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

COVID-19 Clinical Trial

Official title:

Prospective Evaluation of Antibodies Levels Variation Against SARS-CoV-2 in a Vaccinated Population of the Metropolitan Area of Valle de Aburra . Pilot Prospective Cohort.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172167
• Other study ID #: LIME-21-P-02
• Status: Recruiting
• Start date: February 2, 2022
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2022
• Source: Universidad de Antioquia
• Contact: Ivone Jimenez
• Phone: +57 (4) 2196022
• Email: ivone.jimenez[@]udea.edu.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Levels of IgG and IgM SARS-CoV-2 antibodies blood test.
0,1,2 months
• RT-PCR SARS-CoV-2 nasopharyngeal swab
0,1,2 months

Locations

Country	Name	City	State
Colombia	Laboratorio Integrado de Medicina Especializada	Medellin	Antioquia

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Antioquia	Laboratorio integrado de medicina especializada(LIME), Proyecto de regalias BPIN 2020000100152

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG and IgM antibodies blood test levels generated by the different COVID-19 vaccines in people throughout the time of the study.		Through study completion, an average of 2 months
Secondary	Comparing immunoglobulins M and G levels in vaccinated patients against SARS-CoV-2 with RNA and non RNA vaccines.		Through study completion, an average of 2 months
Secondary	SARS-CoV-2 infections in vaccinated patients against COVID-19.		Through study completion, an average of 2 months
Secondary	Correlate through time immunoglobulins M and G levels in people vaccinated against COVID-19 and SARS-CoV-2 acute infected patients.		Through study completion, an average of 2 months