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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSD8432 300mg | Experimental | SSD8432 300mg in combination with ritonavir 100mg |
|
| SSD8432 750mg | Experimental | SSD8432 750mg in combination with ritonavir 100mg |
|
| SSD8432 placebo | Placebo Comparator | SSD8432 placebo in combination with ritonavir placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSD8432 300mg | Drug | SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first nucleic acid turning negative | The time from the first administration to the first nucleic acid turning negative | Baseline through Day28 |
| Measure | Description | Time Frame |
|---|---|---|
| viral load | Changes of viral load compared to the baseline | Baseline through Day28 |
| adverse events | Frequency of TEAE | Baseline through Day28 |
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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 750mg | Drug | SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID |
|
|
| SSD8432Placebo | Drug | SSD8432Placebo in combination with ritonavir placebo,day1--day5,BID |
|
|
| Time to Sustained Alleviation | Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms | baseline through Day28 |
| Resting oxygen saturation | Proportion of subjects with resting oxygen saturation ≥ 95% | Day1 and Day5 |
| Proportion of participants progressing to a worsening status(higher score) | WHO clinical progression scale(0 to 10) | 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 |