Trial · NCT04816721
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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. |
| Secondary | Pooled Population: 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 TND after which no further samples had detectable RSV RNA viral load - date of first dose. |
| Secondary | Part 2: Number of Participants Who Experienced a 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. |
| Secondary | Pooled Population: Number of Participants Who Experienced a 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. |
| 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 | Plasma concentrations of EDP-938 were assessed at the designated time points. |
| 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 | Plasma concentrations of EDP-938 were assessed at the designated time points. |
| Secondary | Part 2: Time to First Hospital Discharge for Hospitalized Participants | Day 1 to Day 28 | Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used. |
| Secondary | Pooled Population: Time to First Hospital Discharge for Hospitalized Participants | Day 1 to Day 28 | Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used. |
| 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 | For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days. |
| 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 | For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days. |
| 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 | The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation case report form (CRF). The 95% confidence interval was reported using the Clopper Pearson confidence interval methods. |
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.
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