ABSTRACT
BACKGROUND: Sotrovimab, a dual-action Fc-engineered human immunoglobulin G (IgG1) mAb, binds to a conserved epitope on the SARS-CoV- 2 receptor binding domain and was developed to treat mild to moderate COVID-19. A high concentration formulation is being evaluated to offer the potential for IM administration at lower volumes and at different injection sites. METHOD(S): COSMIC (NCT05280717) is a phase 1, open-label healthy volunteer study comprising three parts. Part A is an ongoing randomized, parallel group study investigating the relative bioavailability, safety, and tolerability of two concentrations of sotrovimab administered at different injection sites. A total of 215 subjects were randomized in a 2:2:1:1 ratio into 4 treatment arms: dorsogluteal injection (62.5 mg/mL), or 100 mg/mL administered as dorsogluteal, thigh, or deltoid injection(s). PK will be evaluated for 24 weeks post-dose. RESULT(S): Preliminary PK is available from 50 participants who received a 500 mg IM dose of sotrovimab of the higher concentration (100 mg/mL). Administration into thigh or deltoid resulted in higher geometric mean Cmax and AUCD1-15 and lower inter-subject variability compared to 100 mg/mL dorsogluteal. Following gluteal, thigh, or deltoid injections, the geometric mean (%CV) Cmax was 44.8 mug/mL (63.3), 70.9 mug/mL (35.5), and 65.1 mug/mL (27.1), respectively, and the geometric mean (%CV) AUCD1-15 was 534 day*mug/mL (67.5), 814 day*mug/mL (39.7), and 782 day*mug/mL (26.3), respectively. Median Tmax was earlier following thigh (4 days) and deltoid (5.5 days) injection than gluteal (7 days) injection. CONCLUSION(S): Administration of sotrovimab into thigh or deltoid muscles may improve exposure and reduce inter-subject variability compared to gluteal IM administration. These data may inform IM injection site selection for mAbs.
ABSTRACT
PURPOSE: Partnering with the largest Federally Qualified Health Center (FQHC) in New Haven, CT, the goal is to implement and test 4 evidence-based interventions (EBI) to increase CRC screening, while evaluating real-world implementation. Here, we report on the six-month (approximate) follow up of a cohort of 3,127 patients overdue for CRC screening who received 1 or more EBIs in October 2021. BACKGROUND: Sociocultural and medical concerns are barriers to colonoscopy uptake contributing to disparities in CRC screening. An additional barrier is system level capacity. COVID-19 associated delays exacerbated the existing backlog of individuals overdue for CRC screening, underscoring the need to expand Fecal Immunochemical Testing (FIT) capacity. This was particularly evident in the safety-net primary care setting that serves lower socio-economic status individuals living in urban New Haven, CT. METHOD(S): We are testing the unique and additive value of multiple evidence-based interventions (EBIs) for increasing CRC screening. The EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and providing assistance from community health workers (CHW). We randomized 3,127 patients overdue for CRC screening to one of 4 arms of the study. All individuals received a reminder from their providers that they were due/overdue for CRC screening with instructions to contact the FQHC. Arm 2 also included information on SDOH barriers, Arm 3 included this same information with offer of navigation from CHW/navigator;and Arm 4 included the offer of CHW educational video and support if needed. Six-month (approximate) outcomes include: 1) Engagement with FQHC resulting in ordered test;2) completed test. Results by intervention will be assessed at 12 months. RESULT(S): Of the 3,127 randomized patients, ages 50-75, 77% were Hispanic (33%) or Black (44%). At 6+ months, a preliminary look at EMR data show that a minimum of 1,275 (40.8%) patients "engaged" with providers resulting in an ordered FIT Kit (n= 1174) or COMPLETED screening colonoscopy that was not associated with a positive FIT result (n = 102). 217 (18.5%) individuals completed the FIT testing with 13 requiring confirmatory colonoscopy (31% completed at this time). Thus, a minimum of 319 (10%) of 3,127 individuals in the cohort completed CRC screening at approximately 6 months post intervention. DISCUSSION: Despite investments in community engagement, stakeholder input, and FIT kit capacity building, the pandemic presented unforeseen challenges. Flexibility and steadfast commitment from FQHC providers and staff were critical to successful implementation during multiple waves of COVID-19, resulting in CRC screening ordered for 41% of cohort within 6 months of intervention. SUMMARY: At 6 months follow up of 3,127 individual who were overdue for CRC screening, one or more of 4 EBIs, in addition to system level efforts to address CRC screening, resulted CRC screening tests ordered for 41% of cohort with at least 10% completed screening.
