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Bacillus Calmette-Guérin (BCG) Study to Help Prevent COVID-19

The goal of this study is to learn if a Bacillus Calmette-Guérin (BCG) vaccination can help to prevent SARS-CoV2 (COVID-19) infection and/or mitigate the severity of the illness among health care workers when compared to placebo.

SARS-CoV-2 is a contagious virus affecting everyone at this time. There is no current vaccination or treatment against this virus. Researchers at Texas A&M University, in collaboration with MD Anderson Cancer Center, Baylor College Medicine and Cedars Sinai Medical Center, are looking for health care worker volunteers to participate in a study evaluating Bacillus Calmette Guérin (BCG) vaccine as a booster of the immune response and to study if this vaccine reduces illness severity from coronavirus.

This collaborative effort is based on nearly 100 years of research demonstrating that BCG vaccination reduces severity and death due to viral and bacterial infections and has been epidemiologically associated with lower mortality due to COVID-19.

Consent will be collected electronically and by phone in adherence with current social distancing practices. Volunteers receive a one-time vaccination and will submit daily diary entries on an electronic device (e.g. smart phone or tablet) through a secure research "app" or web portal. Optionally, blood samples and stool samples will be collected at designated timepoints.

Health care workers may be eligible if they are:

• Between the ages of 18 and 75
• Healthcare workers taking care of patients with known or suspected SARS-CoV-2 infection or providing, on average, at least 25 hours per week of direct patient care
• Able to use their own device to provide data electronically (i.e. via smartphone or tablet)
• Able to participate for six months
 
Benefits of participating may include: subjects randomized to the BCG vaccine-arm may experience lower incidence of SARS-CoV-2 infection and/or lower risk on developing severe illness caused by SARS-CoV-2.

To see if you are eligible, take the screening survey.

IRB Number 2020-0432F   IRB Approval Date: 06/02/2020