Evaluation of the Safety and Efficacy of Azvudine and Paxlovid in the Treatment of Hospitalized Patients With COVID-19

Study Overview
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Brief Summary
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In this retrospective study, we aimed to evaluate the clinical efficacy and safety of two antiviral drugs on COVID-19 and inpatients with existing complications in the First Affiliated Hospital of Shandong First Medical University. In addition, we also explored a key issue. Is the combined treatment effect of two antiviral drugs, Paxlovid and Azvudine, better than the use of a single drug?

Detailed Description
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We conducted a single center retrospective cohort study on hospitalized patients with severe acute respiratory syndrome coronavirus type 2 infection who received treatment with nimatevir/ritonavir tablets or azivudine tablets at the First Affiliated Hospital of Shandong First Medical University from December 1，2022 to January 31，2023. In the research of this project, it is necessary to extract, sort out and retrospectively analyze the clinical data of all patients with COVID-19 who have received Nematovir/Ritonavir tablets or Azivudine tablets in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital), and respectively identify the relevant epidemiological characteristics of COVID-19 patients, It is planned to use multiple linear regression or logical regression model to explore the relevant factors that affect the drug use efficiency index, safety index and total cost of patients with COVID-19, so as to provide scientific and quantitative evidence support for the drug use mode of the disease, the clinical value of the drug and the rational drug use of patients, and also provide favorable basis for the supervision and decision-making of smart pharmacy of medical institutions.

Official Title
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Evaluation of the Safety and Efficacy of Azvudine and Paxlovid in the Treatment of Hospitalized Patients With COVID-19

Conditions
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Paxlovid, Azvudine, COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. The patient's admission time is from December 1,2022 to January 31,2023. 2. The patient has used either Paxlovid or azivudine tablets during admission. 3. Age ≥ 18 years old. Exclusion Criteria： 1. Patients using other antiviral drugs. 2. Patients with incomplete clinical data.

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 |
| --- | --- |
| Patients with COVID-19 packaged with Paxlovid<br>Treatment of patients with COVID-19 with Paxlovid | |
| Patients with COVID-19 packaged with Azvudine<br>Treatment of patients with COVID-19 with Azvudine | |
| Patients with COVID-19 packaged with Paxlovid and Azvudine<br>Treatment of patients with COVID-19 with Paxlovid and Azvudine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | Mortality rate of patients with COVID-19 treated with COVID-19 Medicine | Through study completion，up to half a year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paxlovid, Azvudine, COVID-19, effectiveness, real-world evidence