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

  • STATUS
    Recruiting
  • days left to enroll
    47
  • participants needed
    70
  • sponsor
    Enanta Pharmaceuticals
Updated on 19 June 2021
fever
dyspnea
congestion
earache
influenza
cough
nasal congestion
wheezing
malaise
respiratory tract infection
nasal discharge
respiratory syncytial virus infection

Summary

This is 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.

Description

Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who test 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) will be allowed in the study.

Approximately 70 subjects will be 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 will be approximately 2 weeks and will consist of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).

Details
Condition Respiratory syncytial virus, Respiratory Syncytial Virus (RSV) Infection
Treatment Placebo, EDP-938
Clinical Study IdentifierNCT04196101
SponsorEnanta Pharmaceuticals
Last Modified on19 June 2021

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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