NCT05172167

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

December 23, 2021

Last Update Submit

February 24, 2022

Conditions

COVID-19

Keywords

Laboratory biomarkersHealth conditionCOVID-19Antibodies levelVaccinated people

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • SARS-CoV-2 infections in vaccinated patients against COVID-19.

    Through study completion, an average of 2 months

  • 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

Study Arms (3)

Early vaccinated against COVID-19

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

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

Late vaccinated against COVID-19

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

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

COVID-19 infection

40 patients diagnostic of COVID-19

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

Interventions

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

0,1,2 months

COVID-19 infectionEarly vaccinated against COVID-19Late vaccinated against COVID-19
RT-PCR SARS-CoV-2 nasopharyngeal swabDIAGNOSTIC_TEST

0,1,2 months

COVID-19 infectionEarly vaccinated against COVID-19Late vaccinated against COVID-19

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with a fully vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia and patients diagnosed with SARS-CoV-2 infection in the last 60 days, without matter vaccination status against SARS-CoV-2.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio Integrado de Medicina Especializada

Medellín, Antioquia, 050022, Colombia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Andres F Zuluaga, MD, MSc, MeH

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivone Jimenez

CONTACT

+57 (4) 2196022ivone.jimenez@udea.edu.co

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University

Study Record Dates

First Submitted

December 23, 2021

First Posted

December 29, 2021

Study Start

February 2, 2022

Primary Completion

April 15, 2022

Study Completion

April 30, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

CO(1)