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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04816721
Registration number
NCT04816721
Ethics application status
Date submitted
23/03/2021
Date registered
25/03/2021
Date last updated
8/07/2025
Titles & IDs
Public title
A Study to Evaluate EDP 938 Regimens in Children With RSV
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Scientific title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
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Secondary ID [1]
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0
EDP 938-201
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Universal Trial Number (UTN)
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Trial acronym
RSVPEDs
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV)
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EDP-938
Treatment: Drugs - Placebo
Experimental: EDP-938 - EDP-938, oral suspension, once daily for 5 days
Placebo comparator: Placebo - Matching placebo, orally, once daily for 5 days
Treatment: Drugs: EDP-938
Oral suspension
Treatment: Drugs: Placebo
Placebo oral suspension to match EDP-938
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Concentrations of EDP-938 in Plasma
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Assessment method [1]
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Plasma concentrations of EDP-938 were assessed at the designated time points.
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Timepoint [1]
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3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
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Primary outcome [2]
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Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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Assessment method [2]
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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.
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Timepoint [2]
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0
Day 1 to Day 28
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Primary outcome [3]
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Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and pre-dose on Days 3, 5, 9, and 14
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Primary outcome [4]
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Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and pre-dose on Days 3, 5, 9, and 14
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Secondary outcome [1]
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Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
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Assessment method [1]
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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.
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Timepoint [1]
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Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14
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Secondary outcome [2]
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Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
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Assessment method [2]
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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.
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Timepoint [2]
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0
Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14
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Secondary outcome [3]
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Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
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Assessment method [3]
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Daily change from baseline in RSV shedding in nasal swab samples was defined as the percent daily change from baseline in RSV RNA viral load and measured using RT-qPCR from nasal swabs.
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Timepoint [3]
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Baseline to pre-dose on Days 3, 5, 9, and Day 14
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Secondary outcome [4]
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Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
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Assessment method [4]
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The RSV RNA viral load was measured using RT-qPCR from nasal swabs.
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Timepoint [4]
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Pre-dose on Days 3, 5, 9 and 14
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Secondary outcome [5]
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Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
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Assessment method [5]
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The RSV RNA viral load was measured using RT-qPCR from nasal swabs.
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Timepoint [5]
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Pre-dose on Days 3, 5, 9 and 14
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Secondary outcome [6]
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Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable
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Assessment method [6]
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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.
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Timepoint [6]
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Day 1 to Day 28
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Secondary outcome [7]
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Pooled Population: Time to RSV RNA Viral Load Being Undetectable
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Assessment method [7]
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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.
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Timepoint [7]
0
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Day 1 to Day 28
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Secondary outcome [8]
0
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Part 2: Number of Participants Who Experienced a TEAE
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Assessment method [8]
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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.
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Timepoint [8]
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0
Day 1 to Day 28
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Secondary outcome [9]
0
0
Pooled Population: Number of Participants Who Experienced a TEAE
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Assessment method [9]
0
0
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.
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Timepoint [9]
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0
Day 1 to Day 28
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Secondary outcome [10]
0
0
Part 2: Concentrations of EDP-938 in Plasma
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Assessment method [10]
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Plasma concentrations of EDP-938 were assessed at the designated time points.
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Timepoint [10]
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0
3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
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Secondary outcome [11]
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Pooled Population: Concentrations of EDP-938 in Plasma
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Assessment method [11]
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Plasma concentrations of EDP-938 were assessed at the designated time points.
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Timepoint [11]
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0
3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
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Secondary outcome [12]
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Part 2: Time to First Hospital Discharge for Hospitalized Participants
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Assessment method [12]
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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.
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Timepoint [12]
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0
Day 1 to Day 28
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Secondary outcome [13]
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Pooled Population: Time to First Hospital Discharge for Hospitalized Participants
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Assessment method [13]
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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.
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Timepoint [13]
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0
Day 1 to Day 28
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Secondary outcome [14]
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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
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Assessment method [14]
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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.
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Timepoint [14]
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0
Day 1 to Day 28
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Secondary outcome [15]
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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
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Assessment method [15]
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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.
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Timepoint [15]
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0
Day 1 to Day 28
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Secondary outcome [16]
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Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
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Assessment method [16]
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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.
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Timepoint [16]
0
0
Day 1 to Day 28
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Secondary outcome [17]
0
0
Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
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Assessment method [17]
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0
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 CRF. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [17]
0
0
Day 1 to Day 28
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Secondary outcome [18]
0
0
Part 2: Time to Mechanical Ventilation for Hospitalized Participants
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Assessment method [18]
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Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis.
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Timepoint [18]
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0
Day 1 to Day 28
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Secondary outcome [19]
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0
Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants
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Assessment method [19]
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Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis.
