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Status unknownNCT05172167Updated Mar 2, 2022

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

An observational study in COVID-19, sponsored by Universidad de Antioquia. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Universidad de Antioquia · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • COVID-19

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Keywords

  • Laboratory biomarkers
  • Health condition
  • COVID-19
  • Antibodies level
  • Vaccinated people
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 200 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testLevels of IgG and IgM SARS-CoV-2 antibodies blood test.

    0,1,2 months

  • Diagnostic testRT-PCR SARS-CoV-2 nasopharyngeal swab

    0,1,2 months

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What researchers measure

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.

    Time frame: Through study completion, an average of 2 months

Secondary outcomes

  1. Comparing immunoglobulins M and G levels in vaccinated patients against SARS-CoV-2 with RNA and non RNA vaccines.

    Time frame: Through study completion, an average of 2 months

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

    Time frame: Through study completion, an average of 2 months

  3. Correlate through time immunoglobulins M and G levels in people vaccinated against COVID-19 and SARS-CoV-2 acute infected patients.

    Time frame: Through study completion, an average of 2 months

07

Study locations

1 of 1 sites recruiting
  • Laboratorio Integrado de Medicina Especializada
    Medellin, Antioquia 050022, Colombia
    • Andres F Zuluaga · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05172167
Lead sponsor
Universidad de Antioquia
Collaborators
Laboratorio integrado de medicina especializada(LIME), Proyecto de regalias BPIN 2020000100152
Responsible party
Andres Felipe Zuluaga Salazar (Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University, Universidad de Antioquia) — Principal investigator
First posted
Dec 29, 2021
Start date
Feb 2, 2022
Primary completion
Apr 15, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Mar 2, 2022

Study contacts

Ivone Jimenez
Contact
ivone.jimenez@udea.edu.co
+57 (4) 2196022
Andres F Zuluaga, MD, MSc, MeH
principal investigator · Universidad de Antioquia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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