A Study of Rilematovir in Adult patients with Respiratory Syncytial Virus (RSV) Infectio
- Conditions
- Health Condition 1: J989- Respiratory disorder, unspecified
- Registration Number
- CTRI/2022/01/039085
- Lead Sponsor
- Janssen Research Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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 molecularbased diagnostic assay
polymerase chain reaction PCR or other on a bilateral nasal midturbinate
swab sample
Has at least one of the following high risk conditions that predispose them to
RSVrelated disease progression a age greater than or equal 65 years
b congestive heart failure CHF c chronic obstructive pulmonary disease
COPD dasthma
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
- 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 participantexamination) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Resolution of Respiratory Syncytial <br/ ><br>Virus (RSV) Lower Respiratory Tract <br/ ><br>Disease (LRTD) Symptoms as Assessed <br/ ><br>by Respiratory Infection Intensity and <br/ ><br>Impact Questionnaire (RiiQ Symptom <br/ ><br>Scale)Timepoint: From initiation of study treatment up to Day <br/ ><br>35
- Secondary Outcome Measures
Name Time Method