Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
10.12138/j.issn.1671-9638.20245379
- VernacularTitle:重组全人源抗新型冠状病毒单克隆抗体注射液(F61注射液)治疗新型冠状病毒感染合并肾损伤患者的有效性和安全性:一项随机对照的探索性临床研究
- Author:
Ding-Hua CHEN
1
;
Chao-Fan LI
;
Yue NIU
;
Li ZHANG
;
Yong WANG
;
Zhe FENG
;
Han-Yu ZHU
;
Jian-Hui ZHOU
;
Zhe-Yi DONG
;
Shu-Wei DUAN
;
Hong WANG
;
Meng-Jie HUANG
;
Yuan-Da WANG
;
Shuo-Yuan CONG
;
Sai PAN
;
Jing ZHOU
;
Xue-Feng SUN
;
Guang-Yan CAI
;
Ping LI
;
Xiang-Mei CHEN
Author Information
1. 中国人民解放军总医院第一医学中心肾脏病医学部 肾脏疾病全国重点实验室 国家慢性肾病临床医学研究中心,北京 100853
- Keywords:
F61 injection;
severe acute respiratory syndrome coronavirus 2;
renal damage;
efficacy;
safety;
anti-severe acute respiratory syndrome coronavirus 2 monoclonal antibody injection
- From:
Chinese Journal of Infection Control
2024;23(3):257-264
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome 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 pa-tients 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-re-lated 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 trea-ting 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.
