Respiratory Syncytial Virus (RSV)Phase 2RSVPEDsNCT04816721
A Study to Evaluate EDP 938 Regimens in Children With RSV
A Phase 2 study testing EDP-938 in people with Respiratory Syncytial Virus (RSV), run by Enanta Pharmaceuticals, Inc at 78 sites in 15 countries.
Trial summary
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection. Read more about this study
- Who is it for?
- Ages 28 days to 36 months
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- EDP-938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 78 sitesin 15 countries
- Study dates
- 26 Apr 2022to 19 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 28 days to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to <6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible.
- Subjects diagnosed with RSV infection
- Subjects with signs of an acute respiratory illness with onset ≤7 days for Part 1 and ≤5 days for Part 2 before the time of signing the ICF
- In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
Who cannot join
- Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
- Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
- Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
- Receiving chronic oxygen therapy at home before admission
- Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
- In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.
Trial locations and contacts
78 sites in 15 countries.
78 sites in 15 countries
United States16 sites
Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Children's Health Specialty Center Dallas Campus
Dallas, Texas, 75207
MedPharmics - Lafayette
Lafayette, Louisiana, 70508
Memorial Care Miller Children's and Women's Hospital
Long Beach, California, 90806
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Norton Children's Research Institute
Louisville, Kentucky, 40202
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Nemours Children's Hospital
Orlando, Florida, 32827
Rexburg Pediatrics
Rexburg, Idaho, 83440
University of California Davis
Sacramento, California, 95817
LSU Health
Shreveport, Louisiana, 71101
Willis-Knighton Health System
Shreveport, Louisiana, 71103
South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
Spain13 sites
Hospital Germans Trias i Pujol
Barcelona
Hospital Universitario Arnau de Vilanova
Lleida
Hospital Clínico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid
Hospital Universitario Quirónsalud Madrid
Madrid
Hospital Universitario Severo Ochoa
Madrid
Unidad de Ensayos Clínicos Pediátricos
Madrid
Hospital Regional Universitario de Málaga
Málaga
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Hospital Universitario Joan XXIII de Tarragona
Tarragona
Mexico7 sites
Panamerican Clinical Research Mexico - Guadalajara
Guadalajara, Prados, 44670
Instituto Nacional de Pediatría
Mexico City, 04530
Hospital Infantil De Mexico Federico Gomez
Mexico City
Karla Adriana Espinosa Bautista
Mexico City
IESCI Clinical Research
Monterrey
PanAmerican Clinical Research
Querétaro
SMIQ S de R.L de C.V
Querétaro
Taiwan6 sites
Hsinchu Mackay Memorial Hospital
Hsinchu
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City
Chung Shan Medical University Hospital
Taichung
Taipei Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei City, Taipei, 100229
Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Taoyuan City, Taoyuan, 333
Argentina5 sites
Hospital Interzonal Dr Jose Penna
Bahía Blanca
Clínica Privada del Sol
Buenos Aires, C1425
Clinica del Niño y la Familia
Mar del Plata, Buenos Aires
Instituto Medico Rio Cuarto
Río Cuarto
Clinica Central S.A
Villa Regina
Brazil5 sites
Universidade Federal do Paraná - Hospital de Clínicas
Curitiba, 80060-900
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, 99010
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, 14015-010
Israel5 sites
Soroka University Medical Center
Beersheba
Rambam Health Care
Haifa, 3109601
Carmel Medical Center
Haifa
Hadassah University Hospital Mount Scopu
Jerusalem
Schneider Children's Medical Center Of Israel
Petah Tikva, 4920235
Australia3 sites
Sydney Children's Hospital - Randwick
Randwick, New South Wales, 2031
Gold Coast University Hospital
Southport
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Germany3 sites
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum Gießen und Marburg - Gießen
Marburg, Bundesland, 35043
Asklepios Klinik Sankt Augustin
Sankt Augustin
Romania3 sites
Spital Clinic de Urgenta Pentru Copii Brasov
Brasov, Brașov County
Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"
Bucharest
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu Mureş, Târgu Mureș
South Africa3 sites
Rahima Moosa Mother and Child Hospital
Johannesburg
Wits Clinical Research
Soweto, 2013
Life Westville Hospital
Westville, Durban
South Korea3 sites
Nowon Eulji Medical Center, Eulji University
Seoul, 1830
Kyung Hee University Hospital
Seoul, 2447
Inje University Sanggye Paik Hospital
Seoul
United Kingdom3 sites
St. George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
Sheffield Children's NHS Foundation Trust
Sheffield
Poland2 sites
IN-VIVO Bydgoszcz
Bydgoszcz
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz
About this study
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
Read the detailed description
This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- EDP-938, Placebo
- Keywords
- Respiratory Syncytial Virus, RSV, Pediatric study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-938Drug
Oral suspension
PlaceboDrug
Placebo oral suspension to match EDP-938
| Study group | Role | What they receive |
|---|---|---|
| EDP-938 | Experimental | EDP-938, oral suspension, once daily for 5 days Receives: Drug: EDP-938 |
| Placebo | Placebo comparator | Matching placebo, orally, once daily for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Concentrations of EDP-938 in Plasma
Plasma concentrations of EDP-938 were assessed at the designated time points.
