebo: 1) with respect to the incidence of post baseline RSV-related complications; 2) on medical resource utilization (MRU) with respect to respiratory therapeutic interventions associated with RSV-related disease progression; 3) on MRU with respect to medically attended visits associated with RSV-related disease progression; 4) on the overall RSV-related disease progression; 5) on the clinical course of RSV infection; 6) Health-Related Quality of Life; 7) on MRU. - To evaluate the: 1) safety and tolerability of rilematovir; 2) the antiviral effect of rilematovir as measured by RSV viral load in bilateral nasal mid-turbinate swab samples by quantitative reverse transcription polymerase chain reaction assay; 3) emergence of mutations in the viral genome potentially associated with resistance to rilematovir; 4) pharmacokinetics of rilematovir.;Primary end point(s): The time to resolution of RSV lower respiratory tract disease symptoms as assessed by using a Patient Reported Outcome Scale.;Timepoint(s) of evaluation of this end point: Initiation of study treatment up to Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: - Proportion of participants with post-baseline complications. - Safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), physical examination, and vital signs. - RSV viral load and change from baseline over time. - Evaluation of Medical resource utilization throughout the study period. - Pharmacokinetic parameters of rilematovir. ;Timepoint(s) of evaluation of this end point: Throughout the study at specified timepoints. | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed