230 results on '"P. A. Fischer"'
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2. How Economic and Political Pressures Are Re-Shaping China's Higher Education System: A Neo-Nationalism and University Brief. Research & Occasional Paper Series: CSHE.15.2023
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University of California, Berkeley. Center for Studies in Higher Education (CSHE) and Karin Fischer
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China's higher-education system has been shaped in recent years by a trio of factors: the COVID-19 pandemic, the ambitions of Chinese leader Xi Jinping to make his country into an innovation superpower that is loyal to the Communist Party, and western alarm about those ambitions. But a fourth development, the slowing of China's formerly super-charged economy, could play a more prominent role going forward. This article examines these four factors.
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- 2023
3. Designing e-Learning Courses for Classroom and Distance Learning in Physics: The Role of Learning Tasks
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Daniel Laumann, Julian Alexander Fischer, Tatjana K. Stürmer-Steinmann, Julia Welberg, Susanne Weßnigk, and Knut Neumann
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Digital learning technologies have grown increasingly important in physics education, partly enforced through the COVID-19 pandemic. During the pandemic, digital technologies allowed for continued teaching and learning of students even when schools were closed. While research in psychology and educational technology has yielded many insights into the effectiveness of e-learning courses, fewer studies have examined the design of e-learning courses. Few studies have empirically investigated the design of learning tasks as a central element of e-learning courses. The present study analyzes how the design of tasks in e-learning courses, specifically with respect to their degree of openness as well as the relevance of their contexts, influences students' behavioral engagement, learning outcomes, and situational interest. Due to the importance of e-learning courses during the COVID-19 pandemic, we also analyzed the extent to which specific learning settings (classroom learning, distance learning) influence the effects of e-learning course design on students' behavioral engagement, learning outcomes, and situational interest. To investigate the research questions, we analyzed a total of N = 1060 datasets for 12 different e-learning courses (3 to 5 lessons, middle school physics), of which n = 557 were completed before and n = 503 during the COVID-19 pandemic. The results suggest that e-learning courses with a high proportion of learning tasks that relate to meaningful real-world contexts appear to be more conducive to behavioral engagement, learning outcomes, and situational interest. Regarding the consideration of open-ended tasks, the results suggest that these appear to be more useful for classroom learning but should be used in a limited way when designing e-learning courses for distance education.
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- 2024
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4. Coping with COVID-19: A Snapshot of College Student Mental Health, Coping, and Expectancies during Stay-at-Home Orders
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Mackenzie L. Shanahan, Ian C. Fischer, Sarah K. Rogers, and Kevin L. Rand
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Objective: The COVID-19 pandemic has disrupted people's lives around the world, including college students. This cross-sectional study aimed to 1) describe psychological distress, coping, and expectancies of undergraduates during COVID-19 "stay-at-home" orders and 2) examine the associations among these variables. Participants and methods: Midwestern US undergraduates (N = 186) completed measures of psychological distress, coping behaviors, and expectancies in March-April 2020 during the initial round of "stay-at-home" orders. Results: Students engaged in approach coping and disease prevention behaviors and had low expectations for contracting COVID-19. Most students reported clinically significant depression or anxiety. Adherence to disease prevention behaviors was associated with less stress but more anxiety. Positive expectancies and approach coping were associated with less distress. Avoidance coping was associated with more distress. Conclusions: This study describes the toll that COVID-19 has had on college students. Continued attention to the mental health of college students during the pandemic is imperative.
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- 2024
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5. Risk and Protective Factors of College Students' Psychological Well-Being during the COVID-19 Pandemic: Emotional Stability, Mental Health, and Household Resources
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Moeller, Julia, von Keyserlingk, Luise, Spengler, Marion, Gaspard, Hanna, Lee, Hye Rin, Yamaguchi-Pedroza, Katsumi, Yu, Renzhe, Fischer, Christian, and Arum, Richard
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Colleges and universities have increasingly worried in recent decades about college students' well-being, with the COVID-19 pandemic aggravating these concerns. Our study examines changes to undergraduate emotional sentiments and psychological well-being from before to after the onset of the pandemic. In addition, we explore whether certain risk factors (i.e., prior mental health impairments, trait emotional stability) and protective factors (i.e., subjective socioeconomic status, parental education, household resources) predicted students' emotions and their intraindividual changes due to the pandemic onset. We compared experience sampling method data from 120 students from before and after the pandemic onset, examining intraindividual trajectories. There was only little change in students' emotions. Prior mental health impairment and trait emotional stability predicted students' emotions, averaged across time points, but not emotion changes. Few associations with emotions were found for subjective socioeconomic status and parental education, but study-related household resources predicted levels and changes in emotions.