Measured: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.
Measured: Day 1 to Day 28
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV ribonucleic acid (RNA) viral load and was measured using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom.
Measured: Baseline and pre-dose on Days 3, 5, 9, and 14
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV RNA viral load and was measured using RT-qPCR from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed.The Satterthwaite approximation is used to estimate the denominator degrees of freedom.
Measured: Baseline and pre-dose on Days 3, 5, 9, and 14
Secondary outcomes (29)
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
The RSV RNA viral load was measured using RT-qPCR from nasal swabs. The AUC was calculated using the trapezoid rule. The AUC was calculated based on all available assessments collected on Days 1, 3, 5, 9 and 14 and the actual date/time of each assessment was used for the calculation.
Measured: Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
The RSV RNA viral load was measured using RT-qPCR from nasal swabs. The AUC was calculated using the trapezoid rule. The AUC was calculated based on all available assessments collected on Days 1, 3, 5, 9 and 14 and the actual date/time of each assessment was used for the calculation. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.
Measured: Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Daily change from baseline in RSV shedding in nasal swab samples was defined as the absolute daily change from baseline in RSV RNA viral load and measured using RT-qPCR from nasal swabs.
Measured: Baseline to pre-dose on Days 3, 5, 9, and Day 14
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
The RSV RNA viral load was measured using RT-qPCR from nasal swabs.
Measured: Pre-dose on Days 3, 5, 9 and 14
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
The RSV RNA viral load was measured using RT-qPCR from nasal swabs.
Measured: Pre-dose on Days 3, 5, 9 and 14
Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable
Time to RSV RNA viral load being undetectable was calculated as: first date of RSV RNA viral load target not detected (TND) after which no further samples had detectable RSV RNA viral load - date of first dose.
Measured: Day 1 to Day 28
Pooled Population: Time to RSV RNA Viral Load Being Undetectable
Time to RSV RNA viral load being undetectable was calculated as: first date of RSV RNA viral load TND after which no further samples had detectable RSV RNA viral load - date of first dose.
Measured: Day 1 to Day 28
Part 2: Number of Participants Who Experienced a TEAE
TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.
Measured: Day 1 to Day 28
Pooled Population: Number of Participants Who Experienced a TEAE
TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.
Measured: Day 1 to Day 28
Part 2: Concentrations of EDP-938 in Plasma
Plasma concentrations of EDP-938 were assessed at the designated time points.
Measured: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Pooled Population: Concentrations of EDP-938 in Plasma
Plasma concentrations of EDP-938 were assessed at the designated time points.
Measured: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Part 2: Time to First Hospital Discharge for Hospitalized Participants
Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used.
Measured: Day 1 to Day 28
Pooled Population: Time to First Hospital Discharge for Hospitalized Participants
Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used.
Measured: Day 1 to Day 28
Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug
For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days.
Measured: Day 1 to Day 28
Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug
For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days.
Measured: Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation case report form (CRF). The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation CRF. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Part 2: Time to Mechanical Ventilation for Hospitalized Participants
Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis.
