A Registry Study of Patients Hospitalized With Confirmed COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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A Registry Study of Patients Hospitalized With Confirmed COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: paxlovid
* Drug: No paxlovid
* Drug: Paxlovid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of COVID-19 infection. Presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity. Exclusion Criteria: No specific exclusion criteria in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paxlovid（Within 5 days after the diagnosis of COVID-19）<br>According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID is within 5 days. | Drug: paxlovid<br>* 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.<br>* Other names: paxlovid within initial 5 days;|
| Paxlovid （More than 5 days after the diagnosis of COVID-19）<br>According to the patient's medical records, the time from the diagnosis of COVID-19 to the prescription of PAXLOVID exceeds 5 days. | Drug: Paxlovid<br>* Patients treated with PAXLOVID outside of the initial 5 days after being diagnosed with covid-19 will be included in this group.<br>* Other names: Paxlovid outside of the initial 5 days;|
| No paxlovid used<br>Patients have never used Paxlovid after being diagnosed with COVID-19, whether before or after hospitalization. | Drug: No paxlovid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospitalized, paxlovid