A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19 infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Shulan(Hangzhou) Hospital
Hangzhou, China
Changes in viral load
Change of viral load compared to the baseline
Time frame: Baseline through Day 7
Change in the total score of COVID-19 symptoms
Change in the total score of COVID-19 symptoms compared to the baseline
Time frame: Baseline through Day 14
Change in the score of each COVID-19 symptom
Change in the score of each COVID-19 symptom compared to the baseline
Time frame: Baseline through Day 14
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D) compared to the baseline
Time frame: Baseline through Day 14
percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit
percentage of patients who reached COVID-19 symptoms scores of 0 for two consecutive days in every visit
Time frame: Baseline through Day 14
Time to the first negative SARS CoV-2 test result
The time from the start of treatment to the time when the first negative SARS CoV-2 qPCR result showed CT value ≥35
Time frame: Baseline through Day 14
progression of COVID-19 infection
the percentage of patients who progressed to severe/critical COVID-19 or death from any cause
Time frame: Baseline through Day 14
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