Trial · NCT03691623
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
NCT03691623, Phase 2, Completed, Enanta Pharmaceuticals, Inc; results first posted 2022-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model. Trials, record NCT03691623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03691623
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
- NCT number
- NCT03691623
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 179 participants, actual
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Conditions
- RSV Infection
- Interventions
- EDP-938 Dose 1, EDP-938 Dose 2, Placebo, EDP-938 Dose 3, EDP-938 Dose 4, Placebo
- First posted
- 2018-10-02
- Last updated
- 2022-05-03
- Results first posted
- 2022-05-03
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | 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. |
| Secondary | Area Under the Curve (AUC) of Total Symptom Score | Three times daily on Day 0 to Day 11, once on Day 12 | 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. |
| Secondary | Peak Total Symptom Score | Day 2 to Day 12 | 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 |
| Secondary | Total Symptom Score | Day 2 to Day 9 | 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 |
| Secondary | Time to Peak Total Symptom Score | Day 2 to Day 12 | 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. |
| Secondary | Time to Resolution From Peak Total Symptom Score | Day 2 to Day 12 | 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. |
| Secondary | Total Weight of Nasal Mucus Produced | Day 2 to Day 12 | Measured via weighed paper tissues and reported as a mean total across all study days. |
| Secondary | Peak Viral Load | Day 2 to Day 12 | 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. |
| Secondary | Time to Peak Viral Load | Day 2 to Day 12 | 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. |
| Secondary | Time to Resolution From Peak Viral Load | Day 2 to Day 12 | 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). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Twice daily on Day 2 through Day 11 and once on Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | hours*log10 copies/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve (AUC) of Total Symptom Score | Three times daily on Day 0 to Day 11, once on Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | hours*score | GEOMETRIC_MEAN |
| SECONDARY | Peak Total Symptom Score | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | Scores on a scale | GEOMETRIC_MEAN |
| SECONDARY | Total Symptom Score | Day 2 to Day 9 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. For cases of 0 participants analyzed, data were not collected from any participants for that time point. | Scores on a scale | GEOMETRIC_MEAN |
| SECONDARY | Time to Peak Total Symptom Score | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | Days | GEOMETRIC_MEAN |
| SECONDARY | Time to Resolution From Peak Total Symptom Score | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection.~9 participants in Part 1 and 5 participants in Part 2 were excluded from the analysis due to having no symptoms in the interval first dose of study drug to Day 12. | Days | GEOMETRIC_MEAN |
| SECONDARY | Total Weight of Nasal Mucus Produced | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | Grams | MEAN |
| SECONDARY | Peak Viral Load | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | log10 copies/milliliter (mL) | MEAN |
| SECONDARY | Time to Peak Viral Load | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. | Days | GEOMETRIC_MEAN |
| SECONDARY | Time to Resolution From Peak Viral Load | Day 2 to Day 12 | Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. Participants were excluded from the analysis if it was concluded that the criteria for laboratory-confirmed RSV infection were not met. | Days | GEOMETRIC_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group393
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Part 1: EDP-938 600 mg | 134.70 | Geometric Coefficient of Variation 85.1 | hours*log10 copies/milliliter (mL) | |
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Part 1: EDP-938 500 mg Then 300 mg | 113.51 | Geometric Coefficient of Variation 99.9 | hours*log10 copies/milliliter (mL) | |
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Part 1: Placebo | 624.30 | Geometric Coefficient of Variation 51.7 | hours*log10 copies/milliliter (mL) | |
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Part 2: EDP-938 600 mg Then 300 mg | 80.61 | Geometric Coefficient of Variation 112.1 | hours*log10 copies/milliliter (mL) | |
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Part 2: EDP-938 400 mg Then 200 mg | 160.81 | Geometric Coefficient of Variation 63.3 | hours*log10 copies/milliliter (mL) | |
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | Part 2: Placebo | 808.28 | Geometric Coefficient of Variation 37.1 | hours*log10 copies/milliliter (mL) | |
| Area Under the Curve (AUC) of Total Symptom Score | Part 1: EDP-938 600 mg | 61.18 | Geometric Coefficient of Variation 347.8 | hours*score | |
| Area Under the Curve (AUC) of Total Symptom Score | Part 1: EDP-938 500 mg Then 300 mg | 37.36 | Geometric Coefficient of Variation 1640.1 | hours*score | |
| Area Under the Curve (AUC) of Total Symptom Score | Part 1: Placebo | 252.49 | Geometric Coefficient of Variation 243.9 | hours*score | |
| Area Under the Curve (AUC) of Total Symptom Score | Part 2: EDP-938 600 mg Then 300 mg | 26.70 | Geometric Coefficient of Variation 730.2 | hours*score |
1 to 10 of 393Source ClinicalTrials.gov
See all 393 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: EDP-938 600 mg | 39 | |
| Overall Study | STARTED | Part 1: EDP-938 500 mg Then 300 mg | 38 | |
| Overall Study | STARTED | Part 1: Placebo | 38 | |
| Overall Study | STARTED | Part 2: EDP-938 600 mg Then 300 mg | 21 | |
| Overall Study | STARTED | Part 2: EDP-938 400 mg Then 200 mg | 21 | |
| Overall Study | STARTED | Part 2: Placebo | 21 | |
| Overall Study | Inoculated With Challenge Virus | Part 1: EDP-938 600 mg | 39 | |
| Overall Study | Inoculated With Challenge Virus | Part 1: EDP-938 500 mg Then 300 mg | 38 | |
| Overall Study | Inoculated With Challenge Virus | Part 1: Placebo | 38 | |
| Overall Study | Inoculated With Challenge Virus | Part 2: EDP-938 600 mg Then 300 mg | 21 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Part 1: EDP-938 600 mg | 0 | 38 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Part 1: EDP-938 500 mg Then 300 mg | 1 | 38 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Part 1: Placebo | 2 | 38 | 2 |
| other | Ear pain | Ear and labyrinth disorders | Part 2: EDP-938 600 mg Then 300 mg | 0 | 21 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Part 2: EDP-938 400 mg Then 200 mg | 1 | 21 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Part 2: Placebo | 0 | 21 | 0 |
| other | Hypoacusis | Ear and labyrinth disorders | Part 1: EDP-938 600 mg | 0 | 38 | 0 |
| other | Hypoacusis | Ear and labyrinth disorders | Part 1: EDP-938 500 mg Then 300 mg | 0 | 38 | 0 |
| other | Hypoacusis | Ear and labyrinth disorders | Part 1: Placebo | 1 | 38 | 1 |
| other | Hypoacusis | Ear and labyrinth disorders | Part 2: EDP-938 600 mg Then 300 mg | 0 | 21 | 0 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: EDP-938 600 mg | 0 | 39 |
| Total, all-cause mortality | Part 1: EDP-938 500 mg Then 300 mg | 0 | 38 |
| Total, all-cause mortality | Part 1: Placebo | 0 | 38 |
| Total, all-cause mortality | Part 2: EDP-938 600 mg Then 300 mg | 0 | 21 |
| Total, all-cause mortality | Part 2: EDP-938 400 mg Then 200 mg | 0 | 21 |
| Total, all-cause mortality | Part 2: Placebo | 0 | 21 |
| Total, other adverse events | Part 1: EDP-938 600 mg | 20 | 38 |
| Total, other adverse events | Part 1: EDP-938 500 mg Then 300 mg | 21 | 38 |
| Total, other adverse events | Part 1: Placebo | 21 | 38 |
| Total, other adverse events | Part 2: EDP-938 600 mg Then 300 mg | 8 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT03691623/registered?page=2