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The trial is taking place at:
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Epic Medical Research | Red Oak, TX

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

Enanta Pharmaceuticals logo

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

Trial contacts and locations

21

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Central trial contact

Guy De La Rosa, MD

Data sourced from clinicaltrials.gov

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