A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Drug: EDP-938Drug: Placebo
- Registration Number
- NCT04196101
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- 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.
- Detailed Description
Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who tested positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease (COPD) were allowed in the study.
Eighty-two (82) subjects were enrolled in this Phase 2b, randomized, double-blind, placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory adult subjects.
For each subject, the duration of study participation was approximately 2 weeks and consisted of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EDP-938 EDP-938 Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days Placebo Placebo Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days
- Primary Outcome Measures
Name Time Method Total Symptom Score (TSS) Area Under the Curve (AUC) Day 1 through Day 14 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.
- Secondary Outcome Measures
Name Time Method RSV RNA Viral Load Area Under the Curve (AUC) Day 1 through Day 14 RSV RNA viral load as measured in nasopharyngeal swab samples by RT-qPCR on Days 1 (Baseline, time 0), 3, 5, 9, and 14 to generate curve for analysis.
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) Days 3, 5, 9 and 14 Proportion of patients that have undetectable RSV RNA by qRT-PCR at Days 3, 5, 9 and 14.
Number of Participants With Adverse Events Day 1 through Day 14
Trial Locations
- Locations (29)
Clinical Projects Research SA pty Ltd
🇿🇦Worcester, Western Cape, South Africa
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Saint Joseph's Clinical Research
🇺🇸Anaheim, California, United States
Cahaba Research Inc. - Birmingham
🇺🇸Pelham, Alabama, 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
FMC Science
🇺🇸Lampasas, Texas, United States
Progressive Medicine of the Triad, LLC
🇺🇸Winston-Salem, North Carolina, United States
Instituto Medico Platense
🇦🇷Buenos Aires, Argentina
Diagnostic and Consulting Center Aleksandrovska EOOD
🇧🇬Sofia, Sofia-Grad, Bulgaria
Multiprofile Hospital for Active Treatment Puls
🇧🇬Blagoevgrad, Bulgaria
Medical Center Hera
🇧🇬Sofia, Sofia-Grad, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
🇧🇬Haskovo, Bulgaria
Medical Center Tara OOD
🇧🇬Veliko Tarnovo, Bulgaria
Medical Center Zdrave-1 OOD
🇧🇬Kozloduy, Bulgaria
Lakeland Clinical Trials - Waikato
🇳🇿Hamilton, New Zealand
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
🇵🇱Tarnów, Malopolskie, Poland
Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota
🇵🇱Ostróda, Poland
Lakeland Clinical Trials
🇳🇿Rotorua, New Zealand
Municipal Enterprise The 1st City Clinical Hospital of Poltava City Council
🇺🇦Poltava, Poltavs'ka Oblast, Ukraine
Limited Liability Company Medical Center Consilium Medical
🇺🇦Kyiv, Ukraine
City Outpatient Clinic #9
🇺🇦Kyiv, Ukraine
Communal Non-Profit Enterprise City Clinical Hospital #1 of Ivano-Frankivsk City Council
🇺🇦Ivano-Frankivs'k, Ivano-Frankivsk, Ukraine
Medical Center of LLC Preventclinic
🇺🇦Kyiv, Ukraine