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Trial record 3 of 16 for:    RSVP

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196101
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : July 24, 2020
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Drug: EDP-938 Drug: Placebo Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: EDP-938
Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days
Drug: EDP-938
Four tablets daily for 5 days

Placebo Comparator: Placebo
Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days
Drug: Placebo
Four tablets daily for 5 days




Primary Outcome Measures :
  1. Total Symptom Score of clinical symptoms [ Time Frame: Day 1 through Day 14 ]

Secondary Outcome Measures :
  1. RSV RNA Viral Load [ Time Frame: Day 1 through Day 14 ]
  2. Safety as measured by frequency of adverse events (AEs) [ Time Frame: Day 1 through Day 14 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196101


Contacts
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Contact: Eoin Coakley, MD +1 617 744 3859 ecoakley@enanta.com

Locations
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Sponsors and Collaborators
Enanta Pharmaceuticals
PPD
Investigators
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Study Director: Nathalie Adda, MD Enanta Pharmaceuticals Inc.
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04196101    
Other Study ID Numbers: EDP 938-102
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
RSV
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases