This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of RAY1216 tablets in the treatment of mild to moderate SARS-CoV-2 infection. The total study duration is up to 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,359
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Time to sustained clinical recovery of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days.
Time frame: Day 1 through Day 29
Proportion of participants who experience hospitalization or death cause by progression to severe disease
Time frame: Day 1 through Day 29
Proportion of participants who experience death from any cause
Time frame: Day 1 through Day 29
Proportion of participants who experience COVID-19 related hospitalization or death from any cause
Time frame: Day 1 through Day 29
SARS-CoV-2 viral shedding time in nasopharyngeal swabs
Time frame: baseline, Day 4, Day 6, Day 10, Day 15
Change of viral load compared to the baseline
Time frame: baseline, Day 4, Day 6, Day 10, Day 15
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time frame: baseline, Day 4, Day 6, Day 10, Day 15
Time to clinical sustained remission
Time frame: Day 1 through Day 29
Proportion of participants in clinical recovery/remission
Time frame: Day 1 through Day 29
Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
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Time frame: Day 1 through Day 29
Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
Time frame: Day 1 through Day 29
Time to sustained clinical recovery of each COVID-19 targeted symptoms
Time frame: Day 1 through Day 29
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 29