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

Janssen Research Development LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•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 preexisted
•Tested positive for RSV infection using a molecularbased diagnostic assay
•polymerase chain reaction PCR or other on a bilateral nasal midturbinate
•swab sample
•Has at least one of the following high risk conditions that predispose them to
•RSVrelated disease progression a age greater than or equal 65 years
•b congestive heart failure CHF c chronic obstructive pulmonary disease
•COPD dasthma
•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

•- 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 participantexamination) 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

发起方