COVID-19NCT05172167
Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra
An observational study of COVID-19, run by Universidad de Antioquia at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Levels of IgG and IgM SARS-CoV-2 antibodies blood test. and RT-PCR SARS-CoV-2 nasopharyngeal swab
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 2 Feb 2022to 30 Apr 2022
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Laboratorio Integrado de Medicina Especializada
Medellín, Antioquia, 050022
Andres F Zuluaga
About this study
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.
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.
- Conditions
- COVID-19
- Being tested
- Levels of IgG and IgM SARS-CoV-2 antibodies blood test., RT-PCR SARS-CoV-2 nasopharyngeal swab
- Keywords
- Laboratory biomarkers, Health condition, COVID-19, Antibodies level, Vaccinated people
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levels of IgG and IgM SARS-CoV-2 antibodies blood test.Diagnostic test
0,1,2 months
RT-PCR SARS-CoV-2 nasopharyngeal swabDiagnostic test
0,1,2 months
| Study group | Role | What they receive |
|---|---|---|
| Early vaccinated against COVID-19 | 80 subjects with less than 4 months after being fully vaccinated against COVID-19 Receives: 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 Receives: 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 Receives: Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.; Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG and IgM antibodies blood test levels generated by the different COVID-19 vaccines in people throughout the time of the study.
Measured: 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.
Measured: Through study completion, an average of 2 months
SARS-CoV-2 infections in vaccinated patients against COVID-19.
Measured: 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.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start2 Feb 2022
- Primary completion15 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorio integrado de medicina especializada(LIME), Proyecto de regalias BPIN 2020000100152
- Responsible party
- Principal investigator, Andres Felipe Zuluaga Salazar, Universidad de Antioquia
- Investigators
- Andres F Zuluaga, MD, MSc, MeH, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172167
- Sponsor's protocol ID
- LIME-21-P-02
- Status last verified
- Feb 2022
- First submitted
- 23 Dec 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05172167
- Acronym / sponsor ID
- LIME-21-P-02
- Conditions
- COVID-19
- Keywords
- Laboratory biomarkers, Health condition, COVID-19, Antibodies level, Vaccinated people
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Laboratorio integrado de medicina especializada(LIME), Proyecto de regalias BPIN 2020000100152
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 29 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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early 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 swab80 subjects with less than 4 months after being fully vaccinated against COVID-19 |
| Late 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 swab80 subjects with more than 4 months after being fully vaccinated against COVID-19 |
| COVID-19 infection | – | Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test., Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab40 patients diagnostic of COVID-19 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Levels of IgG and IgM SARS-CoV-2 antibodies blood test.0,1,2 months | Diagnostic test | COVID-19 infection, Early vaccinated against COVID-19, Late vaccinated against COVID-19 |
| RT-PCR SARS-CoV-2 nasopharyngeal swab0,1,2 months | Diagnostic test | COVID-19 infection, Early vaccinated against COVID-19, Late vaccinated against COVID-19 |
Primary outcome
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
3 secondary outcomes
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
SARS-CoV-2 infections in vaccinated patients against COVID-19.
Time frame: 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.
Time frame: Through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Andres F Zuluaga, MD, MSc, MeH principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Universidad de Antioquia at 1 site in Colombia.
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 3 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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 Ivone Jimenez (+57 (4) 2196022, ivone.jimenez@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 2 Mar 2022.