This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19.
This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19. This study planned to enroll 72 subjects, randomly divided into low-dose group, high-dose group and placebo group according to 1:1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID
SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID
SSD8432Placebo in combination with ritonavir placebo,day1--day5,BID
Time to first nucleic acid turning negative
The time from the first administration to the first nucleic acid turning negative
Time frame: Baseline through Day28
viral load
Changes of viral load compared to the baseline
Time frame: Baseline through Day28
adverse events
Frequency of TEAE
Time frame: Baseline through Day28
Time to Sustained Alleviation
Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms
Time frame: baseline through Day28
Resting oxygen saturation
Proportion of subjects with resting oxygen saturation ≥ 95%
Time frame: Day1 and Day5
Proportion of participants progressing to a worsening status(higher score)
WHO clinical progression scale(0 to 10)
Time frame: Baseline through Day28
Maximum plasma concentration(Cmax)
Plasma concentration of SSD8432
Time frame: Baseline through Day5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.