RSV InfectionPhase 2RSVHRNCT05568706
A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
A Phase 2 study testing EDP-938 in people with RSV Infection, run by Enanta Pharmaceuticals, Inc at 84 sites in 12 countries.
Trial summary
This was a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who were at high risk for complications after RSV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RSV Infection
- What is being tested?
- EDP-938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 84 sitesin 12 countries
- Study dates
- 29 Nov 2022to 23 Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one of the following conditions that predispose them to complications after RSV infection:
- Age ≥65 years
- Congestive heart failure (CHF)
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.
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- The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath
- The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
- A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
- A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
Who cannot join
- The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF
- The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF
- The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF
- The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%
- The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.
- The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation
- The subject has immunocompromised status
- The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility
Trial locations and contacts
84 sites in 12 countries.
84 sites in 12 countries
United States31 sites
Allianz Research Institute - Colorado
Aurora, Colorado, 80014
IMA Clinical Research - Austin - PPDS
Austin, Texas, 78704-7507
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Mercury Street Medical
Butte, Montana, 59701
C&A Clinical Trials Corp
Cape Coral, Florida, 33990
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157
Covenant Pulmonary Criticial Care and Research Ins
East Point, Georgia, 30344
Valley Institute of Research
Fort Worth, Texas, 76164-9041
UCSF Fresno
Fresno, California, 93701
Dinamo Research & Diagnostic center, LLC
Hialeah, Florida, 33015
HDH Research, Inc.
Houston, Texas, 77022
Snake River Research
Idaho Falls, Idaho, 83404
I.H.S Health LLC
Kissimmee, Florida, 34741
Torrance Clinical Research Institute
Lomita, California, 90717
Downtown LA Research Center Inc - ClinEdge - PPDS
Los Angeles, California, 90017
University of Louisville
Louisville, Kentucky, 40202
Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
McKinney, Texas, 75069
SMS Clinical Research, LLC
Mesquite, Texas, 75149
Dynamic Medical Research, LLC
Miami, Florida, 33144
Floridian Research Institute
Miami, Florida, 33179-2537
Orlando VA Healthcare System
Orlando, Florida, 32827
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174
CDC Research Institute, LLC
Port Saint Lucie, Florida, 34952
Eastside Research Associates
Redmond, Washington, 98052
Global Health Institute
Syracuse, New York, 13210-1685
Research Bay, Inc.
Tampa, Florida, 33607
Santos Research Center
Tampa, Florida, 33615
Voyage Medical
Tempe, Arizona, 85282-2455
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
Allianz Research Institute Inc
Westminster, California, 92683
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
Bulgaria18 sites
Multiprofile Hospital for Active Treatment Puls AD - PPDS
Blagoevgrad, Blagoevgrad, 2700
Medical Center For Life EOOD
Burgas, Burgas, 8000
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6305
Medical Center Zdrave-1 OOD
Kozloduy, Kozloduy, 3320
Medical Center Hera - Kyustendil EOOD
Kyustendil, Kyustendil, 2500
Diagnostic Consultative Center 1- Lom EOOD
Lom, Montana, 3600
Medical Center Hera EOOD, Montana
Montana, Montana, 3400
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
Pernik, Pernik, 2300
Medical Center Prolet EOOD
Rousse, Ruse, 7002
Diagnostic Consultative Center-1-Sevlievo EOOD
Sevlievo, Gabrovo, 5400
Medical Center Hipocrena
Sevlievo, Sevlievo, 5400
Medical Center Hera EOOD
Sofia, Sofia, 1202
University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, Sofia, 1750
Medical Center Sanador M EOOD
Sofia, Sofia-Grad, 1431
Specialized Hospital for Active Treatment of Pulmonary Diseases
Troyan Municipality, Lovech, 5600
Medical Centre Pratia Clinic EOOD Varna
Varna, Varna
Medical Center Tara OOD
Veliko Tarnovo, Veliko Tarnovo, 5000
Medical Center Neuromedix EOOD
Veliko Tarnovo, 5006
Mexico10 sites
Instituto Jalisciense de Investigacion Clinica SA de CV
Guadalajara, Jalisco, 44100
CICUM San Miguel
Guadalajara, Jalisco, 44160
Centro de Investigación Clinica Médica y Farmacoló
Guadalajara, Jalisco, 44690
