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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: EDP-235; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 2

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400347
      • County Emergency Hospital
• United States
  • California
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center, Inc.
  • Florida
    • Aventura, Florida, United States, 33180
      • MedBio Trials - Miami
    • Doral, Florida, United States, 33166
      • Doral Medical Research
    • Hollywood, Florida, United States, 33021-6467
      • Encore Medical Research - Hollywood
    • Hollywood, Florida, United States, 33021
      • Universal Medical and Research Center, LLC
    • Immokalee, Florida, United States, 34142
      • Advanced Research for Health Improvement, LLC
    • Miami, Florida, United States, 33176
      • Reed Medical Research
    • Miami, Florida, United States, 33155
      • Florida International Medical Research
    • Miami, Florida, United States, 33155
      • D&H National Research Centers
    • Miami, Florida, United States, 33144
      • Continental Clinical Research, LLC
    • Miami, Florida, United States, 33126-1921
      • LCC Medical Research - Miami - ClinEdge - PPDS
    • Miami, Florida, United States, 33143
      • USPA Advance Concept Medical Research Group. LLC
    • Miami, Florida, United States, 33144
      • Dynamic Medical Research, LLC - Miami
    • Miami, Florida, United States, 33155-6542
      • Bioclinical Research Alliance
    • Miami, Florida, United States, 33174-2968
      • C'A Medical Center Inc Research
    • Port Saint Lucie, Florida, United States, 34952-7536
      • CDC Research Institute, LLC
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Carolina Research Center
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Toledo Institute of Clinical Research
  • Texas
    • Houston, Texas, United States, 77008-1393
      • Trio Clinical Trials LLC
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research, LLC
    • Red Oak, Texas, United States, 75154
      • Epic Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events as a Measure of Safety and Tolerability	Day 1 through Day 33

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 COVID-19 Signs/Symptom Improvement		Day 1 through Day 33
Change From Baseline in COVID-19 Signs/Symptom	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.	Day 1 through Day 33
Proportion of Participants With Medically Attended Visits for COVID-19		Day 1 through Day 33
Proportion of Participants Requiring Hospitalization for COVID-19		Day 1 through Day 33
Proportion of Participants All-cause Mortality		Day 1 through Day 33
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation		Day 1 through Day 33
Mean Plasma PK Concentrations of EDP-235		Day 1 through Day 5

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2, Standard Risk
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EDP 235-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No