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

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus

In brief

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.

Key facts

Study ID

NCT04196101

Run by

Enanta Pharmaceuticals, Inc

People needed

82

Starts

2020-01-22

Expected to finish

2022-01-04

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• History of chronic liver disease (eg, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, autoimmune hepatitis, nonalcoholic steatohepatitis, and/or alcoholic liver disease); a history of biliary disease (eg, primary sclerosing cholangitis, cholecystitis, choledocholithiasis); or a history of portal hypertension. A diagnosis of hepatic steatosis (fatty liver) is not exclusionary.
• 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).
• Known or suspected, in the opinion of the Investigator, renal disease or renal impairment.
• Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged by the Investigator at Screening.
• Use of or intention to use excluded or contraindicated medication(s) or supplements, including any medication known to be a moderate or potent inducer or inhibitor of the cytochrome P450 3A4 enzyme, within 14 days prior to Screening and for the duration of the study.
• Receipt of ≥14 days of systemic immunomodulator therapy (eg, oral corticosteroids) within 3 months of Screening.
• Prior to the first dose of study drug and during study participation, the subject has received any vaccine, investigational agent, or biological product within 30 days or 5 times the half-life, whichever is longer. Note: Influenza vaccination within 7 days of Screening is allowed.
• Use of St John's wort within 28 days prior to the first dose of study drug and for the duration of the study.
• History of or currently experiencing a medical condition or any other finding (including laboratory test results) that, in the opinion of the Investigator, might confound the results of the study; pose an additional risk in administering study drug to the subject; could prevent, limit, or confound the protocol-specified assessments; or deems the subject unsuitable for the study.

Where it is running

• Central Alabama Research — Birmingham, Alabama, United States
• Cahaba Research Inc. - Birmingham — Pelham, Alabama, United States
• Saint Joseph's Clinical Research — Anaheim, California, United States
• Torrance Clinical Research Institute — Lomita, California, United States
• Miami Clinical Research - ClinEdge - PPDS — Miami, Florida, United States
• Pioneer Clinical Research LLC — Bellevue, Nebraska, United States
• Meridian Clinical Research — Norfolk, Nebraska, United States
• Clinical Research of South Nevada — Las Vegas, Nevada, United States
• Carolina Research Center — Shelby, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Progressive Medicine of the Triad, LLC — Winston-Salem, North Carolina, United States
• FMC Science — Lampasas, Texas, United States
• Instituto Medico Platense — Buenos Aires, Argentina
• Diagnostic and Consulting Center Aleksandrovska EOOD — Sofia, Sofia-Grad, Bulgaria
• Medical Center Hera — Sofia, Sofia-Grad, Bulgaria
• Multiprofile Hospital for Active Treatment Puls — Blagoevgrad, Bulgaria
• Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD — Haskovo, Bulgaria
• Medical Center Zdrave-1 OOD — Kozloduy, Bulgaria
• Medical Center Tara OOD — Veliko Tarnovo, Bulgaria
• Lakeland Clinical Trials - Waikato — Hamilton, New Zealand
• Lakeland Clinical Trials — Rotorua, New Zealand
• Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o — Tarnów, Lesser Poland Voivodeship, Poland
• Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota — Ostróda, Poland
• Clinical Projects Research SA pty Ltd — Worcester, Western Cape, South Africa
• Communal Non-Profit Enterprise City Clinical Hospital #1 of Ivano-Frankivsk City Council — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Full record on ClinicalTrials.gov

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