Clinical Evaluation of Umifenovir as a Potential Antiviral Therapy for COVID-19: A Multi-center, Randomized, Controlled Clinical Trial.

Objectives: To evaluate the efficacy and safety of umifenovir as a potential antiviral therapy for COVID-19; specifically, to determine whether umifenovir improves clinical outcomes, reduces hospitalization duration, and enhances recovery rates in patients diagnosed with COVID-19 compared to standard care. Methods: In this multicenter, open-label, randomized controlled trial, 260 patients diagnosed with COVID-19 were randomly assigned to receive either umifenovir (200 mg every six hours for seven days) or standard care. The primary outcome was clinical improvement, assessed via the National Early Warning Score 2 system, while secondary outcomes included changes in computed tomography scan scores, length of hospital stay, intensive care unit admission rates, and mortality. Results: Of the 260 patients enrolled, 193 completed the study. Both groups showed significant reductions in clinical symptoms, although myalgia was more prevalent in the umifenovir group. The intervention group demonstrated a significant decrease in computed tomography scan scores; however, no significant differences were observed between groups regarding in hospital stay duration, intensive care unit admissions, or mortality rates. Conclusions: While umifenovir exhibited some immunological benefits in COVID-19 patients, it did not significantly improve broader patient-important outcomes compared to standard care. Therefore, its routine use in clinical practice for COVID-19 treatment is currently not justified, highlighting the need for further research to explore alternative therapeutic strategies.