RSS 1.0COVID-19 Research
A collection of articles related to coronaviruses that have been authored by researchers at Temple University.
Recent Submissions
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Impact of gender-affirming hormone therapy on the development of COVID-19 infections and associated complications: A systematic reviewBACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can produce a wide range of clinical manifestations from asymptomatic to life-threatening. Various researchers have worked to elucidate the pathogenic mechanisms underlying these variable presentations. Differences in individual responses to systemic inflammation and coagulopathy appear to be modulated by several factors, including sex steroid hormones. Transgender men or non-binary individuals who undergo gender-affirming hormone therapy (GAHT) are a unique population of interest for exploring the androgen-mediated coronavirus disease 2019 (COVID-19) hypothesis. As the search for reliable and effective COVID-19 treatments continues, understanding the risks and benefits of GAHT may mitigate COVID-19 related morbidity and mortality in this patient population. AIM: To investigate the potential role of GAHT in the development of COVID-19 infections and complications. METHODS: This systematic review implemented an algorithmic approach using PRISMA guidelines. PubMed, Scopus, Google Scholar top 100 results, and archives of Plastic and Reconstructive Surgery was on January 12, 2022 using the key words “gender” AND “hormone” AND “therapy” AND “COVID-19” as well as associated terms. Non-English articles, articles published prior to 2019 (prior to COVID-19), and manuscripts in the form of reviews, commentaries, or letters were excluded. References of the selected publications were screened as well. RESULTS: The database search resulted in the final inclusion of 14 studies related to GAHT COVID-19. Of the included studies, only two studies directly involved and reported on COVID-19 in transgender patients. Several clinical trials looked at the relationship between testosterone, estrogen, and progesterone in COVID-19 infected cis-gender men and women. It has been proposed that androgens may facilitate initial COVID-19 infection, however, once this occurs, testosterone may have a protective effect. Multiple clinical studies have shown that low baseline testosterone levels in men with COVID-19 are associated with worsening outcomes. The role of female sex hormones, including estrogen and progesterone have also been proposed as potential protective factors in COVID-19 infection. This was exemplified in multiple studies investigating different outcomes in pre- and post-menopausal women as well as those taking hormone replacement therapy. Two studies related specifically to transgender patients and GAHT found that estrogen and progesterone could help protect men against COVID-19, and that testosterone hormone therapy may increase the risk of contracting COVID-19. CONCLUSION: Few studies were found related to the role of GAHT in COVID-19 infections. Additional research is necessary to enhance our understanding of this relationship and provide better care for transgender patients.
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In-hospital mortality of COVID-19 patients hospitalized with ST-segment elevation myocardial infarction: A meta-analysisIntroduction: Coronavirus Disease 2019 (COVID-19) has been associated with an increased risk of adverse cardiovascular events including arteriovenous thrombosis, myocarditis and acute myocardial injury. Relevant literature to date has reported widely varying estimates of mortality, ranging from approximately 2 to 11 times higher odds of mortality in COVID-19-positive STEMI (ST-segment elevation myocardial infarction) patients. Hence, we conducted this meta-analysis to resolve these inconsistencies and assess the impact of COVID-19 infection on mortality and other clinical outcomes in patients presenting with STEMI. Methods: This meta-analysis was registered in PROSPERO (CRD42021297458) and performed according to the Cochrane Handbook for Systematic Reviews of Interventions. PubMed and Embase were searched from inception to November 2021 (updated on April 2022) using a search strategy consisting of terms relating to COVID-19, STEMI, and mortality. Results: We identified 435 studies through our initial search. After screening according to our eligibility criteria, a total of 11 studies were included. Compared with the non-COVID-19 STEMI patients, the in-hospital mortality rate was higher in COVID-19-positive STEMI patients. Similarly, the risk of cardiogenic shock was higher in the COVID-19-positive patients. Length of hospital stay was longer in STEMI patients with COVID-19. Conclusions: Our study highlights the necessity for early evaluation of COVID-19 status in all STEMI patients followed by risk stratification, prompt reperfusion and more aggressive management of COVID-19-positive patients. Further research is needed to elucidate the mechanisms behind poorer prognosis in such patients.
