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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | SSD8432 750mg and Ritonavir 100mg |
|
| Control group | Placebo Comparator | SSD8432 placebo and Ritonavir placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSD8432 750mg | Drug | Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose) | Baseline through Day6 |
| Time to Sustained Alleviation | Time to Sustained Alleviation of 5 COVID-19 signs/symptoms | Baseline through Day28 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Changes of viral load compared to the baseline | Baseline through Day28 |
| Time to Sustained Alleviation | Time to Sustained Alleviation of target COVID-19 signs/symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genqiang An | Contact | 86-13520683611 | angenqiang@simcere.com |
| Name | Affiliation | Role |
|---|---|---|
| Yumei Yang, Doctor | Jiangsu Xiansheng Pharmaceutical Co., | Study Director |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000723274 | SIM0417 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| SSD8432 placebo | Drug | Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID |
|
|
| Baseline through Day28 |
| Proportion of participants progress to a worsening status(higher score) | WHO clinical progress scale(0 to 10) | Baseline through Day28 |
| Adverse events | Frequency of TEAE | Baseline through Day28 |
| Maximum plasma concentration(Cmax) | Plasma concentration of SSD8432 | Baseline through Day5 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |