Resumen

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.

Descripción detallada

Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 \[depending on timing of first dose\]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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 pre-existed
Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction \[PCR\] or other) on a bilateral nasal mid-turbinate swab sample
Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a. age greater than or equal to (\>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma
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)

Criterios de exclusión

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 participant examination) 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

Ubicaciones

INAER - Investigación en Alergias y Enfermedades Respiratorias

Buenos Aires, Argentina

Centro Respiratorio Quilmes

Quilmes, Argentina

Centro Medico Respire

San Fernando, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

Clinica Mayo de UMCB