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Timepoint [19]
0
0
Day 1 to Day 28
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Secondary outcome [20]
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0
Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
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Assessment method [20]
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The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [20]
0
0
Day 1 to Day 28
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Secondary outcome [21]
0
0
Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
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Assessment method [21]
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0
The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [21]
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0
Day 1 to Day 28
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Secondary outcome [22]
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Part 2: Percentage of Hospitalized Participants Who Died During the Study
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Assessment method [22]
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The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [22]
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0
Day 1 to Day 28
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Secondary outcome [23]
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0
Pooled Population: Percentage of Hospitalized Participants Who Died During the Study
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Assessment method [23]
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The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [23]
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0
Day 1 to Day 28
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Secondary outcome [24]
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Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized
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Assessment method [24]
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Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days.
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Timepoint [24]
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0
Day 1 to Day 28
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Secondary outcome [25]
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Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized
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Assessment method [25]
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Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days.
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Timepoint [25]
0
0
Day 1 to Day 28
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Secondary outcome [26]
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0
Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
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Assessment method [26]
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0
Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [26]
0
0
Day 1 to Day 28
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Secondary outcome [27]
0
0
Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
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Assessment method [27]
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Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
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Timepoint [27]
0
0
Day 1 to Day 28
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Secondary outcome [28]
0
0
Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
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Assessment method [28]
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Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver Respiratory Syncytial Virus (RSV) Foundation (ReSVinet) score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14. During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease.
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Timepoint [28]
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0
Day 1 to Day 14
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Secondary outcome [29]
0
0
Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
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Assessment method [29]
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0
Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver ReSVinet score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14. During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease.
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Timepoint [29]
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0
Day 1 to Day 14
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Eligibility
Key inclusion criteria
* Male or female who is either =6 months to =36 months (for Age Group 1) or =28 days to <6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born =29 weeks of gestation to be eligible.
* Subjects diagnosed with RSV infection
* Subjects with signs of an acute respiratory illness with onset =7 days for Part 1 and =5 days for Part 2 before the time of signing the ICF
* In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
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Minimum age
28
Days
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Maximum age
36
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
* Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency)
* Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
* Receiving chronic oxygen therapy at home before admission
* Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (=37 weeks of gestation) and are less than 12 months of age
* In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/08/2024
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Sample size
Target
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Accrual to date
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Final
99
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
0
0
Sydney Children's Hospital - Randwick - Randwick
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Recruitment hospital [2]
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0
The Children's Hospital at Westmead - Westmead
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Recruitment hospital [3]
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0
Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
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0
2031 - Randwick
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Recruitment postcode(s) [2]
0
0
2145 - Westmead
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Recruitment postcode(s) [3]
0
0
- Southport
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Idaho
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kentucky
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Massachusetts
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Country [8]
0
0
United States of America
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State/province [8]
0
0
South Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Tennessee
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Texas
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Buenos Aires
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Bahía Blanca
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Country [13]
0
0
Argentina
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State/province [13]
0
0
Río Cuarto
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Country [14]
0
0
Argentina
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State/province [14]
0
0
Villa Regina
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Rio Grande Do Sul
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Curitiba
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Country [17]
0
0
Brazil
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State/province [17]
0
0
Ribeirão Preto
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Country [18]
0
0
Germany
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State/province [18]
0
0
Bundesland
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Country [19]
0
0
Germany
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State/province [19]
0
0
Erlangen
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Country [20]
0
0
Germany
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State/province [20]
0
0
Sankt Augustin
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Country [21]
0
0
Israel
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State/province [21]
0
0
Be'er Sheva
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Country [22]
0
0
Israel
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State/province [22]
0
0
Haifa
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Country [23]
0
0
Israel
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State/province [23]
0
0
Jerusalem
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Country [24]
0
0
Israel
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State/province [24]
0
0
Petach Tikva
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Country [25]
0
0
Korea, Republic of
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State/province [25]
0
0
Seoul
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Country [26]
0
0
Mexico
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State/province [26]
0
0
Prados
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Country [27]
0
0
Mexico
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State/province [27]
0
0
Mexico City
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Country [28]
0
0
Mexico
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State/province [28]
0
0
Monterrey
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Country [29]
0
0
Mexico
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State/province [29]
0
0
Querétaro
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Country [30]
0
0
New Zealand
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State/province [30]
0
0
Wellington
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Country [31]
0
0
Poland
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State/province [31]
0
0
Bydgoszcz
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Country [32]
0
0
Poland
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State/province [32]
0
0
Lódz
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Country [33]
0
0
Romania
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State/province [33]
0
0
Bra?ov
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Country [34]
0
0
Romania
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State/province [34]
0
0
Târgu Mure?
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Country [35]
0
0
Romania
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State/province [35]
0
0
Bucharest
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Soweto
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Spain
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Barcelona
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Santiago De Compostela
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Spain
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Tarragona
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Taiwan
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Hsinchu
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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United Kingdom
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Nottinghamshire
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United Kingdom
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London
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Enanta Pharmaceuticals, Inc
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
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Trial website
https://clinicaltrials.gov/study/NCT04816721
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Public notes
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Contacts
Principal investigator
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Enanta Pharmaceuticals, Inc
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Enanta Pharmaceuticals, Inc
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Contact person for public queries
Name
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Enanta Pharmaceuticals, Inc
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Phone
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(617) 607-0800
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/21/NCT04816721/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/21/NCT04816721/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04816721
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