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COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard-of-care | Sham Comparator |
| |
| standard-of-care plus Paxlovid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard-of-care plus Paxlovid | Drug | standard-of-care plus Paxlovid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | the mortality of the subjects within 28 days since the diagnosis of COVID-19 | 28 days since the diagnosis of COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieming Qu, PhD | Contact | +862164370045 | jmqu0906@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jieming Qu | Rui-jin Hospital, Shanghai Jiao-tong University School of Medicine, Shanghai, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Medical School of Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C000719967 | nirmatrelvir and ritonavir drug combination |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard-of-care |
| Drug |
standard-of-care |
|