Status:
COMPLETED
BCG Vaccination for Healthcare Workers in COVID-19 Pandemic
Lead Sponsor:
TASK Applied Science
Conditions:
COVID-19
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worse...
Detailed Description
Morbidity and mortality attributable to COVID-19 is devastating global health systems and economies. Bacillus Calmette Guérin (BCG) vaccination has been in use for many decades to prevent severe forms...
Eligibility Criteria
Inclusion
- Men and women aged ≥18 years
- HCW or other frontline staff currently in contact with, or anticipated to be in contact with, patients with SARS-CoV-2 infection.
- Ability and willingness to provide informed consent.
- Can be reached by mobile phone for follow-up
Exclusion
- Known allergy to (components of) the BCG vaccine or serious reaction to prior BCG administration.
- Known active tuberculosis or any other active or uncontrolled condition that, in the opinion of the investigator or designee, makes participation unsafe or makes it difficult to collect follow-up data over the study period.
- HIV-1 infection
- \- NOTE: If evidence of recent HIV negative test is not available, rapid point-of-care testing will be undertaken as part of screening with a separate informed consent process.
- Symptoms of respiratory tract infection which, in the opinion of the investigator or designee, is likely to interfere with the objectives of the study.
- Known medical history of any of the following immunocompromised states:
- Neutropenia (less than 500 neutrophils/mm3)
- Lymphopenia (less than 400 lymphocytes/mm3)
- Solid organ or bone marrow transplantation
- Primary immunodeficiency
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Pregnancy and breastfeeding
- Current treatment with the following medications:
- Chemotherapy
- Anti-cytokine therapies
- Current treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
- Any experimental, unproven treatment against SARS-CoV-2 infection or COVID-19 including but not limited to chloroquine, hydroxychloroquine, remdesivir, lopinavir/ritonavir and interferon beta-1a.
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04379336
Start Date
May 4 2020
End Date
January 2 2022
Last Update
January 25 2022
Active Locations (1)
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1
TASK Foundation
Cape Town, Western Cape, South Africa, 7500