The study is a multicenter, randomized, double-blind, placebo-controlled efficacy, safety Phase III clinical trial designed to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,350
China Japan Friendship Hospital
Beijing, Beijing Municipality, China
Time from first dose to sustained clinical recovery of 11 COVID-19 symptoms within 28 days
Time frame: Day 1 to Day 28
Decrease in viral load from baseline on Day 5 of treatment
Time frame: Day 1 to Day 28
Percentage of subjects achieving sustained clinical recovery of 11 COVID-19 symptoms at Day 5, 9, 14, 21, and 28
Time frame: Day 1 to Day 28
Time to sustained clinical remission of 11 COVID-19 symptoms within 28 days of treatment
Time frame: Day 1 to Day 28
Percentage of subjects achieving sustained clinical remission of 11 COVID-19 symptoms on Day 5, 9, 14, 21, and 28
Time frame: Day 1 to Day 28
Changes in 11 COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28
Time frame: Day 1 to Day 28
Time from first dose to sustained clinical recovery of 5 key COVID-19 related symptoms within 28 days
Time frame: Day 1 to Day 28
Percentage of subjects achieving sustained clinical recovery of 5 key COVID-19 related symptoms at Day 5, 9, 14, 21, and 28
Time frame: Day 1 to Day 28
Time to sustained clinical remission of 5 key COVID-19 related symptoms within 28 days
Time frame: Day 1 to Day 28
Changes in 5 key COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28
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Time frame: Day 1 to Day 28
Percentage of subjects who experienced COVID-19 progression within 28 days
Time frame: Day 1 to Day 28
Proportion of subjects requiring supplemental oxygen within 28 days
Time frame: Day 1 to Day 28
Change in World Health Organization (WHO) Clinical Progress Scale Score within 28 days
Time frame: Day 1 to Day 28
Time from first dose to SARS-CoV-2 RNA below the threshold after treatment within 14 days
Time frame: Day 1 to Day 14
Percentage of subjects with SARS-CoV-2 RNA below the threshold on Day 3, 5, 7, 9 and 14
Time frame: Day 1 to Day 14
Change from baseline in viral load at each visit from treatment to Day 14
Time frame: Day 1 to Day 14
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 28