COVID-19
Conditions
Keywords
SARS-CoV-2, Standard Risk
Brief summary
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Interventions
DRUGEDP-235
capsule
DRUGPlacebo
capsule
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization * COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening
Exclusion criteria
* Prior SARS-CoV-2 infection \<90 days before enrollment and/or received any COVID-19 vaccine dose \<90 days before enrollment * Has one or more conditions associated with high risk for severe COVID-19 * History of hospitalization for the medical treatment of COVID-19 * Currently hospitalized or anticipated need for hospitalization in the clinical opinion of the investigator * Known medical history of active liver disease * Receiving dialysis or have known moderate to severe renal impairment * Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug * Any comorbidity requiring hospitalization and/or surgery within 7 days before study entry, or that is considered life threatening within 30 days before study entry * Known HIV infection with a HIV viral load greater than 400 copies/mL or medication for HIV treatment that is prohibited in this study based on medical history within 6 months before the screening visit * History of hypersensitivity or other contraindication to any of the components of the study drug * Has received or is expected to receive pre-exposure prophylactic SARS-CoV-2 mAb * Has received or is expected to receive convalescent COVID-19 plasma * Oxygen saturation of ≤93% on room air obtained at rest within 24 hours before randomization * Participating in another interventional clinical study with an investigational agent or device, including those for COVID-19, within 30 days or five half-lives of the agent, whichever is longer, before signing the ICF * Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events as a Measure of Safety and Tolerability | Day 1 through Day 33 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 3, Day 5, Day 9 and Day 14 | — |
| Proportion of Participants With COVID-19 Signs/Symptom Improvement | Day 1 through Day 33 | — |
| Change From Baseline in COVID-19 Signs/Symptom | Day 1 through Day 33 | 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. |
| Proportion of Participants With Medically Attended Visits for COVID-19 | Day 1 through Day 33 | — |
| Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 3, Day 5, Day 9 and Day 14 | — |
| Proportion of Participants All-cause Mortality | Day 1 through Day 33 | — |
| Proportion of Participants Who Require Hospitalization and Mechanical Ventilation | Day 1 through Day 33 | — |
| Mean Plasma PK Concentrations of EDP-235 | Day 1 through Day 5 | — |
| Proportion of Participants Requiring Hospitalization for COVID-19 | Day 1 through Day 33 | — |
Countries
Romania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EDP-235 200mg Once a day orally for 5 days
EDP-235: capsule | 77 |
| EDP-235 400mg Once a day orally for 5 days
EDP-235: capsule | 78 |
| Placebo Once a day orally for 5 days
Placebo: capsule | 76 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Other | 0 | 2 | 0 |
| Overall Study | Physician Decision | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | EDP-235 400mg | Placebo | Total | EDP-235 200mg |
|---|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 11.77 | 42.8 years STANDARD_DEVIATION 11.8 | 43.7 years STANDARD_DEVIATION 12.19 | 43.4 years STANDARD_DEVIATION 13.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 73 Participants | 71 Participants | 218 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 13 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 75 Participants | 70 Participants | 218 Participants | 73 Participants |
| Sex: Female, Male Female | 47 Participants | 42 Participants | 139 Participants | 50 Participants |
| Sex: Female, Male Male | 31 Participants | 34 Participants | 92 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 78 | 0 / 76 |
| other Total, other adverse events | 1 / 77 | 5 / 78 | 2 / 76 |
| serious Total, serious adverse events | 0 / 77 | 0 / 78 | 0 / 76 |
Outcome results
Primary
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1 through Day 33
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EDP-235 200mg | Number of Adverse Events as a Measure of Safety and Tolerability | 1 Number of Adverse Events |
| EDP-235 400mg | Number of Adverse Events as a Measure of Safety and Tolerability | 6 Number of Adverse Events |
| Placebo | Number of Adverse Events as a Measure of Safety and Tolerability | 3 Number of Adverse Events |
Secondary
Change From Baseline in COVID-19 Signs/Symptom
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.
Time frame: Day 1 through Day 33
Population: Only subjects with a value at both baseline and the specific post-baseline visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EDP-235 200mg | Change From Baseline in COVID-19 Signs/Symptom | -12.8 Total score | Standard Deviation 5.94 |
| EDP-235 400mg | Change From Baseline in COVID-19 Signs/Symptom | -14.0 Total score | Standard Deviation 6.2 |
| Placebo | Change From Baseline in COVID-19 Signs/Symptom | -12.8 Total score | Standard Deviation 4.93 |
Secondary
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Time frame: Day 3, Day 5, Day 9 and Day 14
Population: Only subjects with a value at both baseline and the specific post-baseline visit are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDP-235 200mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 3 | -0.743 Viral load (log10 TCID50/mL) | Standard Deviation 1.522 |
| EDP-235 200mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 5 | -0.872 Viral load (log10 TCID50/mL) | Standard Deviation 1.4164 |
| EDP-235 200mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 9 | -0.926 Viral load (log10 TCID50/mL) | Standard Deviation 1.4611 |
| EDP-235 200mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 14 | -0.959 Viral load (log10 TCID50/mL) | Standard Deviation 1.4153 |
| EDP-235 400mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 14 | -1.111 Viral load (log10 TCID50/mL) | Standard Deviation 1.2072 |
| EDP-235 400mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 3 | -0.836 Viral load (log10 TCID50/mL) | Standard Deviation 1.3531 |
| EDP-235 400mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 9 | -1.111 Viral load (log10 TCID50/mL) | Standard Deviation 1.2072 |
| EDP-235 400mg | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 5 | -1.065 Viral load (log10 TCID50/mL) | Standard Deviation 1.1804 |
| Placebo | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 14 | -1.009 Viral load (log10 TCID50/mL) | Standard Deviation 1.3589 |
| Placebo | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 5 | -0.982 Viral load (log10 TCID50/mL) | Standard Deviation 1.3341 |
| Placebo | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 9 | -1.018 Viral load (log10 TCID50/mL) | Standard Deviation 1.3479 |
| Placebo | Change From Baseline in Infectious SARS- CoV-2 Viral Load | Day 3 | -0.705 Viral load (log10 TCID50/mL) | Standard Deviation 1.3627 |
Secondary
Change From Baseline in SARS-CoV-2 RNA Viral Load
Time frame: Day 3, Day 5, Day 9 and Day 14
Population: Only subjects with a value at both baseline and the specific post-baseline visit are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDP-235 200mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 5 | -3.048 Viral load (log10 TCID50/mL) | Standard Deviation 2.0395 |
| EDP-235 200mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 14 | -4.611 Viral load (log10 TCID50/mL) | Standard Deviation 1.5681 |
| EDP-235 200mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 9 | -4.198 Viral load (log10 TCID50/mL) | Standard Deviation 1.8878 |
| EDP-235 200mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 3 | -1.664 Viral load (log10 TCID50/mL) | Standard Deviation 1.9974 |
| EDP-235 400mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 5 | -3.465 Viral load (log10 TCID50/mL) | Standard Deviation 1.7871 |
| EDP-235 400mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 3 | -1.626 Viral load (log10 TCID50/mL) | Standard Deviation 2.0049 |
| EDP-235 400mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 14 | -4.715 Viral load (log10 TCID50/mL) | Standard Deviation 1.5728 |
| EDP-235 400mg | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 9 | -4.237 Viral load (log10 TCID50/mL) | Standard Deviation 1.6148 |
| Placebo | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 14 | -4.757 Viral load (log10 TCID50/mL) | Standard Deviation 1.47 |
| Placebo | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 9 | -4.441 Viral load (log10 TCID50/mL) | Standard Deviation 1.5036 |
| Placebo | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 3 | -1.500 Viral load (log10 TCID50/mL) | Standard Deviation 1.8459 |
| Placebo | Change From Baseline in SARS-CoV-2 RNA Viral Load | Day 5 | -3.340 Viral load (log10 TCID50/mL) | Standard Deviation 1.7956 |
Secondary
Mean Plasma PK Concentrations of EDP-235
Time frame: Day 1 through Day 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EDP-235 200mg | Mean Plasma PK Concentrations of EDP-235 | Study Day 1 Postdose | 571 ng/mL | Standard Deviation 159 |
| EDP-235 200mg | Mean Plasma PK Concentrations of EDP-235 | Study Day 3 Predose | 1050 ng/mL | Standard Deviation 95.8 |
| EDP-235 200mg | Mean Plasma PK Concentrations of EDP-235 | Study Day 5 Predose | 1290 ng/mL | Standard Deviation 79.4 |
| EDP-235 400mg | Mean Plasma PK Concentrations of EDP-235 | Study Day 5 Predose | 2230 ng/mL | Standard Deviation 69 |
| EDP-235 400mg | Mean Plasma PK Concentrations of EDP-235 | Study Day 1 Postdose | 902 ng/mL | Standard Deviation 108 |
| EDP-235 400mg | Mean Plasma PK Concentrations of EDP-235 | Study Day 3 Predose | 2250 ng/mL | Standard Deviation 70 |
Secondary
Proportion of Participants All-cause Mortality
Time frame: Day 1 through Day 33
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDP-235 200mg | Proportion of Participants All-cause Mortality | 0 Participants |
| EDP-235 400mg | Proportion of Participants All-cause Mortality | 0 Participants |
| Placebo | Proportion of Participants All-cause Mortality | 0 Participants |
Secondary
Proportion of Participants Requiring Hospitalization for COVID-19
Time frame: Day 1 through Day 33
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDP-235 200mg | Proportion of Participants Requiring Hospitalization for COVID-19 | 0 Participants |
| EDP-235 400mg | Proportion of Participants Requiring Hospitalization for COVID-19 | 0 Participants |
| Placebo | Proportion of Participants Requiring Hospitalization for COVID-19 | 0 Participants |
Secondary
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation
Time frame: Day 1 through Day 33
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDP-235 200mg | Proportion of Participants Who Require Hospitalization and Mechanical Ventilation | 0 Participants |
| EDP-235 400mg | Proportion of Participants Who Require Hospitalization and Mechanical Ventilation | 0 Participants |
| Placebo | Proportion of Participants Who Require Hospitalization and Mechanical Ventilation | 0 Participants |
Secondary
Proportion of Participants With COVID-19 Signs/Symptom Improvement
Time frame: Day 1 through Day 33
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDP-235 200mg | Proportion of Participants With COVID-19 Signs/Symptom Improvement | 56 Participants |
| EDP-235 400mg | Proportion of Participants With COVID-19 Signs/Symptom Improvement | 61 Participants |
| Placebo | Proportion of Participants With COVID-19 Signs/Symptom Improvement | 51 Participants |
Secondary
Proportion of Participants With Medically Attended Visits for COVID-19
Time frame: Day 1 through Day 33
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EDP-235 200mg | Proportion of Participants With Medically Attended Visits for COVID-19 | 0 Participants |
| EDP-235 400mg | Proportion of Participants With Medically Attended Visits for COVID-19 | 0 Participants |
| Placebo | Proportion of Participants With Medically Attended Visits for COVID-19 | 0 Participants |