This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,200
Capsule administered orally after meals.
Capsule administered orally after meals.
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGTime to 11 COVID-19 Symptom Resolution by Day 28
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
Time frame: Day 1 up to 28
Change of viral load compared to the baseline
Time frame: Baseline, Day 3, and Day 5
Time to 5 COVID-19 Symptom Resolution by Day 28
The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days
Time frame: Day 1 up to 28
Change of viral load compared to the baseline
Time frame: Baseline, Day 7
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time frame: baseline, Day 3, Day 5, and Day 7
Time to sustained alleviation of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days
Time frame: Day 1 up to 28
Proportion of Participants with COVID-19 related Hospitalization
Time frame: Day 1 up to 28
Proportion of severe or critical Participants
Time frame: Day 1 up to 28
Proportion of Participants with All-cause Death
Time frame: Day 1 up to 28
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AE
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to 28