Trial · NCT04816721
A Study to Evaluate EDP 938 Regimens in Children With RSV
NCT04816721, Phase 2, Completed, Enanta Pharmaceuticals, Inc; results first posted 2025-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate EDP 938 Regimens in Children With RSV. Trials, record NCT04816721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04816721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate EDP 938 Regimens in Children With RSV
- NCT number
- NCT04816721
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 99 participants, actual
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Conditions
- Respiratory Syncytial Virus (RSV)
- Interventions
- EDP-938, Placebo
- First posted
- 2021-03-25
- Last updated
- 2025-07-28
- Results first posted
- 2025-07-08
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Concentrations of EDP-938 in Plasma | 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. |
| Primary | Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | 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. |
| Primary | Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples | 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. |
| Primary | Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples | 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. |
| Secondary | Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load | Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14 | 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. |
| Secondary | Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load | Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14 | 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. |
| Secondary | Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples | Baseline to pre-dose on Days 3, 5, 9, and Day 14 | 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. |
| Secondary | Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD) | Pre-dose on Days 3, 5, 9 and 14 | The RSV RNA viral load was measured using RT-qPCR from nasal swabs. |
| Secondary | Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD | Pre-dose on Days 3, 5, 9 and 14 | The RSV RNA viral load was measured using RT-qPCR from nasal swabs. |
| Secondary | Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable | Day 1 to Day 28 | 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. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Concentrations of EDP-938 in Plasma | 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5 | Pharmacokinetic (PK) Population: Included all participants in Part 1 who received one full dose of study drug and had samples with quantifiable plasma levels to allow for estimation of PK parameters. Per protocol, data were analyzed per age group and dose received. | ng/mL | MEAN |
| PRIMARY | Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Day 1 to Day 28 | Safety Population: Included all participants in Part 1 who received any dose (including partial doses) of any study drug. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples | Baseline and pre-dose on Days 3, 5, 9, and 14 | Efficacy Population: Included all participants in Part 2 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | log10 copies/mL | LEAST_SQUARES_MEAN |
| PRIMARY | Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples | Baseline and pre-dose on Days 3, 5, 9, and 14 | Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | log10 copies/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load | Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14 | Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | log10 copies/mL*Days | MEAN |
| SECONDARY | Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load | Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14 | Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | log10 copies/mL*Days | LEAST_SQUARES_MEAN |
| SECONDARY | Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples | Baseline to pre-dose on Days 3, 5, 9, and Day 14 | Efficacy Population: Included all participants in Part 1 who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | log10 copies/mL | MEAN |
| SECONDARY | Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD) | Pre-dose on Days 3, 5, 9 and 14 | Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Included only participants with detectable viral load at baseline and non-missing viral load assessment at the respective visit and was used as a denominator in the percentage population. | percentage of participants | NUMBER |
| SECONDARY | Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD | Pre-dose on Days 3, 5, 9 and 14 | Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Included only participants with detectable viral load at baseline and non-missing viral load assessment at the respective visit and was used as a denominator in the percentage population. | percentage of participants | NUMBER |
| SECONDARY | Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable | Day 1 to Day 28 | Efficacy Population: Included all participants who received one full dose of study drug and had at least one evaluable measurement while on treatment. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | days | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months) | Day 1 | 1132.222 | Standard Deviation 397.4289 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months) | Day 1 | 1989.500 | Standard Deviation 1331.5646 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months) | Day 1 | 1819.286 | Standard Deviation 809.9508 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months) | Day 1 | 1420.000 | Standard Deviation 604.8140 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months) | Day 1 | 1428.250 | Standard Deviation 817.4801 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months) | Day 2 | 368.400 | Standard Deviation 149.8741 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months) | Day 2 | 399.250 | Standard Deviation 423.9515 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months) | Day 2 | 502.350 | Standard Deviation 379.6487 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months) | Day 2 | 249.675 | Standard Deviation 294.5416 | ng/mL |
| Part 1: Concentrations of EDP-938 in Plasma | Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months) | Day 2 | 238.900 | Standard Deviation 239.0287 | ng/mL |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1, Group 1: EDP-938 | 22 | |
| Overall Study | STARTED | Part 1, Group 2: EDP-938 | 14 | |
| Overall Study | STARTED | Part 1, Group 1: Placebo | 11 | |
| Overall Study | STARTED | Part 1, Group 2: Placebo | 6 | |
| Overall Study | STARTED | Part 2, Group 1: EDP-938 | 20 | |
| Overall Study | STARTED | Part 2, Group 2: EDP-938 | 16 | |
| Overall Study | STARTED | Part 2, Group 1: Placebo | 6 | |
| Overall Study | STARTED | Part 2, Group 2: Placebo | 4 | |
| Overall Study | Treated With 5 mg/kg EDP-938 | Part 1, Group 1: EDP-938 | 14 | |
| Overall Study | Treated With 5 mg/kg EDP-938 | Part 1, Group 2: EDP-938 | 13 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events76
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 | Myocardial necrosis marker increased | Investigations | Part 1: EDP-938 | 0 | 36 | 0 |
| other | Myocardial necrosis marker increased | Investigations | Part 1: Placebo | 0 | 16 | 0 |
| other | Myocardial necrosis marker increased | Investigations | Part 2: EDP-938 | 0 | 34 | 0 |
| other | Myocardial necrosis marker increased | Investigations | Part 2: Placebo | 1 | 10 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: EDP-938 | 0 | 36 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Placebo | 0 | 16 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: EDP-938 | 0 | 34 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Placebo | 1 | 10 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Part 1: EDP-938 | 0 | 36 | 0 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Part 1: Placebo | 0 | 16 | 0 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: EDP-938 | 0 | 36 |
| Total, all-cause mortality | Part 1: Placebo | 0 | 16 |
| Total, all-cause mortality | Part 2: EDP-938 | 0 | 34 |
| Total, all-cause mortality | Part 2: Placebo | 0 | 10 |
| Total, other adverse events | Part 1: EDP-938 | 7 | 36 |
| Total, other adverse events | Part 1: Placebo | 7 | 16 |
| Total, other adverse events | Part 2: EDP-938 | 9 | 34 |
| Total, other adverse events | Part 2: Placebo | 4 | 10 |
| Total, serious adverse events | Part 1: EDP-938 | 0 | 36 |
| Total, serious adverse events | Part 1: Placebo | 2 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 |
|---|---|
| Combined EDP-938 vs Combined Placebo: Pooled Population: Number of Participants Who Experienced a TEAE | Trial comparisons |
| Part 1: EDP-938 vs Part 1: Placebo: Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Part 2: EDP-938 vs Part 2: Placebo: Part 2: Number of Participants Who Experienced a TEAE | 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/NCT04816721
GET https://conductscience.org/api/trials/v1/NCT04816721/registered?page=2