RESUMEN
Objectives: To describe and compare real-world outcomes for patients with mild-to-moderate COVID-19 at high risk for progression to severe COVID-19, treated with sotrovimab versus untreated. Method(s): Electronic health records from the National COVID Cohort Collaborative were used to identify US patients (aged >=12 years) diagnosed with COVID-19 (positive test or ICD-10: U07.1) in an ambulatory setting (26 May 2021-30 April 2022) who met Emergency Use Authorization high-risk criteria. Patients receiving the monoclonal antibody (mAb) sotrovimab within 10 days of diagnosis were assigned to the sotrovimab cohort with an index date on the day of infusion. Untreated patients (no evidence of early mAb treatment or prophylaxis mAb or oral antiviral treatment) were assigned to the untreated cohort with an imputed index date based on the time distribution between diagnosis and sotrovimab infusion for the sotrovimab cohort. The primary endpoint was hospitalization or death (both all-cause) within 29 days of index, reported as descriptive rates and adjusted (via inverse-probability-of-treatment weighting [IPTW]) odds ratios (OR) and 95% confidence intervals (CI). Result(s): Of nearly 2.9 million patients diagnosed with COVID-19 during the analysis time period, 4,992 met the criteria for the sotrovimab cohort and 541,325 were included in the untreated cohort. Patients in the sotrovimab cohort were older (60 versus 54 years), more likely to be male (40% versus 38%) and White (85% versus 75%), and met more EUA criteria (3 versus 2) versus the untreated cohort. The 29-day hospitalization or mortality rates were 3.5% (176/4,992) and 4.5% (24,163/541,325) in the sotrovimab and untreated cohorts respectively (unadjusted OR [95% CI]: 0.77 [0.67,0.90];p=0.001;IPTW-adjusted OR [95% CI]: 0.74 [0.61,0.91];p=0.004). Conclusion(s): Sotrovimab demonstrated clinical effectiveness in preventing severe outcomes (hospitalization, mortality) between 26 May 2021-30 April 2022, which included the Delta variant and early surge of Omicron BA.1/BA.2. Funding(s): GSK (Study 219020)Copyright © 2023
RESUMEN
BACKGROUND: Blood pressure (BP) is often inadequately controlled in children treated for hypertension, and personalized (n-of-1) trials show promise for tailoring treatment choices. We assessed whether patients whose treatment choices are informed by an n-of-1 trial have improved BP control compared to usual care. METHODS: A randomized clinical trial was conducted in a pediatric hypertension clinic in Houston from April 2018 to September 2020. Hypertensive adolescents and young adults 10-22 years old were randomized 1:1 to a strategy of n-of-1 trial using ambulatory BP monitoring to inform treatment choice or usual care, with treatment selected by physician preference. The primary outcome was the proportion of patients with ambulatory BP control at 6 months in a Bayesian analysis. RESULTS: Among 49 participants (23 randomized to n-of-1 trials and 26 to usual care), mean age was 15.6 years. Using skeptical priors, we found a 69% probability that n-of-1 trials increased BP control at 6 months (Bayesian odds ratio (OR) 1.24 (95% credible interval (CrI) 0.51, 2.97), and 74% probability using neutral informed priors (OR 1.45 (95% CrI 0.48, 4.53). Systolic BP was reduced in both groups, with a 93% probability of greater reduction in the n-of-1 trial group (mean difference between groups = -3.6 mmHg (95%CrI -8.3, 1.28). There was no significant difference in side effect experience or caregiver satisfaction. CONCLUSIONS: Among hypertensive adolescents and young adults, n-of-1 trials with ambulatory BP monitoring likely increased the probability of BP control. A large trial is needed to assess their use in clinical practice.
RESUMEN
The objective was to evaluate real-world effectiveness of sotrovimab, a monoclonal antibody (mAb) for the treatment of high-risk outpatients with COVID-19, in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. A retrospective analysis was conducted of de-identified, high-risk patients diagnosed with COVID-19 (index date) from 1 September 2021 to 28 February 2022 in the FAIR Health FH NPIC claims database. Patients were divided into 2 cohorts based on claimed procedural codes: treated with sotrovimab and not treated with any mAb (no mAb). Facility-reported mortality ("mortality"), all cause hospitalizations and intensive care unit (ICU) admissions <=30 days of index were identified. Multivariable logistic regression was conducted to estimate the risk of 30-day mortality or hospitalization, adjusting for demographic and clinical factors. Of the high-risk COVID-19 patients identified,13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, sotrovimab treatment was associated with 85% reduced odds of 30-day mortality (OR: 0.15, 95% CI: 0.08-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.44) among high-risk COVID-19 patients. In this US real-world study of high-risk COVID-19 patients during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment.