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Application of Deep Learning on Single-cell RNA Sequencing Data Analysis: A ReviewSingle-cell RNA sequencing (scRNA-seq) has become a routinely used technique to quantify the gene expression profile of thousands of single cells simultaneously. Analysis of scRNA-seq data plays an important role in the study of cell states and phenotypes, and has helped elucidate biological processes, such as those occurring during the development of complex organisms, and improved our understanding of disease states, such as cancer, diabetes, and coronavirus disease 2019 (COVID-19). Deep learning, a recent advance of artificial intelligence that has been used to address many problems involving large datasets, has also emerged as a promising tool for scRNA-seq data analysis, as it has a capacity to extract informative and compact features from noisy, heterogeneous, and high-dimensional scRNA-seq data to improve downstream analysis. The present review aims at surveying recently developed deep learning techniques in scRNA-seq data analysis, identifying key steps within the scRNA-seq data analysis pipeline that have been advanced by deep learning, and explaining the benefits of deep learning over more conventional analytic tools. Finally, we summarize the challenges in current deep learning approaches faced within scRNA-seq data and discuss potential directions for improvements in deep learning algorithms for scRNA-seq data analysis.
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The SARS-CoV-2 spike protein binds and modulates estrogen receptorsThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein binds angiotensin-converting enzyme 2 as its primary infection mechanism. Interactions between S and endogenous proteins occur after infection but are not well understood. We profiled binding of S against >9000 human proteins and found an interaction between S and human estrogen receptor α (ERα). Using bioinformatics, supercomputing, and experimental assays, we identified a highly conserved and functional nuclear receptor coregulator (NRC) LXD-like motif on the S2 subunit. In cultured cells, S DNA transfection increased ERα cytoplasmic accumulation, and S treatment induced ER-dependent biological effects. Non-invasive imaging in SARS-CoV-2–infected hamsters localized lung pathology with increased ERα lung levels. Postmortem lung experiments from infected hamsters and humans confirmed an increase in cytoplasmic ERα and its colocalization with S in alveolar macrophages. These findings describe the discovery of a S-ERα interaction, imply a role for S as an NRC, and advance knowledge of SARS-CoV-2 biology and coronavirus disease 2019 pathology.
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Associations between SARS-CoV-2 infections and thrombotic complications necessitating surgical intervention: A systematic reviewBACKGROUND: Several unique clinical features of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19) infection, have been identified and characterized. One such feature, mostly among patients with severe COVID-19 infection, has become known as COVID-19-induced coagulopathy. Surgical patients with a history of or active COVID-19 infection bear a significantly higher risk for postoperative thrombotic complications. These patients may require surgical intervention to treat severe thrombotic complications. Few studies have been carried out to better characterize this association. The purpose of this study was to perform a systematic review and meta-analysis of the literature on COVID-19 infections that led to thrombotic complications necessitating surgical intervention. We hypothesized that patients with recent or active COVID-19 infection would have high rates of thromboembolic complications both arterial and venous in origin. AIM: To perform a systematic review and meta-analysis of the literature on COVID-19 infections that led to thrombotic complications necessitating surgical intervention. METHODS: The current systematic review implemented an algorithmic approach to review all the currently available English medical literature on surgical interventions necessitated by COVID-19 thrombotic complications using the preferred reporting items for systematic reviews and meta-analysis principles. A comprehensive search of the medical literature in the “PubMed”, “Scopus”, “Google Scholar” top 100 results, and archives of Plastic and Reconstructive Surgery was performed using the key words “COVID-19” AND “surgery” AND “thromboembolism” AND “complication”. The search string was generated and the records which were not specific about surgical interventions or thrombotic complications due to COVID-19 infection were excluded. Titles and abstracts were screened by two authors and full-text articles were assessed for eligibility and inclusion. Finally, results were further refined to focus on articles that focused on surgical interventions that were necessitated by COVID-19 thrombotic complications. RESULTS: The database search resulted in the final inclusion of 22 retrospective studies, after application of the inclusion/exclusion criteria. Of the included studies, 17 were single case reports, 3 were case series and 2 were cross sectional cohort studies. All studies were retrospective in nature. Twelve of the reported studies were conducted in the United States of America, with the remaining studies originating from Italy, Turkey, Pakistan, France, Serbia, and Germany. All cases reported in our study were laboratory confirmed SARS-CoV-2 positive. A total of 70 cases involving surgical intervention were isolated from the 22 studies included in this review. CONCLUSION: There is paucity of data describing the relationship between COVID-19 infection and thrombotic complications necessitating the need for surgical intervention. Intestinal ischemia and acute limb ischemia are amongst the most common thrombotic events due to COVID-19 that required operative management. An overall postoperative mortality of 30% was found in those who underwent operative procedures for thrombotic complications, with most deaths occurring in those with bowel ischemia. Physicians should be aware that despite thromboprophylaxis, severe thrombotic complications can still occur in this patient population, however, surgical intervention results in relatively low mortality apart from cases of ischemic bowel resection.
