Can a 5-Day pill tame RSV in the most vulnerable?

NCT ID NCT05568706

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

187 people

The number who actually took part.

Started

Nov 2022

Finished

Jun 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Accelerium, S. de R.L. de C.V. - PPDS

    Monterrey, Nuevo León, 31000, Mexico

  • Allianz Research Institute - Colorado

    Aurora, Colorado, 80014, United States

  • Allianz Research Institute Inc

    Westminster, California, 92683, United States

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744, United States

  • Be Part Yoluntu Centre

    Paarl, 7646, South Africa

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157, United States

  • C&A Clinical Trials Corp

    Cape Coral, Florida, 33990, United States

  • CDC Research Institute, LLC

    Port Saint Lucie, Florida, 34952, United States

  • CHUS - H. Clinico U. de Santiago

    Santiago de Compostela, 15706, Spain

  • CICUM San Miguel

    Guadalajara, Jalisco, 44160, Mexico

  • Camacho Ortiz, Adrian

    Monterrey, Nuevo León, Mexico

  • Centro de Alta Especialidad Dr. Rafael Lucio

    Veracruz, Veracruz, 91020, Mexico

  • Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS

    Mexico City, Mexico City, 06760, Mexico

  • Centro de Investigaciones Medica Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK, Argentina

  • Centro de Investigación Clinica Médica y Farmacoló

    Guadalajara, Jalisco, 44690, Mexico

  • Centro de salud Cabra Matrona Antonia Mesa Fernández

    Cabra, Cordoba, 14940, Spain

  • Centrum Medyczne PROFAMILIA

    Lodz, Łódź Voivodeship, 91-463, Poland

  • Clinica Mayo de U.M.C.B. S.R.L

    San Miguel de Tucumán, Tucumán Province, T4000NWB, Argentina

  • Clinica Privada Independencia

    Munro, Buenos Aires, B1605, Argentina

  • Clinica de la Costa Ltda - PPDS

    Barranquilla, Atlántico, 080020, Colombia

  • Clínica Universidad De la Sabana

    Chía, Cundinamarca, 250001, Colombia

  • Consultorios Médicos Dr. Doreski

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina

  • Covenant Pulmonary Criticial Care and Research Ins

    East Point, Georgia, 30344, United States

  • Diagnostic Consultative Center 1- Lom EOOD

    Lom, Montana, 3600, Bulgaria

  • Diagnostic Consultative Center-1-Sevlievo EOOD

    Sevlievo, Gabrovo, 5400, Bulgaria

  • Dinamo Research & Diagnostic center, LLC

    Hialeah, Florida, 33015, United States

  • Downtown LA Research Center Inc - ClinEdge - PPDS

    Los Angeles, California, 90017, United States

  • Dynamic Medical Research, LLC

    Miami, Florida, 33144, United States

  • Eastside Research Associates

    Redmond, Washington, 98052, United States

  • FAICIC

    Veracruz, Veracruz, 91700, Mexico

  • Floridian Research Institute

    Miami, Florida, 33179-2537, United States

  • Fundacion Centro de Investigacion Clinica CIC

    Medellín, 050021, Colombia

  • Fundacion Centro de Investigaciones Clinicas IPS Cardiomet Pereira

    Pereira, Risaralda Department, 660003, Colombia

  • Global Health Institute

    Syracuse, New York, 13210-1685, United States

  • HDH Research, Inc.

    Houston, Texas, 77022, United States

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 45235, Mexico

  • Hospital General Universitario Dr. Balmis

    Alicante, Alicante, 03010, Spain

  • Hospital Miri

    Miri, Sarawak, 98000, Malaysia

  • I.H.S Health LLC

    Kissimmee, Florida, 34741, United States

  • IMA Clinical Research - Austin - PPDS

    Austin, Texas, 78704-7507, United States

  • Instituto Del Buen Aire

    Santa Fe, Santa Fe Province, 3000, Argentina

  • Instituto Jalisciense de Investigacion Clinica SA de CV

    Guadalajara, Jalisco, 44100, Mexico

  • Instituto Medico Platense

    La Plata, Buenos Aires, 1900, Argentina

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, 5800, Argentina

  • MUDr. Jakub Strincl, s.r.o.

    Liberec, Liberec Region, 460 14, Czechia

  • Medical Center For Life EOOD

    Burgas, Burgas, 8000, Bulgaria

  • Medical Center Hera - Kyustendil EOOD

    Kyustendil, Kyustendil, 2500, Bulgaria

  • Medical Center Hera EOOD

    Sofia, Sofia, 1202, Bulgaria

  • Medical Center Hera EOOD, Montana

    Montana, Montana, 3400, Bulgaria

  • Medical Center Hipocrena

    Sevlievo, Sevlievo, 5400, Bulgaria

  • Medical Center Neuromedix EOOD

    Veliko Tarnovo, 5006, Bulgaria

  • Medical Center Prolet EOOD

    Rousse, Ruse, 7002, Bulgaria

  • Medical Center Sanador M EOOD

    Sofia, Sofia-Grad, 1431, Bulgaria

  • Medical Center Tara OOD

    Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria

  • Medical Center Zdrave-1 OOD

    Kozloduy, Kozloduy, 3320, Bulgaria

  • Medical Centre Pratia Clinic EOOD Varna

    Varna, Varna, Bulgaria

  • Mercury Street Medical

    Butte, Montana, 59701, United States

  • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B

    McKinney, Texas, 75069, United States

  • Multiprofile Hospital for Active Treatment Puls AD - PPDS

    Blagoevgrad, Blagoevgrad, 2700, Bulgaria

  • Newtown Clinical Research Centre

    Johannesburg, 2001, South Africa

  • Oaxaca Site Management Organization - Clinic - OSMO - PPDS

    Oaxaca City, 68000, Mexico

  • Oinsamed S.A.S - Clinica Misericordia

    Barranquilla, 080020, Colombia

  • Orlando VA Healthcare System

    Orlando, Florida, 32827, United States

  • Ormond Beach Clinical Research

    Ormond Beach, Florida, 32174, United States

  • Plucna ambulancia Hrebenar, s.r.o.

    Spišská Nová Ves, 052 01, Slovakia

  • Progressive Medicine of the Triad, LLC

    Winston-Salem, North Carolina, 27103, United States

  • Res Medica s.r.o.

    Nový Knín, 262 03, Czechia

  • Research Bay, Inc.

    Tampa, Florida, 33607, United States

  • SMS Clinical Research, LLC

    Mesquite, Texas, 75149, United States

  • Santos Research Center

    Tampa, Florida, 33615, United States

  • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin

    Medellín, Antioquia, 50021, Colombia

  • Snake River Research

    Idaho Falls, Idaho, 83404, United States

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

    Haskovo, 6305, Bulgaria

  • Specialized Hospital for Active Treatment of Pulmonary Diseases

    Troyan Municipality, Lovech, 5600, Bulgaria

  • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

    Pernik, Pernik, 2300, Bulgaria

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617, United States

  • Torrance Clinical Research Institute

    Lomita, California, 90717, United States

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • UCSF Fresno

    Fresno, California, 93701, United States

  • University Multiprofile Hospital for Active Treatment Sofiamed OOD

    Sofia, Sofia, 1750, Bulgaria

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • Valley Institute of Research

    Fort Worth, Texas, 76164-9041, United States

  • Voyage Medical

    Tempe, Arizona, 85282-2455, United States

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