Overview

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

Status:
Not yet recruiting
Trial end date:
2023-12-21
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
Inclusion 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 pre-existed

- 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)

Exclusion 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