Status:
COMPLETED
BCG Vaccine for Health Care Workers as Defense Against COVID 19
Lead Sponsor:
Texas A&M University
Collaborating Sponsors:
Baylor College of Medicine
M.D. Anderson Cancer Center
Conditions:
Coronavirus
Coronavirus Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strat...
Detailed Description
Study design: A placebo-controlled adaptive multi-center randomized controlled trial. Study population: High risk HCW with direct patient contacts, defined as physician assistants, respiratory therap...
Eligibility Criteria
Inclusion
- Adult (≥18 years)
- Male or female
- Hospital personnel taking care for patients with known or suspected SARS-CoV-2 infection and providing, on average, at least 25 hours per week of direct patient care
Exclusion
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
- Fever (\>38 C) within the past 24 hours
- Age \> 75 years
- Pregnancy or planning pregnancy within 30 days of study enrollment
- Breastfeeding
- Suspicion of active viral or bacterial infection
- Any Immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with known neutropenic with less than 1500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) known severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
- Living with someone who is immunosuppressed or taking immunosuppressive drugs
- Previous documented infection with COVID19
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Direct involvement in the design or the execution of the study
- Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
- Not in possession of a smartphone
- Inability to keep the vaccine site covered in the case of a draining pustule.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
659 Patients enrolled
Trial Details
Trial ID
NCT04348370
Start Date
April 20 2020
End Date
April 21 2023
Last Update
October 8 2024
Active Locations (6)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Texas A&M Family Care Clinic
Bryan, Texas, United States, 77802
3
Baylor College of Medicine
Houston, Texas, United States, 77030
4
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030