ABSTRACT
Background: The cardiovascular complications of Severe Coronavirus Disease 2019 (COVID-19) may be attributed to the hyperinflammatory state leading to increased mortality in patients with COVID-19. Statins are known to have pleiotropic and anti-inflammatory effects and may influence viral transmission along with their cholesterol-lowering activity. Thus, statin therapy is potentially a potent adjuvant therapy in COVID-19 infection. This study investigated the association of statin use on the outcome of critically ill patients with COVID-19. Methods: A multicenter, retrospective cohort study of all adult critically ill patients with confirmed COVID-19 admitted to Intensive Care Units (ICUs) between March 1, 2020, and March 31, 2021. Eligible patients were classified into two groups based on statin use during ICU stay and were matched with a propensity score based on patient’s age and admission APACHE II and SOFA scores. The primary endpoint was in-hospital mortality, while 30 days Ventilator-free days (VFDs) and ICU complications were secondary endpoints. Results: A total of 1049 patients were eligible; 502 patients were included after propensity score matching (1:1 ratio). The 30-day (hazard ratio 0.75 (95% CI 0.58, 0.98), P =0.03) and in-hospital mortality (hazard ratio 0.69 (95% CI 0.54, 0.89), P =0.004) were significantly lower in patients who received statin therapy on multivariable cox proportional hazards regression analysis. Moreover, patients who received statin had a lower risk of hospital-acquired pneumonia (OR 0.48(95% CI 0.32, 0.69), P =<0.001), lower levels of markers of inflammation on follow up and no increased risk of liver injury. Conclusion: The use of statin during ICU stay in COVID-19 critically ill patients may have a beneficial role and survival benefits with a good safety profile.
Subject(s)
COVID-19 , Coronavirus Infections , Liver DiseasesABSTRACT
IntroductionNoninvasive ventilation delivered by helmet is has been used for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. The aim of this study is to compare helmet noninvasive ventilation with usual care versus usual care alone to reduce the mortality. Methods and analysisThis is a multicenter, pragmatic, parallel, randomized controlled trial that compares helmet noninvasive ventilation with usual care to usual care alone in 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. Ethics and disseminationApprovals are obtained from the Institutional Review Boards (IRBs) of each participating institution. Our findings will be published in peer-review journals and presented at relevant conferences and meetings. Trial registration numberNCT04477668 registered on July 20, 2020 Article SummaryO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThis trial compares helmet NIV to usual care for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. C_LIO_LIThe trial is a multi-center, pragmatic, parallel randomized controlled trial. C_LIO_LIThe main limitation is the unblinded design due to the nature of the intervention. C_LI
Subject(s)
COVID-19 , Pneumonia , Respiratory InsufficiencyABSTRACT
Background and objective Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation having multiple advantages over other support modalities but data about effectiveness are limited. Methods In this multicenter randomized trial of helmet non-invasive ventilation for COVID-19 patients (Helmet-COVID), 320 adult ICU patients with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (with a ratio of arterial oxygen partial pressure to fraction (percent) of inspired oxygen (PaO2/FiO2) <200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate >10 L/min or above) will be randomized to helmet-noninvasive ventilation with usual care or usual care alone. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction from 40% to 25%. Conclusion Consistent with international guidelines, we developed a detailed plan to guide the analysis of the Helmet-COVID trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes to facilitate unbiased analyses of clinical data.
Subject(s)
COVID-19 , Coronavirus Infections , Respiratory InsufficiencyABSTRACT
Background: Diabetes is a risk factor for infection with coronaviruses. This study describes the demographic, clinical data, and outcomes of critically ill patients with diabetes and Middle East Respiratory Syndrome (MERS). Methods: : This retrospective cohort study was conducted at 14 hospitals in Saudi Arabia (September 2012- January 2018). We compared the demographic characteristics, underlying medical conditions, presenting symptoms and signs, management and clinical course, and outcomes of critically ill patients with MERS who had diabetes compared to those with no diabetes. Multivariable logistic regression analysis was performed to determine if diabetes was an independent predictor of 90-day mortality. Results: : Of the 350 critically ill patients with MERS, 171 (48.9%) had diabetes. Patients with diabetes were more likely to be older, and have comorbid conditions, compared to patients with no diabetes. They were more likely to present with respiratory failure requiring intubation, vasopressors, and corticosteroids. The median time to clearance of MERS-CoV RNA was similar (23 days (Q1, Q3: 17, 36) in patients with diabetes and 21.0 days (Q1, Q3: 10, 33) in patients with no diabetes). Mortality at 90 days was higher in patients with diabetes (78.9% versus 54.7%, p<0.0001). Multivariable regression analysis showed that diabetes was an independent risk factor for 90-day mortality (odds ratio, 2.09; 95% confidence interval, 1.18-3.72). Conclusions: : Half of the critically ill patients with MERS have diabetes; which is associated with more severe disease. Diabetes is an independent predictor of mortality among critically patients with MERS.