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 45235
Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
Mexico City, Mexico City, 06760
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, Nuevo León, 31000
Camacho Ortiz, Adrian
Monterrey, Nuevo León
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
Oaxaca City, 68000
Centro de Alta Especialidad Dr. Rafael Lucio
Veracruz, Veracruz, 91020
FAICIC
Veracruz, Veracruz, 91700
Argentina7 sites
Consultorios Médicos Dr. Doreski
Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP
Instituto Medico Platense
La Plata, Buenos Aires, 1900
Centro de Investigaciones Medica Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK
Clinica Privada Independencia
Munro, Buenos Aires, B1605
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, 5800
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000NWB
Instituto Del Buen Aire
Santa Fe, Santa Fe Province, 3000
Colombia6 sites
Clinica de la Costa Ltda - PPDS
Barranquilla, Atlántico, 080020
Oinsamed S.A.S - Clinica Misericordia
Barranquilla, 080020
Clínica Universidad De la Sabana
Chía, Cundinamarca, 250001
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
Medellín, Antioquia, 50021
Fundacion Centro de Investigacion Clinica CIC
Medellín, 050021
Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira
Pereira, Risaralda Department, 660003
Spain3 sites
Hospital General Universitario Dr. Balmis
Alicante, Alicante, 03010
Centro de salud Cabra Matrona Antonia Mesa Fernández
Cabra, Cordoba, 14940
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, 15706
Czechia2 sites
MUDr. Jakub Strincl, s.r.o.
Liberec, Liberec Region, 460 14
Res Medica s.r.o.
Nový Knín, 262 03
South Africa2 sites
Newtown Clinical Research Centre
Johannesburg, 2001
Be Part Yoluntu Centre
Paarl, 7646
Taiwan2 sites
Taichung Veterans General Hospital
Taichung, 40705
Tri-Service General Hospital
Taipei, 11490
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults With Acute Respiratory Syncytial Virus Infection Who Are at High Risk for Complications
This was a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who were at high risk for complications after RSV infection.
- Conditions
- RSV Infection
- Being tested
- EDP-938, Placebo
- Keywords
- High Risk, Respiratory Syncytial Virus
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-938Drug
Subjects took EDP-938 once daily for 5 days
PlaceboDrug
Subjects took matching placebo, once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| EDP-938 | Experimental | EDP-938 800 mg, once daily Receives: Drug: EDP-938 |
| Placebo | Placebo comparator | Matching placebo, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resolution of RSV Lower Respiratory Tract Disease (LRTD) Symptoms
Resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution of LRTD symptoms is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Time to Complete Resolution of LRTD Symptoms for the mITT Population
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Time to Complete Resolution of LRTD Symptoms for the HR3 Population
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by RiiQTM Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Secondary outcomes (25)
Time to Resolution of LRTD Symptoms and 2 Systemic Symptoms
Resolution of LRTD and 2 Systemic Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) and each of the 2 systemic symptoms (feeling fever and fatigue/tiredness) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero or 1; Higher scores indicate worse outcomes (greater symptom intensity and greater impact on daily functioning). Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Time to Resolution of All RSV Symptoms
Resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQ Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Time to Complete Resolution of All RSV Symptoms for the mITT Population
Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero. Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Time to Complete Resolution of All RSV Symptoms for the HR3 Population
Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero. Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Change From Baseline in Severity of RSV LRTD Symptoms
The RiiQ Infection Intensity Scale assesses 4 symptoms of LRTD (cough, shortness of breath, wheezing, and expectoration) on a scale from 0 (absent) to 3 (severe). The composite LRTD Score is the average of all 4 individual item scores.
Measured: Day 1 through Day 33
Change From Baseline for Impact Scale
The RiiQ Impact Scale assesses daily activities (7 items), emotions (4 items), and social relationships (5 items) on a scale of 0 (no impact) to 3 (extreme impact). The composite Impact Score is the average of all 16 individual item scores.
