Novel Tissue Factor Inhibition for Thromboprophylaxis in COVID-19: Primary Results of the ASPEN-COVID-19 Trial.

BACKGROUND: Thrombo-inflammation is central to COVID-19-associated coagulopathy. TF (tissue factor), a driver of disordered coagulation and inflammation in viral infections, may be a therapeutic target in COVID-19. The safety and efficacy of the novel TF inhibitor rNAPc2 (recombinant nematode anticoagulation protein c2) in COVID-19 are unknown. METHODS: ASPEN-COVID-19 was an international, randomized, open-label, active comparator clinical trial with blinded end point adjudication. Hospitalized patients with COVID-19 and elevated D-dimer levels were randomized 1:1:2 to lower or higher dose rNAPc2 on days 1, 3, and 5 followed by heparin on day 8 or to heparin per local standard of care. In comparisons of the pooled rNAPc2 versus heparin groups, the primary safety end point was major or nonmajor clinically relevant International Society of Thrombosis and Haemostasis bleeding through day 8. The primary efficacy end point was proportional change in D-dimer concentration from baseline to day 8, or discharge if before day 8. Patients were followed for 30 days. RESULTS: Among 160 randomized patients, median age was 54 years, 43.1% were female, and 38.8% had severe baseline COVID-19. There were no significant differences between rNAPc2 and heparin in bleeding or other safety events. Overall, median change in D-dimer was -16.8% (interquartile range, -45.7 to 36.8; P=0.41) with rNAPc2 treatment and -11.2% (-36.0 to 34.4; P=0.91) with heparin (Pintergroup=0.47). In prespecified analyses, in severely ill patients, D-dimer levels tended to increase more within the heparin (median, 29.0% [-14.9 to 145.2]; P=0.02) than the rNAPc2 group (median, 25.9% [-49.1 to 136.4]; P=0.14; Pintergroup=0.96); in mildly ill patients, D-dimer levels were reduced within each group with a numerically greater reduction with rNAPc2 versus heparin (rNAPc2 median, -32.7% [-44.7 to 4.3]; P=0.007 and heparin median, -16.8% [-36.0 to 0.5]; P=0.008, Pintergroup=0.34). CONCLUSIONS: rNAPc2 treatment in hospitalized patients with COVID-19 was well tolerated without excess bleeding or serious adverse events but did not significantly reduce D-dimer more than heparin at day 8. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04655586.

Poverty Reduction is Not the Whole Story: The COVID-19 Pandemic Response in Relation to Material Hardship.

As an absolute measure of deprivation poverty fails to capture the impact pandemic-related disruptions had on households. In this study, we use data from the Ypsilanti COVID-19 Study, a cross-sectional survey of 609 residents taken during the summer of 2020, to control for pandemic-related disruptions on bill-paying and food hardship. Using logistic regression models in which specific forms of bill-paying (i.e. late paying rent, late paying utilities) and food hardships (i.e. eating less over 7 days, worried food will run out) served as dependent variables, we find that disruptions to household finances, particularly job loss, significantly increased the likelihood of experiencing bill-paying and food hardship, respectively. Our study also controls for the type of hardship experienced to see which strategies households employed during the pandemic to exit material hardship. Through logistic regression models on methods of exiting material hardship, we find the type of hardship experienced was not predictive of applying for either SNAP or UI. Moreover, we find UI was less accessible to low-income individuals experiencing hardship. The findings from our study elaborate the relationship between pandemic-related disruptions and material hardship, and indicate to policymakers that preventing hardship in the first place is much more meaningful to households than attempting to use policy to bring households out of hardship once they experience it.

The Pat Jasan drug eradication social movement in Northern Myanmar, part one: Origins & reactions.

This commentary provides an introduction to the origins and emergence of Pat Jasan, a social movement that emerged amongst the Kachin population of northern Myanmar in response to a perceived crisis of illicit drug production and consumption. Although frequently presented as a case of drug vigilantism, we seek move beyond this stereotype by providing a granular account of the historical, political, and cultural conditions that lay the ground for the movement's emergence. Pat Jasan arose in the context of intersecting crises linked to protracted armed violence, extractive development and the 'slow violence' associated with widespread drug use. It was a response to a perceived vacuum of policing and the limitations of internationally supported harmed reduction measures to recognize or address the magnitude of the problem. Taking seriously the socially embedded foundations of the Pat Jasan movement provides an entry point for exploring how notions of harm reduction are constructed and understood locally and how movements like Pat Jasan emerge in response to societal concerns surrounding drugs.

Critical policy frontiers: The drugs-development-peacebuilding trilemma.

Recent years have seen the emergence of a policy consensus around the need for fundamental reforms of global drug policies. This is reflected in the call for 'development-oriented drug policies' that align and integrate drug policies with development and peacebuilding objectives, as captured in the Sustainable Development Goals (SDGs). These calls have been important in acknowledging the damage caused by the war on drugs and in drawing attention to how drugs are inextricably linked to wider development and peacebuilding challenges. Yet there is surprisingly limited academic research that looks critically at the drugs-development-peace nexus and which asks whether the goals of a 'drug-free world', 'sustainable development' and 'the promotion of peace' are commensurate with one another, can be pursued simultaneously, or are indeed achievable. This articles studies these policy fields and policy-making processes from the geographical margins of the state - frontiers and borderland regions - because they offer a privileged vantage point for studying the contested nature of policymaking in relation to the drugs-development-peace nexus. We set out a historical political economy framework to critically assess the assumptions underlying the integrationist agenda, as well as the evidence base to support it. By developing the notion of a policy trilemma we are critical of the dominant policy narrative that 'all good things come together', showing instead the fundamental tensions and trade-offs between these policy fields. In exploring the interactions between these policy fields, we aim to advance discussion and debate on how to engage with the tensions and trade-offs that this integrationist agenda reveals, but which have to date been largely ignored.

Precarity, poverty and poppy: Encountering development in the uplands of Shan State, Myanmar.

In recent years there have been growing calls for "development-oriented drug policies" to tackle illicit drug cultivation in the global South. Calls to integrate drugs and development have been important in demonstrating the damage caused by the war on drugs to marginalized communities and in drawing attention to how drug cultivation is inextricably linked to wider development challenges. However, this paper argues that the emerging policy agenda to 'developmentalise' drug policy is founded upon a simplified and misleading conceptualization of the relationship between poverty, development and illicit drug cultivation. Most problematically, it overlooks the fact that people who cultivate drugs because they are poor are not just those who have been 'left behind' by development. They are also those who have experienced new forms of immiseration and precarity as a consequence of processes of economic liberalization, market integration and agricultural 'modernization'. Confronting this blindspot, this article analyses the drivers of rising illicit opium cultivation across parts of Shan State, Myanmar, since the late 1990s. The paper argues that if the current agenda to developmentalise drug policy is to make a meaningful contribution to the lives of the rural poor in drug-producing regions in Myanmar and beyond, it must confront the fact that for many households the decision to cultivate opium has been a response to the very processes of market-led rural development that policymakers claim will alleviate poverty.

"I Think I Can . . . Maybe I Can . . . I Can't": Social Work Women and Local Elected Office.

If women are more interested in running for office, it should be observable in MSW students. Not only are the majority of students women, but they have experienced a dramatic change in political fortunes within the last year. However, the 2016 election may be leading women to doubt their qualifications to run. Using survey data from 545 MSW students and 200 law students, this study considers how interested women are in running for office and what barriers they perceive to doing so. Results suggest that women in MSW programs were significantly more interested in running for local office (city council, school board, county commission) than women in law school. At the same time, women in MSW programs were significantly more likely to doubt their qualifications to run for local office, which significantly decreased their interest in running. Content analysis revealed that women felt this way because they did not believe they had the knowledge and experience to run for local office. These results suggest that field placements in political offices might be a way to provide women in MSW programs with knowledge and experience that increases their sense of qualification to run for local office.

Use of a systems-based approach to an environmental health assessment for a waterborne disease outbreak investigation at a snowmobile lodge in Wyoming.

Investigations into disease outbreaks generally incorporate an epidemiologic investigation, laboratory analysis, and an environmental health assessment. This last component is designed to discover connections between factors in the environment and the outbreak, but is often limited, either by time and resources, or the expertise of the personnel included in outbreak investigation teams. A waterborne Norovirus outbreak investigation in Sheridan County, Wyoming, in 2001 provides an excellent example of the importance of including an in-depth, systems-based environmental health assessment in outbreak investigations. The epidemiologic component of this investigation identified the water supply of a snowmobile lodge in the Bighorn Mountains as the source of the outbreak, a result that was confirmed by laboratory analysis. Including a systems-based environmental health assessment in this investigation also helped to uncover the underlying environmental factors that led to contamination of the water supply. Those factors included an onsite wastewater disposal system that was overloaded by increased use and not well suited to local soil and geologic conditions and a drinking water system with no treatment or disinfection. In addition, heavy precipitation and increased pumping of wells to satisfy higher demands probably facilitated the contamination of the drinking water wells by causing greater movement of wastewater through the soil and underlying bedrock. By focusing on these links between factors in the environment and adverse health outcomes, the systems-based environmental health assessment also helped to highlight prevention strategies for avoiding recurrences.

Responding to detection of aerosolized Bacillus anthracis by autonomous detection systems in the workplace.

Autonomous detection systems (ADSs) are under development to detect agents of biologic and chemical terror in the environment. These systems will eventually be able to detect biologic and chemical hazards reliably and provide approximate real-time alerts that an agent is present. One type of ADS that tests specifically for Bacillus anthracis is being deployed in hundreds of postal distribution centers across the United States. Identification of aerosolized B. anthracis spores in an air sample can facilitate prompt on-site decontamination of workers and subsequent administration of postexposure prophylaxis to prevent inhalational anthrax. Every employer who deploys an ADS should develop detailed plans for responding to a positive signal. Responding to ADS detection of B. anthracis involves coordinating responses with community partners and should include drills and exercises with these partners. This report provides guidelines in the following six areas: 1) response and consequence management planning, including the minimum components of a facility response plan; 2) immediate response and evacuation; 3) decontamination of potentially exposed workers to remove spores from clothing and skin and prevent introduction of B. anthracis into the worker's home and conveyances; 4) laboratory confirmation of an ADS signal; 5) steps for evaluating potentially contaminated environments; and 6) postexposure prophylaxis and follow-up.