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

Sponsor
Enanta Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04196101
Collaborator
PPD (Industry)
82
Enrollment
107
Locations
2
Arms
23.4
Actual Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
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).

Study Design

Study Type:
Interventional
Actual Enrollment :
82 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 :
Jan 22, 2020
Actual Primary Completion Date :
Jan 4, 2022
Actual Study Completion Date :
Jan 4, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total Symptom Score of clinical symptoms [Day 1 through Day 14]

Secondary Outcome Measures

  1. RSV RNA Viral Load [Day 1 through Day 14]

  2. Safety as measured by frequency of adverse events (AEs) [Day 1 through Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Alabama Research Birmingham Alabama United States 35209
2 Lakeview Clinical Research Guntersville Alabama United States 35976
3 Cahaba Research Inc. - Birmingham Pelham Alabama United States 35124
4 Saint Joseph's Clinical Research Anaheim California United States 92804
5 Diagnamics Inc. Encinitas California United States 92024
6 Torrance Clinical Research Institute Lomita California United States 90717
7 Dream Team Clinical Research - ClinEdge - PPDS Pomona California United States 91767
8 Allianz Research Institute Inc Westminster California United States 92683
9 Riverside Clinical Research Edgewater Florida United States 32132
10 Community Research of South Florida Hialeah Florida United States 33016
11 San Marcus Research Clinic Inc Miami Lakes Florida United States 33014
12 Advanced Phase Facility Research LLC Miami Florida United States 33134
13 Miami Clinical Research - ClinEdge - PPDS Miami Florida United States 33155
14 Research Institute of South Florida Inc Miami Florida United States 33173
15 Florida Institute For Clinical Research LLC Orlando Florida United States 32825
16 Palm Beach Research - ClinEdge - PPDS West Palm Beach Florida United States 33409
17 IACT Health IACT - PPDS Rincon Georgia United States 31326
18 North Georgia Clinical Research Woodstock Georgia United States 30189
19 Investigators Research Group, LLC Brownsburg Indiana United States 46112
20 MedPharmics Metairie Louisiana United States 70006
21 George Stanley Walker, MD, LLC New Orleans Louisiana United States 70115
22 Montana Medical Research Missoula Montana United States 59808
23 Pioneer Clinical Research LLC Bellevue Nebraska United States 68005
24 Meridian Clinical Research Norfolk Nebraska United States 68701
25 Meridian Clinical Research Omaha Nebraska United States 68134
26 Clinical Research of South Nevada Las Vegas Nevada United States 89121
27 Burke Primary Care Morganton North Carolina United States 28655
28 Carolina Research Center Shelby North Carolina United States 28150
29 PMG Research of Wilmington Wilmington North Carolina United States 28401
30 Progressive Medicine of the Triad, LLC Winston-Salem North Carolina United States 27103
31 Toledo Institute of Clinical Research Toledo Ohio United States 43617
32 Northwest Research Center Portland Oregon United States 97202
33 Preferred Primary Care Physicians Pittsburgh Pennsylvania United States 15236
34 Frontier Clinical Research, LLC Smithfield Pennsylvania United States 15478
35 VitaLink Research - Upstate - PPDS Greenville South Carolina United States 29615
36 VitaLink Research - Spartanburg - PPDS Spartanburg South Carolina United States 29303
37 Family Medicine Associates of Texas - Hunt - PPDS Carrollton Texas United States 75010
38 FMC Science Lampasas Texas United States 76550
39 Centex Studies Inc McAllen Texas United States 78504
40 ACRC Trials Plano Texas United States 75024
41 Sherman Clinical Research - ClinEdge - PPDS Sherman Texas United States 75092
42 Principle Research Solutions Spokane Washington United States 99204
43 Framingham Centro Médico La Plata Buenos Aires Argentina B1902COS
44 Instituto De Patologías Respiratorias San Miguel De Tucumán Tucuman Argentina 4000
45 Instituto De Enfermedades Respiratorias E Investigacion Medica Buenos Aires Argentina B1853AIK
46 Instituto Medico Platense Buenos Aires Argentina B1900AVG
47 Centro Médico Dra de Salvo - PPDS Buenos Aires Argentina C1426ABP
48 Instituto de Medicina Respiratoria, IMeR Córdoba Argentina X5003DCE
49 Centro de Investigaciones Clínicas Del Litoral SRL Santa Fe Argentina S3000FWO
50 Paratus Clinical Research - Western Sydney Blacktown New South Wales Australia 2148
