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

NCT ID: NCT05996770

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-30

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?

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.

Conditions

Paxlovid; Azvudine; COVID-19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with COVID-19 packaged with Paxlovid

Treatment of patients with COVID-19 with Paxlovid

No interventions assigned to this group

Patients with COVID-19 packaged with Azvudine

Treatment of patients with COVID-19 with Azvudine

No interventions assigned to this group

Patients with COVID-19 packaged with Paxlovid and Azvudine

Treatment of patients with COVID-19 with Paxlovid and Azvudine

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• 1. Patients using other antiviral drugs. 2. Patients with incomplete clinical data.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiao Li，MD

OTHER

Sponsor Role: lead

Responsible Party

Xiao Li，MD

Associate professor of pharmacy

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Xiao Li

Role: CONTACT

lixiao1688@163.com

18210590697

Other Identifiers

LCYX-LX-20230102

Identifier Type: -

Identifier Source: org_study_id