Trial Outcomes & Findings for A Study to Evaluate EDP 938 Regimens in Children With RSV (NCT NCT04816721)
NCT ID: NCT04816721
Last Updated: 2025-07-28
Results Overview
Plasma concentrations of EDP-938 were assessed at the designated time points.
COMPLETED
PHASE2
99 participants
3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
2025-07-28
Participant Flow
A total of 99 participants were enrolled at 78 sites across 15 countries between April 2022 and August 2024.
Participants were randomized 2:1 (Part 1) or 4:1 (Part 2) to EDP-938:placebo.
Participant milestones
| Measure |
Part 1, Group 1: EDP-938
Participants aged ≥ 6 months to \< 12 months received oral 5 mg/kg doses of EDP-938 once daily (QD) from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 5 mg/kg or 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 2: EDP-938
Participants aged ≥ 28 days to \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 1: Placebo
Participants aged ≥ 6 months to ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 2: Placebo
Participants aged between ≥ 28 days and \< 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 1: EDP-938
Participants aged ≥ 6 months to \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 2: EDP-938
Participants aged ≥ 28 days to \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 1: Placebo
Participants aged between ≥ 6 months and ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 2: Placebo
Participants aged between ≥ 28 days and \< 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
14
|
11
|
6
|
20
|
16
|
6
|
4
|
|
Overall Study
Treated With 5 mg/kg EDP-938
|
14
|
13
|
0
|
0
|
8
|
15
|
0
|
0
|
|
Overall Study
Treated With 7.5 mg/kg EDP-938
|
9
|
0
|
0
|
0
|
11
|
0
|
0
|
0
|
|
Overall Study
Treated With Placebo
|
0
|
0
|
11
|
6
|
0
|
0
|
6
|
4
|
|
Overall Study
COMPLETED
|
22
|
12
|
11
|
4
|
19
|
15
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
2
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1, Group 1: EDP-938
Participants aged ≥ 6 months to \< 12 months received oral 5 mg/kg doses of EDP-938 once daily (QD) from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 5 mg/kg or 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 2: EDP-938
Participants aged ≥ 28 days to \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 1: Placebo
Participants aged ≥ 6 months to ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 2: Placebo
Participants aged between ≥ 28 days and \< 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 1: EDP-938
Participants aged ≥ 6 months to \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 2: EDP-938
Participants aged ≥ 28 days to \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 1: Placebo
Participants aged between ≥ 6 months and ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 2: Placebo
Participants aged between ≥ 28 days and \< 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Miscellaneous
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate EDP 938 Regimens in Children With RSV
Baseline characteristics by cohort
| Measure |
Part 1, Group 1: EDP-938
n=23 Participants
Participants aged ≥ 6 months to \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 5 mg/kg or 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 2: EDP-938
n=13 Participants
Participants aged ≥ 28 days to \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 1: Placebo
n=10 Participants
Participants aged between ≥ 6 months and ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1, Group 2: Placebo
n=6 Participants
Participants aged between ≥ 28 days and \< 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 1: EDP-938
n=19 Participants
Participants aged ≥ 6 months to \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study. Participants aged ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 2: EDP-938
n=15 Participants
Participants aged ≥ 28 days to \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 1: Placebo
n=6 Participants
Participants aged between ≥ 6 months and ≤ 36 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2, Group 2: Placebo
n=4 Participants
Participants aged between ≥ 28 days and \< 6 months received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
≥ 28 days to < 3 months
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
22 Participants
n=114 Participants
|
|
Age, Customized
≥ 3 months to < 6 months
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
16 Participants
n=114 Participants
|
|
Age, Customized
≥ 6 months to < 12 months
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
22 Participants
n=114 Participants
|
|
Age, Customized
≥ 12 months to ≤ 36 months
|
16 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
36 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
49 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
47 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
38 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
57 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
15 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
62 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Hospitalization Status on Day 1
Yes
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
77 Participants
n=114 Participants
|
|
Hospitalization Status on Day 1
No
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
19 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5Population: 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.
