Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04196101




Registration number
NCT04196101
Ethics application status
Date submitted
3/12/2019
Date registered
12/12/2019
Date last updated
30/10/2023

Titles & IDs
Public title
A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
Scientific 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)
Secondary ID [1] 0 0
EDP 938-102
Universal Trial Number (UTN)
Trial acronym
RSVP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EDP-938
Treatment: Drugs - Placebo

Experimental: EDP-938 - Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days

Placebo comparator: Placebo - Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days


Treatment: Drugs: EDP-938
Four tablets daily for 5 days

Treatment: Drugs: Placebo
Four tablets daily for 5 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total Symptom Score (TSS) Area Under the Curve (AUC)
Timepoint [1] 0 0
Day 1 through Day 14
Secondary outcome [1] 0 0
RSV RNA Viral Load Area Under the Curve (AUC)
Timepoint [1] 0 0
Day 1 through Day 14
Secondary outcome [2] 0 0
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD)
Timepoint [2] 0 0
Days 3, 5, 9 and 14
Secondary outcome [3] 0 0
Number of Participants With Adverse Events
Timepoint [3] 0 0
Day 1 through Day 14

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2022
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia-Grad
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Blagoevgrad
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Haskovo
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Kozloduy
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Veliko Tarnovo
Country [14] 0 0
New Zealand
State/province [14] 0 0
Hamilton
Country [15] 0 0
New Zealand
State/province [15] 0 0
Rotorua
Country [16] 0 0
Poland
State/province [16] 0 0
Malopolskie
Country [17] 0 0
Poland
State/province [17] 0 0
Ostróda
Country [18] 0 0
South Africa
State/province [18] 0 0
Western Cape
Country [19] 0 0
Ukraine
State/province [19] 0 0
Ivano-Frankivsk
Country [20] 0 0
Ukraine
State/province [20] 0 0
Poltavs'ka Oblast
Country [21] 0 0
Ukraine
State/province [21] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Enanta Pharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Rottinghaus, MD
Address 0 0
Enanta Pharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04196101