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

NCT05996770 | Unknown

• 1 other identifier: LCYX-LX-20230102
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Paxlovid; Azvudine; COVID-19

Keywords

Paxlovid; Azvudine; COVID-19; effectiveness; real-world evidence

Outcome Measures

Primary Outcomes (1)

• mortality

  Mortality rate of patients with COVID-19 treated with COVID-19 Medicine

  Through study completion，up to half a year.

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xiao Li，MD: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xiao Li

CONTACT

18210590697; lixiao1688@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 18, 2023
• Study Start: June 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2023-11