Plasma concentrations of EDP-938 were assessed at the designated time points.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=9 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=4 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
n=7 Participants
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
n=7 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
n=9 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 1: Concentrations of EDP-938 in Plasma
Day 1
|
1132.222 ng/mL
Standard Deviation 397.4289
|
1989.500 ng/mL
Standard Deviation 1331.5646
|
1819.286 ng/mL
Standard Deviation 809.9508
|
1420.000 ng/mL
Standard Deviation 604.8140
|
1428.250 ng/mL
Standard Deviation 817.4801
|
|
Part 1: Concentrations of EDP-938 in Plasma
Day 2
|
368.400 ng/mL
Standard Deviation 149.8741
|
399.250 ng/mL
Standard Deviation 423.9515
|
502.350 ng/mL
Standard Deviation 379.6487
|
249.675 ng/mL
Standard Deviation 294.5416
|
238.900 ng/mL
Standard Deviation 239.0287
|
|
Part 1: Concentrations of EDP-938 in Plasma
Day 3
|
448.000 ng/mL
Standard Deviation 229.1026
|
—
|
346.000 ng/mL
Standard Deviation 54.7449
|
97.533 ng/mL
Standard Deviation 64.9043
|
116.250 ng/mL
Standard Deviation 43.4871
|
|
Part 1: Concentrations of EDP-938 in Plasma
Day 5
|
528.563 ng/mL
Standard Deviation 284.6010
|
201.750 ng/mL
Standard Deviation 98.6623
|
431.429 ng/mL
Standard Deviation 637.5664
|
252.043 ng/mL
Standard Deviation 329.2155
|
180.622 ng/mL
Standard Deviation 158.3268
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=36 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=16 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
|
14 Participants
|
9 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and pre-dose on Days 3, 5, 9, and 14Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=34 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=10 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
Day 3
|
-1.33 log10 copies/mL
Standard Error 0.297
|
-0.37 log10 copies/mL
Standard Error 0.533
|
—
|
—
|
—
|
|
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
Day 5
|
-3.04 log10 copies/mL
Standard Error 0.354
|
-1.62 log10 copies/mL
Standard Error 0.627
|
—
|
—
|
—
|
|
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
Day 9
|
-3.65 log10 copies/mL
Standard Error 0.381
|
-3.22 log10 copies/mL
Standard Error 0.680
|
—
|
—
|
—
|
|
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples
Day 14
|
-4.87 log10 copies/mL
Standard Error 0.388
|
-5.71 log10 copies/mL
Standard Error 0.677
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and pre-dose on Days 3, 5, 9, and 14Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=69 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=27 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 3
|
-1.53 log10 copies/mL
Standard Error 0.192
|
-1.36 log10 copies/mL
Standard Error 0.331
|
—
|
—
|
—
|
|
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 5
|
-2.95 log10 copies/mL
Standard Error 0.230
|
-2.62 log10 copies/mL
Standard Error 0.392
|
—
|
—
|
—
|
|
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 9
|
-4.57 log10 copies/mL
Standard Error 0.275
|
-3.87 log10 copies/mL
Standard Error 0.475
|
—
|
—
|
—
|
|
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 14
|
-5.01 log10 copies/mL
Standard Error 0.278
|
-5.35 log10 copies/mL
Standard Error 0.462
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=34 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=12 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
n=29 Participants
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
n=9 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
Day 1 through Day 9
|
36.03 log10 copies/mL*Days
Standard Deviation 16.229
|
35.20 log10 copies/mL*Days
Standard Deviation 17.156
|
37.00 log10 copies/mL*Days
Standard Deviation 13.652
|
40.39 log10 copies/mL*Days
Standard Deviation 13.371
|
—
|
|
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
Day 1 through Day 3
|
17.80 log10 copies/mL*Days
Standard Deviation 4.522
|
17.26 log10 copies/mL*Days
Standard Deviation 4.691
|
17.15 log10 copies/mL*Days
Standard Deviation 4.663
|
16.91 log10 copies/mL*Days
Standard Deviation 3.266
|
—
|
|
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
Day 1 through Day 5
|
25.54 log10 copies/mL*Days
Standard Deviation 8.301
|
24.55 log10 copies/mL*Days
Standard Deviation 8.457
|
24.76 log10 copies/mL*Days
Standard Deviation 7.914
|
26.22 log10 copies/mL*Days
Standard Deviation 7.069
|
—
|
|
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load
Day 1 through Day 14
|
42.85 log10 copies/mL*Days
Standard Deviation 24.990
|
44.16 log10 copies/mL*Days
Standard Deviation 25.056
|
45.49 log10 copies/mL*Days
Standard Deviation 21.109
|
42.17 log10 copies/mL*Days
Standard Deviation 19.864
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=69 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=27 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
Day 1 through Day 3
|
-1.53 log10 copies/mL*Days
Standard Error 0.192
|
-1.36 log10 copies/mL*Days
Standard Error 0.331
|
—
|
—
|
—
|
|
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
Day 1 through Day 5
|
-6.00 log10 copies/mL*Days
Standard Error 0.540
|
-5.33 log10 copies/mL*Days
