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The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paxlovid（Within 5 days after the diagnosis of COVID-19） | According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID is within 5 days. |
| |
| Paxlovid （More than 5 days after the diagnosis of COVID-19） | According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID exceeds 5 days. |
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| No paxlovid used | Patients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paxlovid | Drug | Patients treated with PAXLOVID within 5 days of being diagnosed with covid-19 will be included in this group. Patients treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression rates | The proportion of patients who experienced any of the following events within 28 days after being diagnosed with COVID-19, including all-cause mortality, requiring invasive mechanical ventilation, or being admitted to the intensive care unit. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause deaths rates | The proportion of patients who experienced all-cause mortality within 28 days after being diagnosed with COVID-19. | up to 28 days |
| rehospitalization event rates | The proportion of patients who experienced a rehospitalization event within 28 days after being diagnosed with COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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This study will focus on COVID-19 infected patients who are admitted to the Beijing Chaoyang Hospital, affiliated with Capital Medical University, from November 15th, 2022 to March 30th, 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Zhang, PhD | Contact | +86 01085231464 | jeffzhang1619@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, PhD | Beijing Chao Yang Hospital | Principal Investigator |
| Zhuoling An, PhD | Beijing Chao Yang Hospital | Principal Investigator |
| Chaohui Tong, PhD |
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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 |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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Residual specimen, plasma, 1 ml. Each specimen will be uniquely identified to ensure that patient privacy is not compromised.
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| No paxlovid | Drug | Patients not treated with PAXLOVID will be included in this group. This study is a non-interventional observational study, and no intervention measures were applied to the clinical diagnosis and treatment process of hospitalized COVID-19 patients. The use of Paxlovid is completely decided by the clinical doctors based on the patients' condition and clinical experience. |
|
| Paxlovid | Drug | Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group. |
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| up to 28 days |
| COVID-19 repositive event rates | The proportion of patients who experienced a COVID-19 repositive event within 28 days after being diagnosed with COVID-19 | up to 28 days |
| adverse drug reaction event | The proportion of patients who experienced any adverse drug reaction events within 28 days after being diagnosed with COVID-19. | up to 28 days |
| thromboembolic event rates | The proportion of patients who experienced thromboembolic events, including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction, within 28 days after being diagnosed with COVID-19. | up to 28 days |
| Beijing Chao Yang Hospital |
| Principal Investigator |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |