Capital Region Collaborative Community Survey Project to Document Disparate Impacts of COVID-19

The Capital Region Collaborative Community Survey project was undertaken in December 2020- January 2021 to document the social, economic and health impacts of COVID-19 on residents in the Capital Region, particularly in the city of Albany with an emphasis on the impacts on Black and African American (B/AA) communities (n=239). Key findings included B/AA participants reported experiencing general racism or racial discrimination significantly more than other racial groups as did Hispanics. The pandemic impacted employment of Capital Region residents significantly as half of the respondents either lost their jobs or had their hours reduced. B/AA individuals were more likely than others to have both their work hours reduced and increased, which aligns with their status as frontline workers in healthcare, food service, groceries and transportation. B/AA were more concerned about losing housing in the near future. Of respondents with children (n=80) 71% reported that the pandemic had affected their child’s emotions very or somewhat negatively with similar percentages reporting that it had affected their child’s school work and child’s social activities very or somewhat negatively. There were no differences between B/AA and Others (members of all other respondent groups combined) in these domains. Reported high rates of regular mask-wearing and vaccine intent were promising, although 19% of B/AA individuals were extremely or somewhat unlikely to receive a vaccine vs only 11.8% of Others. Vaccine safety was the most frequent reason for hesitancy among B/AA respondents. Even though the internet and social media were common sources of information, they were not deemed as trustworthy as doctors, state and federal health organizations, and community clinics. Internet access was very high in this sample of Albany residents. The authors recommend 1) More transparency in communication from public officials; 2) More localization in the distribution of resources – including food, testing, and vaccination; 3) Expansion of community based mental health services and funding of research to determine if there are barriers to obtaining a primary care provider or physician outside of a lack of health insurance: 4) Funding of research into how individuals access the internet and their online information-seeking behaviors, including barriers to information seeking; 5) Supports to address food insecurity (caused by suspension of subsidized school breakfasts and lunches, and low-quality substitutions; and/or having additional family members in households who had been displaced from their housing), and housing insecurity (e.g., rent support); and 6) Supports for children suffering from isolation, lack of physical activity, and supports for parents to assist children with online learning, including guidance and recommendations on how to best support their child’s emotional stability, mental health, and coping strategies

Impacts of the First Year of COVID-19 on Food Security in the New York’s Capital Region

The COVID-19 pandemic has disrupted people\u27s lives and food systems in the United States and worldwide, resulting in impacts on different aspects of food security. To understand how this has affected households in New York’s Capital Region, we conducted two concurrent anonymous online surveys between October 2020 and February 2021. Combined, 1049 people responded to these surveys. We report on respondents\u27 food security experiences since the COVID-19 pandemic started in New York State (March 7, 2020) compared to the prior year. We further explore the differential impacts of the pandemic on food security experiences by race and ethnicity, household income, job disruptions, and households with and without children

NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma.

BACKGROUND: There is an immunologic rationale to evaluate immunotherapy in the older glioblastoma population, who have been underrepresented in prior trials. The NUTMEG study evaluated the combination of nivolumab and temozolomide in patients with glioblastoma aged 65 years and older. METHODS: NUTMEG was a multicenter 2:1 randomized phase II trial for patients with newly diagnosed glioblastoma aged 65 years and older. The experimental arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant nivolumab and temozolomide. The standard arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant temozolomide. The primary objective was to improve overall survival (OS) in the experimental arm. RESULTS: A total of 103 participants were randomized, with 69 in the experimental arm and 34 in the standard arm. The median (range) age was 73 (65-88) years. After 37 months of follow-up, the median OS was 11.6 months (95% CI, 9.7-13.4) in the experimental arm and 11.8 months (95% CI, 8.3-14.8) in the standard arm. For the experimental arm relative to the standard arm, the OS hazard ratio was 0.85 (95% CI, 0.54-1.33). In the experimental arm, there were three grade 3 immune-related adverse events which resolved, with no unexpected serious adverse events. CONCLUSIONS: Due to insufficient evidence of benefit with nivolumab, the decision was made not to transition to a phase III trial. No new safety signals were identified with nivolumab. This complements the existing series of immunotherapy trials. Research is needed to identify biomarkers and new strategies including combinations

Single- and multiple-dose pharmacokinetics and safety of pimodivir, a novel, non-nucleoside polymerase basic protein 2 subunit inhibitor of the influenza A virus polymerase complex, and interaction with oseltamivir: a Phase 1 open-label study in healthy volunteers

