This is a randomized, double-blind, placebo-controlled, phase II/III clinical study toevaluate the efficacy and safety of SSD8432 in combination with ritonavir in adultsubjects 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.
Drug: SSD8432 750mg
Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID
Other Name: Ritonavir 100mg
Drug: SSD8432 placebo
Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID
Other Name: Ritonavir placebo
Inclusion Criteria:
1. ≥18 and ≤80 years old, male or female.
2. Initial positive test of SARS-CoV-2 within 5 days of randomization.
3. mild or common type of COVID-19.
4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
5. Fever or 1 respiratory symptom of COVID-19 on random day
6. Subjects without high risk factors
7. Subjects with at least one high-risk factor
Exclusion Criteria:
1. Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical
ventilation, or ECMO is required or anticipated to be urgently required.
2. Prior to current disease episode, any confirmed SARS-CoV-2 infection.
3. Known medical history of active liver disease (other than nonalcoholic hepatic
steatosis).
4. Receiving dialysis or have known moderate to severe renal impairment.
5. Known human immunodeficiency virus (HIV) infection.
6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that
may interfere with the evaluation of response to the study intervention.
7. Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to
randomization..
8. Treatment with antivirals against SARS-CoV-2 within 14 days.
9. Current or expected use of any medications or substances that are highly dependent
on CYP3A4 for clearance.
10. Concomitant use of any medications or substances that are strong inducers of CYP3A4
are prohibited within 28 days.
11. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent
COVID-19 plasma or other prohibited concomitant medication.
12. Females who are pregnant or breastfeeding.
Not Provided
Genqiang An
86-13520683611
angenqiang@simcere.com
Yumei Yang, Doctor, Study Director
Jiangsu Xiansheng Pharmaceutical Co.,