Standard Error 0.930
|
—
|
—
|
—
|
|
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
Day 1 through Day 9
|
-21.04 log10 copies/mL*Days
Standard Error 1.319
|
-18.32 log10 copies/mL*Days
Standard Error 2.272
|
—
|
—
|
—
|
|
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load
Day 1 through Day 14
|
-45.00 log10 copies/mL*Days
Standard Error 2.105
|
-41.36 log10 copies/mL*Days
Standard Error 3.619
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to pre-dose on Days 3, 5, 9, and Day 14Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=34 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=12 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 3
|
-1.68 log10 copies/mL
Standard Deviation 1.239
|
-2.17 log10 copies/mL
Standard Deviation 1.948
|
—
|
—
|
—
|
|
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 5
|
-2.91 log10 copies/mL
Standard Deviation 1.634
|
-3.44 log10 copies/mL
Standard Deviation 1.585
|
—
|
—
|
—
|
|
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 9
|
-5.34 log10 copies/mL
Standard Deviation 2.338
|
-4.41 log10 copies/mL
Standard Deviation 1.897
|
—
|
—
|
—
|
|
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples
Day 14
|
-5.11 log10 copies/mL
Standard Deviation 2.378
|
-5.15 log10 copies/mL
Standard Deviation 2.118
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 3, 5, 9 and 14Population: 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.
The RSV RNA viral load was measured using RT-qPCR from nasal swabs.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=34 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=12 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
n=28 Participants
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
n=9 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
Day 3
|
0 percentage of participants
Interval 0.0 to 10.28
|
8.3 percentage of participants
Interval 0.21 to 38.48
|
3.6 percentage of participants
Interval 0.09 to 18.35
|
0 percentage of participants
Interval 0.0 to 33.63
|
—
|
|
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
Day 5
|
12.1 percentage of participants
Interval 3.4 to 28.2
|
16.7 percentage of participants
Interval 2.09 to 48.41
|
22.2 percentage of participants
Interval 8.62 to 42.26
|
0 percentage of participants
Interval 0.0 to 33.63
|
—
|
|
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
Day 9
|
62.5 percentage of participants
Interval 43.69 to 78.9
|
36.4 percentage of participants
Interval 10.93 to 69.21
|
28.0 percentage of participants
Interval 12.07 to 49.39
|
25.0 percentage of participants
Interval 3.19 to 65.09
|
—
|
|
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)
Day 14
|
61.3 percentage of participants
Interval 42.19 to 78.15
|
58.3 percentage of participants
Interval 27.67 to 84.83
|
63.0 percentage of participants
Interval 42.37 to 80.6
|
88.9 percentage of participants
Interval 51.75 to 99.72
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 3, 5, 9 and 14Population: 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.
The RSV RNA viral load was measured using RT-qPCR from nasal swabs.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=62 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=21 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
Day 3
|
1.6 percentage of participants
Interval 0.04 to 8.66
|
4.8 percentage of participants
Interval 0.12 to 23.82
|
—
|
—
|
—
|
|
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
Day 5
|
16.7 percentage of participants
Interval 8.29 to 28.52
|
9.5 percentage of participants
Interval 1.17 to 30.38
|
—
|
—
|
—
|
|
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
Day 9
|
47.4 percentage of participants
Interval 33.98 to 61.03
|
31.6 percentage of participants
Interval 12.58 to 56.55
|
—
|
—
|
—
|
|
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD
Day 14
|
62.1 percentage of participants
Interval 48.37 to 74.49
|
71.4 percentage of participants
Interval 47.82 to 88.72
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=34 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=14 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
n=29 Participants
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
n=9 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable
|
10.59 days
Standard Deviation 3.661
|
12.33 days
Standard Deviation 3.018
|
12.46 days
Standard Deviation 3.235
|
12.19 days
Standard Deviation 3.040
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=63 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=23 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Time to RSV RNA Viral Load Being Undetectable
|
11.45 days
Standard Deviation 3.570
|
12.27 days
Standard Deviation 2.958
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=34 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=10 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants Who Experienced a TEAE
|
14 Participants
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=70 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=26 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Number of Participants Who Experienced a TEAE
|
28 Participants
|
13 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5Population: 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.
