This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

At least one of the following conditions that predispose them to complications after RSV infection:
Age ≥65 years
Congestive heart failure (CHF)
Asthma
Chronic obstructive pulmonary disease (COPD)
The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.
The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath
The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction \[PCR\] or other) on a nasal/nasopharyngeal swab sample.
A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Criterios de exclusión

The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF
The subject receives systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days prior to signing the Study ICF
The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF
The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF
The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%
The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.
The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation
The subject has immunocompromised status
The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility

Ubicaciones

Instituto Medico Platense

La Plata, Buenos Aires, Argentina

Centro de Investigaciones Medica Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Clinica Privada Independencia

Munro, Buenos Aires, Argentina

Consultorios Médicos Dr. Doreski

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Instituto Del Buen Aire

Santa Fe, Santa Fe Province, Argentina

Clinica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults With Acute Respiratory Syncytial Virus Infection Who Are at High Risk for Complications

Resumen