Statistical methods for primary and secondary outcomes
respiratory failure, sepsis, pneumonia, COVID-19 disease
PNEUMONIA, RESPIRATORY FAILURE, DISEASE, COVID-19 INFECTION, SECONDARY, SEPTIC SHOCK, SEPSIS, DISEASE, ACUTE RESPIRATORY DISTRESS SYNDROME
For the primary endpoint, the development of COVID-19 infection, we will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert.For the secondary endpoint, the disease severity, we will use the chi-square for significance to calculate the risk ratios for the development of severe COVID-19 disease. Disease severity will be based on the level of care required for individuals who test positive for COVID-19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis, and septic shock. Days absent will also be self-reported via the REDCap Research App. Immunology and epigenetic studies for innate training will be implemented, but in brief, immune cells will be stimulated with non-specific (LPS, mitogen, BCG) and COVID-19-specific antigens with immune function measured by ELISA and flow cytometry. Epigenetic studies are discussed in more detail below.