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临床试验/NCT05160779
NCT05160779Unknown不适用

Impact of Genetic Polymorphisms of Vasoactive Peptides on the Prognosis of Patients Diagnosed With Mild and Severe Cases of COVID19

Leonardo Paroche de Matos2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
151
试验地点
2
主要终点
Correlation between polymorphisms and COVID-19 progression

研究概览

简要总结

Introduction: A pandemic such as the SRAS-CoV-2 (COVID-19) has a great negative socioeconomic impact with very limited therapeutic options. As with any disease, a detailed understanding of its pathophysiological mechanisms is critical for the development of new therapies. In SRAS-CoV-2, few studies have verified a possible relationship of these vasoactive peptide polymorphisms with patient prognosis. Objective: To analyze and relate polymorphisms found in components of vasoactive peptide systems in DNA samples collected from patients diagnosed with SARS-CoV-2 (COVID-19) who developed severe conditions and patients infected with mild or asymptomatic conditions. Methodology: Cross-sectional, analytical and qualitative study that will be conducted with approximately 151 participants previously diagnosed with SARS-CoV-2 with mild or asymptomatic forms of the pathology, diagnosed in primary care in the city of Guarulhos/SP- specifically in the Basic Health Unit of Nova Saúde Bonsucesso- well with participants who were diagnosed with the severe forms that required hospitalization in 2021. For the collection of biological material, a sterile swab will be used in order to collect cells from the oral cavity, specifically from the oral mucosa. Expected results: We hope to identify and relate the polymorphisms of vasoactive peptide genes from patients with mild, asymptomatic or severe forms of SARS-CoV-2 infection, thus contributing to the understanding of the different clinical evolutions of the disease.

详细描述

Cross-sectional, analytical and qualitative study that will be carried out with approximately 151 participants who were previously diagnosed with SARS-CoV-2 with mild and severe symptoms of the pathology, diagnosed in primary care in the city of Guarulhos/SP - specifically in the Basic Health Unit Nova Bonsucesso or who have a history of previous admissions - requiring hospitalization in the year 2021 (which will be removed from the COVID case monitoring spreadsheet available at the study UBS). Cells will be collected from the participants' oral cavity using a sterile cotton swab. The collections will be carried out at the Basic Health Unit Nova Bonsucesso, located in the city of Guarulhos/SP (mild/asymptomatic cases), under the supervision and responsibility of the dentist and collaborator of this Leonardo Paroche de Matos project. The Free and Informed Consent Form will be filled out and signed after guidance on the research and its subsequent acceptance by the participant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

No masking of groups

入排标准

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

入选标准

  • •Individuals over 18 years old
  • •With or without associated comorbidities: any pathology of the systems: cardiovascular, respiratory, endocrine, digestive, neurological, psychiatric, genitourinary
  • •Diagnosed with COVID-19 through RT-PCR (naso-oropharyngeal swab)
  • •Who agreed to participate in the research voluntarily

排除标准

  • •Participants who refuse to participate in the survey
  • •Who have lesions in the oral mucosa that make the collection of material unfeasible
  • •Individuals with severe xerostomia
  • •In cancer treatment.

研究组 & 干预措施

Mild/asymptomatic cases

Active Comparator

For the collection of cells from the oral cavity, a sterile swab will be used for the procedure, and will be opened by the collector in the presence of the participant. The biological material will be collected from the participant's cheek mucosa (rotating the swab 360º using light pressure (approximately 75N) on the mucosa tissue and then packed in a tube containing 3ml of sterile 0.9% saline solution) of the participant. confirmation of identification data in order to analyze and relate polymorphisms found in components of vasoactive peptide systems in DNA samples collected from patients diagnosed with SARS-CoV-2 (COVID-19) who developed mild or asymptomatic conditions.

干预措施: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19 (Other)

Serious cases

Active Comparator

For the collection of cells from the oral cavity, a sterile swab will be used for the procedure, and will be opened by the collector in the presence of the participant. The biological material will be collected from the participant's cheek mucosa (rotating the swab 360º using light pressure (approximately 75N) on the mucosa tissue and then packed in a tube containing 3ml of sterile 0.9% saline solution) of the participant. confirmation of identification data in order to analyze and relate polymorphisms found in components of vasoactive peptide systems in DNA samples collected from patients diagnosed with SARS-CoV-2 (COVID-19) who developed severe pathology.

干预措施: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19 (Other)

结局指标

主要结局

Correlation between polymorphisms and COVID-19 progression

时间窗: 1 month

To investigate a possible correlation between gene polymorphism and disease progression (SARS-CoV-2) for asymptomatic, mild or severe conditions

次要结局

未报告次要终点

研究者

发起方
Leonardo Paroche de Matos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Paroche de Matos

Msc; Doctoral student in medicine at the Universidade Nove de Julho

Leonardo Paroche de Matos

研究点 (2)

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