Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Colchicine vs no active treatment
研究概览
简要总结
There is emerging evidence that patients with SARS-CoV-2 are affected by increased coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to the lung but also involving the kidneys, heart and gut.
Thrombin plays a central role in mediating clot forming as well as in mediating inflammation. A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the risk of venous and arterial thrombotic complications.
Colchicine is an inexpensive (generic drug), orally administered, and a potent anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance.
The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.
排除标准
- •Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including Child-Pugh C cirrhosis with portal hypertension.
- •Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
- •Uncontrolled severe hypertension.
- •Ongoing or planned treatment with parenteral or oral anticoagulants
- •Unilateral or bilateral above knee lower extremity amputation.
- •Inability to take oral medication or otherwise unable or unwilling to undergo/perform study-specified procedures
- •Have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
- •Pregnancy or breast-feeding or any plan to become pregnant during the study. Women (and men, for Colchicine group only) with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible, both partners should use adequate barrier birth control).
- •Need for dual anti-platelet therapy consisting of aspirin and an oral P2Y12 inhibitor
- •Inflammatory bowel disease or chronic diarrhea or neuromuscular disease
- •Creatinine clearance (CrCl) <15 ml/min
- •Anticipated use of Hydroxychloroquine
- •Participation in any other clinical trial
- •Inability to understand the requirements of the study and to provide informed consent
研究组 & 干预措施
Edoxaban
Edoxaban 60 mg q.d., or 30 mg q.d. in patients with CrCl = or <50 ml/min or body weight equal or less than 60 kg from randomization to end of study visit at day 25 (+/-3).
干预措施: Edoxaban Tablets (Drug)
Colchicine
Colchicine at 0.5 mg per os (PO) twice daily for the first 3 days and then once daily from randomization to day 14 (+/-3) days. Treatment could be continued to day 25 (+3/-3 days).
干预措施: Colchicine Tablets (Drug)
Edoxaban and Colchicine
Edoxaban 60 mg q.d., or 30 mg q.d. in patients with CrCl = or <50 ml/min or body weight equal or less than 60 kg from randomization to end of study visit at day 25 (+/-3).
Colchicine at 0.5 mg per os (PO) twice daily for the first 3 days and then once daily from randomization to day 14 (+/-3) days. Treatment could be continued to day 25 (+3/-3 days).
干预措施: Edoxaban Tablets (Drug)
Edoxaban and Colchicine
Edoxaban 60 mg q.d., or 30 mg q.d. in patients with CrCl = or <50 ml/min or body weight equal or less than 60 kg from randomization to end of study visit at day 25 (+/-3).
Colchicine at 0.5 mg per os (PO) twice daily for the first 3 days and then once daily from randomization to day 14 (+/-3) days. Treatment could be continued to day 25 (+3/-3 days).
干预措施: Colchicine Tablets (Drug)
结局指标
主要结局
Colchicine vs no active treatment
时间窗: Baseline to day 14
To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.
Edoxaban vs. no active treatment
时间窗: Baseline to day 25
To assess the effect of edoxaban versus no active treatment on the composite endpoint of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-CNS systemic embolism or death at day 25 (+/-3) after randomization.
次要结局
- Number of patients with asymptomatic proximal deep-vein thrombosis(Baseline to day 25)
- Number of patients with symptomatic proximal or distal deep-vein thrombosis(Baseline to day 25)
- Number of patients with non-CNS systemic embolism(Baseline to day 25)
- Number of patients with ischemic stroke(Baseline to day 25)
- Number of deaths(Baseline to day 25)
- Ventilation need(Baseline to day 25)
- Number of patient with symptomatic pulmonary embolism or thrombosis(Baseline to day 25)
- Number of patients with myocardial infarction(Baseline to day 25)