Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Time to clinical change
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •History of or type 2 diabetes mellitus or a diagnosis of type 2 diabetes during hospitalization.
- •Confirmation of infection with SARS-CoV-2 by PCR testing.
- •Patients within 10 days from symptom onset or patients within 48 hours after laboratory diagnosis (SARS-CoV-2 PCR).
排除标准
- •WHO COVID-19 Ordinal Scale for Clinical Improvement ≥
- •Respiratory failure requiring mechanical ventilation prior to randomization.
- •Use of vasopressor or inotropic medications prior to randomization.
- •Intolerance/hypersensitivity to dipeptidyl peptidase-4 inhibitors.
- •Patients expected to require intensive care unit admission or immediate surgical intervention.
- •Participation in another trial assessing any treatment for COVID-
- •Current treatment with a DPP-4 inhibitor.
研究组 & 干预措施
DPP-4 inhibition
Participants in the Dipeptidyl Peptidase-4 (DPP-4) inhibition group will receive linagliptin in addition to standard of care insulin regimen as per hospital protocol during their entire hospitalization.
干预措施: Linagliptin 5 MG (Drug)
结局指标
主要结局
Time to clinical change
时间窗: 28 days
Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
次要结局
- Ventilator-free days.(28 days)
- Percent of patients with clinical improvement.(28 days)
- Length of hospitalization.(28 days)
- Supplemental oxygen-free days.(28 days)
- Percent of mechanical ventilation use.(28 days)
- Percent of serious adverse events and premature discontinuation of treatment.(28 days)
- All-cause mortality.(28 days)
- Percent of supplemental oxygen use.(28 days)
- Percent of ICU admissions.(28 days)
- ICU-free days.(28 days)
- Percent of 50% decrease in C-reactive protein (CRP) levels(Up to 28 days)
- Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test.(28 days)
研究者
Ran Abuhasira
Dr. Ran Abuhasira, Internal Medicine B
Rabin Medical Center