Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra

NCT ID: NCT05172167

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-02

Study Completion Date

2022-04-30

Brief Summary

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Recent research evidence shows that levels of antibodies acquierd post vacunation against SARS-Cov-2 decrease over time as well as the efficacy to control the infection, additionally in a multicenter study carried out in 2020 were evidenced differences in the time it took to decrease the antibodies according to the type of vaccine, defined as mRNA or other types of vaccine.

In this study , the variation of the SARS-Cov-2 antibody levels in patients from Valle de Aburrá will be correlated according to the COVID-19 vaccine received.

Detailed Description

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After being informed about the study, all patients giving written informed consent will undergo a serial IgM -IgG COVID-19 antibodies blood test and SARS-Cov-2 PCR by nasopharingeal swab, that will be taken at the beginning of the study and mensually for two months.

During the study will be done an active search for SARS-CoV-2 infections in the vaccinated people cohort, and if it is posible to characterize the variant of SARS-CoV-2 in participants previously vaccinated against this pathogen.

The main objective of this study is to describe the pattern of antibodies blood test based in the type of vaccine and correlated the pattern of antibodies SARS-Cov-2 levels in a population of Valle de Aburrá.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early vaccinated against COVID-19

80 subjects with less than 4 months after being fully vaccinated against COVID-19

Levels of IgG and IgM SARS-CoV-2 antibodies blood test.

Intervention Type DIAGNOSTIC_TEST

0,1,2 months

RT-PCR SARS-CoV-2 nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

0,1,2 months

Late vaccinated against COVID-19

80 subjects with more than 4 months after being fully vaccinated against COVID-19

Levels of IgG and IgM SARS-CoV-2 antibodies blood test.

Intervention Type DIAGNOSTIC_TEST

0,1,2 months

RT-PCR SARS-CoV-2 nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

0,1,2 months

COVID-19 infection

40 patients diagnostic of COVID-19

Levels of IgG and IgM SARS-CoV-2 antibodies blood test.

Intervention Type DIAGNOSTIC_TEST

0,1,2 months

RT-PCR SARS-CoV-2 nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

0,1,2 months

Interventions

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Levels of IgG and IgM SARS-CoV-2 antibodies blood test.

0,1,2 months

Intervention Type DIAGNOSTIC_TEST

RT-PCR SARS-CoV-2 nasopharyngeal swab

0,1,2 months

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult over 18 years old
* The vaccinated patients to be included must have received a complete vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia
* SARS-CoV-2 infection in the last 2 months, verified by rtPCR test

Exclusion Criteria

* Immunocompromised patients
* Immunosuppressive treatments, chemotherapy or antiretroviral therapy
* Outpatient anticoagulant therapy
* For vaccinated people (groups 1 and 2): if have had COVID-19 infection in the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratorio integrado de medicina especializada(LIME)

UNKNOWN

Sponsor Role collaborator

Proyecto de regalias BPIN 2020000100152

UNKNOWN

Sponsor Role collaborator

Universidad de Antioquia

OTHER

Sponsor Role lead

Responsible Party

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Andres Felipe Zuluaga Salazar

Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andres F Zuluaga, MD, MSc, MeH

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

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Laboratorio Integrado de Medicina Especializada

Medellín, Antioquia, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Ivone Jimenez

Role: CONTACT

+57 (4) 2196022

Facility Contacts

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Andres F Zuluaga

Role: primary

Other Identifiers

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LIME-21-P-02

Identifier Type: -

Identifier Source: org_study_id

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