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

Purpose

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

Condition

  • COVID-19

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EDP-235 200mg 		Once a day orally for 5 days
  • Drug: EDP-235
    capsule
Experimental
EDP-235 400mg 		Once a day orally for 5 days
  • Drug: EDP-235
    capsule
Placebo Comparator
Placebo 		Once a day orally for 5 days
  • Drug: Placebo
    capsule

Recruiting Locations

More Details

NCT ID
NCT05616728
Status
Completed
Sponsor
Enanta Pharmaceuticals, Inc