Plasma concentrations of EDP-938 were assessed at the designated time points.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=7 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=8 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
n=7 Participants
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
n=9 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Concentrations of EDP-938 in Plasma
Day 1
|
1116.286 ng/mL
Standard Deviation 217.9983
|
1169.903 ng/mL
Standard Deviation 802.0744
|
1551.429 ng/mL
Standard Deviation 363.8419
|
1368.111 ng/mL
Standard Deviation 469.7815
|
—
|
|
Part 2: Concentrations of EDP-938 in Plasma
Day 2
|
585.400 ng/mL
Standard Deviation 119.6089
|
273.500 ng/mL
Standard Deviation 150.4616
|
140.783 ng/mL
Standard Deviation 73.3099
|
200.700 ng/mL
Standard Deviation 134.3896
|
—
|
|
Part 2: Concentrations of EDP-938 in Plasma
Day 3
|
194.000 ng/mL
Standard Deviation NA
Standard deviation was not estimable as only 1 participant had available data.
|
926.000 ng/mL
Standard Deviation 57.9828
|
112.000 ng/mL
Standard Deviation NA
Standard deviation was not estimable as only 1 participant had available data.
|
115.967 ng/mL
Standard Deviation 84.9347
|
—
|
|
Part 2: Concentrations of EDP-938 in Plasma
Day 5
|
516.333 ng/mL
Standard Deviation 247.6697
|
519.714 ng/mL
Standard Deviation 436.8130
|
69.110 ng/mL
Standard Deviation 40.4604
|
153.450 ng/mL
Standard Deviation 102.4372
|
—
|
SECONDARY outcome
Timeframe: 3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5Population: 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.
Plasma concentrations of EDP-938 were assessed at the designated time points.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=16 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=12 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
n=14 Participants
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
n=7 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
n=18 Participants
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Concentrations of EDP-938 in Plasma
Day 1
|
1125.250 ng/mL
Standard Deviation 321.4278
|
1443.102 ng/mL
Standard Deviation 1027.5197
|
1685.357 ng/mL
Standard Deviation 619.0267
|
1420.000 ng/mL
Standard Deviation 604.8140
|
1396.412 ng/mL
Standard Deviation 635.3537
|
|
Pooled Population: Concentrations of EDP-938 in Plasma
Day 2
|
458.817 ng/mL
Standard Deviation 173.0322
|
323.800 ng/mL
Standard Deviation 276.9576
|
285.410 ng/mL
Standard Deviation 293.0727
|
249.675 ng/mL
Standard Deviation 294.5416
|
221.269 ng/mL
Standard Deviation 191.0117
|
|
Pooled Population: Concentrations of EDP-938 in Plasma
Day 3
|
363.333 ng/mL
Standard Deviation 218.5162
|
926.000 ng/mL
Standard Deviation 57.9828
|
287.500 ng/mL
Standard Deviation 125.2478
|
97.533 ng/mL
Standard Deviation 64.9043
|
116.080 ng/mL
Standard Deviation 63.8730
|
|
Pooled Population: Concentrations of EDP-938 in Plasma
Day 5
|
522.918 ng/mL
Standard Deviation 257.0945
|
404.091 ng/mL
Standard Deviation 378.3365
|
250.269 ng/mL
Standard Deviation 472.9799
|
252.043 ng/mL
Standard Deviation 329.2155
|
167.835 ng/mL
Standard Deviation 131.6054
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=29 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=7 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Time to First Hospital Discharge for Hospitalized Participants
|
3.93 days
Standard Deviation 1.870
|
4.00 days
Standard Deviation 3.367
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=56 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=21 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Time to First Hospital Discharge for Hospitalized Participants
|
3.71 days
Standard Deviation 2.006
|
3.57 days
Standard Deviation 2.959
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=1 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
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
|
0.51 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant had available data.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=29 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=7 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
|
24.1 percentage of participants
Interval 10.3 to 43.54
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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. Only participants who were hospitalized at randomization and/or during the study were included.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=56 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=21 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug
|
25.0 percentage of participants
Interval 14.39 to 38.37
|
19.0 percentage of participants
Interval 5.45 to 41.91
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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 only participants who were hospitalized at baseline and experienced mechanical ventilation were included, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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. As only participants who were hospitalized at baseline and experienced mechanical ventilation after their first dose of study drug were included, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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 hospitalized participants who were not on mechanical ventilation prior to the first dose of study drug were included.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=29 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=7 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
|
0 percentage of participants
Interval 0.0 to 11.94
|
0 percentage of participants
Interval 0.0 to 40.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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. Only hospitalized participants who were not on mechanical ventilation prior to the first dose of study drug were included.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=56 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=21 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation
|
0 percentage of participants
Interval 0.0 to 6.38
|
0 percentage of participants
Interval 0.0 to 16.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=29 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=7 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Hospitalized Participants Who Died During the Study
|
0 percentage of participants
Interval 0.0 to 11.94
|
0 percentage of participants
