Trial Outcomes & Findings for Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection (NCT NCT04488575)

NCT ID: NCT04488575

Last Updated: 2022-12-19

Results Overview

Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) \[S/F ratio\]

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2022-12-19

Participant Flow

Participant milestones

Measure	Placebo Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Overall Study STARTED	7	9
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection

Baseline characteristics by cohort

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14	-30.0 Ratio Standard Deviation 114.95	-63.8 Ratio Standard Deviation 76.85

SECONDARY outcome

Timeframe: 14 days

Population: All participants providing data at the relevant timepoints.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Change in S/F Ratio Day 4	37.4 Ratio Interval -59.0 to 148.0	-23.0 Ratio Interval -188.0 to 167.0
Change in S/F Ratio Day 7	-16.0 Ratio Interval -65.0 to 20.0	-86.7 Ratio Interval -130.0 to 6.0
Change in S/F Ratio Day 10	37.0 Ratio Interval -68.0 to 142.0	-111.0 Ratio Interval -115.0 to -107.0
Change in S/F Ratio Day 14	-83.0 Ratio Interval -83.0 to -83.0	-14.0 Ratio Interval -53.0 to 25.0

SECONDARY outcome

Timeframe: 14 days

Population: All participants providing data at the relevant timepoints.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Percentage Change in S/F Ratio Day 4	10.97 percentage change Interval -33.1 to 49.3	-5.33 percentage change Interval -66.0 to 104.4
Percentage Change in S/F Ratio Day 7	-10.41 percentage change Interval -36.5 to 8.4	-36.48 percentage change Interval -57.6 to 2.1
Percentage Change in S/F Ratio Day 10	109.7 percentage change Interval -38.2 to 147.9	-46.6 percentage change Interval -48.7 to -44.4
Percentage Change in S/F Ratio Day 14	-46.6 percentage change Interval -46.6 to -46.6	-5.7 percentage change Interval -22.0 to 10.6

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data at the relevant timepoints.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42.

(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 0	1 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 1	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 2	0 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 3	1 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 4	5 Participants	5 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 5	0 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 6	0 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 7	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 4 · WHO OSCI score - 8	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 0	1 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 1	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 2	3 Participants	2 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 3	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 4	2 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 5	1 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 6	0 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 7	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 7 · WHO OSCI score - 8	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 0	3 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 1	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 2	2 Participants	3 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 3	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 4	1 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 5	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 6	0 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 7	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 14 · WHO OSCI score - 8	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 0	4 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 1	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 2	1 Participants	4 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 3	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 4	1 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 5	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 6	0 Participants	1 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 7	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 21 · WHO OSCI score - 8	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 0	4 Participants	3 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 1	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 2	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 3	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 4	1 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 5	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 6	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 7	0 Participants	0 Participants
Percentage of Participants at Each Level on the WHO OSCI Score Day 42 · WHO OSCI score - 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data at the relevant timepoints.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42.

(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 0	1 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 2	0 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 3	1 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 4	4 Participants	5 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 5	0 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 6	0 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 4; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 0	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 2	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 4	1 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 6	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 4 · Baseline WHO OSCI score 5; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 0	1 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 2	3 Participants	2 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 4	1 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 5	1 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 6	0 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 4; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 0	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 2	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 4	1 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 6	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day7 · Baseline WHO OSCI score 5; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 0	3 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 2	2 Participants	3 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 4	1 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 6	0 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 4; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 0	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 2	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 4	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 6	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 14 · Baseline WHO OSCI score 5; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 0	4 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 2	1 Participants	4 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 4	1 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 6	0 Participants	1 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 4; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 0	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 2	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 4	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 6	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 21 · Baseline WHO OSCI score 5; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 0	4 Participants	3 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 2	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 4	1 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 6	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 4; WHO OSCI Score - 8	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 0	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 1	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 2	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 3	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 4	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 5	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 6	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 7	0 Participants	0 Participants
Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline Day 42 · Baseline WHO OSCI score 5; WHO OSCI Score - 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data at the relevant timepoints.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.

(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) Day 4	7 Participants	7 Participants
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) Day 7	6 Participants	3 Participants
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) Day 14	5 Participants	4 Participants
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) Day 21	5 Participants	4 Participants
Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower) Day 42	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 42 days

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day.

(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Score = 3	1 Participants	0 Participants
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Score = 4	4 Participants	7 Participants
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Score = 5	2 Participants	1 Participants
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Score = 6	0 Participants	1 Participants
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Score = 7	0 Participants	0 Participants
Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day Score = 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data at the relevant timepoints.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 5; 4-7 days	1 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 3; 1 day	1 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 3; 2-3 days	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 3; 4-7 days	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 3; >7 days	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 4; 1 day	0 Participants	2 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 4; 2-3 days	2 Participants	3 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 4; 4-7 days	2 Participants	1 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 4; >7 days	0 Participants	1 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 5: 1 day	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 5; 2-3 days	1 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 5; >7days	0 Participants	1 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 6; 1 days	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 6; 2-3 days	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 6; 4-7 days	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 6; >7 days	0 Participants	1 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 7	0 Participants	0 Participants
The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death). Score = 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 days

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.

(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Intubation and Mechanical-ventilation Free Survival Number of pts who died or required intubation/mechanical ventilation	0 Participants	1 Participants
Intubation and Mechanical-ventilation Free Survival Number of participants censored	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 42 days

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Overall Survival Number of participants who died	0 Participants	0 Participants
Overall Survival Number of participants censored	7 Participants	9 Participants

SECONDARY outcome

Timeframe: 42 days

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Number of Days Requiring Oxygen Therapy Days 1-14	6.9 days Standard Deviation 5.01	6.8 days Standard Deviation 4.52
Number of Days Requiring Oxygen Therapy Days 1-28	8.9 days Standard Deviation 9.30	8.8 days Standard Deviation 8.66
Number of Days Requiring Oxygen Therapy Days 1-42	10.9 days Standard Deviation 14.28	9 days Standard Deviation 9.22

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data within the relevant interval.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Number of Days With Pyrexia Days 1-14	0.1 Days Standard Deviation 0.38	0.4 Days Standard Deviation 0.73
Number of Days With Pyrexia Days 1-28	0.1 Days Standard Deviation 0.38	0.4 Days Standard Deviation 0.73
Number of Days With Pyrexia Days 1-42	0.1 Days Standard Deviation 0.38	0.4 Days Standard Deviation 0.73

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data within the relevant interval.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Maximum Daily Temperature Days 1-14	37.21 degress c Standard Deviation 0.414	37.32 degress c Standard Deviation 0.854
Maximum Daily Temperature Days 1-28	37.21 degress c Standard Deviation 0.414	37.32 degress c Standard Deviation 0.854
Maximum Daily Temperature Days 1-42	37.21 degress c Standard Deviation 0.414	37.32 degress c Standard Deviation 0.854

SECONDARY outcome

Timeframe: 42 days

Population: All participants providing data within the relevant interval.

The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
SpO2 Level Days 1-7 (min)	92.3 percentage of oxygen saturation Standard Deviation 2.43	91.7 percentage of oxygen saturation Standard Deviation 2.18
SpO2 Level Days 1-7 (max)	96.0 percentage of oxygen saturation Standard Deviation 1.83	96.7 percentage of oxygen saturation Standard Deviation 2.50
SpO2 Level Days 1-14 (min)	92.0 percentage of oxygen saturation Standard Deviation 2.71	91.7 percentage of oxygen saturation Standard Deviation 2.18
SpO2 Level Days 1-14 (max)	96.0 percentage of oxygen saturation Standard Deviation 1.83	97.1 percentage of oxygen saturation Standard Deviation 2.37
SpO2 Level Days 1-28 (min)	92.0 percentage of oxygen saturation Standard Deviation 2.71	91.7 percentage of oxygen saturation Standard Deviation 2.18
SpO2 Level Days 1-28 (max)	96.0 percentage of oxygen saturation Standard Deviation 1.83	97.1 percentage of oxygen saturation Standard Deviation 2.37
SpO2 Level Days 1-42 (min)	92.0 percentage of oxygen saturation Standard Deviation 2.71	91.7 percentage of oxygen saturation Standard Deviation 2.18
SpO2 Level Days 1-42 (max)	96.6 percentage of oxygen saturation Standard Deviation 2.07	97.1 percentage of oxygen saturation Standard Deviation 2.37

SECONDARY outcome

Timeframe: 42 days

The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Time to Discharge Number of participants discharged	6 Participants	6 Participants
Time to Discharge Number of participants who died	0 Participants	0 Participants
Time to Discharge Number of participants censored	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 42 days

The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Time to Oxygen Saturation (SpO2) ≥94% Number of participants who achieved SpO2 >=94% without further requirement for oxygen therapy	6 Participants	6 Participants
Time to Oxygen Saturation (SpO2) ≥94% Number of participants who died	0 Participants	0 Participants
Time to Oxygen Saturation (SpO2) ≥94% Number of participants censored	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 42 days

The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Time to Recovery Number of participants who recovered	4 Participants	4 Participants
Time to Recovery Number of participants who died	0 Participants	0 Participants
Time to Recovery Number of participants censored	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 42 days

Population: The numbers analyzed only includes those participants who experienced adverse events.

The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Acute Respiratory Distress Syndrome : Not related	0 Participants	1 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Acute Respiratory Distress Syndrome : Related	0 Participants	0 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Diarrhoea : Not related	0 Participants	1 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Diarrhoea : Related	0 Participants	0 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Abdominal distension : Not related	0 Participants	1 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Abdominal distension : Related	0 Participants	0 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Hypertension : Not related	0 Participants	2 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Hypertension : Related	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 days

Population: Any clinically significant abnormal lab parameters were included as AEs.

The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Incidence of Clinically Significant Abnormal Lab Parameters	0 number of participants	0 number of participants

SECONDARY outcome

Timeframe: 42 days

Population: Only serious AEs, AEs of CTCAE Grade 3 or above and AEs of special interest (all CTCAE grades) were documented and included in the summary.

The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness

Outcome measures

Measure	Placebo n=7 Participants Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 Participants Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Acute Respiratory Distress Syndrome	0 Participants	0 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Diarrhoea	0 Participants	0 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Abdominal distension	0 Participants	0 Participants
Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment Hypertension	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EDP1815

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=7 participants at risk Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 participants at risk Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/7 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.

Other adverse events

Measure	Placebo n=7 participants at risk Patients will receive placebo in addition to standard of care Placebo: Placebo oral capsule	EDP1815 n=9 participants at risk Patients will receive EDP1815 in addition to standard of care EDP1815: EDP1815 is an orally administered monoclonal microbe
Vascular disorders Hypertension	0.00% 0/7 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.	22.2% 2/9 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP. AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.

Additional Information

Duncan McHale, MBBS, MRCP, PhD

Evelo Biosciences Inc

Phone: +447500128938

Email: duncan@evelobio.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER