Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
Torrance Clinical Research Institute
Lomita, California, United States
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1 through Day 33
Change From Baseline in SARS-CoV-2 RNA Viral Load
Time frame: Day 3, Day 5, Day 9 and Day 14
Change From Baseline in Infectious SARS- CoV-2 Viral Load
Time frame: Day 3, Day 5, Day 9 and Day 14
Proportion of Participants With COVID-19 Signs/Symptom Improvement
Time frame: Day 1 through Day 33
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
Proportion of Participants With Medically Attended Visits for COVID-19
Time frame: Day 1 through Day 33
Proportion of Participants Requiring Hospitalization for COVID-19
Time frame: Day 1 through Day 33
Proportion of Participants All-cause Mortality
Time frame: Day 1 through Day 33
Proportion of Participants Who Require Hospitalization and Mechanical Ventilation
Time frame: Day 1 through Day 33
Mean Plasma PK Concentrations of EDP-235
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Time frame: Day 1 through Day 5