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

Sponsor

Xiao Li，MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05996770

Collaborator

(none)

1,500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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?

Condition or Disease	Intervention/Treatment	Phase
Paxlovid Azvudine COVID-19

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with COVID-19 packaged with Paxlovid Treatment of patients with COVID-19 with Paxlovid
Patients with COVID-19 packaged with Azvudine Treatment of patients with COVID-19 with Azvudine
Patients with COVID-19 packaged with Paxlovid and Azvudine Treatment of patients with COVID-19 with Paxlovid and Azvudine

Outcome Measures

Primary Outcome Measures

mortality [Through study completion，up to half a year.]
Mortality rate of patients with COVID-19 treated with COVID-19 Medicine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.