Clinical trial NCT05160779: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sars-CoV-2 Infection
Keywords: SARS-CoV-2 infection
Genetic polymorphism
Polymerase Chain Reaction
Lead sponsor: Leonardo Paroche de Matos
Sponsor class: OTHER
Collaborators: name: Prof. Dr. José Antônio Silva Júnior
name: Msc. Allan Luis Barboza Atum
First posted: 2021-12-16
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 ".
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Correlation between polymorphisms and COVID-19 progression
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Ninth of July
state: Sao Paulo
city: Guarulhos
country: Brazil
facility: Guarulhos City Hall
state: São Paulo
Study officials:
affiliation: University Ninth of July
name: José Antônio Silva Júnior, PhD
role: STUDY_DIRECTOR
References: