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Objectives To test whether BCG vaccination would reduce the incidence of COVID-19 and other respiratory tract infections in older adults with one or more comorbidities. Methods Community-dwelling adults over 60 years old with one or more underlying comorbidities and no contra-indications for BCG vaccination were randomized 1:1 to BCG or placebo vaccination and followed for six months. The primary endpoint was self-reported test-confirmed COVID-19 incidence. Secondary endpoints included COVID-19 hospital admissions and clinically relevant RTI (i.e. RTI including but not limited to COVID-19 requiring medical intervention). COVID-19 and clinically relevant RTI episodes were adjudicated. Incidences were compared using Fine and Gray regression, accounting for competing events. Results A total of 6,112 participants with a median age of 69 years (inter-quartile range 65-74) and median of 2 (inter-quartile range 1-3) comorbidities were randomized to BCG (n=3,058) or placebo (n=3,054) vaccination. COVID-19 infections were reported by 129 BCG recipients compared to 115 placebo recipients (hazard ratio (HR) 1.12;95% confidence interval (CI) 0.87-1.44). COVID-19-related hospitalization occurred in 18 BCG and 21 placebo recipients (HR 0.86;95% CI 0.46-1.61). During the study period 13 BCG recipients compared to 18 placebo recipients died (HR 0.71;95% CI 0.35 - 1.43) of which 11 deaths (35%) were COVID-19 related six in the placebo group and five in the BCG group. Clinically relevant RTI was reported by 66 BCG and 72 placebo recipients (HR 0.92;95% CI 0.66-1.28). Conclusion BCG vaccination does not protect older adults with comorbidities against COVID-19, COVID-19 hospitalization or clinically relevant RTI.
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OBJECTIVES: To test whether Bacillus Calmette-Guérin (BCG) vaccination would reduce the incidence of COVID-19 and other respiratory tract infections (RTIs) in older adults with one or more comorbidities. METHODS: Community-dwelling adults aged 60 years or older with one or more underlying comorbidities and no contraindications to BCG vaccination were randomized 1:1 to BCG or placebo vaccination and followed for 6 months. The primary endpoint was a self-reported, test-confirmed COVID-19 incidence. Secondary endpoints included COVID-19 hospital admissions and clinically relevant RTIs (i.e. RTIs including but not limited to COVID-19 requiring medical intervention). COVID-19 and clinically relevant RTI episodes were adjudicated. Incidences were compared using Fine-Gray regression, accounting for competing events. RESULTS: A total of 6112 participants with a median age of 69 years (interquartile range, 65-74) and median of 2 (interquartile range, 1-3) comorbidities were randomized to BCG (n = 3058) or placebo (n = 3054) vaccination. COVID-19 infections were reported by 129 BCG recipients compared to 115 placebo recipients [hazard ratio (HR), 1.12; 95% CI, 0.87-1.44]. COVID-19-related hospitalization occurred in 18 BCG and 21 placebo recipients (HR, 0.86; 95% CI, 0.46-1.61). During the study period, 13 BCG recipients died compared with 18 placebo recipients (HR, 0.71; 95% CI, 0.35-1.43), of which 11 deaths (35%) were COVID-19-related: six in the placebo group and five in the BCG group. Clinically relevant RTI was reported by 66 BCG and 72 placebo recipients (HR, 0.92; 95% CI, 0.66-1.28). DISCUSSION: BCG vaccination does not protect older adults with comorbidities against COVID-19, COVID-19 hospitalization, or clinically relevant RTIs.
