Print

Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.