A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19

Study Overview
=================
Brief Summary
-----------------
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: EDP-235
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening Exclusion Criteria: Prior SARS-CoV-2 infection <90 days before enrollment and/or received any COVID-19 vaccine dose <90 days before enrollment Has one or more conditions associated with high risk for severe COVID-19 History of hospitalization for the medical treatment of COVID-19 Currently hospitalized or anticipated need for hospitalization in the clinical opinion of the investigator Known medical history of active liver disease Receiving dialysis or have known moderate to severe renal impairment Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug Any comorbidity requiring hospitalization and/or surgery within 7 days before study entry, or that is considered life threatening within 30 days before study entry Known HIV infection with a HIV viral load greater than 400 copies/mL or medication for HIV treatment that is prohibited in this study based on medical history within 6 months before the screening visit History of hypersensitivity or other contraindication to any of the components of the study drug Has received or is expected to receive pre-exposure prophylactic SARS-CoV-2 mAb Has received or is expected to receive convalescent COVID-19 plasma Oxygen saturation of ≤93% on room air obtained at rest within 24 hours before randomization Participating in another interventional clinical study with an investigational agent or device, including those for COVID-19, within 30 days or five half-lives of the agent, whichever is longer, before signing the ICF Females who are pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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-235 200mg<br>Once a day orally for 5 days | Drug: EDP-235<br>* capsule<br>|
| Experimental: EDP-235 400mg<br>Once a day orally for 5 days | Drug: EDP-235<br>* capsule<br>|
| Placebo Comparator: Placebo<br>Once a day orally for 5 days | Drug: Placebo<br>* capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by frequency of adverse events (AEs) |  | Day 1 through Day 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in SARS-CoV-2 RNA viral load |  | Day 1 through Day 14 | 
| Change from baseline in infectious SARS- CoV-2 viral load |  | Day 1 through Day 14 | 
| Proportion of participants with COVID-19 signs/symptom improvement |  | Day 1 through Day 33 | 
| Change from baseline in COVID-19 signs/symptom |  | Day 1 through Day 33 | 
| Proportion of participants with medically attended visits for COVID-19 |  | Day 1 through Day 33 | 
| Proportion of participants requiring hospitalization for COVID-19 |  | Day 1 through Day 33 | 
| Proportion of participants all-cause mortality |  | Day 1 through Day 33 | 
| Proportion of participants who require hospitalization and mechanical ventilation |  | Day 1 through Day 33 | 
| Plasma PK Concentrations of EDP-235 |  | Day 1 through Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Standard Risk