Oral Azvudine for Mild-to-Moderate COVID-19 in High Risk, Non-Hospitalized Adults: Results of a Real-World Study

Background: COVID-19 demands safe, effective oral antiviral drugs. Azvudine is recommended by Chinese health authorities for COVID-19 treatment but has not been tested in real-world clinical studies yet.Methods: This was a retrospective cohort study, looking at outpatients who tested positive for SARS-CoV-2. Patients admitted between December 19, 2022, and January 5, 2023, were included. Those who received Azvudine treatment were in the Azvudine group, while those who received supportive treatment were the control group. The primary outcome was the disease progression rate by day 28. Secondary outcomes were individual disease progression outcomes (death or COVID-19 related hospitalization) and duration of fever. The safety outcomes were assessed based on adverse events (AEs) overall, as well as AEs that were considered to be related to the drug.Findings: Our study found that Azvudine could reduce the rate of disease progression, as well as rate of COVID-19 related hospitalization in patients. Furthermore, if taken within three days of the onset of symptoms, it could also shorten the duration of fever. Despite a higher incidence of drug related AEs compared to supportive treatment, the majority of these were mild.Interpretation: Azvudine has been found to be effective in reducing the rate of disease progression of COVID-19, albeit with a slight increase in AEs. This study addresses the research gap regarding the clinical important outcomes of Azvudine and provides evidence for its use in real-world applications.Funding: This research did not receive any specific grant from funding agencies.Declaration of Interest: We have no interests to declare.Ethical Approval: This study was approved by the institutional review board of Beijing Chao-Yang Hospital (Ethics Approval: 2023-1-29-1).