RESUMEN
INTRODUCTION: The Surviving Sepsis Campaign guidelines recommend prompt intravenous antibiotic administration within one hour for patients with septic shock or a high likelihood of sepsis. To improve timeliness of antibiotic administration, piperacillin-tazobactam and cefepime were stocked in the automated dispensing cabinets (ADCs) in five intensive care units (ICU).The aim of this study was to evaluate the time from order entry of piperacillintazobactam or cefepime to administration in ICU patients before and after addition to the ADC. METHOD(S): This was a retrospective study of adult, presumed septic patients who received their first dose of piperacillin-tazobactam or cefepime in an ICU. Patients included from March 23, 2019 - March 23, 2020 received antibiotics from the inpatient pharmacy (Pre-ADC) and those from March 25, 2020 - March 25, 2021 received piperacillintazobactam and cefepime from the ICU ADCs (Post-ADC). The primary outcome was time from antibiotic order entry to administration. Secondary outcomes included time from order entry to pharmacy verification, in-hospital mortality, and hospital length of stay. RESULT(S): One thousand eight hundred and three patients were included with 903 patients in the Pre-ADC group and 900 in the Post-ADC group. Baseline characteristics were similar, and respiratory infection was the most common antibiotic indication (37% Pre-ADC vs. 36% Post-ADC). Additionally, more Post-ADC patients had isolation precautions at the time of antibiotic administration (15% Pre-ADC vs. 19% Post-ADC, p=0.04). The median (IQR) time (minutes) from order of antibiotics to administration was shorter in the Pre-ADC group at 57 (32-97) vs. 75 (43-126) Post-ADC (p < 0.001). Median (IQR) time (minutes) from pharmacy verification to nursing administration was 51 (28- 91) Pre-ADC vs. 75 (43-126) Post-ADC, p< 0.001. Hospital length of stay and mortality were similar between the groups. CONCLUSION(S): Adding piperacillin-tazobactam and cefepime to the ICU ADCs did not result in earlier antibiotic administration in presumed septic patients. Due to the timing of this study, the COVID-19 pandemic and isolation precautions likely confounded the results. Further investigation of antibiotic administration barriers is needed to optimize patient care and meet Surviving Sepsis Campaign recommendations.
RESUMEN
Background. Sotrovimab, a monoclonal antibody (mAb), received Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with symptomatic COVID-19. The study objective was to evaluate real-world effectiveness of sotrovimab (500 mg intravenous) in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. Methods. A retrospective analysis was conducted of de-identified patients (pts) diagnosed with COVID-19 (ICD-10: U07.1) from 9/1/2021 to 2/28/2022 in the FAIR Health FH NPIC claims database. Pts were divided into 2 cohorts based on HCPCS codes: treated with sotrovimab and not treated with any mAb (no mAb). Pts meeting EUA high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records <= 24 months prior to their first COVID-19 diagnosis (index date). Facility-reported mortality (referred to as 'mortality'), all cause hospitalizations and intensive care unit (ICU) admissions within 30 days of index were identified. Chi-square test, ANOVA, or t-tests were performed to statistically compare cohorts at a 0.05 level of significance (2-sided). P-values were not adjusted for multiplicity. Multivariable logistic regression was conducted to estimate the risk of mortality or hospitalization within 30 days, adjusting for demographic and clinical factors. Results. Of the high-risk COVID-19 pts identified, 13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. Compared to the no mAb cohort, the sotrovimab cohort was older, had more baseline conditions, and were more likely to be female (all p < 0.0001). In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, treatment with sotrovimab was associated with 83% reduced odds of 30-day mortality (OR: 0.17, 95% CI: 0.09-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.43) among high-risk COVID-19 pts. Conclusion. In this US real-world observational study of high-risk COVID-19 pts during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment.
RESUMEN
The emergence of the COVID-19 pandemic and airborne particulate matter pollution have caused a surge in the consumption of face masks in recent years. Typically, face masks are made from nondegradable petroleum-derived nonwoven materials adding to global plastic pollution and aggravating environmental concerns. Therefore, it is important to fabricate sustainable biodegradable replacements. This review intends to highlight and discuss state-of-the-art research activities that centre on the development of biodegradable nonwoven materials for face mask applications. We also identify potential candidates and strategies for future research and product development efforts. Finally, we present our perspectives on a wide avenue in need of further exploration concerning materials, methods, advanced functionalities, cost, scalability, and shelf life of sustainable advanced face masks. © 2023 The Royal Society of Chemistry.
RESUMEN
In March 2020, the UN Secretary General issued a call for a global ceasefire to help tackle the COVID-19 pandemic. This call was expected to result in a variety of responses from governments, diplomats, armed groups, NGOs, humanitarian actors, and mediators. Since these organizations are typically focused on specific countries and contexts, it was important to provide them and researchers of conflict and peacemaking dynamics with clear, concise, and well-presented data on the full variety of conflict parties' responses to the UNSG's call, the COVID-19 pandemic and to track the impacts of the pandemic on attempts to end armed conflict. Our tracker, called 'Ceasefires in a time of COVID-19' supports these efforts and SDG 16, i.e., promotion of just, peaceful, and inclusive societies. It features a timeline, an interactive map, and a search tool that displays qualitative data about the ceasefires and related events. This tool is unique in its application, bringing together ceasefires declarations and the COVID-19 infection rates from the Johns Hopkins COVID-19 database, and in its design, with input from the academic and practitioner communities. In this paper, we further describe the methodology used in designing the tool and argue in favor of broad interdisciplinary and cross-industry participation in dataset and user interface design, in order to reflect the requirements of the interested publics.
RESUMEN
The occurrence of pandemics in the last several decades has sharply highlighted the need for robust and coordinated plans for animal research facilities, as the welfare of both the animals and the human personnel caring for them must be maintained to the fullest extent possible. Specifically, the pandemic caused by SARS-CoV-2 has greatly impacted animal research facilities worldwide in a myriad of ways. The United States Army Institute of Surgical Research (USAISR) Vivarium in San Antonio, Texas is in a unique situation in terms of emergency response to pandemics due to being designated as a backup mass casualty (MASCAL) site to Brooke Army Medical Center (BAMC). At the start of the pandemic, BAMC needed innovative, effectual plans to alleviate a potentially high number of severe COVID-19 cases in the surrounding area. As part of this mitigation strategy, USAISR staff was tasked with converting the vivarium for human use to potentially receive patients, including the set-up of intensive care unit (ICU) units. The animals were safely moved to an off-site location to start the conversion process. Areas of the vivarium were then assigned to fulfill specific hospital needs, and additional equipment, such as ventilators and anesthesia machines, were accrued. Personnel were brought in to assist with clearing out rooms and moving equipment, while still observing critical social distancing measures. Because the vivarium was not designed for human use, some facility challenges were identified and addressed to still ensure mission success. After the completion of over 600 man hours of work by dedicated personnel, the 120,000 square foot animal facility was converted into a human hospital capable of supporting 72 patients, including 32 ICU beds. We have updated our disaster plan and facility SOPs to facilitate the execution of this scenario should the need arise again in order to save both human and animal lives.
RESUMEN
Social distancing is a matter of individuals' choices as well as of regulation. We analyse weekly panel data on such behaviour for English Upper Tier Local Authorities (UTLAs) from March to July 2020, paying attention to the influence of poverty, as measured by free school meals provision. Panel regressions suggest that, although more stringent regulation and slightly lagged local cases of infection increase social distancing, both effects are weaker in UTLAs with higher levels of poverty, in part because of poor housing, and also because shortage of money has forced the poor to keep working. Thus motivated, we develop a two-class (rich/poor) model, in which a Nash non-cooperative equilibrium arises from individual choices in a regulatory regime with penalties for non-compliance. The model yields results in keeping with the empirical findings, indicating the desirability of generous measures to furlough workers in low-paid jobs as a complement to the stringency of general regulation. © 2021 Walter de Gruyter GmbH, Berlin/Boston 2021.
RESUMEN
Across healthcare systems stringent measures have been introduced to prevent the sustained transmission of COVID-19. With the ease of lockdown the provision of all routine, non-urgent dental care will continue to be affected in England for some time. The provision of urgent dental care (UDC) via a robust and safe service has been constructed across every NHS region. In the South West, phone triaging has been an integral part of UDC centres operating procedure. Phone triaging will be required for some time. This proforma will be a valuable resource, especially for primary care practices as they move to re-opening. CPD/Clinical Relevance: The clinical relevance is to share the effective use of a standardized telephone triage form supported by NHS England and NHS Improvement − South West (NHSE/I SW). © 2020 George Warman Publications. All rights reserved.