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

April 2, 2024 updated by: Xiao Li，MD
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?

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All inpatients who were treated with nimatevir/ritonavir tablets and azivudine tablets at the First Affiliated Hospital of Shandong First Medical University from December 1,2022 to January 31,2023.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiao Li，MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCYX-LX-20230102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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