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Little Brown Bats (Myotis lucifugus) Support the Binding of SARS-CoV-2 Spike and Are Likely Susceptible to SARS-CoV-2 InfectionSevere acute respiratory syndrome coronavirus-2 (SARS-CoV-2), believed to have originated from a bat species, can infect a wide range of non-human hosts. Bats are known to harbor hundreds of coronaviruses capable of spillover into human populations. Recent studies have shown a significant variation in the susceptibility among bat species to SARS-CoV-2 infection. We show that little brown bats (LBB) express angiotensin-converting enzyme 2 receptor and the transmembrane serine protease 2, which are accessible to and support SARS-CoV-2 binding. All-atom molecular dynamics (MD) simulations revealed that LBB ACE2 formed strong electrostatic interactions with the RBD similar to human and cat ACE2 proteins. In summary, LBBs, a widely distributed North American bat species, could be at risk of SARS-CoV-2 infection and potentially serve as a natural reservoir. Finally, our framework, combining in vitro and in silico methods, is a useful tool to assess the SARS-CoV-2 susceptibility of bats and other animal species.
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Current SARS-CoV-2 Protective Strategies for Healthcare ProfessionalsSevere acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for the Coronavirus disease 2019 (COVID-19). COVID-19 was first reported in China in December 2019. SARS-CoV-2 is highly contagious and spread primarily via an airborne route. Hand hygiene, surgical masks, vaccinations and boosters, air filtration, environmental sanitization, instrument sterilization, mouth rinses, and social distancing are essential infection control measures against the transmission of SARS-CoV-2. This paper aims to provide healthcare professionals with evidence-based protective strategies.
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The Effect of COVID-19 on Maternal Mental Health and Medical SupportThe Coronavirus disease 2019 (COVID-19) is a pandemic that affected the overall mental health of the population. As seen in previous situations, there seemed to be an extreme impact of disasters on the mental health of pregnant women and new mothers; therefore, we investigated the relationship between COVID-19 and maternal mental health. The pregnant subjects were identified during the study period through convenience sampling. The study received Institutional Review Board approval and online surveys were sent to subjects via email. The questions were focused on feelings about being pregnant and the influence of the practices during the pandemic. Fifty-one (51) pregnant patients were identified. Our study found that 92.3% of the participants felt negatively, as the COVID-19 precautions did not permit their significant other to attend their routine prenatal visits with them. 64.7% felt that the visits were less personal, 100% felt that they had to take more precautions. Only 42% of the doctors of the subjects discussed how COVID-19 could affect the pregnancy and the baby. Pregnant subjects all had negative feelings towards the pandemic, routine precautions, and the inability to include significant others in prenatal visits and delivery. The majority did not feel their medical teams discussed how COVID-19 could affect the baby.
