An Observational, Ambispective Cohort Study of Azvudine in the Treatment of Patients With COVID-19 Pneumonia

NCT05621993 | Unknown

• 1 other identifier: 2022-11-16-QFS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine treatment group after 48 hours after the first positive for nucleic acid, short course of Azvudine treatment without nucleic acid turning negative, and the control group) . This study aims to analyze the efficacy and safety of Azvudine in the treatment of patients with COVID-19.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Time from positive nucleic acid to negative

  The time from the day when patients are first positive nucleic acid to the day when the Ct value of nucleic acid test is ≥35 or the result of nucleic acid test is negative.

  every 3 days

Secondary Outcomes (2)

• Proportion of patients with relapsed positive nucleic acid test within 28 days after negative

  up tp 28 days

• Proportion of patients with adverse events

  up tp 28 days

Study Arms (4)

Combination therapy group

Patients who are treated with the combination therapy of Azvudine and Chinese herbal medicine will be included in this group. The combination therapy is Azvudine treatment (5 mg once a day) within 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment.

Drug: Azvudine

Sequential therapy group

Patients who are treated with the sequential therapy of Azvudine and Chinese herbal medicine will be included in this group. The sequential therapy is Azvudine treatment (5 mg once a day) after 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment.

Drug: Azvudine

Non-standard therapy group

Patients are treated with Azvudine combined with Chinese herbal medicine treatment. But Azvudine treatment is discontinued before the nucleic acid turns negative.

Drug: Azvudine

The control group

Patients are treated with Chinese herbal medicine without Azvudine.

Interventions

Azvudine DRUG

Azvudine is a small molecular antiviral drug. On August 9, 2022, Azvudine was included in the Diagnostic and therapeutic protocol for COVID-9 in China.

Combination therapy group; Non-standard therapy group; Sequential therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients who were diagnosed as COVID-19 pneumonia will be included in the study.

You may qualify if:

• Patients with confirmed diagnosis of COVID-19 pneumonia
• Patients with the ability to take medication orally

You may not qualify if:

• Severe vomiting and difficulty in taking oral medication or ingestion of drugs after oral administration
• Suspected or confirmed active systemic infection other than COVID-19 pneumonia
• Pregnant or lactating women
• Patients with mental disorders
• Patients with severe liver damage
• Patients who are treated with small molecule drugs such as Nirmatrelvir Tablets/Ritonavir Tablets(co-packaged)
• Patients who are treated with RNA-dependent RNA polymerase (RDRP) inhibitors (Junshipharma VV116, Ascletis Pharma Inc. Asc10, Kexing biopharm Shen26, and Molnupiravir).

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China

Jinan, Shandong, China

RECRUITING

MeSH Terms

Interventions

azvudine

Central Study Contacts

Qian Qi, Dr.

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 18, 2022
• Study Start: November 22, 2022
• Primary Completion: November 16, 2023
• Study Completion: December 31, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)