COVID-19 Respiratory Infection
Conditions
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.
Interventions
DRUGAzvudine
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.
Sponsors
Qianfoshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from positive nucleic acid to negative | every 3 days | 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. |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactQian Qi, Dr.
Outcome results
None listed