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Identification of Evolutionary Trajectories Shared across Human BetacoronavirusesComparing the evolution of distantly related viruses can provide insights into common adaptive processes related to shared ecological niches. Phylogenetic approaches, coupled with other molecular evolution tools, can help identify mutations informative on adaptation, although the structural contextualization of these to functional sites of proteins may help gain insight into their biological properties. Two zoonotic betacoronaviruses capable of sustained human-to-human transmission have caused pandemics in recent times (SARS-CoV-1 and SARS-CoV-2), although a third virus (MERS-CoV) is responsible for sporadic outbreaks linked to animal infections. Moreover, two other betacoronaviruses have circulated endemically in humans for decades (HKU1 and OC43). To search for evidence of adaptive convergence between established and emerging betacoronaviruses capable of sustained human-to-human transmission (HKU1, OC43, SARS-CoV-1, and SARS-CoV-2), we developed a methodological pipeline to classify shared nonsynonymous mutations as putatively denoting homoplasy (repeated mutations that do not share direct common ancestry) or stepwise evolution (sequential mutations leading towards a novel genotype). In parallel, we look for evidence of positive selection and draw upon protein structure data to identify potential biological implications. We find 30 candidate mutations, from which 4 (codon sites 18121 [nsp14/residue 28], 21623 [spike/21], 21635 [spike/25], and 23948 [spike/796]; SARS-CoV-2 genome numbering) further display evolution under positive selection and proximity to functional protein regions. Our findings shed light on potential mechanisms underlying betacoronavirus adaptation to the human host and pinpoint common mutational pathways that may occur during establishment of human endemicity.
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COVID-19: Variants, Immunity, and Therapeutics for Non-Hospitalized PatientsThe continuing transmission of coronavirus disease 2019 (COVID-19) remains a world-wide 21st-century public health emergency of concern. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused greater than 600 million cases of COVID-19 and over 6 million deaths globally. COVID-19 continues to be a highly transmissible disease despite efforts by public health officials and healthcare providers to manage and control the disease. Variants identified in selected worldwide epicenters add to the complexity of vaccine efficacy, overage, and antibody titer maintenance and bioactivity. The identification of the SARS-CoV-2 variants is described with respect to evading protective efficacy of COVID-19 vaccines and breakthrough infections. Vaccines and other therapeutics have prevented millions of SARS-CoV-2 infections and thousands of deaths in the United States. We explore aspects of the immune response in a condensed discussion to understand B and T cell lymphocyte regulatory mechanisms and antibody effectiveness and senescence. Finally, COVID-19 therapies including Paxlovid, Remdisivir, Molnupiravir and convalescent plasma in non-hospitalized patients are presented with limitations for identification, collection, and distribution to infected patients.
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COVID-19: An opportunity to engage African Americans and women in research on cardiovascular diseaseIntroduction: African Americans (AA) have been disproportionately affected with the COVID-19 disease experiencing 30%-60% of the deaths, while only making up 13% of the US population. Early data suggest that pregnant women and those with cardiovascular disease (CVD) may experience worse outcomes with severe coronavirus infection. There is an urgent need to incorporate AA and female perspectives into the design of research on the CVD complications related to COVID-19. Objectives: The goal of this project was to incorporate perspectives of AA and female patients in developing research priorities and AN agenda related to COVID-19. Objectives included: (a) develop a strong, research-ready partnership capable of executing PCOR, (b) creation of a research agenda and a set of priorities on racial/sex-specific CVD disparities in COVID-19 which reflects the perspectives of AA's and women; (c) long-term objective is creation of a set of research questions suitable for clinical research using the AHA Registry. Methods: The project used principles of active and adult learning within the framework of capacity building to build a strong, patient-centered vision of research needs. Different methods of obtaining patient input were used to identify questions suitable for research using the America Heart Association COVID-19 CVD Quality Improvement Registry: focus groups and town halls to identify concerns and interests vis-à-vis CVD and COVID research; narrative medicine methods collected compelling real-life, COVID-19 health stories; a research advisory council reviewed and prioritized research questions. Results: Outcomes include a replicable method of obtaining patient-oriented input into the creation of a research agenda and a set of research priorities for COVID-19. Outputs include the establishment of a research advisory council and stakeholder training using the PCORI funded, PORTAL program resources; a catalogue of patient generated narratives on COVID-19 experiences in the voice of AAs and women, and a set of research questions suitable for research using the AHA Registry. Conclusion: The project created a research ready stakeholder network, ready to develop a research agenda about COVID-19.
