Sars-CoV-2 InfectionNCT05160779
Impact of Genetic Polymorphisms of Vasoactive Peptides on the Prognosis of Patients With COVID19
A study testing Analysis of genetic polymorphisms of vasoactive peptides in COVID-19 in people with Sars-CoV-2 Infection, run by Leonardo Paroche de Matos at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- Analysis of genetic polymorphisms of vasoactive peptides in COVID-19
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2022to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Guarulhos City Hall
Guarulhos, São Paulo, 07175530
University Ninth of July
São Paulo, São Paulo, 01.504-001
Leonardo Paroche de Matos, Msc, +55112453168
About this study
Official title: 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.
Read the 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.
- Conditions
- Sars-CoV-2 Infection
- Being tested
- Analysis of genetic polymorphisms of vasoactive peptides in COVID-19
- Keywords
- SARS-CoV-2 infection, Genetic polymorphism, Polymerase Chain Reaction
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of genetic polymorphisms of vasoactive peptides in COVID-19Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Paroche de Matos
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. José Antônio Silva Júnior, Msc. Allan Luis Barboza Atum
- Responsible party
- Principal investigator, Leonardo Paroche de Matos, Leonardo Paroche de Matos
- Investigators
- José Antônio Silva Júnior, PhD, Study director, University Ninth of July
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160779
- Sponsor's protocol ID
- 20211214
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared at any stage of the survey.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Genetic Polymorphisms of Vasoactive Peptides on the Prognosis of Patients Diagnosed With Mild and Severe Cases of COVID19
- ClinicalTrials.gov ID
- NCT05160779
- Acronym / sponsor ID
- 20211214
- Conditions
- Sars-CoV-2 Infection
- Keywords
- SARS-CoV-2 infection, Genetic polymorphism, Polymerase Chain Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Leonardo Paroche de MatosUniversity, hospital or other
- Collaborators
- Prof. Dr. José Antônio Silva Júnior, Msc. Allan Luis Barboza Atum
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 ".
| Arm | Type | Receives |
|---|---|---|
| Mild/asymptomatic cases | Active comparator | Other: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19For 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. |
| Serious cases | Active comparator | Other: Analysis of genetic polymorphisms of vasoactive peptides in COVID-19For 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of genetic polymorphisms of vasoactive peptides in COVID-19Evaluate 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. | Other | Mild/asymptomatic cases, Serious cases |
Primary outcome
Correlation between polymorphisms and COVID-19 progression
Time frame: 1 month
To investigate a possible correlation between gene polymorphism and disease progression (SARS-CoV-2) for asymptomatic, mild or severe conditions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared at any stage of the survey.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Antônio Silva Júnior, PhD study director
University Ninth of July
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of genetic polymorphisms of vasoactive peptides in COVID-19 in people with Sars-CoV-2 Infection, run by Leonardo Paroche de Matos at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Paroche de Matos, Msc (+551124532163, leonardoparoche@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between polymorphisms and COVID-19 progression (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.