A Study of EDP-938 in Non-hospitalized Adults with RSV Who Are At High Risk for Complications. (RSVHR)

Enanta Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: RSV Infection

Treatments: Drug: Placebo; Drug: EDP-938

Study type: Interventional

Funder types: Industry

Identifiers

NCT05568706

EDP 938-104

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least one of the following conditions that predispose them to complications after RSV infection:

  1. Age ≥65 years
  2. Congestive heart failure (CHF)
  3. Asthma
  4. 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

EDP-938

Experimental group

Description:

EDP-938 800 mg, once daily

Treatment:

Drug: EDP-938

Placebo

Placebo Comparator group

Description:

Matching placebo, once daily

Treatment:

Drug: Placebo