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Prolonged mask wearing does not alter the oral microbiome, salivary flow rate or gingival health status – A pilot studyThe COVID-19 pandemic has resulted in the widespread use of N95 respirators and surgical masks, with anecdotal reports among healthcare providers and the public of xerostomia, halitosis, and gingivitis, a consortium of symptoms colloquially termed “mask mouth”. However, this has not been scientifically verified. The aim of this study was to assess changes in salivary flow rate, gingival health status and oral microbiome associated with prolonged mask use. A total of 25 dental students (mean age = 26.36 ± 1.58) were included in the study and evaluated at three time points: T1, at the end of at least 2 months of full-day mask wear (7.26 ± 1.56 hours/day); T2, at the end of a period of minimal mask use (1.13 ± 1.13 hours/day); and T3, at the end of 2-3 weeks of resuming full-day mask wear (6.93 ± 1.80 hours/day). Unstimulated whole saliva (UWS) flow rate, xerostomia (on a quantitative scale of 10), gingival index (GI) and plaque index (PI) were assessed at each time point. The salivary microbiome was characterized using 16S rRNA gene sequencing. Overall, UWS flow rates were normal (mean of 0.679 ml/min) and xerostomia, PI and GI scores were low (Mean of 3.11, 0.33 and 0.69, respectively) with no significant differences as a result of prolonged mask wearing. Similarly, there were no significant microbial changes at a false discovery rate (FDR) ≤ 0.05. However, some trends were identified using a nominal p-value cut-off of ≤ 0.01, namely Gemella sanguinis, Streptococcus sp. Oral taxon 066 and Oral taxon 058 were associated with prolonged mask wear. Trends were also seen by gender, race and age, for example an increase in P. gingivalis and P. intermedia with age. In conclusion, we found no evidence that prolonged mask wear adversely affects oral health. The findings support that the oral microbiome of healthy individuals is resilient.
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“It's my frenemy”: A qualitative exploration of knowledge and perceptions of fentanyl use during the COVID-19 pandemic in people who use drugs at a syringe services program in Philadelphia, PABackground: Exacerbated by the COVID-19 pandemic and the proliferation of fentanyl and fentanyl analogs, overdose deaths have surged in the United States, making it important to understand how individuals who use drugs experience and perceive the risks of fentanyl use and how it has changed during the COVID-19 pandemic. Methods: Twenty clients from a Philadelphia syringe services program completed a questionnaire and in-depth interview about their fentanyl experiences from January to March 2021. These interviews were transcribed and analyzed using thematic analysis methods. Results: Sixty percent of participants were female and racial/ethnic minority. Participants indicated they believed fentanyl use accounted for most Philadelphia opioid-related overdoses and understood that fentanyl was different from other opioids. Fentanyl use was characterized as “all-consuming” by taking over lives and inescapable. While most perceived their risk of fentanyl overdose as high, there was low interest in and reported use of harm reduction strategies such as fentanyl test strips. The COVID-19 pandemic was noted to have negative effects on fentanyl availability, use and overdose risk, as well as mental health effects that increase drug use. Conclusions: The divide between perceived risk and uptake of protective strategies could be driven by diminished self-efficacy as it relates to acting on and engaging with resources available at the syringe services program and represents a potential intervention target for harm reduction intervention uptake. But the COVID-19 pandemic has exacerbated risks due to fentanyl use, making an effective, accessible, and well-timed intervention important to address the disconnect between perceived overdose risk and use of preventive behaviors.
