BCG Vaccine for Health Care Workers as Defense Against COVID 19

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). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

Conditions

• Coronavirus
• Coronavirus Infection
• Coronavirus as the Cause of Diseases Classified Elsewhere

Interventions

BIOLOGICAL

BCG Vaccine

BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.

BIOLOGICAL

Placebo Vaccine

Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Harvard University

  collaborator OTHER

• Texas A&M University

  lead OTHER

Principal Investigators

• Jeffrey D Cirillo, PhD · Texas A&M University

• Andrew DiNardo, MD · Baylor College of Medicine

• Ashish M Kamat, MD · M.D. Anderson Cancer Center

• Moshe Arditi, MD · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-20

Primary Completion

2023-04-21

Completion

2023-04-21

FDA Drug

Yes

Countries

• United States

Study Locations