Background We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. Methods In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov , NCT04501978 . Findings Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–...
Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has ravaged many urban and high-density areas in the USA. However, rural areas (despite their low population density) may be especially vulnerable to poor outcomes from COVID-19, owing to limited healthcare infrastructure, long distances to advanced health care, and population characteristics (e.g., high tobacco use, hypertension, obesity, older age). A panel of experts who are actively engaged in treating and managing COVID-19 at a rural academic center was convened to address this topic. In this commentary, we provide readers with some specific issues faced by rural healthcare providers and offer guidance in overcoming these challenges. This guidance includes alternative ventilator strategies, personal protective equipment (PPE), and common therapeutic options.
Background:Transitions of care can be difficult to manage and if not performed properly, can lead to increased readmissions and poor outcomes. Transitions are more complex when patients are discharged to skilled nursing facilities.Purpose:We assessed the impact of pharmacist-led initiatives, including medication reconciliation, on readmission rates between an academic medical center and a local skilled nursing facility (SNF).Methods:We conducted a two-phase quality improvement project focusing on pharmacist-led medication reconciliation at different points in the transition process. All-cause 30-day readmission rates, medication reconciliation completion rates, and total pharmacist interventions were compared between the 2 groups.Results:The combined intervention and baseline cohorts resulted in a 29.8% relative reduction (14.5% vs. 20.6%) in readmission rates. Medication reconciliation was completed on 93.8% of SNF admitted patients in the first phase and 97.7% of patients in the second phase. Pharmacist interventions per reconciliation were 2.39 in the first phase compared with 1.82 in the second phase.Conclusion:Pharmacist-led medication reconciliation can contribute to reduction of hospital readmissions from SNFs and is an essential part of the SNF transition process.
The mortality effects and risk-benefit profile of low dose rivaroxaban (2.5 mg twice daily) in patients with coronary heart disease are not completely understood. Five randomized controlled trials (26,110 patients) were selected using PubMed and Cochrane library till April 2019. The background antiplatelet therapy was aspirin in 3 trials, P2Y12 inhibitor in 1 trial, and in 1 trial 65% patients received aspirin and 35% were on dual antiplatelet therapy (DAPT). The outcomes of interest were cardiovascular mortality, all-cause mortality, myocardial infarction (MI), stroke and major bleeding events. Random effects hazard ratios (HR) with 95% confidence intervals (CI) were calculated. Low dose rivaroxaban did not reduce the risk of cardiovascular mortality (HR 0.90, 95% CI 0.73-1.11, P = 0.34) or all-cause mortality (HR 0.91, 95% CI 0.74-1.12, P = 0.38) compared with control. However, low dose rivaroxaban was associated with reduction in MI (HR 0.85, 95% CI 0.73-0.99, P = 0.04), and stroke (HR 0.59, 95%CI 0.48-0.73, P < 0.001) at the expense of major bleeding (HR 1.64, 95% CI 1.39-1.94, P < 0.001) compared with control. These effects did not vary according to acute coronary syndrome or stable coronary heart disease (Pinteraction > 0.05). The use of low dose rivaroxaban in patients with coronary heart disease predominantly receiving antiplatelet monotherapy did not reduce cardiovascular or all-cause
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