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- 2022
6. Socially Distanced Teaching: The Mental Health Impact of the COVID-19 Pandemic on Special Education Teachers
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Cormier, Christopher J., McGrew, John, Ruble, Lisa, and Fischer, Melanie
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Little is known about the impact of the COVID-19 pandemic on special education teachers. Of 468 surveyed across the United States, 38.4% met clinical criteria for generalized anxiety disorder, a rate 12.4 times greater than the U.S. population, and 37.6% for major depressive disorder, a rate 5.6 times greater than the population. Race/ethnicity, gender, or school funding was not related to mental health. The impact of the pandemic was moderate to extreme on stress (91%), depression (58%), anxiety (76%), and emotional exhaustion (83%).
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- 2022
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7. The International Student Experience at U.S. Community Colleges at the Onset of the COVID-19 Pandemic
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Whatley, Melissa and Fischer, Heidi
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This study's purpose is to explore the impact of the COVID-19 pandemic on international students who were studying at U.S. community colleges at the onset of this public health crisis. While previous work has explored the impact of the pandemic on international students generally, we argue that community college international students deserve focused attention due to their potentially marginalized status on their campuses. Using a mixed methods research approach, we analyze survey and interview data provided by community college international educators. Our results speak to two overarching themes: the supports provided to students at the onset of the pandemic (and educators' reasons for providing these specific supports) and the unique impact of the pandemic on community college international students due to their citizenship or residency status. These findings have important implications for community college leaders and international educators as they work with international students during future times of crisis.
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- 2022
8. A Preliminary Evaluation of a Digital Token Economy to Increase Student Engagement during Group Teletherapy
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King, Hunter, Miller-Johnson, Katerra, McCulla, Keely, Fischer, Aaron J., Wu, Shengtian, and Miller, Mikey
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Shortly following the temporary nationwide school dismissal amid COVID-19, the current exploratory case-study evaluated the feasibility of two engagement strategies delivered during group teletherapy: Class Dojo and opportunities to respond (OTR). Three elementary students with emotional and behavioral difficulties participated. An A-B-A design was used to evaluate the effects of Class Dojo on student engagement with therapist-delivered OTRs. Due to one student's poor response to the contingency, an A-B-C design was used to evaluate the additive effect of student-delivered OTRs on his engagement. Results indicated moderate to high rates of student attendance, and consistently high rates of engagement for two students. When students delivered OTRs, the student who initially struggled to engage demonstrated an increase in engagement. Practical issues are discussed and recommendations are considered for future research on increasing student engagement during online settings.
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- 2021
9. A Different Experience in a Different Moment? Teachers' Social Media Use before and during the COVID-19 Pandemic
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Aguilar, Stephen J., Rosenberg, Joshua M., Greenhalgh, Spencer P., Fütterer, Tim, Lishinski, Alex, and Fischer, Christian
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Teachers participate in professional learning activities to enhance their pedagogical knowledge and share best practices--and the increasing role of technologies in education, including social media, is shifting how this professional learning occurs. The COVID-19 pandemic provided an opportunity to consider the role of social media for professional learning. Using intensive longitudinal methods, we repeatedly surveyed 14 teachers' use of social media both before and during the pandemic (N = 386 total responses). We found patterns in social media platforms uptake and their purposes, but teachers' use of social media was largely idiosyncratic. Also, teachers demonstrated notable shifts in social media use after the pandemic started; multilevel models indicated that teachers were more likely to use social media to connect and share, especially, as well as learn and follow, compared with before the pandemic. Higher levels of COVID-19-related family stress were also associated with more use of social media to find materials.
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- 2021
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10. Using a Design Thinking Approach for an Asynchronous Learning Platform during COVID-19
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Severino, Lori, Petrovich, Mark, Mercanti-Anthony, Samantha, and Fischer, Samuel
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The COVID-19 pandemic abruptly shut down schools in an urban based school district in the Spring of 2020. As the closures persisted over months, an immediate educational need arose for online curricula that could help alleviate the learning gaps caused by the shutdown. The purpose of this study was to create a process and model for the development of a fully asynchronous online learning environment for prekindergarten through 2nd grade students that could help other districts implement similar projects. Since the turnaround time for development and implementation was a matter of weeks the project team used an iterative process to solve a "wicked problem" and identified solutions to create an improved user experience. A modified design thinking model approach was developed through the process of developing this six-week, theme based virtual curriculum that included interactivities in early literacy, writing, reading comprehension, science and math. This adjusted model includes 6 stages: discover, interpretation, ideation, experimentation, implementation, and evolution. This research focuses on the processes involved during each of the stages and the resulting use by the intended audience. The curriculum was used by over 5,800 prekindergarten through second grade students during the 6-week period of the summer of 2020. The online platform continues to be used by students presently.
