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
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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UNKNOWN
500 participants
OBSERVATIONAL
2022-11-22
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with the ability to take medication orally
Exclusion Criteria
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Qianfoshan Hospital
OTHER
Responsible Party
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Qian Qi
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-11-16-QFS
Identifier Type: -
Identifier Source: org_study_id
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