Background and rationale
Bacillus Calmette-Guérin, latently infected, pneumonia
PNEUMONIA, SARS-COV-2 INFECTION, BCG VACCINE, TUBERCULOSIS, OTHER INFECTIOUS DISEASES, SEVERE ACUTE RESPIRATORY SYNDROME
On 30 December 2019, a novel enveloped RNA betacoronavirus was detected from a patient with pneumonia of unknown etiology in Wuhan, the capital city of Hubei province. The pathogen was named the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) [Bacillus Calmette-Guérin (BCG) was developed as a vaccine against tuberculosis, but studies have shown its ability to induce protection against other infectious diseases or, so-called, non-specific effects (NSEs) [This study will evaluate the efficacy of BCG to prevent and improve the clinical course of SARS-CoV-2 infection. BCG vaccine in immunocompetent adult people is considered safe, even in latently infected adults with prior infant BCG vaccination [Given the immediate threat of the SARS-CoV-2 pandemic, this trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously (e.g., symptoms continuously and serology every other week) measured. This allows for the most rapid identification of a beneficial outcome that would allow healthcare workers and other high-risk individuals to benefit from the BCG vaccination intervention, if it is effective, at the earliest possible time during the pandemic.