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- 2021
11. Learning to Spend Time in Unusual Times: An Inquiry into the Potential for Sustainability Learning during COVID-19-Induced School Closures
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Claire Grauer, Pascal Frank, and Daniel Fischer
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While current research on school closures during the COVID-19 pandemic is predominantly concerned with learning deficits, the exploratory study presented here focuses on the previously neglected question of young people's concrete learning experiences during this disruptive period, with a focus on how they used their time and how this relates to their individual needs. The authors interviewed German secondary school students via Zoom and used a grounded theory approach and a transformative learning theory framework to derive recommendations for environmental and sustainability education (ESE). Their findings highlight two important insights: first, that the predominant focus on academic learning loss obscures a more comprehensive understanding of students' learning experiences; and second, that real-world experiments such as the involuntary school closures during the pandemic may hold the potential to start meaningful, transformative learning processes and experimentation with new strategies for needs satisfaction.
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- 2023
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12. 'Attending Lectures in Your Pyjamas': Student Agency in Constrained Circumstances
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Ajjawi, Rola, Fischer, Juan, Tai, Joanna, Bearman, Margaret, and Jorre de St Jorre, Trina
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COVID-19 forced the digitalisation of teaching and learning in a response often described as emergency remote teaching (ERT). This rapid response changed the social, spatial, and temporal arrangements of higher education and required important adaptations from educators and students alike. However, while the literature has examined the constraints students faced (e.g. availability of the internet) and the consequences of the pandemic (e.g. student mental health), students' active management of these constraints for learning remains underexplored. This paper aims to "think with" COVID-19 to explore student agency in home learning under constrained circumstances. This qualitative study used semi-structured interviews to understand the day-to-day actions of nineteen undergraduate students managing their learning during the COVID-19 lockdowns in Victoria, Australia. Emirbayer and Mische's multiple dimensions of agency -- iterative, projective, and practical-evaluative -- are used to explore student experience. The findings illustrate students' adaptability and agency in navigating life-integrated learning, with most of their actions oriented to their present circumstances. This practical evaluative form of agency was expressed through (1) organising self, space, time, and relationships; (2) self-care; and (3) seeking help. Although this study took place in the context of ERT, it has implications beyond the pandemic because higher education always operates under constraints, and in other circumstances, many students still experience emotionally and materially difficult times.
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- 2023
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13. Science Knowledge and Trust in Medicine Affect Individuals' Behavior in Pandemic Crises
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Sailer, Michael, Stadler, Matthias, Botes, Elouise, Fischer, Frank, and Greiff, Samuel
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In pandemic crises such as the COVID-19 pandemic, individuals' behavior has a strong impact on epidemiological processes. Compliance with prevention guidelines, such as social distancing, is critical to avoid further spreading an infectious disease or to slow down its spread. However, some individuals also or instead engage in panic behavior, such as hoarding. We investigate how education prepares individuals to respond adequately by modelling the path from seeking information about COVID-19 to eventual behavior. Based on a sample of N = 1182 adult Americans, gathered at the pandemic's onset (March 2020), we conclude that science knowledge helps individuals convert information into coronavirus knowledge. This knowledge then helps individuals avoid panic behavior. Individuals lacking coronavirus knowledge and science knowledge still comply with prevention guidelines when they have a general trust in medicine. Individuals lacking knowledge still follow prevention guidelines when they trust in medicine. Facilitating science knowledge and trust in science through education and targeted public health messaging are likely to be of fundamental importance for bringing crises such as the COVID-19 pandemic under control.
