A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
Condition: Respiratory Syncytial Virus
MeSH terms: Respiratory Tract Infections
Intervention: EDP-938; Placebo
Intervention description: Four tablets daily for 5 days; Four tablets daily for 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: RSV

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.