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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EDP-235
Placebo
Sponsored by
Enanta Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Standard Risk

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Cahaba Research Inc. - BirminghamRecruiting
  • Torrance Clinical Research Institute
  • LA Universal Research Center, Inc.Recruiting
  • MedBio Trials - MiamiRecruiting
  • Doral Medical ResearchRecruiting
  • Universal Medical and Research Center, LLCRecruiting
  • Advanced Research for Health Improvement, LLCRecruiting
  • USPA Advance Concept Medical Research Group. LLCRecruiting
  • Continental Clinical Research, LLCRecruiting
  • Nuren Medical and Research CenterRecruiting
  • US Associates in Research IncRecruiting
  • D&H National Research CentersRecruiting
  • Florida International Medical ResearchRecruiting
  • Reed Medical ResearchRecruiting
  • IMIC Inc.Recruiting
  • Carolina Research CenterRecruiting
  • Toledo Institute of Clinical ResearchRecruiting
  • Frontier Clinical Research, LLC
  • SMS Clinical Research, LLCRecruiting
  • Epic Medical ResearchRecruiting
  • Progressive Clinical Research LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EDP-235 200mg

EDP-235 400mg

Placebo

Arm Description

Once a day orally for 5 days

Once a day orally for 5 days

Once a day orally for 5 days

Outcomes

Primary Outcome Measures

Safety as measured by frequency of adverse events (AEs)

Secondary Outcome Measures

Change from baseline in SARS-CoV-2 RNA viral load
Change from baseline in infectious SARS- CoV-2 viral load
Proportion of participants with COVID-19 signs/symptom improvement
Change from baseline in COVID-19 signs/symptom
Proportion of participants with medically attended visits for COVID-19
Proportion of participants requiring hospitalization for COVID-19
Proportion of participants all-cause mortality
Proportion of participants who require hospitalization and mechanical ventilation
Plasma PK Concentrations of EDP-235

Full Information

First Posted
November 9, 2022
Last Updated
December 6, 2022
Sponsor
Enanta Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05616728
Brief Title
A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
Acronym
SPRINT
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Standard Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EDP-235 200mg
Arm Type
Experimental
Arm Description
Once a day orally for 5 days
Arm Title
EDP-235 400mg
Arm Type
Experimental
Arm Description
Once a day orally for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once a day orally for 5 days
Intervention Type
Drug
Intervention Name(s)
EDP-235
Intervention Description
capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsule
Primary Outcome Measure Information:
Title
Safety as measured by frequency of adverse events (AEs)
Time Frame
Day 1 through Day 33
Secondary Outcome Measure Information:
Title
Change from baseline in SARS-CoV-2 RNA viral load
Time Frame
Day 1 through Day 14
Title
Change from baseline in infectious SARS- CoV-2 viral load
Time Frame
Day 1 through Day 14
Title
Proportion of participants with COVID-19 signs/symptom improvement
Time Frame
Day 1 through Day 33
Title
Change from baseline in COVID-19 signs/symptom
Time Frame
Day 1 through Day 33
Title
Proportion of participants with medically attended visits for COVID-19
Time Frame
Day 1 through Day 33
Title
Proportion of participants requiring hospitalization for COVID-19
Time Frame
Day 1 through Day 33
Title
Proportion of participants all-cause mortality
Time Frame
Day 1 through Day 33
Title
Proportion of participants who require hospitalization and mechanical ventilation
Time Frame
Day 1 through Day 33
Title
Plasma PK Concentrations of EDP-235
Time Frame
Day 1 through Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy De La Rosa, MD
Phone
(617) 607-0800
Email
gdelarosa@enanta.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals, Inc
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Research Inc. - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance Clinical Research Institute
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
LA Universal Research Center, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
MedBio Trials - Miami
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Doral Medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Universal Medical and Research Center, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research for Health Improvement, LLC
City
Immokalee
State/Province
Florida
ZIP/Postal Code
34142
Country
United States
Individual Site Status
Recruiting
Facility Name
USPA Advance Concept Medical Research Group. LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
Continental Clinical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Nuren Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
US Associates in Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H National Research Centers
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida International Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Reed Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
IMIC Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research Center
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Toledo Institute of Clinical Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Clinical Research LLC
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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