AIMS: The aim of this study was to evaluate the drug-drug interaction between pimodivir, a novel, non-nucleoside polymerase basic protein 2 (PB2) subunit inhibitor of the influenza A virus polymerase complex, and oseltamivir, to assess the feasibility of this combination therapy. Furthermore, single- and multiple-dose pharmacokinetics and safety of pimodivir in healthy volunteers were assessed. METHODS: In Part 1 of this open-label Phase 1 study, healthy volunteers (n = 18) were randomized to one of six cross-over treatment sequences, each comprising administration of oseltamivir 75 mg or pimodivir 600 mg or combination thereof twice daily on Days 1-4, followed by a single morning dose on Day 5. Between each treatment session, there was a minimum 5-day washout period. In Part 2, healthy volunteers (n = 16) randomly received pimodivir 600 mg or placebo (3:1) twice daily on Days 1-9, followed by a single morning dose on Day 10. Pharmacokinetics of pimodivir, oseltamivir and oseltamivir carboxylate, and safety were assessed. RESULTS: In Part 1, co-administration of pimodivir with oseltamivir increased the Cmax of pimodivir by 31% (90% CI: 0.92-1.85) with no change in Cmin or AUC12h . Pimodivir had no effect on oseltamivir or oseltamivir carboxylate pharmacokinetics. In Part 2, after single- and multiple-dose administration of pimodivir, there was a 1.2- and 1.8-fold increase in Cmax and AUC12h , respectively, between Day 1 and Day 10. The most frequently reported treatment-emergent adverse event was diarrhoea (n = 7 each in Part 1 and 2). CONCLUSION: Combination treatment with pimodivir and oseltamivir in healthy volunteers showed no clinically relevant drug-drug interactions. No safety concerns were identified with pimodivir 600 mg twice daily alone or in combination with oseltamivir 75 mg twice daily.status: publishe

Disparate Impacts of COVID-19 in New York’s Capital Region: A View from the Local Community on the Socioemotional Experience of the Pandemic

The Capital Region Collaborative Community Survey project was undertaken in December 2020-January 2021 to document the social, economic and health impacts of COVID-19 on residents in the Capital Region, particularly in the city of Albany. A special emphasis was made on documenting disparate impacts on Black and African American (B/AA) communities, as they have been consistently identified as being disproportionately affected by COVID-19. With the active participation of the Albany Minority Health Task Force (AMHTF) – a group of professionals from the Albany community concerned with the health of Communities of Color within the Capital Region, an interdisciplinary study team disseminated a comprehensive survey (N = 239) cataloging healthcare utilization, social relationships, demographics, job and living conditions, technology access, and information-seeking during the COVID-19 pandemic; and conducted 25 follow-up interviews with survey participants. This report focuses on a subset of findings from the full survey that are related to the socioemotional impact of the pandemic. More specifically, we report data on (1) the impact of the pandemic on work, income, and on food and shelter insecurities; (2) direct and indirect experiences of the virus and associated anxieties; and (3) the indirect impact of the virus on health and well being through its effect on accessing routine health services, increased needs to access mental health services, concerns about the impact on the well being of children, and experiences of racism. Implications of these findings are discussed, and recommendations for action are provided, which are grounded in interviewees’ responses when asked what they would most like public officials to know about the experience of the pandemic for them and their local communities, as well as the quantitative survey results, and the assessment of the data by the Albany Minority Health Task Force in the context of their knowledge of the local community

Resilience and ongoing quality care for cancer clinical trials during COVID-19: Experience from a tertiary hospital in Australia

Background: The COVID-19 pandemic has forced rapid system-wide changes to be implemented within cancer care at an alarming pace. Clinical trials are a key element of comprehensive cancer care. Ensuring the continuing safe conduct of cancer clinical trials in the context of a pandemic is challenging. Methods: We aimed to describe the COVID-19 pandemic response of a Cancer Care Clinical Research Unit (CRU) of a tertiary hospital in Queensland, Australia. We used a mixed methods approach for this case study. Emailed directives from CRU managers to all CRU staff sharing were qualitatively analysed and mapped against our unit activities over longitudinal time points. Data from patient recruitment and protocol deviations were analysed using descriptive statistics. Results: Mapping activity from 11 March to 30 September 2020 revealed rapid change during the first 2 weeks. Four key strategies to accommodate change were identified: supporting patients and families, introduction of telehealth, accessing investigational product, and social distancing. Early in the pandemic we recognised that our core key stakeholders were integral to our response. When compared to the previous 12 months, our recruitment numbers dropped markedly in early phases of the response but recovered over time, as we accommodated internal and external impacts. Conclusion: Our experience of agility as a necessity, adapting to support patients, and managing both clinical research activity and sponsors during the height of the pandemic response is presented here in order to inform future disaster response planning by clinical trial organisations.</p