Subject(s)
COVID-19 , Humans , Aged , COVID-19/epidemiology , COVID-19/prevention & control , BCG Vaccine , Vaccination , Hospitalization , IncidenceABSTRACT
Early recognition of sepsis is essential for improving outcomes and preventing complications such as organ failure, depression, and neurocognitive impairment. The emergency department (ED) plays a key role in the early identification of sepsis, but clinicians lack diagnostic tools. Potentially, biomarkers could be helpful in assisting clinicians in the ED, but no marker has yet been successfully implemented in daily practice with good clinical performance. Pancreatic stone protein (PSP) is a promising biomarker in the context of sepsis, but little is known about the diagnostic performance of PSP in the ED. We prospectively investigated the diagnostic value of PSP in such a population for patients suspected of infection. PSP was compared with currently used biomarkers, including white blood cell count (WBC) and C-reactive protein (CRP). Of the 156 patients included in this study, 74 (47.4%) were diagnosed with uncomplicated infection and 26 (16.7%) patients with sepsis, while 56 (35.9%) eventually had no infection. PSP was significantly higher for sepsis patients compared to patients with no sepsis. In multivariate regression, PSP was a significant predictor for sepsis, with an area under the curve (AUC) of 0.69. Positive and negative predictive values for this model were 100% and 84.4%, respectively. Altogether, these findings show that PSP, measured at the ED of a tertiary hospital, is associated with sepsis but lacks the diagnostic performance to be used as single marker.
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BACKGROUND: the geographical similarities of the Dutch 2007-2010 Q fever outbreak and the start of the 2020 coronavirus disease 19 (COVID-19) outbreak in the Netherlands raised questions and provided a unique opportunity to study an association between Coxiella burnetii infection and the outcome following SARS-CoV-2 infection. METHODS: We performed a retrospective cohort study in two Dutch hospitals. We assessed evidence of previous C. burnetii infection in COVID-19 patients diagnosed at the ED during the first COVID-19 wave and compared a combined outcome of in-hospital mortality and intensive care unit (ICU) admission using adjusted odds ratios (OR). RESULTS: In total, 629 patients were included with a mean age of 68.0 years. Evidence of previous C. burnetii infection was found in 117 patients (18.6%). The combined primary outcome occurred in 40.2% and 40.4% of patients with and without evidence of previous C. burnetii infection respectively (adjusted OR of 0.926 (95% CI 0.605-1.416)). The adjusted OR of the secondary outcomes in-hospital mortality, ICU-admission and regular ward admission did not show an association either. CONCLUSION: no influence of previous C. burnetii infection on the risk of ICU admission and/or mortality for patients with COVID-19 presenting at the ED was observed.
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OBJECTIVES: The COVID-19 pandemic pressurised healthcare with increased shortage of care. This resulted in an increase of awareness for code status documentation (ie, whether limitations to specific life-sustaining treatments are in place), both in the medical field and in public media. However, it is unknown whether the increased awareness changed the prevalence and content of code status documentation for COVID-19 patients. We aim to describe differences in code status documentation between infectious patients before the pandemic and COVID-19 patients. SETTING: University Medical Centre of Utrecht, a tertiary care teaching academic hospital in the Netherlands. PARTICIPANTS: A total of 1715 patients were included, 129 in the COVID-19 cohort (a cohort of COVID-19 patients, admitted from March 2020 to June 2020) and 1586 in the pre-COVID-19 cohort (a cohort of patients with (suspected) infections admitted between September 2016 to September 2018). PRIMARY AND SECONDARY OUTCOME MEASURES: We described frequency of code status documentation, frequency of discussion of this code status with patient and/or family, and content of code status. RESULTS: Frequencies of code status documentation (69.8% vs 72.7%, respectively) and discussion (75.6% vs 73.3%, respectively) were similar in both cohorts. More patients in the COVID-19 cohort than in the before COVID-19 cohort had any treatment limitation as opposed to full code (40% vs 25%). Within the treatment limitations, 'no intensive care admission' (81% vs 51%) and 'no intubation' (69% vs 40%) were more frequently documented in the COVID-19 cohort. A smaller difference was seen in 'other limitation' (17% vs 9%), while 'no resuscitation' (96% vs 92%) was comparable between both periods. CONCLUSION: We observed no difference in the frequency of code status documentation or discussion in COVID-19 patients opposed to a pre-COVID-19 cohort. However, treatment limitations were more prevalent in patients with COVID-19, especially 'no intubation' and 'no intensive care admission'.