Trial · NCT04816721
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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 |
| SECONDARY | Pooled Population: 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 |
| SECONDARY | Part 2: Number of Participants Who Experienced a TEAE | Day 1 to Day 28 | Safety Population: Included all participants in Part 2 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 |
| SECONDARY | Pooled Population: Number of Participants Who Experienced a TEAE | Day 1 to Day 28 | Safety Population: Included all participants 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 |
| SECONDARY | Part 2: 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 | PK Population: Included all participants in Part 2 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 |
| SECONDARY | Pooled Population: 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 | PK Population: Included all participants 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 |
| SECONDARY | Part 2: Time to First Hospital Discharge for Hospitalized Participants | Day 1 to Day 28 | 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. Only participants who were hospitalized at randomization were included. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | days | MEAN |
| SECONDARY | Pooled Population: Time to First Hospital Discharge for Hospitalized Participants | 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. Only participants who were hospitalized at randomization were included. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. | days | MEAN |
| SECONDARY | 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 | Day 1 to Day 28 | 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. As there were no participants in Part 2 in both arms who were hospitalized at randomization who were not receiving oxygen at the time they received the first dose of study drug, no data were collected for this outcome measure. | ||
| SECONDARY | 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 | Day 1 to Day 28 | Efficacy Population. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose. Only hospitalized participants who were not receiving oxygen at the time they received the first dose of study drug were included. In the Placebo arm, there were no hospitalized participants who were not receiving oxygen at the time they received the first dose of study drug. | days | MEAN |
| SECONDARY | Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug | Day 1 to Day 28 | 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. Only participants who were hospitalized at randomization and/or during the study were included. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04816721/outcomes