NL-OMON55080已完成2 期
A phase 2, double blind, randomized, placebo controlled clinical trial to investigate the safety and effects of oral vitamin K2 supplementation in COVID-19. - KOVIT
Canisius Wilhelmina Ziekenhuis0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •COVID-19 patients who are admitted to the CWZ with COVID-19 as primary reason
- •for admission, with a laboratory confirmed SARS-CoV-2 infection within the
- •previous 14 days.
- •Respiratory failure requiring supplemental oxygen, defined as requiring
- •supplemental oxygen to sustain an arterial PO2 *70mmHg (measured by arterial
- •blood gas) or an oxygen saturation of *94% (measured using a pulse oximeter)
- •At least 18 years old.
- •Able to safely swallow the study medication or possibility of safely
- •administering this through a nasogastric tube.
- •Use of prophylactic heparin or LWMH according to hospital protocols, or use of
- •therapeutic dosages if there is a medical indication for this.
- •Informed consent signed by patient.
排除标准
- •Use of oral anticoagulation drugs; patients may be included when they have been
- •switched to LMWH.
- •Patients on vitamin K antagonists with a supra-therapeutic anticoagulation at
- •admission who require vitamin K supplementation to correct this, or were
- •administered vitamin K for this reason within the preceding 5 days.
- •Patients already using vitamin K supplements at admission.
- •Participation in another intervention study.
- •Direct admission to an intensive care unit (ICU) for invasive ventilation at
- •presentation.
- •Confirmed active pulmonary embolism or deep venous thrombosis prior to
- •Known allergy to any of the components of the study medication or placebo.
- •Patients who are hemodialysis dependent at admission.
- •Pregnancy at the time of inclusion.
- •Diagnosed active malignancy at the time of inclusion.
研究者
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