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- 2022
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14. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trial
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Evering, Teresa H, Moser, Carlee, Jilg, Nikolaus, Ritz, Justin, Wohl, David A, Li, Jonathan Z, Margolis, David, Javan, Arzhang Cyrus, Eron, Joseph J, Currier, Judith S, Daar, Eric S, Smith, Davey M, Hughes, Michael D, Chew, Kara W, Chew, Kara, Smith, David, Daar, Eric, Wohl, David, Currier, Judith, Eron, Joseph, Hughes, Michael, Giganti, Mark, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Li, Jonathan, Fletcher, Courtney, Fischer, William, Ignacio, Rachel Bender, Cardoso, Sandra, Corado, Katya, Jagannathan, Prasanna, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Singh, Upinder, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, Shahkolahi, Akbar, Lacal, Verónica, Salusso, Diego, Nuñez, Sebastian, Rodriguez, Marcelo Rodrigo, Laborde, Luciana, Papasidero, Marcelo, Wehbe, Luis, Gonzalez, Mariana, Voena, Felicitas Fernandez, Alvarez, Tomas, Lopez, Amaru, Huhn, Virginia, Nores, Ulises D'Andrea, Dieser, Pablo, Bordese, Fernando, Mussi, Marisa, de Carvalho Santana, Rodrigo, Bárbaro, Adriana Aparecida Tiraboschi, Santos, Breno, de Cássia Alves Lira, Rita, da Silva, Andre Luiz Machado, Cardoso, Sandra Wagner, Ribeiro, Maria Pia Diniz, Soliva, Nathália, Vasconcellos, Eduardo, Ribeiro, Jorge Eurico, Enéas, Miriam Amaral, Pinto, Jorge, de Morais Caporali, Julia Fonseca, Ferreira, Flávia Gomes Faleiro, Martinez, Norma Erendira Rivera, Lopez, Victor Casildo Bohorquez, Frias, Melchor Victor, Fetalvero, Krystle, Maranan, Alyxzza, Rosa, Jennifer, Coetzer, Thomas, Mohata, Maureen, Lalloo, Umesh, Madlala, Penelope, Pillay-Ramaya, Larisha, and Bennet, Jaclyn Ann
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Prevention ,Infectious Diseases ,Emerging Infectious Diseases ,Coronaviruses ,6.1 Pharmaceuticals ,Good Health and Well Being ,COVID-19 ,Monoclonal antibodies ,Outpatient treatment ,Clinical trial ,Post COVID conditions ,Long COVID ,Post-acute sequelae of SARS-CoV-2 infection ,ACTIV-2/A5401 Study Team ,Clinical sciences ,Health services and systems ,Public health - Abstract
BackgroundIt is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID.MethodsNon-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo.FindingsParticipants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53-0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID.InterpretationAmubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID.FundingNational Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.
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- 2024
15. Host and viral determinants of airborne transmission of SARS-CoV-2 in the Syrian hamster.
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Port, Julia, Morris, Dylan, Riopelle, Jade, Yinda, Claude, Avanzato, Victoria, Holbrook, Myndi, Bushmaker, Trenton, Schulz, Jonathan, Saturday, Taylor, Barbian, Kent, Russell, Colin, Perry-Gottschalk, Rose, Shaia, Carl, Martens, Craig, Fischer, Robert, Munster, Vincent, and Lloyd-Smith, James
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SARS-CoV-2 ,airborne ,infectious disease ,microbiology ,syrian hamster ,transmission ,variants of concern ,virus kinetics ,viruses ,Cricetinae ,Animals ,Male ,SARS-CoV-2 ,COVID-19 ,Mesocricetus ,Respiratory Aerosols and Droplets - Abstract
It remains poorly understood how SARS-CoV-2 infection influences the physiological host factors important for aerosol transmission. We assessed breathing pattern, exhaled droplets, and infectious virus after infection with Alpha and Delta variants of concern (VOC) in the Syrian hamster. Both VOCs displayed a confined window of detectable airborne virus (24-48 hr), shorter than compared to oropharyngeal swabs. The loss of airborne shedding was linked to airway constriction resulting in a decrease of fine aerosols (1-10 µm) produced, which are suspected to be the major driver of airborne transmission. Male sex was associated with increased viral replication and virus shedding in the air. Next, we compared the transmission efficiency of both variants and found no significant differences. Transmission efficiency varied mostly among donors, 0-100% (including a superspreading event), and aerosol transmission over multiple chain links was representative of natural heterogeneity of exposure dose and downstream viral kinetics. Co-infection with VOCs only occurred when both viruses were shed by the same donor during an increased exposure timeframe (24-48 hr). This highlights that assessment of host and virus factors resulting in a differential exhaled particle profile is critical for understanding airborne transmission.
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- 2024
16. Deaths in Immigration and Customs Enforcement (ICE) detention: A Fiscal Year (FY) 2021-2023 update.
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Buchanan, Cara, Ahmed, Sameer, Nwadiuko, Joseph, Dekker, Annette, Zeidan, Amy, Bitrán, Eva, Urich, Thomas, Fischer, Briah, Burner, Elizabeth, Parmar, Parveen, and Terp, Sophie
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COVID-19 ,correctional health ,immigration detention ,immigration health ,public health - Abstract
BACKGROUND: This study describes the deaths of individuals in Immigration and Customs Enforcement (ICE) detention between FY2021-2023, updating a report from FY2018-2020, which identified an increased death rate amidst the COVID-19 pandemic. METHODS: Data was extracted from death reports published online by ICE. Causes of deaths were recorded, and death rates per 100,000 admissions were calculated using population statistics reported by ICE. Reports of individuals released from ICE custody just prior to death were also identified and described. RESULTS: There were 12 deaths reported from FY2021-2023, compared to 38 deaths from FY2018-2020. The death rate per 100,000 admissions in ICE detention was 3.251 in FY2021, 0.939 in FY2022, and 1.457 in FY2023, compared with a pandemic-era high of 10.833 in FY2020. Suicide caused 1 of 12 (8.3%) deaths in FY2021-2023 compared with 9 of 38 (23.7%) deaths in FY2018-2020. COVID-19 was contributory in 3 of 11 (25%) medical deaths in FY2021-2023, compared with 8 of 11 (72.7%) in the COVID-era months of FY2020 (p = 0.030). Overall, 4 of 11 (36.3%) medical deaths in FY2021-2023 resulted from cardiac arrest in detention facilities, compared with 6 of 29 (20.3%) in FY2018-2020. Three deaths of hospitalized individuals released from ICE custody with grave prognoses were identified. CONCLUSIONS: The death rate among individuals in ICE custody decreased in FY2021-2023, which may be explained in part by the release of vulnerable individuals following recent federal legal determinations (e.g., Fraihat v. ICE). Identification of medically complex individuals released from ICE custody just prior to death and not reported by ICE indicates that reported deaths underestimate total deaths associated with ICE detention. Attentive monitoring of mortality outcomes following release from ICE custody is warranted.
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- 2024
17. The Antiviral Activity of the Lectin Griffithsin against SARS-CoV-2 Is Enhanced by the Presence of Structural Proteins.
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Bains, Arjan, Fischer, Kathryn, Guan, Wenyan, and Liwang, Patricia
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C-type lectin receptor ,COVID-19 ,DC-SIGN ,Griffithsin ,M protein ,SARS-CoV-2 ,lectin ,prophylaxis ,structural proteins ,trans-infection ,Humans ,Spike Glycoprotein ,Coronavirus ,SARS-CoV-2 ,COVID-19 ,Antiviral Agents - Abstract
Although COVID-19 transmission has been reduced by the advent of vaccinations and a variety of rapid monitoring techniques, the SARS-CoV-2 virus itself has shown a remarkable ability to mutate and persist. With this long track record of immune escape, researchers are still exploring prophylactic treatments to curtail future SARS-CoV-2 variants. Specifically, much focus has been placed on the antiviral lectin Griffithsin in preventing spike protein-mediated infection via the hACE2 receptor (direct infection). However, an oft-overlooked aspect of SARS-CoV-2 infection is viral capture by attachment receptors such as DC-SIGN, which is thought to facilitate the initial stages of COVID-19 infection in the lung tissue (called trans-infection). In addition, while immune escape is dictated by mutations in the spike protein, coronaviral virions also incorporate M, N, and E structural proteins within the particle. In this paper, we explored how several structural facets of both the SARS-CoV-2 virion and the antiviral lectin Griffithsin can affect and attenuate the infectivity of SARS-CoV-2 pseudovirus. We found that Griffithsin was a better inhibitor of hACE2-mediated direct infection when the coronaviral M protein is present compared to when it is absent (possibly providing an explanation regarding why Griffithsin shows better inhibition against authentic SARS-CoV-2 as opposed to pseudotyped viruses, which generally do not contain M) and that Griffithsin was not an effective inhibitor of DC-SIGN-mediated trans-infection. Furthermore, we found that DC-SIGN appeared to mediate trans-infection exclusively via binding to the SARS-CoV-2 spike protein, with no significant effect observed when other viral proteins (M, N, and/or E) were present. These results provide etiological data that may help to direct the development of novel antiviral treatments, either by leveraging Griffithsin binding to the M protein as a novel strategy to prevent SARS-CoV-2 infection or by narrowing efforts to inhibit trans-infection to focus on DC-SIGN binding to SARS-CoV-2 spike protein.
