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临床试验/NCT04394208
NCT04394208Unknown3 期

Trial of Silymarin in Adults With COVID-19 Pneumonia

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
Time to clinical improvement

研究概览

简要总结

A randomized placebo controlled trial to assess the clinical outcome in COVID-19 Pneumonia following administration of Silymarin owing to its role as a p38 MAPK pathway inhibitor and its antiviral, anti-inflammatory and anti-oxidant effects

详细描述

To date, there are no drugs or other therapeutics approved by the U.S. Food and Drug Administration (FDA) to prevent or treat COVID-19 that has spread globally resulting in the ongoing pandemic as declared by the World Health Organization (WHO) on 11 March 2020. While the majority of patients have mild symptoms, some progress to viral pneumonia and multi-organ failure (MOF).

Older age, cardiovascular disease, diabetes mellitus, chronic respiratory illness, systemic hypertension, and malignancy are all associated with an increased risk of death in COVID-19.

In fatal cases of human severe acute respiratory syndrome-associated coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and SARS-CoV-2 infections, patients suffer from severe respiratory distress necessitating mechanical ventilation. Previous studies showed that genetic susceptibility and inflammatory cytokines (Interleukins: IL-6, 8, 10, Tumor Necrosis Factor [TNF] and Vascular endothelial growth factor [VEGF]) are closely related to the occurrence of acute respiratory distress syndrome (ARDS).

Cytokine storm is another life-threatening condition, and likely a leading cause of fatality.

Rapid viral replication and apoptosis together with virus-induced angiotensin-converting enzyme 2 (ACE-2) down-regulation and shedding and antibody-dependent enhancement (ADE) are responsible for aggressive inflammation caused by SARS-CoV-2, which is closely related to SARS-CoV; where both viruses hijack the same entry receptor ACE-2 suggesting the likelihood of the same population of cells being targeted and infected.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 patients with CT Chest-proven viral pneumonia with any degree of severity.

排除标准

  • Patients < 18 years of age.
  • Patients with mild symptoms (as per WHO criteria) of SARS-CoV-2

研究组 & 干预措施

Group 1

Placebo Comparator

Patients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment plus placebo

干预措施: Placebo (Drug)

Group 2

Experimental

patients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + Silymarin Oral 420mg/day in 3 divided doses

干预措施: Silymarin (Drug)

结局指标

主要结局

Time to clinical improvement

时间窗: 7-28 days

Defined as the time from randomization to an improvement of two points (from the status of randomization) on seven category ordinal scale or live discharge from the hospital, whichever comes first.

次要结局

  • Duration of Mechanical Ventilation(Randomization till hospital discharge or death whichever came first, assessed up to 28 days)
  • Hospitalization(Randomization till hospital discharge or death whichever came first, assessed up to 28 days)
  • Clinical outcome(7-14 days)
  • Virologic Response(Randomization till discharge, up to 28 days)
  • Adverse events(Randomization till hospital discharge, up to 28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Mohammed Korany Salem

Assistant Lecturer

Cairo University

研究点 (1)

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