RSV InfectionPhase 2NCT03691623
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
A Phase 2 study testing EDP-938 Dose 1, EDP-938 Dose 2 and EDP-938 Dose 3 in people with RSV Infection, run by Enanta Pharmaceuticals, Inc at 1 site in United Kingdom.
Trial summary
A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection
- What is being tested?
- EDP-938 Dose 1, EDP-938 Dose 2 and EDP-938 Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2018to 18 Oct 2019
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An informed consent document signed and dated by the subject
- Age 18 to 55 years, inclusive
- In good health with no history of major medical conditions
- A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2
Who cannot join
- Pregnant or nursing females
- Acute or chronic medical illness
- Abnormal lung function
- Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test
- Nose or nasopharynx abnormalities
- Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.
A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.
- Conditions
- RSV Infection
- Being tested
- EDP-938 Dose 1, EDP-938 Dose 2, Placebo, EDP-938 Dose 3, EDP-938 Dose 4
- Keywords
- challenge study, RSV, antiviral, RSV-A Memphis 37b
- 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-938 Dose 1Drug
Oral suspension for 5 days
EDP-938 Dose 2Drug
Oral suspension for 5 days
PlaceboDrug
Oral suspension for 5 days
EDP-938 Dose 3Drug
Oral suspension for 5 days
EDP-938 Dose 4Drug
Oral suspension for 5 days
PlaceboDrug
Oral suspension for 5 days
| Study group | Role | What they receive |
|---|---|---|
| EDP-938 Arm A | Experimental | Subjects will take EDP-938 Dose 1 oral suspension for 5 days Receives: Drug: EDP-938 Dose 1 |
| EDP-938 Arm B | Experimental | Subjects will take EDP-938 Dose 2 oral suspension for 5 days Receives: Drug: EDP-938 Dose 2 |
| Placebo Arm C | Placebo comparator | Subjects will take matching placebo oral suspension for 5 days Receives: Drug: Placebo |
| EDP-938 Arm D | Experimental | Subjects will take EDP-938 Dose 3 oral suspension for 5 days Receives: Drug: EDP-938 Dose 3 |
| EDP-938 Arm E | Experimental | Subjects will take EDP-938 Dose 4 oral suspension for 5 days Receives: Drug: EDP-938 Dose 4 |
| Placebo Arm F | Placebo comparator | Subjects will take matching placebo oral suspension for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.
Measured: Twice daily on Day 2 through Day 11 and once on Day 12
Secondary outcomes (23)
Area Under the Curve (AUC) of Total Symptom Score
Total symptom scores (from the 10-item Diary Card) were used to calculate the AUC. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities:
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise (Tiredness)
- Cough
- Shortness of breath
- Headache
- Muscle/ joint ache/ stiffness
Total symptom score is the sum of individual symptom scores with a potential range of 0 (best) to 30 (worst). Data presented is hours x score.
Measured: Three times daily on Day 0 to Day 11, once on Day 12
Peak Total Symptom Score
Peak total symptom score was defined as the highest total symptom score between first dose of study drug and Day 12. Values presented are a sum of individual symptom scores, with a potential range of 0 (best) to 30 (worst). Total symptom scores at the time of the first dose of study drug can be before or after dosing.
Measured by the 10-item Diary Card. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities:
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise (Tiredness)
- Cough
- Shortness of breath
- Headache
- Muscle/ joint ache/ stiffness
Measured: Day 2 to Day 12
Total Symptom Score
Measured by the 10-item Diary Card. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities. Total symptom score is the sum of individual symptom scores with a potential range of 0 (best) to 30 (worst).
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise (Tiredness)
- Cough
- Shortness of breath
- Headache
- Muscle/ joint ache/ stiffness
Measured: Day 2 to Day 9
Time to Peak Total Symptom Score
Time to peak total symptom score was defined as the time in days to the highest total symptom score between first dose of study drug and Day 12. Total symptom scores at the time of the first dose of study drug can be before or after dosing.
