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

Enanta Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: EDP-235

Study type: Interventional

Funder types: Industry

Identifiers

NCT05616728

EDP 235-101

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 3 patient groups, including a placebo group

EDP-235 200mg

Experimental group

Description:

Once a day orally for 5 days

Treatment:

Drug: EDP-235

EDP-235 400mg

Experimental group

Description:

Once a day orally for 5 days

Treatment:

Drug: EDP-235

Placebo

Placebo Comparator group

Description:

Once a day orally for 5 days

Treatment:

Drug: Placebo