EDP-938 for Respiratory Syncytial Virus

(RSVHR Trial)

Recruiting at 88 trial locations

Overseen By Enanta Pharmaceuticals, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Enanta Pharmaceuticals, Inc

Must not be taking: Antivirals, Antibacterials

Disqualifiers: COPD, HIV, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an oral medication called EDP-938 for adults with RSV who are at high risk of severe illness. The goal is to help fight the virus or reduce its impact.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken certain antiviral, antibacterial, antifungal, or antimycobacterial medications within 7 days before joining. It's best to discuss your current medications with the trial team.

Who Is on the Research Team?

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Are You a Good Fit for This Trial?

Adults over 65 or those with heart failure, asthma, COPD at high risk for RSV complications can join. They must have recent respiratory symptoms and a positive RSV test. Participants need to use contraception if of childbearing potential. Exclusions include recent COVID-19 infection, severe lung function impairment, certain heart conditions, living in care facilities receiving acute respiratory management, imminent hospitalization need, recent systemic anti-infective therapy or active viral hepatitis/HIV.

Inclusion Criteria

I am 65 or older, or have CHF, asthma, or COPD.

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

Exclusion Criteria

I have had a lung infection, other than RSV, within the last week.

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

I have not taken any antiviral, antibacterial, antifungal, or antimycobacterial medication in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EDP-938 or placebo orally once daily

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDP-938
• Placebo

Trial Overview The trial is testing EDP-938 against a placebo in non-hospitalized adults with confirmed RSV who are at high risk for complications. It's a Phase 2b study where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting (double-blind).

How Is the Trial Designed?

Group I: EDP-938 Experimental Treatment 1 Intervention

EDP-938 800 mg, once daily

Group II: Placebo Placebo Group 1 Intervention

Matching placebo, once daily

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials

42

Recruited

3,200+