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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616728
• Other study ID #: EDP 235-101
• Status: Recruiting
• Phase: Phase 2
• Start date: November 10, 2022
• Est. completion date: March 2023

Study information

• Verified date: November 2022
• Source: Enanta Pharmaceuticals, Inc
• Contact: Guy De La Rosa, MD
• Phone: (617) 607-0800
• Email: gdelarosa[@]enanta.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• EDP-235
capsule
• Placebo
capsule

Locations

Country	Name	City	State
United States	MedBio Trials - Miami	Aventura	Florida
United States	Cahaba Research Inc. - Birmingham	Birmingham	Alabama
United States	Progressive Clinical Research LLC	Bountiful	Utah
United States	Doral Medical Research	Doral	Florida
United States	Universal Medical and Research Center, LLC	Hollywood	Florida
United States	Advanced Research for Health Improvement, LLC	Immokalee	Florida
United States	Torrance Clinical Research Institute	Lomita	California
United States	LA Universal Research Center, Inc.	Los Angeles	California
United States	SMS Clinical Research, LLC	Mesquite	Texas
United States	Continental Clinical Research, LLC	Miami	Florida
United States	D&H National Research Centers	Miami	Florida
United States	Florida International Medical Research	Miami	Florida
United States	Nuren Medical and Research Center	Miami	Florida
United States	Reed Medical Research	Miami	Florida
United States	US Associates in Research Inc	Miami	Florida
United States	USPA Advance Concept Medical Research Group. LLC	Miami	Florida
United States	IMIC Inc.	Palmetto Bay	Florida
United States	Epic Medical Research	Red Oak	Texas
United States	Carolina Research Center	Shelby	North Carolina
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Toledo Institute of Clinical Research	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by frequency of adverse events (AEs)		Day 1 through Day 33
Secondary	Change from baseline in SARS-CoV-2 RNA viral load		Day 1 through Day 14
Secondary	Change from baseline in infectious SARS- CoV-2 viral load		Day 1 through Day 14
Secondary	Proportion of participants with COVID-19 signs/symptom improvement		Day 1 through Day 33
Secondary	Change from baseline in COVID-19 signs/symptom		Day 1 through Day 33
Secondary	Proportion of participants with medically attended visits for COVID-19		Day 1 through Day 33
Secondary	Proportion of participants requiring hospitalization for COVID-19		Day 1 through Day 33
Secondary	Proportion of participants all-cause mortality		Day 1 through Day 33
Secondary	Proportion of participants who require hospitalization and mechanical ventilation		Day 1 through Day 33
Secondary	Plasma PK Concentrations of EDP-235		Day 1 through Day 5