Observational study of Azvudine for treating COVID-19 pneumonia
Efficacy and Safety of Azvudine in the Treatment of Patients With Corona Virus Disease (COVID-19) Pneumonia in China: an Multi-center Observational, Ambispective Cohort, Real-world Study
Qianfoshan Hospital · NCT05621993
This study tests how well Azvudine works and how safe it is for people with COVID-19 pneumonia by looking at different ways it can be used.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05621993 on ClinicalTrials.gov |
What this trial studies
This multicenter, ambispective observational cohort study focuses on patients diagnosed with COVID-19 pneumonia. Participants will be divided into four groups based on the timing and conditions of Azvudine treatment. The study aims to evaluate the efficacy and safety of Azvudine in these patients. By analyzing different treatment approaches, the study seeks to provide insights into optimal management strategies for COVID-19 pneumonia.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of COVID-19 pneumonia who can take medication orally.
Not a fit: Patients with severe vomiting, other active systemic infections, or those on specific antiviral treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from COVID-19 pneumonia.
How similar studies have performed: Other studies have explored treatments for COVID-19, but the specific use of Azvudine in this context is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Jinan, Shandong
- 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)
Study contacts
- Study coordinator: Qian Qi, Dr.
- Email: qiqianqlh@163.com
- Phone: +86 13706380314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COVID-19 Respiratory Infection