ABSTRACT
Actualmente nos encontramos ante una situación excepcional de pandemia por SARS-CoV-2 que requirió el confinamiento de la población general durante semanas. Presentamos 6 casos de afectación esporádica de nervio peroneal en la rodilla remitidos al servicio de Neurofisiología Clínica del Hospital General Universitario de Castellón que ocurrieron durante el estado de alarma (desde el 14 de marzo al 21 de junio de 2020), lo cual constituye un incremento del 50% con respecto a los 3 años anteriores. La mayoría fueron varones jóvenes sin antecedentes médicos. Tres refirieron posturas mantenidas durante horas. El EMG descartó otras afectaciones y objetivó una neuroapraxia moderada-grave con leve-moderada degeneración axonal. Es importante evitar posturas inadecuadas de forma prolongada (cruce de piernas o apoyo de rodilla sobre superficies duras) para prevenir la compresión del nervio peroneal en la rodilla. El estudio EMG es útil para confirmar el diagnóstico, descartar otros procesos y emitir un pronóstico temprano.
ABSTRACT
Purpose: We partnered with a local Federally Qualified Health Center (FQHC) to test implementation of evidence-based interventions (EBI) promoting Fecal Immunochemical Test (FIT) CRC screening in an environment in which colonoscopy has been the prevailing screening strategy. We report on implementation adaptations and preliminary results. Background: Sociocultural and medical concerns are barriers to colonoscopy uptake in some populations. An additional barrier to CRC screening is system level capacity for colonoscopy that results in a back log of cases and long wait times. With Covid-19, the additional backlog in overdue CRC screening has underscored the need to expand FIT testing capacity to address screening needs and to pre-empt further racial/ethnic and SES disparities in CRC outcomes. This trial tests the unique and additive value of multiple EBIs for increasing CRC screening (primarily through FIT testing, but also colonoscopy when indicated) while evaluating the success of implementing these approaches. EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and assistance from community health workers. Methods: Participants (3500), ages 45-75, were identified from a large FQHC in New Haven, CT and determined to be overdue for CRC screening. Participants were randomly assigned to one of the four arms of the study: 1) Provider reminder (overdue for CRC screening) only;2) Provider Reminder + SDOH short message and one-size-fits all link to resources;3) Provider Reminder + SDOH short message and offer for individualized navigation (trained navigators from local community) to address SDOH and other barriers;4) Provider Reminder + offer to participate in a CRC educational program as phase 2 of the NCI's Screen to Save program (not an EBI). Preliminary data on uptake of CRC screening will be presented. Results: With input from stakeholders, we have: 1) lowered age eligibility from 50 to 45 to align with new guidelines;2) expanded the target population to 2 additional satellite clinics, more than doubling the proposed study enrollment;3) incorporated design changes in the patient reminders. The collaboration between research team and clinician stakeholders has been critical in minimizing disruptions to clinical workflow while assuring fidelity to the evidence-based interventions. Preliminary outcomes (within one month of intervention) on uptake of intervention across the 4 arms of the study, i.e., referral for CRC screening and test completion will be presented. Conclusion: The unique challenges of this urban community of primarily African American/Black, Hispanic/Latinx and/or low socioeconomic status individuals stem from the disproportionate burden of SDOH barriers. Findings will inform primary care setting implementation of EBIs to address the anticipated increase in disparities in CRC screening, exacerbated by COVID-19 changes in health care access and utilization, as well as the increased demand associated with the change in guidelines.
ABSTRACT
Based on the spread of the COVID-2019, a lockdown was declared in the Santiago Metropolitan area in Chile. The application of containment measures allowed to reduce the impact of the COVID-2019 pandemic on the National Health System (MINSAL) but at the same time these restriction measures gave also the opportunity to assess the effect of anthropogenic activities on air pollutants. A comparative study of typical behavior of atmospheric pollutants O-3, NO2, NOx and PM2.5 during the years 2015-2020 are presented. For the eight studied stations (Las Condes, Pudahuel, El Bosque, Cerro Navia, La Florida, Independencia, Parque O'Higgins and Puente Alto) it was possible to determine the seasonal variation of NO2, NOx, O-3 and PM2.5. As results of impact of the lockdown, in this paper we have been determined a significant reduction of pollutants concentration mainly due to vehicular traffic.
ABSTRACT
Measures such as frequent handwashing, mandatory use of face masks by the general population in public spaces, social and physical distancing, and mandatory confinement of most people at their homes have contributed to slowing down the spread of the new coronavirus (SARS-CoV-2), which is the source of the current COVID-19 pandemic. However, adopting some of these measures has caused delays in the diagnosis and treatment of various diseases, including sleep disorders. There-fore, it is urgent for sleep specialists and sleep centers to gradually resume activities, as long as strict biosecurity protocols aimed at reducing the risk of contagion are implemented. In this scenario, and in order to help somnologists reopen sleep centers and resume the proce-dures performed there, the Asociación Colombiana de Medicina del Sueño (Colombian Association of Sleep Medicine) proposes through this reflection paper several recommendations that should be considered during the reactivation process. These recommendations are based on the COVID-19 spread mitigation strategies established by the Colombian health authorities, the guidelines issued by the American Academy of Sleep Medicine, and relevant literature on this subject, which was re-viewed after performing a search in the PubMed, SciELO, and Google Scholar databases using the search terms “sleep” “sleep medicine” and “COVID19”. © 2021, Universidad Nacional de Colombia. All rights reserved.