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: 20.0Level: HLTClassification code 10038717Term: Respiratory syncytial viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005980-30-IT
• Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-27
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• 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.

Please refer to the Study Protocol for a full list of inclusion criteria.
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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.

Please refer to the Study Protocol for a full list of exclusion criteria.

Study & Design

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