Can a 5-Day pill tame RSV in the most vulnerable?
NCT ID NCT05568706
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial tests an experimental antiviral pill, EDP-938, in adults with a confirmed RSV infection who are at high risk for complications—such as those over 65 or with asthma, COPD, or heart failure. Participants take the drug or a placebo once daily for five days. The goal is to see if the drug can shorten the time it takes for symptoms like cough, wheezing, and shortness of breath to resolve, potentially reducing the burden of RSV in vulnerable people.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EDP-938, an experimental antiviral drug taken by mouth once daily for 5 days
- What this could lead to
- If it works, EDP-938 could become a treatment that shortens RSV illness and prevents serious complications in vulnerable adults.
- What could go wrong
- This is an early-phase trial, so the drug may not prove effective or safe. It is also tested only in a specific high-risk group, so results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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187 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * At least one of the following conditions that predispose them to complications after RSV infection: 1. Age ≥65 years 2. Congestive heart failure (CHF) 3. Asthma 4. 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. * 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. Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, Nuevo León, 31000, Mexico
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Allianz Research Institute - Colorado
Aurora, Colorado, 80014, United States
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Allianz Research Institute Inc
Westminster, California, 92683, United States
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Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
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Be Part Yoluntu Centre
Paarl, 7646, South Africa
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Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157, United States
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C&A Clinical Trials Corp
Cape Coral, Florida, 33990, United States
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CDC Research Institute, LLC
Port Saint Lucie, Florida, 34952, United States
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CHUS - H. Clinico U. de Santiago
Santiago de Compostela, 15706, Spain
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CICUM San Miguel
Guadalajara, Jalisco, 44160, Mexico
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Camacho Ortiz, Adrian
Monterrey, Nuevo León, Mexico
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Centro de Alta Especialidad Dr. Rafael Lucio
Veracruz, Veracruz, 91020, Mexico
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Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
Mexico City, Mexico City, 06760, Mexico
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Centro de Investigaciones Medica Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK, Argentina
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Centro de Investigación Clinica Médica y Farmacoló
Guadalajara, Jalisco, 44690, Mexico
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Centro de salud Cabra Matrona Antonia Mesa Fernández
Cabra, Cordoba, 14940, Spain
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Centrum Medyczne PROFAMILIA
Lodz, Łódź Voivodeship, 91-463, Poland
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Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000NWB, Argentina
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Clinica Privada Independencia
Munro, Buenos Aires, B1605, Argentina
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Clinica de la Costa Ltda - PPDS
Barranquilla, Atlántico, 080020, Colombia
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Clínica Universidad De la Sabana
Chía, Cundinamarca, 250001, Colombia
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Consultorios Médicos Dr. Doreski
Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina
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Covenant Pulmonary Criticial Care and Research Ins
East Point, Georgia, 30344, United States
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Diagnostic Consultative Center 1- Lom EOOD
Lom, Montana, 3600, Bulgaria
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Diagnostic Consultative Center-1-Sevlievo EOOD
Sevlievo, Gabrovo, 5400, Bulgaria
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Dinamo Research & Diagnostic center, LLC
Hialeah, Florida, 33015, United States
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Downtown LA Research Center Inc - ClinEdge - PPDS
Los Angeles, California, 90017, United States
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Dynamic Medical Research, LLC
Miami, Florida, 33144, United States
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Eastside Research Associates
Redmond, Washington, 98052, United States
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FAICIC
Veracruz, Veracruz, 91700, Mexico
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Floridian Research Institute
Miami, Florida, 33179-2537, United States
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Fundacion Centro de Investigacion Clinica CIC
Medellín, 050021, Colombia
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Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira
Pereira, Risaralda Department, 660003, Colombia
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Global Health Institute
Syracuse, New York, 13210-1685, United States
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HDH Research, Inc.
