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

Primary Purpose

Sars-CoV-2 Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Analysis of genetic polymorphisms of vasoactive peptides in COVID-19
Sponsored by
Leonardo Paroche de Matos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sars-CoV-2 Infection focused on measuring SARS-CoV-2 infection, Genetic polymorphism, Polymerase Chain Reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Ninth of July
  • Guarulhos City Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mild/asymptomatic cases

Serious cases

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 14, 2021
Last Updated
December 14, 2021
Sponsor
Leonardo Paroche de Matos
Collaborators
Prof. Dr. José Antônio Silva Júnior, Msc. Allan Luis Barboza Atum
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1. Study Identification

Unique Protocol Identification Number
NCT05160779
Brief Title
Impact of Genetic Polymorphisms of Vasoactive Peptides on the Prognosis of Patients With COVID19
Official Title
Impact of Genetic Polymorphisms of Vasoactive Peptides on the Prognosis of Patients Diagnosed With Mild and Severe Cases of COVID19
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leonardo Paroche de Matos
Collaborators
Prof. Dr. José Antônio Silva Júnior, Msc. Allan Luis Barboza Atum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV-2 Infection
Keywords
SARS-CoV-2 infection, Genetic polymorphism, Polymerase Chain Reaction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 ".
Masking
None (Open Label)
Masking Description
No masking of groups
Allocation
Randomized
Enrollment
151 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild/asymptomatic cases
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Serious cases
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Analysis of genetic polymorphisms of vasoactive peptides in COVID-19
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between polymorphisms and COVID-19 progression
Description
To investigate a possible correlation between gene polymorphism and disease progression (SARS-CoV-2) for asymptomatic, mild or severe conditions
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Paroche de Matos, Msc
Phone
+551124532163
Email
leonardoparoche@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Antônio Silva Júnior, PhD
Organizational Affiliation
University Ninth of July
Official's Role
Study Director
Facility Information:
Facility Name
University Ninth of July
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01.504-001
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Paroche de Matos, Msc
Phone
+55112453168
Facility Name
Guarulhos City Hall
City
Guarulhos
State/Province
São Paulo
ZIP/Postal Code
07175530
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared at any stage of the survey.

Learn more about this trial

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

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