Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04887246 |
| Other study ID # |
52932 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Universidad Nacional de Colombia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
There are relevant questions that need to be answered about the effectiveness and safety of
COVID-19 vaccines. The objective of this observational study is to follow up the clinical
outcomes after vaccination in all the headquarters of the National University of Colombia. It
is a project that is considered institutional importance and is part of the actions that the
National University of Colombia has proposed to the national government to accompany the
national vaccination program.
The proposed follow-up includes the sociodemographic, cultural, clinical and pharmacological
characterization of the vaccinated population, including the report of adverse events
occurring after the vaccination process, the behavior of the population after the
administration of the vaccine, monitoring serological outcomes, identification of medication
errors and therapeutic failure. Three stages are proposed in which the population affiliated
to UNISALUD is gradually included, then the beneficiaries and later the student community and
their families.
The scope of the attached protocol includes Stage I, which corresponds to teachers and
administrative staff (active and retired) linked to UNISALUD.
Description:
OBJECTIVE: To evaluate the clinical outcomes and adverse events associated with immunization
(ESAVI) of vaccines against COVID-19 in the cohort of the university community, affiliates
and beneficiaries of UNISALUD and students of the National University of Colombia.
METHODOLOGY: Descriptive longitudinal, prospective and observational study. Follow-up to a
cohort without a control group. Modular multi-center stage study. The development of the
research is proposed through a modular, multicenter and staged study. For the first phase,
all employees of the National University of Colombia (active and retired) who agree to
participate in the study will be monitored. The second phase includes monitoring the
beneficiaries of UNISALUD affiliates and the third phase includes students and their
families. For the calculation of the sample size in phase III, it will be carried out by
applying formulas for descriptive studies.
Follow-up Time: It is estimated to be one year from the date of the first dose of the
vaccine. A second phase is expected to follow up the outcomes for another additional year.
Data collection: It will begin with the presentation of the informed consent for the
presentation of the study. Subsequently, a periodic follow-up will be carried out via
telephone or email to identify and complete the established sociodemographic, cultural,
clinical and pharmacological variables.
Serological Follow-up: The humoral immune response and its duration will be analyzed through
serological tests with a blood sample to a sample of the study population. Serological
follow-up will be carried out in 3 moments: prior to vaccination, after the first dose of the
vaccine, and at the end of the study. The collected samples will be taken to the Laboratory
of the Faculty of Medicine of the National University of Colombia for their separation.
Antibody analysis will be done by chemiluminescence using the Advia Centaur COV2 platform
from Siemens (3).
ETHICAL ASPECTS: This research is considered a research with minimal risk (Resolution No.
008430 of October 4, 1993 in article 11 of Colombia's Ministry of Healt ). When handling very
sensitive information, the informed consent of the user and / or his manager will be filled
out, prior to the start of the application of the data collection instrument, and the
collection of blood samples for serological monitoring.
Access to the clinical and pharmacological information of the participants affiliated and
beneficiaries of UNISALUD will be required, which will be provided by the same entity, as
well as the databases adjusted to the vaccination phases in Colombia. In the case of
students, basic contact information and financial situation will be needed, which will be
reported by the University Welfare Directorate.
The treatment of information and data collected in accordance with Law 1266 of 2008 "Habeas
Data" and subject to acceptance by the participants through informed consent.
This study protocol has the endorsement of the ethics committee of the Faculty of Sciences in
a meeting held on March 1, 2021 (Minutes 02-2021).
