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

Respiratory Syncytial Virus Clinical Trial

— RSVP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196101
• Other study ID #: EDP 938-102
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2020
• Est. completion date: January 4, 2022

Study information

• Verified date: September 2023
• Source: Enanta Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Respiratory Tract Infections

Intervention

Drug:
• EDP-938
Four tablets daily for 5 days
• Placebo
Four tablets daily for 5 days

Locations

Country	Name	City	State
Argentina	Instituto Medico Platense	Buenos Aires
Bulgaria	Multiprofile Hospital for Active Treatment Puls	Blagoevgrad
Bulgaria	Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD	Haskovo
Bulgaria	Medical Center Zdrave-1 OOD	Kozloduy
Bulgaria	Diagnostic and Consulting Center Aleksandrovska EOOD	Sofia	Sofia-Grad
Bulgaria	Medical Center Hera	Sofia	Sofia-Grad
Bulgaria	Medical Center Tara OOD	Veliko Tarnovo
New Zealand	Lakeland Clinical Trials - Waikato	Hamilton
New Zealand	Lakeland Clinical Trials	Rotorua
Poland	Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota	Ostróda
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o	Tarnów	Malopolskie
South Africa	Clinical Projects Research SA pty Ltd	Worcester	Western Cape
Ukraine	Communal Non-Profit Enterprise City Clinical Hospital #1 of Ivano-Frankivsk City Council	Ivano-Frankivs'k	Ivano-Frankivsk
Ukraine	City Outpatient Clinic #9	Kyiv
Ukraine	Limited Liability Company Medical Center Consilium Medical	Kyiv
Ukraine	Medical Center of LLC Preventclinic	Kyiv
Ukraine	Municipal Enterprise The 1st City Clinical Hospital of Poltava City Council	Poltava	Poltavs'ka Oblast
United States	Saint Joseph's Clinical Research	Anaheim	California
United States	Pioneer Clinical Research LLC	Bellevue	Nebraska
United States	Central Alabama Research	Birmingham	Alabama
United States	FMC Science	Lampasas	Texas
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Torrance Clinical Research Institute	Lomita	California
United States	Miami Clinical Research - ClinEdge - PPDS	Miami	Florida
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Cahaba Research Inc. - Birmingham	Pelham	Alabama
United States	Carolina Research Center	Shelby	North Carolina
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Progressive Medicine of the Triad, LLC	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc	PPD

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  New Zealand,  Poland,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Symptom Score (TSS) Area Under the Curve (AUC)	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.	Day 1 through Day 14
Secondary	RSV RNA Viral Load Area Under the Curve (AUC)	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.	Day 1 through Day 14
Secondary	Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD)	Proportion of patients that have undetectable RSV RNA by qRT-PCR at Days 3, 5, 9 and 14.	Days 3, 5, 9 and 14
Secondary	Number of Participants With Adverse Events		Day 1 through Day 14