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

NCT05160779 | Unknown DMC

• 1 other identifier: 20211214
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sars-CoV-2 Infection

Keywords

SARS-CoV-2 infection; Genetic polymorphism; Polymerase Chain Reaction

Outcome Measures

Primary Outcomes (1)

• Correlation between polymorphisms and COVID-19 progression

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

  1 month

Study Arms (2)

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.

Other: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19

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.

Other: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19

Interventions

Analysis of genetic polymorphisms of vasoactive peptides in COVID-19 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.

Mild/asymptomatic cases; Serious cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leonardo Paroche de Matos: lead
• Prof. Dr. José Antônio Silva Júnior: collaborator
• Msc. Allan Luis Barboza Atum: collaborator

Study Sites (2)

Guarulhos City Hall

Guarulhos, São Paulo, 07175530, Brazil

Location

University Ninth of July

São Paulo, São Paulo, 01.504-001, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• José Antônio Silva Júnior, PhD

  University Ninth of July

  STUDY DIRECTOR

Central Study Contacts

Leonardo Paroche de Matos, Msc

CONTACT

+551124532163; leonardoparoche@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking of groups
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc; Doctoral student in medicine at the Universidade Nove de Julho

Model Details: 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 ".

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 16, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)