Jiangsu Simcere Pharmaceutical Co., Ltd.
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.
COVID-19
SSD8432 300mg
SSD8432 750mg
SSD8432Placebo
Phase 2
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 |
Estimated Enrollment : | 72 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Evaluation of SSD8432 in Combination With Ritonavir in Asymptomatic Infections or Mild/Common Randomized, Double-blind, Safety Study of Efficacy and Safety in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study |
Actual Study Start Date : | May 20, 2022 |
Estimated Primary Completion Date : | October 31, 2022 |
Estimated Study Completion Date : | March 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: SSD8432 300mg SSD8432 300mg in combination with ritonavir 100mg |
Drug: SSD8432 300mg |
Experimental: SSD8432 750mg SSD8432 750mg in combination with ritonavir 100mg |
Drug: SSD8432 750mg |
Placebo Comparator: SSD8432 placebo SSD8432 placebo in combination with ritonavir placebo |
Drug: SSD8432Placebo |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.