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

Phase 2

Completed

Conditions: COVID-19

Interventions: Drug: Placebo
Drug: EDP-235

Registration Number: NCT05616728

Lead Sponsor: Enanta Pharmaceuticals, Inc

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 231

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Once a day orally for 5 days
EDP-235 200mg	EDP-235	Once a day orally for 5 days
EDP-235 400mg	EDP-235	Once a day orally for 5 days

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events as a Measure of Safety and Tolerability	Day 1 through Day 33

Secondary Outcome Measures

Name	Time	Method
Mean Plasma PK Concentrations of EDP-235	Day 1 through Day 5
Change From Baseline in SARS-CoV-2 RNA Viral Load	Day 3, Day 5, Day 9 and Day 14
Change From Baseline in Infectious SARS- CoV-2 Viral Load	Day 3, Day 5, Day 9 and Day 14
Proportion of Participants With Medically Attended Visits for COVID-19	Day 1 through Day 33
Proportion of Participants With COVID-19 Signs/Symptom Improvement	Day 1 through Day 33
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation	Day 1 through Day 33
Proportion of Participants All-cause Mortality	Day 1 through Day 33
Change From Baseline in COVID-19 Signs/Symptom	Day 1 through Day 33	The total score is computed as the sum across all 14 COVID-19 symptom severity scores for each visit. Total scores range from 0 to 42; higher scores indicate more severe symptoms. For symptom score, 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe for each symptom.
Proportion of Participants Requiring Hospitalization for COVID-19	Day 1 through Day 33

Trial Locations

Locations (23): County Emergency Hospital
🇷🇴
Cluj-Napoca, Cluj, Romania
D&H National Research Centers
🇺🇸
Miami, Florida, United States
USPA Advance Concept Medical Research Group. LLC
🇺🇸
Miami, Florida, United States
Toledo Institute of Clinical Research
🇺🇸
Toledo, Ohio, United States
LA Universal Research Center, Inc.
🇺🇸
Los Angeles, California, United States
Torrance Clinical Research Institute
🇺🇸
Lomita, California, United States
Encore Medical Research - Hollywood
🇺🇸
Hollywood, Florida, United States
Doral Medical Research
🇺🇸
Doral, Florida, United States
Advanced Research for Health Improvement, LLC
🇺🇸
Immokalee, Florida, United States
MedBio Trials - Miami
🇺🇸
Aventura, Florida, United States
Universal Medical and Research Center, LLC
🇺🇸
Hollywood, Florida, United States
LCC Medical Research - Miami - ClinEdge - PPDS
🇺🇸
Miami, Florida, United States
BioClinical Research Alliance
🇺🇸
Miami, Florida, United States
Continental Clinical Research, LLC
🇺🇸
Miami, Florida, United States
Dynamic Medical Research, LLC - Miami
🇺🇸
Miami, Florida, United States
Florida International Medical Research
🇺🇸
Miami, Florida, United States
Reed Medical Research
🇺🇸
Miami, Florida, United States
C'A Medical Center Inc Research
🇺🇸
Miami, Florida, United States
CDC Research Institute, LLC
🇺🇸
Port Saint Lucie, Florida, United States
Trio Clinical Trials LLC
🇺🇸
Houston, Texas, United States
Carolina Research Center
🇺🇸
Shelby, North Carolina, United States
Epic Medical Research
🇺🇸
Red Oak, Texas, United States
SMS Clinical Research, LLC
🇺🇸
Mesquite, Texas, United States