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

Sponsor
Enanta Pharmaceuticals, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05616728
Collaborator
(none)
200
21
3
3.6
9.5
2.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 10, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety as measured by frequency of adverse events (AEs) [Day 1 through Day 33]

Secondary Outcome Measures

  1. Change from baseline in SARS-CoV-2 RNA viral load [Day 1 through Day 14]

  2. Change from baseline in infectious SARS- CoV-2 viral load [Day 1 through Day 14]

  3. Proportion of participants with COVID-19 signs/symptom improvement [Day 1 through Day 33]

  4. Change from baseline in COVID-19 signs/symptom [Day 1 through Day 33]

  5. Proportion of participants with medically attended visits for COVID-19 [Day 1 through Day 33]

  6. Proportion of participants requiring hospitalization for COVID-19 [Day 1 through Day 33]

  7. Proportion of participants all-cause mortality [Day 1 through Day 33]

  8. Proportion of participants who require hospitalization and mechanical ventilation [Day 1 through Day 33]

  9. Plasma PK Concentrations of EDP-235 [Day 1 through Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cahaba Research Inc. - Birmingham Birmingham Alabama United States 35242
2 Torrance Clinical Research Institute Lomita California United States 90717
3 LA Universal Research Center, Inc. Los Angeles California United States 90057
4 MedBio Trials - Miami Aventura Florida United States 33180
5 Doral Medical Research Doral Florida United States 33166
6 Universal Medical and Research Center, LLC Hollywood Florida United States 33021
7 Advanced Research for Health Improvement, LLC Immokalee Florida United States 34142
8 USPA Advance Concept Medical Research Group. LLC Miami Florida United States 33143
9 Continental Clinical Research, LLC Miami Florida United States 33144
10 Nuren Medical and Research Center Miami Florida United States 33144
11 US Associates in Research Inc Miami Florida United States 33144
12 D&H National Research Centers Miami Florida United States 33155
13 Florida International Medical Research Miami Florida United States 33155
14 Reed Medical Research Miami Florida United States 33176
15 IMIC Inc. Palmetto Bay Florida United States 33157
16 Carolina Research Center Shelby North Carolina United States 28150
17 Toledo Institute of Clinical Research Toledo Ohio United States 43617
18 Frontier Clinical Research, LLC Smithfield Pennsylvania United States 15478
19 SMS Clinical Research, LLC Mesquite Texas United States 75149
20 Epic Medical Research Red Oak Texas United States 75154
21 Progressive Clinical Research LLC Bountiful Utah United States 84010

Sponsors and Collaborators

  • Enanta Pharmaceuticals, Inc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT05616728
Other Study ID Numbers:
  • EDP 235-101
First Posted:
Nov 15, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enanta Pharmaceuticals, Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2022