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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| The control group | Patients are treated with Chinese herbal medicine without Azvudine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All the patients who were diagnosed as COVID-19 pneumonia will be included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Qi, Dr. | Contact | +86 13706380314 | qiqianqlh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| C540945 | azvudine |
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