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

Sars-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05160779
• Other study ID #: 20211214
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: February 2022

Study information

• Verified date: December 2021
• Source: Leonardo Paroche de Matos
• Contact: Leonardo Paroche de Matos, Msc
• Phone: +551124532163
• Email: leonardoparoche[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 151
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

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.

Locations

Country	Name	City	State
Brazil	Guarulhos City Hall	Guarulhos	São Paulo
Brazil	University Ninth of July	São Paulo	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Leonardo Paroche de Matos	Msc. Allan Luis Barboza Atum, Prof. Dr. José Antônio Silva Júnior

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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