EUCTR2020-001808-42-ES进行中（未招募）1 期
PHASE II CLINICAL TRIAL, SINGLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED TO EXPLORE THE EFFECTIVENESS AND SAFETY OF MELATONIN I.V. IN PATIENTS WITH COVID-19 ENTERED INTO THE ICU (MELCOVID STUDY) - MELCOVID
Pharmamel S.L.0 个研究点目标入组 18 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Granting of informed consent by the patient, their family member or their legal representative.
- •Age equal to or greater than 18 years.
- •Presence of SARS-CoV-2 infection, with compatible symptoms and confirmation by PCR.
- •Admission to the ICU with acute hypoxemic respiratory failure attributed to SARS-CoV-2 infection
- •Have been admitted to the ICU for less than 7 days, with or without mechanical ventilation (MV) and with no signs of improvement in respiratory failure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Be included in another COVID-19 study that involves the administration of a drug in clinical development phase that lacks a prior marketing authorization.
- •Liver transaminases> 5 times the ULN.
- •Stage IV or dialysis kidney failure (GFR <30)
- •Pregnancy
- •Terminal medical or surgical illness.
- •Autoimmune disease.
- •Any condition of the patient that, in the opinion of the investigator, prevents the study procedures from being carried out.
研究者
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