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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sars-CoV-2 Infection
• Intervention / Treatment: Other: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 151
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonardo Paroche de Matos, Msc; Phone Number: +551124532163; Email: leonardoparoche@gmail.com

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01.504-001
      • University Ninth of July
      • Contact: Leonardo Paroche de Matos, Msc; Phone Number: +55112453168
  • São Paulo
    • Guarulhos, São Paulo, Brazil, 07175530
      • Guarulhos City Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Leonardo Paroche de Matos
• Collaborators: Prof. Dr. José Antônio Silva Júnior; Msc. Allan Luis Barboza Atum
• Investigators: Study Director: José Antônio Silva Júnior, PhD, University Ninth of July

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2 infection; Genetic polymorphism; Polymerase Chain Reaction
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20211214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared at any stage of the survey.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No