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临床试验/NCT04618861
NCT04618861已完成不适用

Surfactant Protein D Levels in Covid-19 Infection: Case-Control Study

Kafkas University1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2020年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia.

研究概览

简要总结

This study aims to provide some insight into the variation of SD-D protein levels in patients with Covid-19 (-) pneumonia, Covid-19 (+) pneumonia, and CT negative Covid-19 infection in comparison to the normal population through a larger number of cases. Objective of the study is to determine the serum surfactant protein D (SP-D) levels in Covid-19 pneumonia infection.

详细描述

This study aims to provide some insight into the variation of SD-D protein levels in patients with Covid-19 (-) pneumonia, Covid-19 (+) pneumonia, and CT negative Covid-19 infection in comparison to the normal population through a larger number of cases. Subjects will assessed in accordance with the inclusion and exclusion criteria, they were divided into four groups as the CT (-), PCR (+) SARS-CoV-2 infection group, SARS-CoV-2 (+) Pneumonia Group, CT (+), PCR (-) Suspected Pneumonia Group and Healthy group (Control Group). Demographic data, medical history, vital findings (fever, blood pressure, sPO2), laboratory findings (complete blood count; C-reactive protein (CRP), D-dimer, Ferritin and hsTnT parameters) and radiological findings, time to onset of symptoms, Comorbid diseases, hospitalization location of the patients (service or ICU), clinical scores, CT severity scores will determine. SP-D level will analyze by the Enzyme-Linked Immunosorbent Assay (ELISA) method.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • who presented to the Covid-19 outpatient polyclinic of the ED with pneumonia symptoms,
  • whose CT imaging's were compatible with Covid-19 pneumonia in accordance with the RSNAEC criteria and whose PCR tests were positive,
  • whose SARS-CoV-2 PCR tests were positive as a result of contact tracing,
  • who presented to the ED for further examination.
  • who gave their written consent to participate in the study.
  • Giving written consent to participate in the study.

排除标准

  • diagnosis of kidney or liver failure
  • acute pulmonary embolism
  • chronic inflammatory disease history (rheumatological disease, autoimmune disease),
  • pregnancy
  • presence of any cancer diagnosis
  • chronic obstructive pulmonary disease
  • asthma disease,
  • history of cerebrovascular disease.
  • the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.
  • For control group Inclusion Criteria
  • no known acute, subacute or chronic disease history
  • not suffer from any infection in the last fortnight,
  • not to be on a particular medication,
  • Presenting to the ED with reasons other than infectious complaints
  • Giving written consent to participate in the study.
  • Exclusion Criteria:
  • diagnosis of kidney or liver failure
  • acute pulmonary embolism
  • chronic inflammatory disease history (rheumatological disease, autoimmune disease),
  • pregnancy
  • presence of any cancer diagnosis
  • chronic obstructive pulmonary disease
  • asthma disease,
  • history of cerebrovascular disease.

结局指标

主要结局

Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia.

时间窗: 2 months

First primary outcome is determining the serum surfactant protein D level changes in patient who have Covid-19 infection or pneumonia aganist healty controls.

Analyzing the correlations between serum surfactant protein D levels and demographic,laboratory, clinical and radiological datas.

时间窗: 2 months

Determining the correlation between between serum surfactant protein D levels and demographic datas (age,gender), medical history, vital findings (fever, blood pressure, sPO2), laboratory findings (complete blood count; C-reactive protein (CRP), D-dimer, Ferritin and hsTnT parameters) and radiological findings, time to onset of symptoms, Comorbid diseases, hospitalization location of the patients (service or ICU), clinical scores (PSI and CURB65 scores), CT severity scores .

次要结局

未报告次要终点

研究者

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

Ramazan Sbirli

Dr.

Kafkas University

研究点 (1)

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