Measured: Day 1 to Day 28
Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants
Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis.
Measured: Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Died During the Study
The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Died During the Study
The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized
Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days.
Measured: Day 1 to Day 28
Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized
Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days.
Measured: Day 1 to Day 28
Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Measured: Day 1 to Day 28
Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver Respiratory Syncytial Virus (RSV) Foundation (ReSVinet) score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14.
During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease.
Measured: Day 1 to Day 14
Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver ReSVinet score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14.
During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease.
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start26 Apr 2022
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
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 Respiratory Syncytial Virus (RSV)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 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
- NCT04816721
- Sponsor's protocol ID
- EDP 938-201
- Acronym
- RSVPEDs
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2021
- Last updated
- 28 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
- ClinicalTrials.gov ID
- NCT04816721
- Acronym / sponsor ID
- RSVPEDs / EDP 938-201
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Respiratory Syncytial Virus, RSV, Pediatric study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
Detailed description
This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDP-938 | Experimental | Drug: EDP-938EDP-938, oral suspension, once daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo, orally, once daily for 5 days |
Who may qualify
- Ages
- 28 days to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to <6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible.
- Subjects diagnosed with RSV infection
- Subjects with signs of an acute respiratory illness with onset ≤7 days for Part 1 and ≤5 days for Part 2 before the time of signing the ICF
- In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
Key exclusion criteria (6 listed)
- Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
- Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
- Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
- Receiving chronic oxygen therapy at home before admission
- Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP-938Oral suspension | Drug | EDP-938 |
| PlaceboPlacebo oral suspension to match EDP-938 | Drug | Placebo |
Primary outcome
Part 1: Concentrations of EDP-938 in Plasma
Time frame: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Plasma concentrations of EDP-938 were assessed at the designated time points.
Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 28
TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
Time frame: Baseline and pre-dose on Days 3, 5, 9, and 14
Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV ribonucleic acid (RNA) viral load and was measured using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom.
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Time frame: Baseline and pre-dose on Days 3, 5, 9, and 14
Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV RNA viral load and was measured using RT-qPCR from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed.The Satterthwaite approximation is used to estimate the denominator degrees of freedom.
29 secondary outcomes
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
Time frame: Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
Time frame: Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Time frame: Baseline to pre-dose on Days 3, 5, 9, and Day 14
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
Time frame: Pre-dose on Days 3, 5, 9 and 14
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
Time frame: Pre-dose on Days 3, 5, 9 and 14
Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable
Time frame: Day 1 to Day 28
Pooled Population: Time to RSV RNA Viral Load Being Undetectable
Time frame: Day 1 to Day 28
Part 2: Number of Participants Who Experienced a TEAE
Time frame: Day 1 to Day 28
Pooled Population: Number of Participants Who Experienced a TEAE
Time frame: Day 1 to Day 28
Part 2: Concentrations of EDP-938 in Plasma
Time frame: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Pooled Population: Concentrations of EDP-938 in Plasma
Time frame: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Part 2: Time to First Hospital Discharge for Hospitalized Participants
Time frame: Day 1 to Day 28
Pooled Population: Time to First Hospital Discharge for Hospitalized Participants
Time frame: Day 1 to Day 28
Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug
Time frame: Day 1 to Day 28
Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug
Time frame: Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
Time frame: Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
Time frame: Day 1 to Day 28
Part 2: Time to Mechanical Ventilation for Hospitalized Participants
Time frame: Day 1 to Day 28
Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants
Time frame: Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
Time frame: Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
Time frame: Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Died During the Study
Time frame: Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Died During the Study
Time frame: Day 1 to Day 28
Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized
Time frame: Day 1 to Day 28
Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized
Time frame: Day 1 to Day 28
Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
Time frame: Day 1 to Day 28
Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
Time frame: Day 1 to Day 28
Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
Time frame: Day 1 to Day 14
Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
Time frame: Day 1 to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
78 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP-938 in people with Respiratory Syncytial Virus (RSV), run by Enanta Pharmaceuticals, Inc at 78 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Spain, Mexico, Taiwan, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Concentrations of EDP-938 in Plasma (time frame: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.