Status:
WITHDRAWN
Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of COVID-19 Infection.
Lead Sponsor:
Universidad de Antioquia
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Off...
Detailed Description
Problem Statement To date, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases (1). Of...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Men and women
- Between ≥18 and ≤ 65 years old
- Healthcare workers (doctors, nurses and nursing assistants) from clinics and hospitals in Medellín, who are directly involved in the care of patients with COVID-19
- A negative test for COVID-19 and being asymptomatic at baseline
- Are able and willing to give signed informed consent (Subjects whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol)
- Exclusion Criteria
- Have a previous diagnosis (probable or confirmed) of COVID-19
- Immunosuppression (pharmacological or clinical)
- Are taking immunosuppressive medications
- Pregnant or lactating women; or women of childbearing age who do not agree to take contraceptives during the month following vaccination.
- Have received any live or replicative vaccine one month before the time of screening.
- Permanent teleworking activity.
- History of active tuberculosis
- Currently are receiving Hydroxychloroquine, Chloroquine, Lopinavir/ritonavir, Tocilizumab, or Azithromycin.
- Known or suspected history of hypersensitivity to vaccines.
- Patients who do not wish to attend or who cannot keep up with the follow-up visits.
Exclusion
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04362124
Start Date
August 1 2020
End Date
November 1 2021
Last Update
November 27 2020
Active Locations (1)
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1
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, Colombia, 1226