Measured: Day 2 to Day 12
Time to Resolution From Peak Total Symptom Score
Time to resolution from peak total symptom score was defined as the time in days from the highest total symptom score (between first dose of study drug and Day 12) until the start of the first 24-hour symptom-free period (after the highest total symptom score). Total symptom scores at the time of the first dose of study drug can be before or after dosing.
Measured: Day 2 to Day 12
Total Weight of Nasal Mucus Produced
Measured via weighed paper tissues and reported as a mean total across all study days.
Measured: Day 2 to Day 12
Peak Viral Load
Peak viral load was defined as the highest quantitative reverse transcription polymerase chain reaction (RT-qPCR) viral load value between first dose of study drug and Day 12. Measured by nasal wash RT-qPCR.
Measured: Day 2 to Day 12
Time to Peak Viral Load
Time to peak viral load was defined as the time to the highest quantitative reverse transcription polymerase chain reaction (RT-qPCR) viral load value between first dose of study drug and Day 12. Measured by nasal wash RT-qPCR.
Measured: Day 2 to Day 12
Time to Resolution From Peak Viral Load
Time to resolution from peak viral load was defined as the time from peak until first confirmed undetectable assessment between first dose of study drug and Day 12. Measured by by nasal wash quantitative reverse transcription polymerase chain reaction (RT-qPCR).
Measured: Day 2 to Day 12
Time to Cessation of Virus Detection
Time to cessation of virus detection was measured by nasal wash quantitative reverse transcription polymerase chain reaction (RT-qPCR).
Measured: Day 2 to Day 12
Safety and Tolerability as Assessed by Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant physical examinations, vital signs, clinical laboratory tests (including biochemistry, hematology, coagulation [if required], cardiac enzymes and urine analysis), 12-lead electrocardiograms (ECGs) and spirometry results were recorded as adverse events.
Measured: Day 2 to Day 28
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Apparent Systemic Clearance at Steady State (CLss/F) of EDP-938
Measured: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Volume of Distribution at Steady State (Vss/F) of EDP-938
Measured: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2 and Day 7; 12 hours post-dose
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2 and Day 7; 24 hours post-dose
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites
The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.
Measured: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Viral Load AUC
The overall criteria to define correlation was based on identifying a PK AUC associated with a less favorable viral load AUC i.e. a low PK AUC and a high viral load AUC indicated a correlation.
Measured: Day 2 to Day 18
Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Total Symptom Score (TSS) AUC
The overall criteria to define correlation was based on identifying a PK AUC associated with a less favorable TSS AUC, i.e. a low PK AUC and a high TSS AUC indicated a correlation.
Measured: Day 2 to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start15 Oct 2018
- Primary completion30 Sep 2019
- Study completion18 Oct 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- hVIVO Services Limited
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691623
- Sponsor's protocol ID
- EDP 938-101
- Status last verified
- Aug 2019
- First submitted
- 28 Sep 2018
- Last updated
- 3 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Levene RE, DeVincenzo J, Conery AL, Ahmad A, Or YS, Rhodin MHJ. EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus. J Infect Dis. 2025 Feb 20;231(2):e290-e298. doi: 10.1093/infdis/jiae471.
PubMed 39441691Ahmad A, Eze K, Noulin N, Horvathova V, Murray B, Baillet M, Grey L, Mori J, Adda N. EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. N Engl J Med. 2022 Feb 17;386(7):655-666. doi: 10.1056/NEJMoa2108903.
PubMed 35172056
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.
