A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection who are at High Risk for RSV-related Disease Progression - PRIMROSE

Janssen-Cilag International NV0 个研究点目标入组 180 人开始时间: 2021年7月8日最近更新: 2022年5月16日

试验速览

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•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

•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.

发起方