Effects of Rilematovir in Adult Outpatients with RSV Infection who are at High Risk for RSV-related Disease Progressio

Phase 1

• Conditions: Respiratory Syncytial Virus; MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005980-30-HU
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified