跳至主要内容
临床试验/NCT04403061
NCT04403061已完成不适用

Th1/Th2/Th17/TREG Response and TLRs Activation/KIR Receptors for Predicting the Evolution of the SARS Cov-2 Infected Patients

Asociacion para el Estudio de las Enfermedades Infecciosas1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2020年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Changes in cytokines associated with SARS CoV-2 infection

研究概览

简要总结

To ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies

详细描述

COVID-19 is a disease with an initial viral phase followed, usually at the 7th day, of an inflammatory state (cytokine storm) leading to respiratory distress, ICU admission and risk of death. Thus, several biological agents, antagonists of the different cytokines (IL-6, IL-1) have been used for patients with severe disease. However, there are no data about the cytokine changes, at admission and after therapy, and its predictive value, a fundamental knowledge to establish the best therapeutic strategy.

The first line of immune defense is the interaction of the virus with innate immunity cell members. The toll like receptors (TLRs) family is a group of pattern recognition receptors that include many different molecules (21-23). These bindings can activate dendritic cells, monocytes, macrophages. There is an important RNA and DNA connection, activation of TLRs, the production of type I interferons, and the development of some autoimmune diseases. TLR7 and TLR8 specifically recognize simple-chain RNA of viruses and are expressed in endosomal membranes. TLR8 is expressed in regulatory cells (Treg) and its activation results in inhibition of its regulatory functions. Natural killer cells (NK) respond to alterations of class I HLA molecules present in infected cells (24-26). An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. Therefore, the reasons for KIR binding are often variable between individuals and between populations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of COVID-19 (PCR confirmed)

排除标准

  • No informed consent
  • Presence of chronic therapy with immunomodulators, corticoids or antineoplastic agents.

结局指标

主要结局

Changes in cytokines associated with SARS CoV-2 infection

时间窗: 1 month

KIR phenotype determination

时间窗: 1 month

Evaluation of cellular response

时间窗: 1 month

TLRs activation

时间窗: 1 month

次要结局

未报告次要终点

研究者

发起方
Asociacion para el Estudio de las Enfermedades Infecciosas
申办方类型
Network
责任方
Sponsor

研究点 (1)

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