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- 2023
18. Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial
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Jagannathan, Prasanna, Chew, Kara W, Giganti, Mark J, Hughes, Michael D, Moser, Carlee, Main, Mark J, Monk, Phillip D, Javan, Arzhang Cyrus, Li, Jonathan Z, Fletcher, Courtney V, McCarthy, Caitlyn, Wohl, David A, Daar, Eric S, Eron, Joseph J, Currier, Judith S, Singh, Upinder, Smith, Davey M, Fischer, William, Team, ACTIV-2 A5401 Study, Chew, Kara, Smith, David, Daar, Eric, Wohl, David, Currier, Judith, Eron, Joseph, Hughes, Michael, Giganti, Mark, Ritz, Justin, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Li, Jonathan, Fletcher, Courtney, Evering, Teresa, Ignacio, Rachel Bender, Cardoso, Sandra, Corado, Katya, Jilg, Nikolaus, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, Shahkolahi, Akbar, Pierone, Gerald, Elliott, Juliana, Jacobson, Jeffrey, Hojat, Leila, Pasternak, Julie, Berardi, Jonathan, Arar, Celine, Bukhman, Yevgeniy, Jain, Manish, Bukhman, Eugene, Shaik, Sadia, Hatlen, Timothy, Dooley, Kelly, Becker, Becky, Wilkins, Adaliah, Pérez, Jose, Roman, Eloy, Fernández, Heriberto, Hoover, Keila, Renfroe, James, Weldon, Mauney, Bougher, Genei, Malvestutto, Carlos, Harber, Heather, Cicarella, Robyn, Neytman, Gene, Herman, Jack, Herman, Craig, Aziz, Mariam, Swiatek, Joan, Pathak, Divya, Choudhary, Madhu, Sullivano, Jennifer, Osiyemi, Olayemi, Izquierdo, Myriam, Torna, Odelsey, Khodabakhshian, Aleen, and Fortier, Samantha
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Clinical Research ,Coronaviruses ,Infectious Diseases ,Coronaviruses Therapeutics and Interventions ,Emerging Infectious Diseases ,Patient Safety ,Prevention ,Lung ,6.1 Pharmaceuticals ,5.1 Pharmaceuticals ,Infection ,Good Health and Well Being ,Inhaled interferon ,SARS-CoV-2 ,COVID-19 ,ACTIV-2 ,Randomized clinical trial ,ACTIV-2/A5401 Study Team ,Clinical sciences ,Health services and systems ,Public health - Abstract
BackgroundWith the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical need.MethodsSafety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials.govNCT04518410). Adult outpatients with confirmed SARS-CoV-2 infection within 10 days of symptom onset were randomized and initiated either orally inhaled nebulized SNG001 given once daily for 14 days (n = 110) or blinded pooled placebo (n = 110) between February 10 and August 18, 2021.FindingsThe proportion of participants reporting premature treatment discontinuation was 9% among SNG001 and 13% among placebo participants. There were no differences between participants who received SNG001 or placebo in the primary outcomes of treatment emergent Grade 3 or higher adverse events (3.6% and 8.2%, respectively), time to symptom improvement (median 13 and 9 days, respectively), or proportion with unquantifiable nasopharyngeal SARS-CoV-2 RNA at days 3 (28% [26/93] vs. 39% [37/94], respectively), 7 (65% [60/93] vs. 66% [62/94]) and 14 (91% [86/95] vs. 91% [83/81]). There were fewer hospitalizations with SNG001 (n = 1; 1%) compared with placebo (n = 7; 6%), representing an 86% relative risk reduction (p = 0.07). There were no deaths in either arm.InterpretationIn this trial, SNG001 was safe and associated with a non-statistically significant decrease in hospitalization for COVID-19 pneumonia.FundingThe ACTIV-2 platform study is funded by the NIH. Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, UM1 AI068636 and UM1 AI106701. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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- 2023
19. One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial
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Jilg, Nikolaus, Chew, Kara W, Giganti, Mark J, Daar, Eric S, Wohl, David A, Javan, Arzhang Cyrus, Kantor, Amy, Moser, Carlee, Coombs, Robert W, