Status:
COMPLETED
Using BCG Vaccine to Protect Health Care Workers in the COVID-19 Pandemic
Lead Sponsor:
Bandim Health Project
Collaborating Sponsors:
University of Southern Denmark
Conditions:
COVID-19
Non-specific Effects of Vaccines
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
Background: The COVID-19 pandemic challenges the available hospital capacity, and this will be augmented by absenteeism of healthcare workers (HCW). HCW are at high risk, currently HCW constitute 20% ...
Detailed Description
BACKGROUND Health-care workers face an elevated risk of exposure to - and infection with - SARS-CoV-2. It is imperative to ensure the safety, health and fitness of hospital personnel in order to safeg...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet the following criteria:
- Adult (≥18 years);
- Hospital personnel caring for patients with COVID-19.
Exclusion
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
- Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species
- Previous M. tuberculosis infection
- Previous confirmed COVID-19 infection
- Fever (\>38 C) within the past 24 hours
- Suspicion of active viral or bacterial infection
- Pregnancy
- Severely immunocompromised subjects (This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months)
- Active solid or non-solid malignancy or lymphoma within the prior two years;
- Direct involvement in the design or the execution of the BCG-DENMARK-COVID study
- Employed to the hospital \< 22 hours per week
- Not in possession of a smartphone/tablet.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
1293 Patients enrolled
Trial Details
Trial ID
NCT04373291
Start Date
May 18 2020
End Date
October 1 2021
Last Update
October 8 2021
Active Locations (1)
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1
University of Southern Denmark
Odense, Region Syddanmark, Denmark, 5000