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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enanta Pharmaceuticals, Inc

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