Houston, Texas, 77022, United States
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Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 45235, Mexico
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Hospital General Universitario Dr. Balmis
Alicante, Alicante, 03010, Spain
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Hospital Miri
Miri, Sarawak, 98000, Malaysia
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I.H.S Health LLC
Kissimmee, Florida, 34741, United States
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IMA Clinical Research - Austin - PPDS
Austin, Texas, 78704-7507, United States
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Instituto Del Buen Aire
Santa Fe, Santa Fe Province, 3000, Argentina
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Instituto Jalisciense de Investigacion Clinica SA de CV
Guadalajara, Jalisco, 44100, Mexico
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Instituto Medico Platense
La Plata, Buenos Aires, 1900, Argentina
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Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, 5800, Argentina
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MUDr. Jakub Strincl, s.r.o.
Liberec, Liberec Region, 460 14, Czechia
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Medical Center For Life EOOD
Burgas, Burgas, 8000, Bulgaria
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Medical Center Hera - Kyustendil EOOD
Kyustendil, Kyustendil, 2500, Bulgaria
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Medical Center Hera EOOD
Sofia, Sofia, 1202, Bulgaria
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Medical Center Hera EOOD, Montana
Montana, Montana, 3400, Bulgaria
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Medical Center Hipocrena
Sevlievo, Sevlievo, 5400, Bulgaria
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Medical Center Neuromedix EOOD
Veliko Tarnovo, 5006, Bulgaria
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Medical Center Prolet EOOD
Rousse, Ruse, 7002, Bulgaria
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Medical Center Sanador M EOOD
Sofia, Sofia-Grad, 1431, Bulgaria
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Medical Center Tara OOD
Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria
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Medical Center Zdrave-1 OOD
Kozloduy, Kozloduy, 3320, Bulgaria
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Medical Centre Pratia Clinic EOOD Varna
Varna, Varna, Bulgaria
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Mercury Street Medical
Butte, Montana, 59701, United States
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Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
McKinney, Texas, 75069, United States
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Multiprofile Hospital for Active Treatment Puls AD - PPDS
Blagoevgrad, Blagoevgrad, 2700, Bulgaria
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Newtown Clinical Research Centre
Johannesburg, 2001, South Africa
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Oaxaca Site Management Organization - Clinic - OSMO - PPDS
Oaxaca City, 68000, Mexico
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Oinsamed S.A.S - Clinica Misericordia
Barranquilla, 080020, Colombia
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Orlando VA Healthcare System
Orlando, Florida, 32827, United States
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Ormond Beach Clinical Research
Ormond Beach, Florida, 32174, United States
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Plucna ambulancia Hrebenar, s.r.o.
Spišská Nová Ves, 052 01, Slovakia
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Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103, United States
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Res Medica s.r.o.
Nový Knín, 262 03, Czechia
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Research Bay, Inc.
Tampa, Florida, 33607, United States
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SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
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Santos Research Center
Tampa, Florida, 33615, United States
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Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
Medellín, Antioquia, 50021, Colombia
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Snake River Research
Idaho Falls, Idaho, 83404, United States
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Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6305, Bulgaria
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Specialized Hospital for Active Treatment of Pulmonary Diseases
Troyan Municipality, Lovech, 5600, Bulgaria
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Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
Pernik, Pernik, 2300, Bulgaria
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Taichung Veterans General Hospital
Taichung, 40705, Taiwan
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Toledo Institute of Clinical Research
Toledo, Ohio, 43617, United States
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Torrance Clinical Research Institute
Lomita, California, 90717, United States
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Tri-Service General Hospital
Taipei, 11490, Taiwan
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UCSF Fresno
Fresno, California, 93701, United States
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University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, Sofia, 1750, Bulgaria
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University of Louisville
Louisville, Kentucky, 40202, United States
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Valley Institute of Research
Fort Worth, Texas, 76164-9041, United States
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Voyage Medical
Tempe, Arizona, 85282-2455, United States
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Other studies related to the condition(s) this trial covers.
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- RSV drug trial for kids under 5 halted early – only 4 children enrolled
- Triple-Threat vaccine aims to shield seniors from three respiratory viruses