Trial Outcomes & Findings for A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19 (NCT NCT05616728)
NCT ID: NCT05616728
Last Updated: 2024-08-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
231 participants
Primary outcome timeframe
Day 1 through Day 33
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
EDP-235 200mg
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
76
|
|
Overall Study
COMPLETED
|
75
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
2
|
Reasons for withdrawal
| Measure |
EDP-235 200mg
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19
Baseline characteristics by cohort
| Measure |
EDP-235 200mg
n=77 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=78 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=76 Participants
Once a day orally for 5 days
Placebo: capsule
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.02 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 11.77 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 11.80 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 12.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 33Outcome measures
| Measure |
EDP-235 200mg
n=77 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=78 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=76 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Number of Adverse Events as a Measure of Safety and Tolerability
|
1 Number of Adverse Events
|
6 Number of Adverse Events
|
3 Number of Adverse Events
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 9 and Day 14Population: Only subjects with a value at both baseline and the specific post-baseline visit are included.
Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Change From Baseline in SARS-CoV-2 RNA Viral Load
Day 3
|
-1.664 Viral load (log10 TCID50/mL)
Standard Deviation 1.9974
|
-1.626 Viral load (log10 TCID50/mL)
Standard Deviation 2.0049
|
-1.500 Viral load (log10 TCID50/mL)
Standard Deviation 1.8459
|
|
Change From Baseline in SARS-CoV-2 RNA Viral Load
Day 5
|
-3.048 Viral load (log10 TCID50/mL)
Standard Deviation 2.0395
|
-3.465 Viral load (log10 TCID50/mL)
Standard Deviation 1.7871
|
-3.340 Viral load (log10 TCID50/mL)
Standard Deviation 1.7956
|
|
Change From Baseline in SARS-CoV-2 RNA Viral Load
Day 9
|
-4.198 Viral load (log10 TCID50/mL)
Standard Deviation 1.8878
|
-4.237 Viral load (log10 TCID50/mL)
Standard Deviation 1.6148
|
-4.441 Viral load (log10 TCID50/mL)
Standard Deviation 1.5036
|
|
Change From Baseline in SARS-CoV-2 RNA Viral Load
Day 14
|
-4.611 Viral load (log10 TCID50/mL)
Standard Deviation 1.5681
|
-4.715 Viral load (log10 TCID50/mL)
Standard Deviation 1.5728
|
-4.757 Viral load (log10 TCID50/mL)
Standard Deviation 1.4700
|
SECONDARY outcome
Timeframe: Day 3, Day 5, Day 9 and Day 14Population: Only subjects with a value at both baseline and the specific post-baseline visit are included.
Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Day 14
|
-0.959 Viral load (log10 TCID50/mL)
Standard Deviation 1.4153
|
-1.111 Viral load (log10 TCID50/mL)
Standard Deviation 1.2072
|
-1.009 Viral load (log10 TCID50/mL)
Standard Deviation 1.3589
|
|
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Day 3
|
-0.743 Viral load (log10 TCID50/mL)
Standard Deviation 1.5220
|
-0.836 Viral load (log10 TCID50/mL)
Standard Deviation 1.3531
|
-0.705 Viral load (log10 TCID50/mL)
Standard Deviation 1.3627
|
|
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Day 5
|
-0.872 Viral load (log10 TCID50/mL)
Standard Deviation 1.4164
|
-1.065 Viral load (log10 TCID50/mL)
Standard Deviation 1.1804
|
-0.982 Viral load (log10 TCID50/mL)
Standard Deviation 1.3341
|
|
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Day 9
|
-0.926 Viral load (log10 TCID50/mL)
Standard Deviation 1.4611
|
-1.111 Viral load (log10 TCID50/mL)
Standard Deviation 1.2072
|
-1.018 Viral load (log10 TCID50/mL)
Standard Deviation 1.3479
|
SECONDARY outcome
Timeframe: Day 1 through Day 33Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Proportion of Participants With COVID-19 Signs/Symptom Improvement
|
56 Participants
|
61 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 33Population: Only subjects with a value at both baseline and the specific post-baseline visit are included.
The total score is computed as the sum across all 14 COVID-19 symptom severity scores for each visit. Total scores range from 0 to 42; higher scores indicate more severe symptoms. For symptom score, 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe for each symptom.
Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Change From Baseline in COVID-19 Signs/Symptom
|
-12.8 Total score
Standard Deviation 5.94
|
-14.0 Total score
Standard Deviation 6.20
|
-12.8 Total score
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Day 1 through Day 33Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Proportion of Participants With Medically Attended Visits for COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 33Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Proportion of Participants Requiring Hospitalization for COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 33Outcome measures
| Measure |
EDP-235 200mg
n=77 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=78 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=76 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Proportion of Participants All-cause Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 33Outcome measures
| Measure |
EDP-235 200mg
n=62 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=67 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=61 Participants
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 5Outcome measures
| Measure |
EDP-235 200mg
n=70 Participants
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=76 Participants
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Mean Plasma PK Concentrations of EDP-235
Study Day 1 Postdose
|
571 ng/mL
Standard Deviation 159
|
902 ng/mL
Standard Deviation 108
|
—
|
|
Mean Plasma PK Concentrations of EDP-235
Study Day 3 Predose
|
1050 ng/mL
Standard Deviation 95.8
|
2250 ng/mL
Standard Deviation 70.0
|
—
|
|
Mean Plasma PK Concentrations of EDP-235
Study Day 5 Predose
|
1290 ng/mL
Standard Deviation 79.4
|
2230 ng/mL
Standard Deviation 69.0
|
—
|
Adverse Events
EDP-235 200mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EDP-235 400mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EDP-235 200mg
n=77 participants at risk
Once a day orally for 5 days
EDP-235: capsule
|
EDP-235 400mg
n=78 participants at risk
Once a day orally for 5 days
EDP-235: capsule
|
Placebo
n=76 participants at risk
Once a day orally for 5 days
Placebo: capsule
|
|---|---|---|---|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.3%
1/77 • Through day 33
|
1.3%
1/78 • Through day 33
|
0.00%
0/76 • Through day 33
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/77 • Through day 33
|
1.3%
1/78 • Through day 33
|
0.00%
0/76 • Through day 33
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/77 • Through day 33
|
1.3%
1/78 • Through day 33
|
0.00%
0/76 • Through day 33
|
|
General disorders
Face oedema
|
0.00%
0/77 • Through day 33
|
1.3%
1/78 • Through day 33
|
0.00%
0/76 • Through day 33
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/77 • Through day 33
|
1.3%
1/78 • Through day 33
|
0.00%
0/76 • Through day 33
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/77 • Through day 33
|
0.00%
0/78 • Through day 33
|
1.3%
1/76 • Through day 33
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/77 • Through day 33
|
0.00%
0/78 • Through day 33
|
1.3%
1/76 • Through day 33
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/77 • Through day 33
|
1.3%
1/78 • Through day 33
|
0.00%
0/76 • Through day 33
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/77 • Through day 33
|
0.00%
0/78 • Through day 33
|
1.3%
1/76 • Through day 33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place