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Impact of Genetic Polymorphisms of Vasoactive Peptides on the Prognosis of Patients With COVID19

NCT ID: NCT05160779

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sars-CoV-2 Infection

Keywords

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SARS-CoV-2 infection Genetic polymorphism Polymerase Chain Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The allocation of participants in the two research groups will happen in a stratified random way, so that individuals who were diagnosed and presented the mild or asymptomatic form of the disease (with treatment and monitoring carried out by primary care) will be gathered in the study group called " mild/asymptomatic cases", and individuals who were diagnosed and presented with severe forms of the disease, and who required hospitalization in the Intensive Care Unit (ICU) (with or without invasive mechanical ventilation) will be grouped in the group called "severe cases ".
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking of groups

Study Groups

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Mild/asymptomatic cases

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.

Group Type ACTIVE_COMPARATOR

Analysis of genetic polymorphisms of vasoactive peptides in COVID-19

Intervention Type OTHER

Evaluate the frequency of the insertion/deletion (I/D) polymorphism in the ACE gene; to assess the frequency of polymorphism in the bradykinin B2 receptor gene; to assess the frequency of the polymorphism in the CK-M gene and compare the frequencies of these polymorphisms between patients with severe and mild conditions.

Serious cases

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.

Group Type ACTIVE_COMPARATOR

Analysis of genetic polymorphisms of vasoactive peptides in COVID-19

Intervention Type OTHER

Evaluate the frequency of the insertion/deletion (I/D) polymorphism in the ACE gene; to assess the frequency of polymorphism in the bradykinin B2 receptor gene; to assess the frequency of the polymorphism in the CK-M gene and compare the frequencies of these polymorphisms between patients with severe and mild conditions.

Interventions

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Analysis of genetic polymorphisms of vasoactive peptides in COVID-19

Evaluate the frequency of the insertion/deletion (I/D) polymorphism in the ACE gene; to assess the frequency of polymorphism in the bradykinin B2 receptor gene; to assess the frequency of the polymorphism in the CK-M gene and compare the frequencies of these polymorphisms between patients with severe and mild conditions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. José Antônio Silva Júnior

UNKNOWN

Sponsor Role collaborator

Msc. Allan Luis Barboza Atum

UNKNOWN

Sponsor Role collaborator

Leonardo Paroche de Matos

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Paroche de Matos

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Antônio Silva Júnior, PhD

Role: STUDY_DIRECTOR

University Ninth of July

Locations

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Guarulhos City Hall

Guarulhos, São Paulo, Brazil

Site Status

University Ninth of July

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Leonardo Paroche de Matos, Msc

Role: CONTACT

Phone: +551124532163

Email: [email protected]

Facility Contacts

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Leonardo Paroche de Matos, Msc

Role: primary

Other Identifiers

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20211214

Identifier Type: -

Identifier Source: org_study_id