- ClinicalTrials.gov ID
- NCT03691623
- Acronym / sponsor ID
- EDP 938-101
- Conditions
- RSV Infection
- Keywords
- challenge study, RSV, antiviral, RSV-A Memphis 37b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- hVIVO Services Limited
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 3 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EDP-938 Arm A | Experimental | Drug: EDP-938 Dose 1Subjects will take EDP-938 Dose 1 oral suspension for 5 days |
| EDP-938 Arm B | Experimental | Drug: EDP-938 Dose 2Subjects will take EDP-938 Dose 2 oral suspension for 5 days |
| Placebo Arm C | Placebo comparator | Drug: PlaceboSubjects will take matching placebo oral suspension for 5 days |
| EDP-938 Arm D | Experimental | Drug: EDP-938 Dose 3Subjects will take EDP-938 Dose 3 oral suspension for 5 days |
| EDP-938 Arm E | Experimental | Drug: EDP-938 Dose 4Subjects will take EDP-938 Dose 4 oral suspension for 5 days |
| Placebo Arm F | Placebo comparator | Drug: PlaceboSubjects will take matching placebo oral suspension for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- An informed consent document signed and dated by the subject
- Age 18 to 55 years, inclusive
- In good health with no history of major medical conditions
- A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2
Key exclusion criteria (6 listed)
- Pregnant or nursing females
- Acute or chronic medical illness
- Abnormal lung function
- Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test
- Nose or nasopharynx abnormalities
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-938 Dose 1Oral suspension for 5 days | Drug | EDP-938 Arm A |
| EDP-938 Dose 2Oral suspension for 5 days | Drug | EDP-938 Arm B |
| PlaceboOral suspension for 5 days | Drug | Placebo Arm C |
| EDP-938 Dose 3Oral suspension for 5 days | Drug | EDP-938 Arm D |
| EDP-938 Dose 4Oral suspension for 5 days | Drug | EDP-938 Arm E |
| PlaceboOral suspension for 5 days | Drug | Placebo Arm F |
Primary outcome
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Time frame: Twice daily on Day 2 through Day 11 and once on Day 12
Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.
23 secondary outcomes
Area Under the Curve (AUC) of Total Symptom Score
Time frame: Three times daily on Day 0 to Day 11, once on Day 12
Peak Total Symptom Score
Time frame: Day 2 to Day 12
Total Symptom Score
Time frame: Day 2 to Day 9
Time to Peak Total Symptom Score
Time frame: Day 2 to Day 12
Time to Resolution From Peak Total Symptom Score
Time frame: Day 2 to Day 12
Total Weight of Nasal Mucus Produced
Time frame: Day 2 to Day 12
Peak Viral Load
Time frame: Day 2 to Day 12
Time to Peak Viral Load
Time frame: Day 2 to Day 12
Time to Resolution From Peak Viral Load
Time frame: Day 2 to Day 12
Time to Cessation of Virus Detection
Time frame: Day 2 to Day 12
Safety and Tolerability as Assessed by Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 2 to Day 28
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites
Time frame: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites
Time frame: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites
Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Apparent Systemic Clearance at Steady State (CLss/F) of EDP-938
Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites
Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Volume of Distribution at Steady State (Vss/F) of EDP-938
Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites
Time frame: Day 2 and Day 7; 12 hours post-dose
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites
Time frame: Day 2 and Day 7; 24 hours post-dose
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites
Time frame: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites
Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose
Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Viral Load AUC
Time frame: Day 2 to Day 18
Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Total Symptom Score (TSS) AUC
Time frame: Day 2 to Day 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39441691Levene RE, DeVincenzo J, Conery AL, Ahmad A, Or YS, Rhodin MHJ. EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus. J Infect Dis. 2025 Feb 20;231(2):e290-e298. doi: 10.1093/infdis/jiae471.
- Derived from this study: PubMed 35172056Ahmad A, Eze K, Noulin N, Horvathova V, Murray B, Baillet M, Grey L, Mori J, Adda N. EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. N Engl J Med. 2022 Feb 17;386(7):655-666. doi: 10.1056/NEJMoa2108903.
Related trials for RSV Infection
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingObservational study
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
RSV Infection
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP-938 Dose 1, EDP-938 Dose 2 and EDP-938 Dose 3 in people with RSV Infection, run by Enanta Pharmaceuticals, Inc at 1 site in United Kingdom.
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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 3 May 2022). 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?
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load (time frame: Twice daily on Day 2 through Day 11 and once on Day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691623, which also lists 2 linked publications.
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 3 May 2022.