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Get Help Finding a Digital Copy: A pandemic response becomes the new normalOur large, urban research university serves a sizeable, diverse community and is open to all. Library building closures in the early stages of the pandemic challenged us to maintain a comparable degree of openness and access virtually. We saw an opportunity to enhance our virtual reference services and keep the library "open" even when our buildings were closed. Since access to our physical collections was suddenly cut off, we established a new Get Help Finding a Digital Copy service that connected patrons to librarians working from home who could help them find digital copies of inaccessible physical items. Our crisis response became part of our permanent virtual reference services and ultimately improved the user experience of our library catalog. This poster will describe the service and present data illustrating how we meet patron needs and keep staff-patron relationships engaged during times of potential disconnection and disengagement. Learning Outcomes: Participants will learn how to enhance traditional email reference services by adding a focus on finding digital copies of inaccessible or inconveniently accessible physical materials. Participants will identify ways of deploying virtual reference technologies already in use at many libraries to facilitate access to their resources, even when buildings are closed, or patrons and staff are at a distance. Participants will learn techniques for helping virtual reference staff adapt to increased request volume and remote work conditions.
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Religiosity and COVID-19: Impact on Use of Remote Worship and Changes in Self-Reported Social SupportThis study examines associations between changes in the use of remote worship services and changes in the types of social support among religious adults during the COVID-19 pandemic. Materials and Methods: Cross-sectional, web survey data (n = 461; 15 May to 6 July 2020) were collected during the COVID-19 pandemic. Multinomial logistic regression models calculated unadjusted odds of increases and decreases of three types of perceived social support from before to during COVID-19 based on remote worship use. Results: Adults who initiated use of remote worship had lower odds of gaining social support for personal problems (OR: 0.38; 95% CI: 0.19, 0.79) and greater odds of reporting less ease of getting practical help from neighbors (OR: 1.77; 95% CI: 1.04, 3.02) compared to adults who never used or stopped using remote worship. Adults who continued using remote worship services were more likely to report less ease of getting practical help from their neighbors (OR: 2.23; 95% CI: 1.17, 4.25) and decreased interest and concern felt from other people (OR: 2.62; 95% CI: 1.24, 5.51) than adults who never used or stopped using remote worship. Conclusions: Adults who initiated and continued using remote worship during the COVID-19 pandemic had poorer perceived social support outcomes relative to adults who never used or stopped using remote services. Despite continued engagement with their religious communities, adults participating in worship remotely may have had residual personal, emotional, and instrumental social support needs that remote worship did not mitigate.
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Characteristics and Outcomes of People With Gout Hospitalized Due to COVID-19: Data From the COVID-19 Global Rheumatology Alliance Physician-Reported RegistryObjective: To describe people with gout who were diagnosed with coronavirus disease 2019 (COVID-19) and hospitalized and to characterize their outcomes. Methods: Data on patients with gout hospitalized for COVID-19 between March 12, 2020, and October 25, 2021, were extracted from the COVID-19 Global Rheumatology Alliance registry. Descriptive statistics were used to describe the demographics, comorbidities, medication exposures, and COVID-19 outcomes including oxygenation or ventilation support and death. Results: One hundred sixty-three patients with gout who developed COVID-19 and were hospitalized were included. The mean age was 63 years, and 85% were male. The majority of the group lived in the Western Pacific Region (35%) and North America (18%). Nearly half (46%) had two or more comorbidities, with hypertension (56%), cardiovascular disease (28%), diabetes mellitus (26%), chronic kidney disease (25%), and obesity (23%) being the most common. Glucocorticoids and colchicine were used pre-COVID-19 in 11% and 12% of the cohort, respectively. Over two thirds (68%) of the cohort required supplemental oxygen or ventilatory support during hospitalization. COVID-19-related death was reported in 16% of the overall cohort, with 73% of deaths documented in people with two or more comorbidities. Conclusion: This cohort of people with gout and COVID-19 who were hospitalized had high frequencies of ventilatory support and death. This suggests that patients with gout who were hospitalized for COVID-19 may be at risk of poor outcomes, perhaps related to known risk factors for poor outcomes, such as age and presence of comorbidity.
