Trial · NCT04196101
A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
NCT04196101, Phase 2, Completed, Enanta Pharmaceuticals, Inc; results first posted 2023-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects. Trials, record NCT04196101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04196101
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
- NCT number
- NCT04196101
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 82 participants, actual
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Conditions
- Respiratory Syncytial Virus
- Interventions
- EDP-938, Placebo
- First posted
- 2019-12-12
- Last updated
- 2023-10-30
- Results first posted
- 2023-10-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Symptom Score (TSS) Area Under the Curve (AUC) | Day 1 through Day 14 | Assessed by the RSV Symptom Diary, including 13 items assessing the severity of RSV-related signs and symptoms. The diary uses a 4-point scale that consists of grading symptoms on a scale of 0 to 3 for each item, where Grade 0 is Absent, Grade 1 is Noticeable, Grade 2 is Bothersome but not preventing activity, and Grade 3 is Bothersome and interfering with activities. TSS is derived daily by summing of the 13 observed symptom grade values from Day 1 through Day 14 to generate the curve for analysis. |
| Secondary | RSV RNA Viral Load Area Under the Curve (AUC) | Day 1 through Day 14 | RSV RNA viral load as measured in nasopharyngeal swab samples by RT-qPCR on Days 1 (Baseline, time 0), 3, 5, 9, and 14 to generate curve for analysis. |
| Secondary | Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) | Days 3, 5, 9 and 14 | Proportion of patients that have undetectable RSV RNA by qRT-PCR at Days 3, 5, 9 and 14. |
| Secondary | Number of Participants With Adverse Events | Day 1 through Day 14 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Symptom Score (TSS) Area Under the Curve (AUC) | Day 1 through Day 14 | The mITT population included 66 subjects, comprised of all randomized subjects positively diagnosed using the central RT-PCR test who received at least one dose of the assigned study drug or placebo. Per SAP, one subject in the EDP-938 group with only baseline data was excluded from analysis. | days x Score | MEAN |
| SECONDARY | RSV RNA Viral Load Area Under the Curve (AUC) | Day 1 through Day 14 | The mITT population included 66 subjects, comprised of all randomized subjects positively diagnosed using the central RT-PCR test who received at least one dose of the assigned study drug or placebo. Per SAP, one subject in the placebo group and two subjects in the EDP-938 group with only baseline data were excluded from analysis. | days x log10 copies/mL | MEAN |
| SECONDARY | Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) | Days 3, 5, 9 and 14 | Based on subjects positively diagnosed using the central RT-PCR test and with detectable viral load at baseline and non-missing viral load assessment at the respective visit and is used as a denominator in the percentage calculation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | Day 1 through Day 14 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Symptom Score (TSS) Area Under the Curve (AUC) | EDP-938 | RSV A | 93.64 | Standard Deviation 97.180 | days x Score |
| Total Symptom Score (TSS) Area Under the Curve (AUC) | Placebo | RSV A | 62.53 | Standard Deviation 40.310 | days x Score |
| Total Symptom Score (TSS) Area Under the Curve (AUC) | EDP-938 | RSV B | 73.75 | Standard Deviation 66.652 | days x Score |
| Total Symptom Score (TSS) Area Under the Curve (AUC) | Placebo | RSV B | 78.34 | Standard Deviation 58.051 | days x Score |
| RSV RNA Viral Load Area Under the Curve (AUC) | EDP-938 | 37.00 | Standard Deviation 24.003 | days x log10 copies/mL | |
| RSV RNA Viral Load Area Under the Curve (AUC) | Placebo | 46.96 | Standard Deviation 21.002 | days x log10 copies/mL | |
| Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) | EDP-938 | Day 3 | 5 | Participants | |
| Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) | Placebo | Day 3 | 2 | Participants | |
| Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) | EDP-938 | Day 5 | 12 | Participants | |
| Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) | Placebo | Day 5 | 5 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EDP-938 | 41 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | EDP-938 | 31 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | EDP-938 | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events64
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 | Conjunctivitis | Infections and infestations | EDP-938 | 0 | 40 | 0 |
| other | Conjunctivitis | Infections and infestations | Placebo | 1 | 41 | 1 |
| other | Influenza | Infections and infestations | EDP-938 | 0 | 40 | 0 |
| other | Influenza | Infections and infestations | Placebo | 1 | 41 | 1 |
| other | Laryngitis | Infections and infestations | EDP-938 | 0 | 40 | 0 |
| other | Laryngitis | Infections and infestations | Placebo | 1 | 41 | 1 |
| other | Oral herpes | Infections and infestations | EDP-938 | 0 | 40 | 0 |
| other | Oral herpes | Infections and infestations | Placebo | 2 | 41 | 2 |
| other | Oropharyngeal candidiasis | Infections and infestations | EDP-938 | 0 | 40 | 0 |
| other | Oropharyngeal candidiasis | Infections and infestations | Placebo | 1 | 41 | 1 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EDP-938 | 0 | 40 |
| Total, all-cause mortality | Placebo | 0 | 41 |
| Total, other adverse events | EDP-938 | 11 | 40 |
| Total, other adverse events | Placebo | 11 | 41 |
| Total, serious adverse events | EDP-938 | 0 | 40 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EDP-938 vs Placebo: Number of Participants With Adverse Events | Trial comparisons |
| EDP-938 vs Placebo: deaths from any cause | Trial comparisons |
| EDP-938 vs Placebo: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04196101
GET https://conductscience.org/api/trials/v1/NCT04196101/events?page=2