Table_1_A Randomized Clinical Trial of Linagliptin vs. Standard of Care in Patients Hospitalized With Diabetes and COVID-19.docx

ObjectiveTo assess the effect of linagliptin vs. standard therapy in improving clinical outcomes in patients hospitalized with diabetes and coronavirus disease 2019 (COVID-19).Materials and MethodsWe did an open-label, prospective, multicenter, randomized clinical trial in 3 Israeli hospitals between October 1, 2020, and April 4, 2021. Eligible patients were adults with type 2 diabetes mellitus and a diagnosis of COVID-19. A total of 64 patients, 32 in each group, were randomized to receive linagliptin 5 mg PO daily throughout the hospitalization or standard of care therapy. The primary outcome was time to clinical improvement within 28 days after randomization, defined as a 2-point reduction on an ordinal scale ranging from 0 (discharged without disease) to 8 (death).ResultsThe mean age was 67 ± 14 years, and most patients were male (59.4%). Median time to clinical improvement was 7 days (interquartile range (IQR) 3.5-15) in the linagliptin group compared with 8 days (IQR 3.5–28) in the standard of care group (hazard ratio, 1.22; 95% CI, 0.70–2.15; p = 0.49). In-hospital mortality was 5 (15.6%) and 8 (25.0%) in the linagliptin and standard of care groups, respectively (odds ratio, 0.56; 95% CI, 0.16–1.93). The trial was prematurely terminated due to the control of the COVID-19 outbreak in Israel.ConclusionsIn this randomized clinical trial of hospitalized adult patients with diabetes and COVID-19 who received linagliptin, there was no difference in the time to clinical improvement compared with the standard of care.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT04371978.

研究目标：评估利格列汀与标准疗法在改善因糖尿病和新型冠状病毒肺炎（COVID-19）住院患者临床结局方面的效果。研究方法：本研究为于2020年10月1日至2021年4月4日期间在以色列3家医院进行的一项开放标签、前瞻性、多中心、随机临床试验。符合纳入标准的受试者为患有2型糖尿病并确诊为COVID-19的成年人。共64名患者，每组32人，随机分配接受利格列汀5毫克口服每日一次，直至住院结束，或接受标准护理疗法。主要结局指标为随机分组后28天内临床改善的时间，定义为从0分（未患病出院）至8分（死亡）的等级量表上2分的降低。研究结果：平均年龄为67±14岁，其中大多数患者为男性（59.4%）。利格列汀组的临床改善中位时间为7天（四分位数间距（IQR）3.5-15），而标准护理组为8天（IQR 3.5–28）（风险比，1.22；95%置信区间，0.70–2.15；p=0.49）。利格列汀组和标准护理组的院内死亡率分别为5例（15.6%）和8例（25.0%）（比值比，0.56；95%置信区间，0.16–1.93）。由于以色列COVID-19疫情的管控，试验提前终止。结论：在本项针对接受利格列汀治疗的住院成年糖尿病患者和COVID-19患者的随机临床试验中，与标准护理组相比，临床改善的时间无显著差异。临床试验注册：ClinicalTrials.gov，注册号NCT04371978。