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

NCT ID: NCT05621993

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Respiratory Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Azvudine

Intervention Type 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.

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.

Azvudine

Intervention Type 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.

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.

Azvudine

Intervention Type 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.

The control group

Patients are treated with Chinese herbal medicine without Azvudine.

No interventions assigned to this group

Interventions

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Azvudine

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qian Qi

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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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

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Qi, Dr.

Role: CONTACT

+86 13706380314

Facility Contacts

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Qian Qi, Dr.

Role: primary

+86 13706380314

Other Identifiers

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2022-11-16-QFS

Identifier Type: -

Identifier Source: org_study_id

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