Interval 0.0 to 40.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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. Only participants who were hospitalized at randomization and/or during the study were included.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=56 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=21 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Percentage of Hospitalized Participants Who Died During the Study
|
0 percentage of participants
Interval 0.0 to 6.38
|
0 percentage of participants
Interval 0.0 to 16.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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 only participants who were not hospitalized at randomization but subsequently hospitalized were included, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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. As only participants who were not hospitalized at randomization but subsequently hospitalized were included, no data were collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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 not hospitalized at randomization were included.
Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=5 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=3 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
|
0 percentage of participants
Interval 0.0 to 52.18
|
0 percentage of participants
Interval 0.0 to 70.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: 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. Only participants who were not hospitalized at randomization were included.
Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=13 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=6 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died
|
0 percentage of participants
Interval 0.0 to 24.71
|
0 percentage of participants
Interval 0.0 to 45.93
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 14Population: 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 not hospitalized were included.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=3 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=2 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
|
2.60 days
Standard Deviation 1.686
|
1.49 days
Standard Deviation 0.702
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 14Population: 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. Only participants who were not hospitalized were included.
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.
Outcome measures
| Measure |
Part 1: EDP-938 5mg/kg (≥ 28 Days to < 3 Months)
n=8 Participants
Participants aged between ≥ 28 days and \< 3 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 3 Months to < 6 Months)
n=5 Participants
Participants aged between ≥ 3 months and \< 6 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 6 Months to < 12 Months)
Participants aged between ≥ 6 months and \< 12 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 5mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: EDP-938 7.5 mg/kg (≥ 12 Months to ≤ 36 Months)
Participants aged between ≥ 12 months to ≤ 36 months received oral 7.5 mg/kg doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|---|
|
Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized
|
2.42 days
Standard Deviation 1.163
|
4.20 days
Standard Deviation 5.552
|
—
|
—
|
—
|
Adverse Events
Part 1: EDP-938
Part 1: Placebo
Part 2: EDP-938
Part 2: Placebo
Serious adverse events
| Measure |
Part 1: EDP-938
n=36 participants at risk
Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: Placebo
n=16 participants at risk
Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2: EDP-938
n=34 participants at risk
Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2: Placebo
n=10 participants at risk
Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/16 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
2.9%
1/34 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
Other adverse events
| Measure |
Part 1: EDP-938
n=36 participants at risk
Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 1: Placebo
n=16 participants at risk
Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2: EDP-938
n=34 participants at risk
Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study.
|
Part 2: Placebo
n=10 participants at risk
Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study.
|
|---|---|---|---|---|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/16 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
10.0%
1/10 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/16 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
10.0%
1/10 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/16 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
5.9%
2/34 • Number of events 2 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/16 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
10.0%
1/10 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
4/36 • Number of events 4 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
8.8%
3/34 • Number of events 3 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
2.9%
1/34 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.8%
1/36 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.8%
1/36 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
2.9%
1/34 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/16 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
5.9%
2/34 • Number of events 2 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
10.0%
1/10 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
2.9%
1/34 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
10.0%
1/10 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Otitis media acute
|
2.8%
1/36 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
2.9%
1/34 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/36 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
6.2%
1/16 • Number of events 1 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/34 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
0.00%
0/10 • Up to Day 28
The analysis population for serious adverse events and other (non-serious) adverse events was the safety population which included all participants who received any dose (including partial doses) of any study drug. Per Section 4.1 of the SAP, analyses were planned to be grouped by treatment, rather than by specific dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place