This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects with mild/common COVID-19.
This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects with mild/common COVID-19. This study plan to enroll 670 mild or common type adult COVID-19 subjects, Randomly assigned to the experimental group and the control group according to 1:1, experimental group:335subjects will receive SSD8432 and Ritonavir; control group :335subjects will receive SSD8432 placebo and Ritonavir placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
670
Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID
Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID
Viral load
Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)
Time frame: Baseline through Day6
Time to Sustained Alleviation
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Time frame: Baseline through Day28
Viral load
Changes of viral load compared to the baseline
Time frame: Baseline through Day28
Time to Sustained Alleviation
Time to Sustained Alleviation of target COVID-19 signs/symptoms
Time frame: Baseline through Day28
Proportion of participants progress to a worsening status(higher score)
WHO clinical progress scale(0 to 10)
Time frame: Baseline through Day28
Adverse events
Frequency of TEAE
Time frame: Baseline through Day28
Maximum plasma concentration(Cmax)
Plasma concentration of SSD8432
Time frame: Baseline through Day5
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