51 Paratus Central Coast Kanwal New South Wales Australia 2259
52 Mater Adult Hospital South Brisbane Queensland Australia 4101
53 CMAX Adelaide South Australia Australia 5000
54 Paratus Clinical Research - Canberra Bruce Australia 2617
55 Medical Center - Smolyan OOD Smolyan Smoylan Bulgaria 4700
56 Medical Center Excelsior OOD - PPDS Sofia Sofia-Grad Bulgaria 1407
57 Diagnostic and Consulting Center Aleksandrovska EOOD Sofia Sofia-Grad Bulgaria 1431
58 Medical Center Hera Sofia Sofia-Grad Bulgaria 1510
59 Multiprofile Hospital for Active Treatment Puls Blagoevgrad Bulgaria 2700
60 Medical Center Asklepii Dupnitsa Bulgaria 2600
61 Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD Haskovo Bulgaria 6300
62 Medical Center Zdrave-1 OOD Kozloduy Bulgaria 3320
63 MHAT Stamen Iliev AD Montana Bulgaria 3400
64 Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD Pernik Bulgaria 2300
65 Medical Center Medconsult Pleven OOD Pleven Bulgaria 5800
66 Medical center Unimed EOOD Plovdiv Bulgaria 4023
67 Medical Center Prolet EOOD Ruse Bulgaria 7000
68 Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Ruse Bulgaria 7002
69 Multiprofile Hospital for Active Treatment - Samokov EOOD Samokov Bulgaria 2000
70 Medical Center-1-Sevlievo EOOD Sevlievo Bulgaria 5400
71 Diagnostic- Consultative Center Convex EOOD Sofia Bulgaria 1680
72 Medical Center New rehabilitation center EOOD Stara Zagora Bulgaria 6003
73 Medical Center Tara OOD Veliko Tarnovo Bulgaria 5000
74 Dr. Anil K. Gupta Medicine Professional Corporation Toronto Ontario Canada M9V 4B4
75 Southern Clinical Trials Totara Auckland New Zealand 600
76 Lakeland Clinical Trials - Waikato Hamilton New Zealand 3200
77 Lakeland Clinical Trials Rotorua New Zealand 3010
78 Clinical Horizons Ltd Tauranga New Zealand 3112
79 Culloden Research Ltd. Tauranga New Zealand 3118
80 NZOZ IGNIS dr med. Alicja Lobinska Świdnik Lubelskie Poland 21-040
81 SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Łódź Lódzkie Poland 90-141
82 Centrum Medyczne PROFAMILIA Łódź Lódzkie Poland 91-463
83 Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o Tarnów Malopolskie Poland 33-100
84 Ostrowieckie Centrum Medyczne Ostrowiec Świętokrzyski Swietokrzyskie Poland 27-400
85 Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota Ostróda Poland 14-100
86 ETG Skierniewice Skierniewice Poland 96-100
87 Iatros International Bloemfontein Free State South Africa 9301
88 Mzansi Ethical Research Centre Middelburg Mpumalanga South Africa 1055
89 Dr Sabelo N Xaba Witbank Mpumalanga South Africa 1039
90 Tshepong Hospital Klerksdorp North - West South Africa 2574
91 Somerset West Clinical Trial Unit Cape Town Western Cape South Africa 7130
92 Langeberg Clinical Trials Cape Town Western Cape South Africa 7570
93 Clinical Projects Research SA pty Ltd Worcester Western Cape South Africa 6850
94 Enhancing Care Foundation Durban South Africa 4026
95 Office of Dr Jaco Cornelius Juhl Jurgens Krugersdorp South Africa 1724
96 Communal Non-Profit Enterprise City Clinical Hospital #1 of Ivano-Frankivsk City Council Ivano-Frankivs'k Ivano-Frankivsk Ukraine 76014
97 Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council Kharkiv Kharkivs'ka Oblast Ukraine 61124
98 Educational and Scientific Medical Complex The University Clinic of Kharkiv NMU Kharkiv Kharkivs'ka Oblast Ukraine 61157
99 Municipal Enterprise The 1st City Clinical Hospital of Poltava City Council Poltava Poltavs'ka Oblast Ukraine 36039
100 Medical Center OK! Clinic+LLC International Institute of Clinical Research Kyiv Ukraine 2091
101 Medical Center of LLC Preventclinic Kyiv Ukraine 3035
102 SI "National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine" Kyiv Ukraine 3680
103 Limited Liability Company Medical Center Consilium Medical Kyiv Ukraine 4050
104 Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem Kyiv Ukraine 4050
105 Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov Vinnytsia Ukraine 21029
106 Medical Clinical Research Center of Medical Center LLC Health Clinic Vinnytsia Ukraine
107 Medical Center of LLC Diaservis Zaporizhzhia Ukraine

Sponsors and Collaborators

  • Enanta Pharmaceuticals
  • PPD

Investigators

  • Study Director: Nathalie Adda, MD, Enanta Pharmaceuticals Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04196101
Other Study ID Numbers:
  • EDP 938-102
First Posted:
Dec 12, 2019
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
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:
Respiratory Tract Infections

Study Results

No Results Posted as of Feb 11, 2022