A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
RSV Infection

Intervention / Treatment
-----------------
* Drug: EDP-938
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-938<br>EDP-938 800 mg, once daily | Drug: EDP-938<br>* Subjects will take EDP-938 once daily for 5 days<br>|
| Placebo Comparator: Placebo<br>Matching placebo, once daily | Drug: Placebo<br>* Subjects will take matching placebo, once daily for 5 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms |  | Day 1 through Day 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of LRTD symptoms and 2 systemic symptoms |  | Day 1 through Day 33 | 
| Time to resolution of all RSV symptoms |  | Day 1 through Day 33 | 
| Change from Baseline in severity of RSV LRTD symptoms |  | Day 1 through Day 33 | 
| Change from Baseline for impact scale |  | Day 1 through Day 33 | 
| Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms |  | Day 1 through Day 33 | 
| Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships |  | Day 1 through Day 33 | 
| Percentage of participants with post-baseline RSV-related complications |  | Day 1 through Day 33 | 
| Time to improvement in RSV disease |  | Day 1 through Day 33 | 
| Change from Baseline for Health-Related Quality of Life |  | Day 1 through Day 33 | 
| Time to return to usual health |  | Day 1 through Day 33 | 
| Time to return to usual activities |  | Day 1 through Day 33 | 
| Percentage of subjects requiring hospitalization for RSV or other causes; |  | Day 1 through Day 33 | 
| Duration of hospitalization for RSV or other causes |  | Day 1 through Day 33 | 
| All-cause mortality |  | Day 1 through Day 33 | 
| RSV RNA viral load change from Baseline |  | Days 3, 5, 9, and 14 | 
| Change in infectious RSV viral load over time |  | Up to Day 14 | 
| Plasma PK Concentrations of EDP-938 |  | Up to Day 5 | 
| Safety as measured by frequency of adverse events (AEs) |  | Up to Day 33 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Risk, Respiratory Syncytial Virus