Abstract:Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2)monoclonal antibody injection (F61 injection) in the treatment of patients with coronavirus disease 2019 (COVID-19) combined with renal damage. Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected. Subjects were randomly divided into two groups. Control group was treated with conventional anti-COVID-19 therapy, while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection. A 15-day follow-up was conducted after drug administration. Clinical symptoms, laboratory tests, electrocardiogram, and chest CT of patients were performed to analyze the efficacy and safety of F61 injection. Results Twelve subjects (7 in trial group and 5 in control group) were included in study. Neither group had any clinical progression or death cases. The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days (P=0.046), respectively. The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group (both P < 0.05). According to the clinical staging and World Health Organization 10-point graded disease progression scale, both groups of subjects improved but didn't show statistical differences (P>0.05). For safety, trial group didn't present any infusion-related adverse event. Subjects in both groups demonstrated varying degrees of elevated blood glucose, elevated urine glucose, elevated urobilinogen, positive urine casts, and cardiac arrhythmia, but the differences were not statistica-lly significant (all P>0.05). Conclusion F61 injection has initially demonstrated safety and clinical benefit in treating patients with COVID-19 combined with renal damage. As the domestically produced drug, it has good clinical accessibility and may provide more options for clinical practice.