COVID-19 Clinical Trial
Official title:
Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial
Verified date | October 2021 |
Source | TASK Applied Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Status | Completed |
Enrollment | 1000 |
Est. completion date | January 2, 2022 |
Est. primary completion date | January 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | TASK Foundation | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
TASK Applied Science |
South Africa,
Kleinnijenhuis J, Quintin J, Preijers F, Joosten LA, Ifrim DC, Saeed S, Jacobs C, van Loenhout J, de Jong D, Stunnenberg HG, Xavier RJ, van der Meer JW, van Crevel R, Netea MG. Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proc Natl Acad Sci U S A. 2012 Oct 23;109(43):17537-42. doi: 10.1073/pnas.1202870109. Epub 2012 Sep 17. — View Citation
Netea MG, Schlitzer A, Placek K, Joosten LAB, Schultze JL. Innate and Adaptive Immune Memory: an Evolutionary Continuum in the Host's Response to Pathogens. Cell Host Microbe. 2019 Jan 9;25(1):13-26. doi: 10.1016/j.chom.2018.12.006. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of HCWs hospitalized due to COVID-19 per arm | To compare the incidence of HCWs hospitalized due to COVID-19 per arm. | 52 weeks | |
Secondary | Incidence of SARS-CoV-2 infection per arm | To determine the incidence of SARS-CoV-2 infection in HCW by molecular or serological testing (as available) at entry, 10, 26 and/or 52 weeks. | 52 weeks | |
Secondary | Incidence of upper respiratory tract infections per arm | To compare the incidence of symptoms of upper respiratory tract infection per arm. | 52 weeks | |
Secondary | Days of unplanned absenteeism due to COVID-19 or any reason per arm | To compare the number of days of (unplanned) absenteeism because of documented SARS-CoV-2 infection, COVID-19 or any reason per arm. | 52 weeks | |
Secondary | Incidence of hospitalization for any reason per arm | To compare the incidence of hospitalization of HCW for any reason per arm. | 52 weeks | |
Secondary | Incidence of intensive care unit admission per arm | To compare the incidence of intensive care admission of HCW due to COVID-19 or any reason per arm. | 52 weeks | |
Secondary | Incidence of death per arm | To compare the incidence of death of HCW due to COVID-19 or any reason per arm. | 52 weeks | |
Secondary | Prevalence of latent TB infection | To describe the prevalence of latent TB infection as determined by interferon gamma release assay (IGRA) at enrolment and at week 52. | 52 weeks | |
Secondary | Incidence of active TB per arm | To compare the incidence of active TB of HCW per arm. | 52 weeks | |
Secondary | Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm | To compare the effect of latent TB infection on morbidity and mortality of HCW due to COVID-19 per arm. The risk of morbidity and mortality of latent TB infected individuals is not known, we will examine whether there is a higher risk of disease severity and poor outcomes in this group. | 52 weeks | |
Secondary | Incidence of treatment related adverse events | To compare the incidence of grade 2 or higher adverse events and vaccination site reactions per arm. | 52 weeks |
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