A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
(PRIMROSE Trial)
Recruiting in Palo Alto (17 mi)
+147 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Janssen Research & Development, LLC
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
JR
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
Inclusion Criteria
Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (RSV) infection
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)
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
See 3 more
Treatment Details
Interventions
- Rilematovir (Virus Therapy)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment A: RilematovirExperimental Treatment1 Intervention
Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days.
Group II: Treatment B: PlaceboPlacebo Group1 Intervention
Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires