Trial Outcomes & Findings for A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. (NCT NCT05568706)

Last Updated: 2026-08-19

Results Overview

Resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution of LRTD symptoms is calculated as: date/time of resolution - date/time of first dose with conversion to days.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

187 participants

Primary outcome timeframe

Day 1 through Day 33

Results posted on

2026-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	EDP-938 EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Overall Study STARTED	123	64
Overall Study COMPLETED	116	60
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	EDP-938 EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	6	2
Overall Study Death	0	1

Baseline Characteristics

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days	Total n=175 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 14.29 • n=298 Participants	68.1 years STANDARD_DEVIATION 15.46 • n=102 Participants	68.0 years STANDARD_DEVIATION 14.66 • n=400 Participants
Sex: Female, Male Female	69 Participants n=298 Participants	45 Participants n=102 Participants	114 Participants n=400 Participants
Sex: Female, Male Male	46 Participants n=298 Participants	15 Participants n=102 Participants	61 Participants n=400 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	72 Participants n=298 Participants	29 Participants n=102 Participants	101 Participants n=400 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=298 Participants	31 Participants n=102 Participants	74 Participants n=400 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=298 Participants	0 Participants n=102 Participants	0 Participants n=400 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=298 Participants	0 Participants n=102 Participants	1 Participants n=400 Participants
Race (NIH/OMB) Asian	4 Participants n=298 Participants	2 Participants n=102 Participants	6 Participants n=400 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=298 Participants	1 Participants n=102 Participants	2 Participants n=400 Participants
Race (NIH/OMB) Black or African American	11 Participants n=298 Participants	2 Participants n=102 Participants	13 Participants n=400 Participants
Race (NIH/OMB) White	98 Participants n=298 Participants	54 Participants n=102 Participants	152 Participants n=400 Participants
Race (NIH/OMB) More than one race	0 Participants n=298 Participants	0 Participants n=102 Participants	0 Participants n=400 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=298 Participants	1 Participants n=102 Participants	1 Participants n=400 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 33

Population: Modified Intent-to-Treat (mITT) population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who meet the resolution definition at baseline are excluded from the analysis.

Outcome measures

Outcome measures
Measure	EDP-938 n=100 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=54 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Resolution of RSV Lower Respiratory Tract Disease (LRTD) Symptoms	5.0 days Interval 4.0 to 7.0	4.1 days Interval 3.0 to 5.9

PRIMARY outcome

Timeframe: Day 1 through Day 33

Population: Modified Intent-to-Treat (mITT) population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug. Subjects without complete resolution prior to Day 33 are censored at Day 33. Subjects who meet the complete resolution definition at baseline are excluded from the analysis.

Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=84 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=47 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Complete Resolution of LRTD Symptoms for the mITT Population	12.5 Days Interval 11.2 to 15.3	13.0 Days Interval 9.6 to 19.0

PRIMARY outcome

Timeframe: Day 1 through Day 33

Population: HR3 Population: All subjects in the mITT population excluding (1) those who are \<65 years of age with asthma as the only condition that predisposes to complications after RSV infection and (2) those who are \>=65 to \<=74 years of age with no other condition that predisposes to complications after RSV infection. Subjects without complete resolution prior to Day 33 are censored at Day 33. Subjects who meet the complete resolution definition at baseline are excluded from the analysis.

Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by RiiQTM Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=66 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=38 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Complete Resolution of LRTD Symptoms for the HR3 Population	12.0 Days Interval 10.0 to 15.2	15.0 Days Interval 9.9 to 20.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who meet the resolution definition at baseline are excluded from the analysis.

Resolution of LRTD and 2 Systemic Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) and each of the 2 systemic symptoms (feeling fever and fatigue/tiredness) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero or 1; Higher scores indicate worse outcomes (greater symptom intensity and greater impact on daily functioning). Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=103 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=56 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Resolution of LRTD Symptoms and 2 Systemic Symptoms	5.0 days Interval 4.1 to 6.0	5.0 days Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who meet the resolution definition at baseline are excluded from the analysis.

Resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQ Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=103 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=56 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Resolution of All RSV Symptoms	5.9 days Interval 5.0 to 6.8	5.0 days Interval 4.8 to 7.1

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug. Subjects without complete resolution prior to Day 33 are censored at Day 33. Subjects who meet the complete resolution definition at baseline are excluded from the analysis.

Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero. Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=81 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=43 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Complete Resolution of All RSV Symptoms for the mITT Population	13.8 Days Interval 12.0 to 16.1	16.0 Days Interval 12.0 to 23.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: HR3 Population=All subjects in the mITT population excluding (1) those who are \<65 years of age with asthma as the only condition that predisposes to complications after RSV infection and (2) those who are \>=65 to \<=74 years of age with no other condition that predisposes to complications after RSV infection. Subjects without complete resolution prior to Day 33 are censored at Day 33. Subjects who meet the complete resolution definition at baseline are excluded from the analysis.

Outcome measures

Outcome measures
Measure	EDP-938 n=64 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=34 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Complete Resolution of All RSV Symptoms for the HR3 Population	12.2 Days Interval 11.1 to 16.1	18.9 Days Interval 13.0 to 24.7

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: Subjects included in the mITT population with non-missing measurements at Baseline and specified timepoints.

The RiiQ Infection Intensity Scale assesses 4 symptoms of LRTD (cough, shortness of breath, wheezing, and expectoration) on a scale from 0 (absent) to 3 (severe). The composite LRTD Score is the average of all 4 individual item scores.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Change From Baseline in Severity of RSV LRTD Symptoms Day 2	-0.320 RiiQ Scale Score Standard Deviation 0.5362	-0.315 RiiQ Scale Score Standard Deviation 0.5056
Change From Baseline in Severity of RSV LRTD Symptoms Day 3	-0.411 RiiQ Scale Score Standard Deviation 0.5411	-0.513 RiiQ Scale Score Standard Deviation 0.6168
Change From Baseline in Severity of RSV LRTD Symptoms Day 5	-0.815 RiiQ Scale Score Standard Deviation 0.6400	-0.811 RiiQ Scale Score Standard Deviation 0.5830
Change From Baseline in Severity of RSV LRTD Symptoms Day 7	-1.052 RiiQ Scale Score Standard Deviation 0.6785	-1.022 RiiQ Scale Score Standard Deviation 0.7043
Change From Baseline in Severity of RSV LRTD Symptoms Day 9	-1.165 RiiQ Scale Score Standard Deviation 0.7136	-1.086 RiiQ Scale Score Standard Deviation 0.7427
Change From Baseline in Severity of RSV LRTD Symptoms Day 14	-1.376 RiiQ Scale Score Standard Deviation 0.6785	-1.327 RiiQ Scale Score Standard Deviation 0.6699
Change From Baseline in Severity of RSV LRTD Symptoms Day 33	-1.439 RiiQ Scale Score Standard Deviation 0.7911	-1.473 RiiQ Scale Score Standard Deviation 0.7378

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: Subjects included in the mITT population with non-missing measurements at Baseline and specified timepoints.

The RiiQ Impact Scale assesses daily activities (7 items), emotions (4 items), and social relationships (5 items) on a scale of 0 (no impact) to 3 (extreme impact). The composite Impact Score is the average of all 16 individual item scores.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Change From Baseline for Impact Scale Day 2	-0.314 Impact Scale Score Standard Deviation 0.5568	-0.229 Impact Scale Score Standard Deviation 0.6998
Change From Baseline for Impact Scale Day 3	-0.415 Impact Scale Score Standard Deviation 0.6554	-0.434 Impact Scale Score Standard Deviation 0.7848
Change From Baseline for Impact Scale Day 5	-0.640 Impact Scale Score Standard Deviation 0.6847	-0.592 Impact Scale Score Standard Deviation 0.7620
Change From Baseline for Impact Scale Day 7	-0.864 Impact Scale Score Standard Deviation 0.8279	-0.707 Impact Scale Score Standard Deviation 0.8685
Change From Baseline for Impact Scale Day 9	-1.001 Impact Scale Score Standard Deviation 0.9005	-0.786 Impact Scale Score Standard Deviation 0.9597
Change From Baseline for Impact Scale Day 14	-1.001 Impact Scale Score Standard Deviation 0.8945	-0.940 Impact Scale Score Standard Deviation 0.8526
Change From Baseline for Impact Scale Day 33	-1.154 Impact Scale Score Standard Deviation 0.8800	-1.130 Impact Scale Score Standard Deviation 0.8767

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who meet the resolution definition at baseline are excluded from the analysis.

Resolution of Symptoms is defined as the first of two consecutive timepoints where each of the RSV symptoms (4 LRTD symptoms \[cough, short of breath, wheezing, coughing up phlegm \[sputum\]\], 2 URTD symptoms \[nasal congestion and sore throat\], 2 Systemic symptoms \[feeling feverish and fatigue\[tiredness\]\]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=103 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=56 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Resolution of Upper Respiratory Tract Disease Congestion, LRTD, and 2 Systemic Symptoms	5.8 days Interval 5.0 to 6.2	5.0 days Interval 4.0 to 6.1

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who have no or mild impact of RSV disease at baseline are excluded from the analysis.

Resolution of No or Mild Impact of RSV is defined as the first of two consecutive timepoints where each of the 3 impact Scale Scores (daily activities, emotions and social relationships) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=79 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=40 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to no or Mild Impact of RSV Disease on Daily Activities, Emotions, and Social Relationships	3.0 days Interval 2.0 to 3.0	2.0 days Interval 1.9 to 4.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Percentage of Participants With Post-baseline RSV-related Complications	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without improvement prior to Day 33 are censored at Day 33.

Time to Improvement is defined as the time from first dose to first timepoint where the response assessed by PGI-C is 'Much better'. Time to Improvement is calculated as: date/time of Improvement - date/time of first timepoint.

Outcome measures

Outcome measures
Measure	EDP-938 n=94 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=47 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Improvement in RSV Disease	5.0 days Interval 4.0 to 6.0	6.0 days Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: Subjects included in the mITT population with non-missing measurements at Baseline and specified timepoints.

Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire; 5 dimensions (mobility, taking care of yourself, usual activities, pain/discomfort, and anxiety/depression) are scored on 5 levels from 1 (full health) to 5 (extreme disability). An index score is derived based on the 5 reported levels where 1.0 represents full health and 0.0 the worst possible health.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Change From Baseline for Health-Related Quality of Life Day 5	0.108 EQ-5D 5L Score Standard Deviation 0.1836	0.083 EQ-5D 5L Score Standard Deviation 0.1407
Change From Baseline for Health-Related Quality of Life Day 9	0.207 EQ-5D 5L Score Standard Deviation 0.2030	0.152 EQ-5D 5L Score Standard Deviation 0.1679
Change From Baseline for Health-Related Quality of Life Day 14	0.210 EQ-5D 5L Score Standard Deviation 0.2142	0.169 EQ-5D 5L Score Standard Deviation 0.1549
Change From Baseline for Health-Related Quality of Life Day 33	0.233 EQ-5D 5L Score Standard Deviation 0.1951	0.182 EQ-5D 5L Score Standard Deviation 0.1544

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without return to usual health prior to Day 33 are censored at Day 33.

Time to return to usual health is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Health is 'Yes'. Time to return to usual health is calculated as: date/time of return to usual health - date/time of response to 'Yes'.

Outcome measures

Outcome measures
Measure	EDP-938 n=100 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=51 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Return to Usual Health	8.0 days Interval 6.1 to 10.0	8.0 days Interval 6.0 to 10.7

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population. Subjects without resolution prior to Day 33 are censored at Day 33.

Time to return to usual activities is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Activities is 'Yes'. Time to return to usual activities is calculated as: date/time of return to usual activities - date/time of first response to 'Yes'.

Outcome measures

Outcome measures
Measure	EDP-938 n=101 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=46 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Return to Usual Activities	6.0 days Interval 5.0 to 7.0	6.5 days Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Percentage of Subjects Requiring Hospitalization for RSV or Other Causes	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population subjects requiring hospitalization for RSV Infection or other causes.

Outcome measures

Outcome measures
Measure	EDP-938 n=2 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=3 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Duration of Hospitalization for RSV or Other Causes	3.5 days Interval 3.0 to 4.0	7.0 days Interval 5.0 to 11.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
All-cause Mortality	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Days 3, 5, 9, and 14

Population: Subjects included in the mITT population with non-missing measurements at Baseline and specified timepoints. Data presented is the Mixed Model Repeated Measures (MMRM) adjusted Least Square (LS) mean score.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
RSV RNA Viral Load Change From Baseline for the mITT Population Day 3	-1.199 RSV viral load (log10 copies/mL) Standard Error 0.1757	-0.803 RSV viral load (log10 copies/mL) Standard Error 0.2417
RSV RNA Viral Load Change From Baseline for the mITT Population Day 5	-2.153 RSV viral load (log10 copies/mL) Standard Error 0.2107	-1.561 RSV viral load (log10 copies/mL) Standard Error 0.2895
RSV RNA Viral Load Change From Baseline for the mITT Population Day 9	-3.698 RSV viral load (log10 copies/mL) Standard Error 0.2289	-3.401 RSV viral load (log10 copies/mL) Standard Error 0.3072
RSV RNA Viral Load Change From Baseline for the mITT Population Day 14	-4.424 RSV viral load (log10 copies/mL) Standard Error 0.1985	-4.326 RSV viral load (log10 copies/mL) Standard Error 0.2635

SECONDARY outcome

Timeframe: Up to Day 14

Population: Subjects included in the mITT population with non-missing measurements at Baseline and specified timepoints.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Change in Infectious RSV Viral Load Over Time Day 14	-0.664 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.4534	-0.908 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.6033
Change in Infectious RSV Viral Load Over Time Day 5	-0.656 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.4389	-0.836 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.7683
Change in Infectious RSV Viral Load Over Time Day 9	-0.662 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.4442	-0.937 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.6041
Change in Infectious RSV Viral Load Over Time Day 3	-0.590 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.4789	-0.517 RSV Viral Load (log10 TCID50/ml) Standard Deviation 1.5516

SECONDARY outcome

Timeframe: Days 1, 3, 5, 9 and 14

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population Day 1	4 Participants	3 Participants
Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population Day 3	14 Participants	5 Participants
Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population Day 5	27 Participants	6 Participants
Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population Day 9	55 Participants	26 Participants
Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population Day 14	70 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 14

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug. Subjects without achieving RSV RNA viral load TND are censored on Day 14 assessment date.

Time to RSV viral load TND is defined as the time between the date of first dose to the first date of achieving viral load TND.

Outcome measures

Outcome measures
Measure	EDP-938 n=77 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=40 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to RSV RNA Viral Load TND for the mITT Population	8.0 Days Interval 7.9 to 12.8	11.9 Days Interval 8.0 to 13.0

SECONDARY outcome

Timeframe: Up to Day 5

Population: Pharmacokinetic Population: includes all subjects receiving active study drug and having any measurable plasma concentration of study drug at any time point. Number of subjects with evaluable data.

Outcome measures

Outcome measures
Measure	EDP-938 n=112 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Plasma PK Concentrations of EDP-938 Visit 1 - Postdose	847.00 ng/mL Interval 0.0 to 5200.0	—
Plasma PK Concentrations of EDP-938 Visit 2 - Predose	926.00 ng/mL Interval 0.0 to 5060.0	—
Plasma PK Concentrations of EDP-938 Visit 3 - Predose	979.50 ng/mL Interval 0.0 to 4040.0	—
Plasma PK Concentrations of EDP-938 Early Disc/EOS	883.00 ng/mL Interval 366.0 to 1400.0	—

SECONDARY outcome

Timeframe: Up to Day 33

Population: Safety Population: includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65.

Number of subjects experiencing any Treatment-Emergent Adverse Events (TEAEs)

Outcome measures

Outcome measures
Measure	EDP-938 n=121 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=65 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Safety as Measured by Frequency of Adverse Events (AEs)	27 Participants	16 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who meet the resolution definition at baseline are excluded from the analysis.

PGI-S is a 7-point patient-reported scale ranging from 1 (normal/none) to 7 (among the most extremely ill); lower scores indicate less severe disease. Time to resolution is defined as time from the first dose to first of two consecutive timepoints where the response assessed by PGI-S is 'None'. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

Outcome measures

Outcome measures
Measure	EDP-938 n=92 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=46 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Resolution of RSV Infection Symptoms by Patient Global Impression of Severity (PGI-S) Scale Score for the mITT Population	9.0 Days Interval 8.0 to 10.0	10.9 Days Interval 9.0 to 15.0

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug.

Incidence was defined as the number of subjects with new antibiotic, bronchodilators, inhaled corticosteroids or oxygen use

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Incidence of New Antibiotic Use, or New or Increased Use of Bronchodilators, Systemic or Inhaled Corticosteroids, or Oxygen Supplementation for the mITT Population	16 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug.

Incidence was defined as the number of subjects with unscheduled medically attended visits for RSV infection or other causes.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Incidence of Unscheduled Medically Attended Visits for RSV Infection or Other Causes for the mITT Population	8 Participants	4 Participants

POST_HOC outcome

Timeframe: Day 1 through Day 33

Population: HR3 Population: All subjects in the mITT population excluding (1) those who are \<65 years of age with asthma as the only condition that predisposes to complications after RSV infection and (2) those who are \>=65 to \<=74 years of age with no other condition that predisposes to complications after RSV infection. Data presented is the Mixed Model Repeated Measures (MMRM) adjusted Least Square (LS) mean score.

The RiiQ Infection Intensity Scale assesses 4 lower respiratory, 2 upper respiratory, and 7 systemic symptoms on a scale of 0 (absent) to 3 (severe). The composite Total Symptom Score is the average of all 13 individual item scores.

Outcome measures

Outcome measures
Measure	EDP-938 n=92 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=50 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 2	1.213 MMRM adjusted LS mean score Standard Error 0.0420	1.209 MMRM adjusted LS mean score Standard Error 0.0561
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 3	1.072 MMRM adjusted LS mean score Standard Error 0.0464	1.061 MMRM adjusted LS mean score Standard Error 0.0622
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 5	0.713 MMRM adjusted LS mean score Standard Error 0.0446	0.723 MMRM adjusted LS mean score Standard Error 0.0597
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 7	0.452 MMRM adjusted LS mean score Standard Error 0.0468	0.569 MMRM adjusted LS mean score Standard Error 0.0620
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 9	0.320 MMRM adjusted LS mean score Standard Error 0.0443	0.470 MMRM adjusted LS mean score Standard Error 0.0586
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 14	0.194 MMRM adjusted LS mean score Standard Error 0.0369	0.331 MMRM adjusted LS mean score Standard Error 0.0493
Total RSV Symptom Score by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale for the HR3 Population Day 33	0.083 MMRM adjusted LS mean score Standard Error 0.0224	0.095 MMRM adjusted LS mean score Standard Error 0.0302

POST_HOC outcome

Timeframe: Day 1 through Day 33

Population: mITT population: all randomized subjects positively diagnosed with RSV using the central RT-qPCR test who receive at least one dose of assigned study drug. Data presented is the Mixed Model Repeated Measures (MMRM) adjusted Least Square (LS) mean score.

Outcome measures

Outcome measures
Measure	EDP-938 n=115 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=60 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 2	1.208 MMRM adjusted LS mean score Standard Error 0.0377	1.172 MMRM adjusted LS mean score Standard Error 0.0514
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 3	1.049 MMRM adjusted LS mean score Standard Error 0.0428	1.001 MMRM adjusted LS mean score Standard Error 0.0587
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 5	0.695 MMRM adjusted LS mean score Standard Error 0.0397	0.686 MMRM adjusted LS mean score Standard Error 0.0543
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 7	0.456 MMRM adjusted LS mean score Standard Error 0.0415	0.517 MMRM adjusted LS mean score Standard Error 0.0563
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 9	0.332 MMRM adjusted LS mean score Standard Error 0.0387	0.425 MMRM adjusted LS mean score Standard Error 0.0523
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 14	0.211 MMRM adjusted LS mean score Standard Error 0.0333	0.300 MMRM adjusted LS mean score Standard Error 0.0454
Total RSV Symptom Score by RiiQ Scale for the mITT Population Day 33	0.069 MMRM adjusted LS mean score Standard Error 0.0183	0.078 MMRM adjusted LS mean score Standard Error 0.0253

POST_HOC outcome

Timeframe: Days 3, 5, 9, and 14

Population: HR3 Population: All subjects in the mITT population excluding (1) those who are \<65 years of age with asthma as the only condition that predisposes to complications after RSV infection and (2) those who are \>=65 to \<=74 years of age with no other condition that predisposes to complications after RSV infection. Data presented is the Mixed Model Repeated Measures (MMRM) adjusted Least Square (LS) mean score.

Outcome measures

Outcome measures
Measure	EDP-938 n=92 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=50 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
RSV RNA Viral Load Change From Baseline for the HR3 Population Day 3	-1.079 RSV viral load (log10 copies/mL) Standard Error 0.2096	-0.522 RSV viral load (log10 copies/mL) Standard Error 0.2827
RSV RNA Viral Load Change From Baseline for the HR3 Population Day 5	-1.880 RSV viral load (log10 copies/mL) Standard Error 0.2407	-1.226 RSV viral load (log10 copies/mL) Standard Error 0.3233
RSV RNA Viral Load Change From Baseline for the HR3 Population Day 9	-3.437 RSV viral load (log10 copies/mL) Standard Error 0.2697	-2.904 RSV viral load (log10 copies/mL) Standard Error 0.3510
RSV RNA Viral Load Change From Baseline for the HR3 Population Day 14	-4.046 RSV viral load (log10 copies/mL) Standard Error 0.2475	-3.865 RSV viral load (log10 copies/mL) Standard Error 0.3149

POST_HOC outcome

Timeframe: Day 1 through Day 33

Complete resolution of total RiiQ scale score (Q1-29) is defined as the first of two consecutive timepoints where the score of each of the 29 questions is zero. Time to complete resolution (days) is calculated as: date/time of complete resolution - date/time of first dose.

Outcome measures

Outcome measures
Measure	EDP-938 n=78 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=38 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Complete Resolution of Total Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score for the mITT Population	15.3 Days Interval 12.2 to 19.5	18.9 Days Interval 13.1 to 28.0

POST_HOC outcome

Timeframe: Day 1 through Day 33

Outcome measures

Outcome measures
Measure	EDP-938 n=61 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=29 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Complete Resolution of Total RiiQ Scale Score for the HR3 Population	13.8 Days Interval 11.9 to 19.9	21.0 Days Interval 13.1 to Upper limit of 95% confidence interval was not estimable due to a limited number of resolution events.

POST_HOC outcome

Timeframe: Day 1 through Day 33

Population: HR3 Population: All subjects in the mITT population excluding (1) those who are \<65 years of age with asthma as the only condition that predisposes to complications after RSV infection and (2) those who are \>=65 to \<=74 years of age with no other condition that predisposes to complications after RSV infection. Subjects without resolution prior to Day 33 are censored at Day 33. Subjects who meet the resolution definition at baseline are excluded from the analysis.

Outcome measures

Outcome measures
Measure	EDP-938 n=78 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=36 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to Resolution of RSV Infection Symptoms by PGI-S Scale Score for the HR3 Population	9.0 Days Interval 8.0 to 11.0	10.9 Days Interval 9.0 to 16.0

POST_HOC outcome

Timeframe: Days 1, 3, 5, 9 and 14

Outcome measures

Outcome measures
Measure	EDP-938 n=92 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=50 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Proportion of Subjects With RSV RNA Viral Load TND for the HR3 Population Day 1	4 Participants	3 Participants
Proportion of Subjects With RSV RNA Viral Load TND for the HR3 Population Day 3	14 Participants	4 Participants
Proportion of Subjects With RSV RNA Viral Load TND for the HR3 Population Day 5	22 Participants	5 Participants
Proportion of Subjects With RSV RNA Viral Load TND for the HR3 Population Day 9	44 Participants	18 Participants
Proportion of Subjects With RSV RNA Viral Load TND for the HR3 Population Day 14	52 Participants	27 Participants

POST_HOC outcome

Timeframe: Day 1 through Day 14

Population: HR3 Population: All subjects in the mITT population excluding (1) those who are \<65 years of age with asthma as the only condition that predisposes to complications after RSV infection and (2) those who are \>=65 to \<=74 years of age with no other condition that predisposes to complications after RSV infection. Subjects without achieving RSV RNA viral load TND are censored on Day 14 assessment date.

Time to RSV viral load TND is defined as the time between the date of first dose to the first date of achieving viral load TND.

Outcome measures

Outcome measures
Measure	EDP-938 n=57 Participants EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=30 Participants Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Time to RSV RNA Viral Load TND for the HR3 Population	8.0 Days Interval 7.8 to 13.0	12.9 Days Interval 8.0 to 13.1

Adverse Events

EDP-938

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	EDP-938 n=121 participants at risk EDP-938 800 mg, once daily EDP-938: Subjects took EDP-938 once daily for 5 days	Placebo n=65 participants at risk Matching placebo, once daily Placebo: Subjects took matching placebo, once daily for 5 days
Infections and infestations Influenza	0.83% 1/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	0.00% 0/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Infections and infestations Pneumonia	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Infections and infestations Pneumonia bacterial	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Respiratory, thoracic and mediastinal disorders Asthma	0.83% 1/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	0.00% 0/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Cardiac disorders Cardiac failure chronic	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
General disorders Systemic inflammatory response syndrome	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.
Renal and urinary disorders Renal impairment	0.00% 0/121 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.	1.5% 1/65 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 33. Serious Adverse Events and Other Adverse Events are reported for the Safety Population which includes all subjects who receive at least one dose of study drug. NOTE: One subject randomized to receive EDP-938 actually received Placebo, increasing the N to 65. All Cause Mortality is reported for the mITT population.

Other adverse events

Additional Information

Medical Monitor

Enanta Pharmaceuticals, Inc

Phone: 617-607-0800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Enanta's standard agreement is to retain rights to first publication of the data with no other disclosure restrictions.
Publication restrictions are in place

Restriction type: OTHER