Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets
A total of 30 patients with mild to moderate novel coronavirus infection (COVID-19) were enrolled and randomized in a 2:1 ratio to the experimental and placebo groups, and subjects received 5 days of oral administration of SHEN211 or SHEN211 placebo to assess the effectiveness of SHEN211 tablets in the treatment of mild to moderate COVID-19 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
SHEN211 tablets, participants will receive 330 mg (3 tablets) QD (once a day) on Day 1 and 110 mg (1 tablet) SHEN211 tablets QD orally on Days 2-5.
Placebo tablets, participants will receive 3 tablets QD (once daily) on Day 1 and 1 tablet QD orally on Days 2-5
Shenzhen Third People 's Hospital
Shenzhen, Guangdong, China
Change from baseline in SARS-CoV-2 viral load at each time point
Change from baseline in SARS-CoV-2 viral load at each time point
Time frame: Up to day 28
Time of recovery
To assess the time to first sustained recovery of 5/7/11 clinical symptoms (defined as time from first dose to COVID-19 symptom score of 0 and two days) in mild and moderate COVID-19 patients
Time frame: Up to day 28
Time to response
To assess time to first sustained resolution of 5/7/11 clinical symptoms (defined as time from first dose to COVID-19 symptom score of 0 or 1 and lasting 2 days) in mild and moderate COVID-19 patients
Time frame: Up to day 28
Time to negative
Time to Positive Viral Nucleic Acid Test to Negative
Time frame: Up to day 28
Percentage of subjects with disappearance of clinical symptoms
Percentage of subjects with disappearance of clinical symptoms on Days 1, 3, 5, 7, 10, 14, 21, and 28
Time frame: Up to day 28
Change in COVID-19 symptom score
Change in COVID-19 symptom score from baseline to Days 1, 3, 5, 7, 10, 14, 21, and 28
Time frame: Up to day 28
Ct value change from baseline
Change from baseline in SARS-CoV-2 Ct values on Days 1, 3, 5, 7, 10, 14, 21 and 28
Time frame: Up to day 28
Change from baseline in chest CT scan (optional)
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Change from Baseline in Chest CT Scan on Days 3, 7, or 10 (Optional)
Time frame: Up to day 28
Percentage of Subjects Progressed
Percentage of subjects with COVID-19 progression (progression defined as severe/critical COVID-19 or death due to any cause) by Day 28
Time frame: Up to day 28
Percent of Subjects Who Died
Percentage of subjects with all-cause mortality by Day 28
Time frame: Up to day 28
Safety Assessment Results
Safety assessments (eg, AEs and SAEs) through Day 28
Time frame: Up to day 28