A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects

NCT04196101 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EDP 938-102
• Study Type: interventional
• Target: 82
• Locations: 7 countries
• Sites: 29

Brief Summary

This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.

Conditions

Respiratory Syncytial Virus

Keywords

RSV

Outcome Measures

Primary Outcomes (1)

• Total Symptom Score (TSS) Area Under the Curve (AUC)

  Assessed by the RSV Symptom Diary, including 13 items assessing the severity of RSV-related signs and symptoms. The diary uses a 4-point scale that consists of grading symptoms on a scale of 0 to 3 for each item, where Grade 0 is Absent, Grade 1 is Noticeable, Grade 2 is Bothersome but not preventing activity, and Grade 3 is Bothersome and interfering with activities. TSS is derived daily by summing of the 13 observed symptom grade values from Day 1 through Day 14 to generate the curve for analysis.

  Day 1 through Day 14

Secondary Outcomes (3)

• RSV RNA Viral Load Area Under the Curve (AUC)

  Day 1 through Day 14

• Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD)

  Days 3, 5, 9 and 14

• Number of Participants With Adverse Events

  Day 1 through Day 14

Study Arms (2)

EDP-938

EXPERIMENTAL

Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days

Drug: EDP-938

Placebo

PLACEBO COMPARATOR

Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days

Drug: Placebo

Interventions

EDP-938 DRUG

Four tablets daily for 5 days

EDP-938

Placebo DRUG

Four tablets daily for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent document must be signed and dated by the subject
• Male or female individuals aged 18 to 75 years, inclusive.
• Up to 48 hours of URTI symptoms with at least one of the following symptoms:
• Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, and/or symptoms of fever.
• Positive for RSV infection and negative for influenza virus based on rapid diagnostic.
• Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, and restrictions, as described in this protocol.

You may not qualify if:

• SARS-CoV-2 positive within 28 days of Screening or at Screening following signature of full ICF.
• Clinical evidence of a lower respiratory tract infection, as determined by the Investigator.
• Anticipated need for hospitalization or emergency room care within 24 hours of Screening.
• Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening and for the duration of the study
• Awareness of concomitant respiratory infections that are viral (other than RSV), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days of Screening.
• Frailty scale score ≥4 at Screening.
• Heart disease: any congenital heart disease, acute or chronic heart failure, ischemic heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation.
• Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy \[seizure disorders\], stroke, muscular dystrophy, or spinal cord injury).
• Malignant tumor or history of malignancy that may interfere with the aims of the study or a subject completing the study.
• Prior receipt or the subject is waiting to receive a bone marrow, stem cell, or solid organ transplantation.
• Diagnosis of cystic fibrosis.
• Known positive human immunodeficiency virus, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current or treated hepatitis C virus infection.
• Prior or planned ileal resection or bariatric surgery.
• Pregnant or nursing female subjects.
• History of alcohol addiction or current heavy alcohol use defined as: \>14 standard drinks per week and/or ≥4 standard drinks per occasion for males and \>7 standard drinks per week and/or ≥3 standard drinks per occasion for females. A standard drink is 12 oz of beer (5% alcohol), 5 oz table wine (12% alcohol), or 1.5 oz of spirits (40% alcohol).

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• PPD Development, LP: collaborator

Study Sites (29)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Cahaba Research Inc. - Birmingham

Pelham, Alabama, 35124, United States

Location

Saint Joseph's Clinical Research

Anaheim, California, 92804, United States

Location

Torrance Clinical Research Institute

Lomita, California, 90717, United States

Location

Miami Clinical Research - ClinEdge - PPDS

Miami, Florida, 33155, United States

Location

Pioneer Clinical Research LLC

Bellevue, Nebraska, 68005, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Clinical Research of South Nevada

Las Vegas, Nevada, 89121, United States

Location

Carolina Research Center

Shelby, North Carolina, 28150, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, 27103, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

Instituto Medico Platense

Buenos Aires, B1900AVG, Argentina

Location

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Medical Center Hera

Sofia, Sofia-Grad, 1510, Bulgaria

Location

Multiprofile Hospital for Active Treatment Puls

Blagoevgrad, 2700, Bulgaria

Location

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

Haskovo, 6300, Bulgaria

Location

Medical Center Zdrave-1 OOD

Kozloduy, 3320, Bulgaria

Location

Medical Center Tara OOD

Veliko Tarnovo, 5000, Bulgaria

Location

Lakeland Clinical Trials - Waikato

Hamilton, 3200, New Zealand

Location

Lakeland Clinical Trials

Rotorua, 3010, New Zealand

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota

Ostróda, 14-100, Poland

Location

Clinical Projects Research SA pty Ltd

Worcester, Western Cape, 6850, South Africa

Location

Communal Non-Profit Enterprise City Clinical Hospital #1 of Ivano-Frankivsk City Council

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014, Ukraine

Location

Municipal Enterprise The 1st City Clinical Hospital of Poltava City Council

Poltava, Poltava Oblast, 36039, Ukraine

Location

City Outpatient Clinic #9

Kyiv, 3035, Ukraine

Location

Medical Center of LLC Preventclinic

Kyiv, 3035, Ukraine

Location

Limited Liability Company Medical Center Consilium Medical

Kyiv, 4050, Ukraine

Location

MeSH Terms

Interventions

EDP-938

Results Point of Contact

• Title: Guy De La Rosa, MD Senior Director, Infectious Diseases
• Organization: Enanta Pharmaceuticals, Inc

gdelarosa@enanta.com

(617) 607-0800

Study Officials

• Scott Rottinghaus, MD

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 12, 2019
• Study Start: January 22, 2020
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: October 30, 2023
• Results First Posted: October 30, 2023

Record last verified: 2023-09

Locations

ZA (1); UA (5); US (12); BU (6); NZ (2); AR (1); PL (2)