Using BCG Vaccine to Enhance Nonspecific Protection of Health Care Workers During the COVID-19 Pandemic: A Randomized Controlled Trial.

BACKGROUND: The BCG (Bacillus Calmette-Guérin) vaccine can induce nonspecific protection against unrelated infections. We aimed to test the effect of BCG on absenteeism and health of Danish health care workers (HCWs) during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: A single-blinded randomized controlled trial included 1221 HCWs from 9 Danish hospitals. Participants were randomized 1:1 to standard dose BCG or placebo. Primary outcome was days of unplanned absenteeism. Main secondary outcomes were incidence of COVID-19, all-cause hospitalization, and infectious disease episodes. RESULTS: There was no significant effect of BCG on unplanned absenteeism. Mean number of days absent per 1000 workdays was 20 in the BCG group and 17 in the placebo group (risk ratio, 1.23; 95% credibility interval, 0.98-1.53). BCG had no effect on incidence of COVID-19 or all-cause hospitalization overall. In secondary analyses BCG revaccination was associated with higher COVID-19 incidence (hazard ratio [HR], 2.47; 95% confidence interval [CI], 1.07-5.71), but also reduced risk of hospitalization (HR, 0.28; 95% CI, .09-.86). The incidence of infectious disease episodes was similar between randomization groups (HR, 1.09; 95% CI, .96-1.24). CONCLUSIONS: In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes. CLINICAL TRIALS REGISTRATION: NCT0437329 and EU Clinical Trials Register (EudraCT number 2020-001888-90).

Limitation of life-sustaining treatment and patient involvement in decision-making: a retrospective study of a Danish COVID-19 patient cohort.

BACKGROUND: The coronavirus (COVID-19) pandemic and the risk of an extensive overload of the healthcare systems have elucidated the need to make decisions on the level of life-sustaining treatment for patients requiring hospitalisation. The purpose of the study was to investigate the proportion and characteristics of COVID-19 patients with limitation of life-sustaining treatment decisions and the degree of patient involvement in the decisions. METHODS: A retrospective observational descriptive study was conducted in three Danish regional hospitals, looking at all patients ≥ 18 years of age admitted in 2020 with COVID-19 as the primary diagnosis. Lists of hospitalised patients admitted due to COVID-19 were extracted. The data registration included age, gender, comorbidities, including mental state, body mass index, frailty, recent hospital admissions, COVID-19 life-sustaining treatment, ICU admission, decisions on limitations of life-sustaining treatment before and during current hospitalisation, hospital length of stay, and hospital mortality. RESULTS: A total of 476 patients were included. For 7% (33/476), a decision about limitation of life-sustaining treatment had been made prior to hospital admission. At the time of admission, one or more limitations of life-sustaining treatment were registered for 16% (75/476) of patients. During the admission, limitation decisions were made for an additional 11 patients, totaling 18% (86/476). For 40% (34/86), the decisions were either made by or discussed with the patient. The decisions not made by patients were made by physicians. For 36% (31/86), no information was disclosed about patient involvement. CONCLUSIONS: Life-sustaining treatment limitation decisions were made for 18% of a COVID-19 patient cohort. Hereof, more than a third of the decisions had been made before hospital admission. Many records lacked information on patient involvement in the decisions.