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临床试验/NCT04623619
NCT04623619Unknown不适用

Use of Acetyl L-Carnitine in Patients With Covid-19 Pneumonia

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo0 个研究点目标入组 100 人开始时间: 2020年12月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
In-hospital mortality

研究概览

简要总结

Different studies showed that acetyl L-Carnitine (LC) positively affects the development and maturation of T lymphocytes, involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of the systemic inflammatory syndrome.

Given the potential protective effects of LC, it is suggested as a supportive and therapeutic option in patients with coronavirus infection. Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 2 gr of LC orally in addition to the standard of care therapy (SOC).

The investigators hypothesize that the use of LC will be associated with an earlier improvement of clinical and biohumoral parameters after 14 days of LC treatment when compared to the group of patients provided with standard care.

详细描述

Different studies showed that acetyl L-Carnitine (LC) positively affects the development and maturation of T lymphocytes, involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of the systemic inflammatory syndrome.

SARS-CoV-2 virus activates the human cell ACE2 receptor, triggering a series of deleterious events. In COVID19, renin-angiotensin is upregulated and the pathway is overexpressed and a progressive cytokine storm is always observed. In all these pathogenic processes, LC could play a modifier function to enhance condition. LC can be beneficial to the antioxidant effects of Angiotensin II by inhibiting NF-kB and down-regulating NOX1and NOX2. For LC, an anti-apoptotic and genome-stabilizer role was estimated by inhibiting pro-apoptotic caspases and activating PARP-1. LC is an immunomodulator that downregulates pro-inflammatory cytokines including TNF-α, IL-6, and IL-1 that could extinguish the cytokine storm. LC can also serve as a protective agent against COVID19 cardiotoxicity due to disruption in the ACE2-mediated signaling pathway, cytokine storm, pulmonary dysfunction, and side effects of medications.

In patients with coronavirus infection, provided LC's possible protective effects, it is suggested as a supportive and therapeutic alternative.

Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 2 gr of LC orally in addition to the standard of care therapy (SOC).

The investigators hypothesize that the use of LC will be associated with an earlier improvement of clinical and humoral parameters after 14 days of LC treatment when compared to the group of patients provided with standard care.

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
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

入选标准

  • Positive swab test of SARS-CoV-2
  • Pneumonia related to SARS-CoV-2
  • Signature of informed consent

排除标准

  • Unsigned informed consent
  • Negative swab test of SARS-CoV-2

结局指标

主要结局

In-hospital mortality

时间窗: 72 hours

Change of hospital mortality

次要结局

  • Duration of positive PCR swab(5 days)
  • C reactive protein (CRP) levels(72 hours)
  • IL-6 levels(72 hours)
  • D-dimer levels(72 hours)
  • Hospital stay(up to 24 weeks)

研究者

发起方
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Cascio

Direttore UOC Malattie Infettive e Tropicali

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

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