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The post-scarcity world and the post-pandemic officeWe are not yet in the post-scarcity world that John Maynard Keynes famously envisioned, and vaccines have only recently allowed us to hope that a post-COVID-19 future may arrive soon. However, it is not too early to consider the impact of both on the traditional office, and on attempts to bring it back for reasons that may be socially harmful. One lesson of the pandemic is that many workers can be as—or even more—productive working from home, thanks chiefly to software such as Zoom, Microsoft Teams, and Slack, among others, which enable better collaboration across distances than was previously possible. At the turn of the century, we moved toward an economy in which important products were increasingly characterized by low marginal costs of production, such as pharmaceuticals and software. Over the past decade, we have seen fixed costs reduced in some situations—consider how Uber greatly eliminates the need for a central taxi dispatcher, and makes use of idle capital invested in personal vehicles. The traditional office represents a massive fixed cost for many industries; tech-driven work-from-home greatly reduces the need for this fixed cost. While software, Internet connectivity and the cloud are not free, preliminary estimates suggest that replacing traditional offices with work-from-home greatly lowers costs, creates economic efficiencies and, relatedly, reduces environmental harm. That said, the story of work-from-home is not one of unbridled optimism. Real estate firms and local governments are already trying to use law as a tool to return workers to the pre-pandemic traditional office. Various levels of government seek to return workers to physical offices, often motivated by declines in tax receipts. Attempts to bolster a return to the traditional office may raise fixed costs for firms and generate substantial avoidable environmental damage. This Chapter recommends competition advocacy to counterbalance state and local attempts to prevent the efficient disruption of the traditional office's fixed costs. Work-from-home represents an important step toward the post-scarcity world; but without a focus on what amounts to state-and-local protectionism in this sphere, we could wind up taking another step backwards.
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Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin AmericaObjectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.
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Factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy: results from the COVID-19 Global Rheumatology Alliance physician-reported registryObjectives: To investigate factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy (IIM). Methods: Demographic data, clinical characteristics and COVID-19 outcome severity of adults with IIM were obtained from the COVID-19 Global Rheumatology Alliance physician-reported registry. A 3-point ordinal COVID-19 severity scale was defined: (1) no hospitalisation, (2) hospitalisation (and no death) and (3) death. ORs were estimated using multivariable ordinal logistic regression. Sensitivity analyses were performed using a 4-point ordinal scale: (1) no hospitalisation, (2) hospitalisation with no oxygen (and no death), (3) hospitalisation with oxygen/ventilation (and no death) and 4) death. Results: Of 348 patients, 48% were not hospitalised, 39% were hospitalised (and did not die) and 13% died. Older age (OR=1.59/decade, 95% CI 1.31 to 1.91), high disease activity (OR=3.50, 95% CI 1.25 to 9.83; vs remission), ≥2 comorbidities (OR=2.63, 95% CI 1.39 to 4.98; vs none), prednisolone-equivalent dose >7.5 mg/day (OR=2.40, 95% CI 1.09 to 5.28; vs no intake) and exposure to rituximab (OR=2.71, 95% CI 1.28 to 5.72; vs conventional synthetic disease-modifying antirheumatic drugs only) were independently associated with severe COVID-19. In addition to these variables, in the sensitivity analyses, male sex (OR range: 1.65–1.83; vs female) was also significantly associated with severe outcomes, while COVID-19 diagnosis after 1 October 2020 (OR range: 0.51–0.59; vs on/before 15 June 2020) was significantly associated with less severe outcomes, but these associations were not significant in the main model (OR=1.57, 95% CI 0.95 to 2.59; and OR=0.61, 95% CI 0.37 to 1.00; respectively). Conclusions: This is the first large registry data on outcomes of COVID-19 in people with IIM. Older age, male sex, higher comorbidity burden, high disease activity, prednisolone-equivalent dose >7.5 mg/day and rituximab exposure were associated with severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with IIM.
