Trials / Unknown
UnknownNCT05373433
To Evaluate SSD8432/Ritonavir in Adults With COVID-19
A Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Study Evaluating the Efficacy and Safety of SSD8432 in Combination With Ritonavir in Adult Subjects With Mild/Common COVID-19
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 670 (estimated)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SSD8432 750mg | Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID |
| DRUG | SSD8432 placebo | Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID |
Timeline
- Start date
- 2022-05-26
- Primary completion
- 2023-05-31
- Completion
- 2023-10-31
- First posted
- 2022-05-13
- Last updated
- 2022-05-24
Source: ClinicalTrials.gov record NCT05373433. Inclusion in this directory is not an endorsement.