NL-OMON49145撤回3 期
Continuous low dose subcutaneous lidocaine for treatment of the symptoms of COVID*19. A randomised controlled open*label phase III study. - Not applicable
Julius Clinical0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 100
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
- •1. Each patient (or the patient*s legally authorized representatives) must sign
- •an informed consent form (ICF) indicating that they understand the purpose of
- •and procedures required for this study, are willing to participate in the study
- •and attend all scheduled visits, and are willing and able to comply with all
- •study-related procedures, and adhere to the prohibitions and restrictions as
- •specified in the protocol.
- •2. Age >=18 years.
- •3. Acute disease with a positive test for COVID-19.
- •4. Patients with symptoms of COVID-19 admitted to the ICU, the hospital ward or
- •residing in a nursing home are eligible for inclusion in the study. Should a
- •patient with spontaneous breathing deteriorate requiring mechanical ventilation
- •after the inclusion the patient will remain in the study.
排除标准
- •1. Patients known with allergy or hypersensitivity to lidocaine, xylocaine or
- •lignocaine.
- •2. Patients with severe hypoalbuminaemia (decreased drug-protein binding),
- •3. Patients with potentially reduced elimination speed of lidocaine:
- •a. Severe liver and kidney dysfunction
- •b. Use of certain medications: erythromycin, beta-blockers, ciprofloxacin,
- •cimetidine, clonidine, amiodarone or phenytoin.
研究者
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