Measured: Day 1 through Day 33
Time to Resolution of Upper Respiratory Tract Disease Congestion, LRTD, and 2 Systemic Symptoms
Resolution of Symptoms is defined as the first of two consecutive timepoints where each of the RSV symptoms (4 LRTD symptoms [cough, short of breath, wheezing, coughing up phlegm [sputum]], 2 URTD symptoms [nasal congestion and sore throat], 2 Systemic symptoms [feeling feverish and fatigue[tiredness]]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Time to no or Mild Impact of RSV Disease on Daily Activities, Emotions, and Social Relationships
Resolution of No or Mild Impact of RSV is defined as the first of two consecutive timepoints where each of the 3 impact Scale Scores (daily activities, emotions and social relationships) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Percentage of Participants With Post-baseline RSV-related Complications
Measured: Day 1 through Day 33
Time to Improvement in RSV Disease
Time to Improvement is defined as the time from first dose to first timepoint where the response assessed by PGI-C is 'Much better'. Time to Improvement is calculated as: date/time of Improvement - date/time of first timepoint.
Measured: Day 1 through Day 33
Change From Baseline for Health-Related Quality of Life
Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire; 5 dimensions (mobility, taking care of yourself, usual activities, pain/discomfort, and anxiety/depression) are scored on 5 levels from 1 (full health) to 5 (extreme disability). An index score is derived based on the 5 reported levels where 1.0 represents full health and 0.0 the worst possible health.
Measured: Day 1 through Day 33
Time to Return to Usual Health
Time to return to usual health is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Health is 'Yes'. Time to return to usual health is calculated as: date/time of return to usual health - date/time of response to 'Yes'.
Measured: Day 1 through Day 33
Time to Return to Usual Activities
Time to return to usual activities is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Activities is 'Yes'. Time to return to usual activities is calculated as: date/time of return to usual activities - date/time of first response to 'Yes'.
Measured: Day 1 through Day 33
Percentage of Subjects Requiring Hospitalization for RSV or Other Causes
Measured: Day 1 through Day 33
Duration of Hospitalization for RSV or Other Causes
Measured: Day 1 through Day 33
All-cause Mortality
Measured: Day 1 through Day 33
RSV RNA Viral Load Change From Baseline for the mITT Population
Measured: Days 3, 5, 9, and 14
Change in Infectious RSV Viral Load Over Time
Measured: Up to Day 14
Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population
Measured: Days 1, 3, 5, 9 and 14
Time to RSV RNA Viral Load TND for the mITT Population
Time to RSV viral load TND is defined as the time between the date of first dose to the first date of achieving viral load TND.
Measured: Day 1 through Day 14
Plasma PK Concentrations of EDP-938
Measured: Up to Day 5
Safety as Measured by Frequency of Adverse Events (AEs)
Number of subjects experiencing any Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 33
Time to Resolution of RSV Infection Symptoms by Patient Global Impression of Severity (PGI-S) Scale Score for the mITT Population
PGI-S is a 7-point patient-reported scale ranging from 1 (normal/none) to 7 (among the most extremely ill); lower scores indicate less severe disease.
Time to resolution is defined as time from the first dose to first of two consecutive timepoints where the response assessed by PGI-S is 'None'. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Measured: Day 1 through Day 33
Incidence of New Antibiotic Use, or New or Increased Use of Bronchodilators, Systemic or Inhaled Corticosteroids, or Oxygen Supplementation for the mITT Population
Incidence was defined as the number of subjects with new antibiotic, bronchodilators, inhaled corticosteroids or oxygen use
Measured: Day 1 through Day 33
Incidence of Unscheduled Medically Attended Visits for RSV Infection or Other Causes for the mITT Population
Incidence was defined as the number of subjects with unscheduled medically attended visits for RSV infection or other causes.
Measured: Day 1 through Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start29 Nov 2022
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568706
- Sponsor's protocol ID
- EDP 938-104
- Acronym
- RSVHR
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2022
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No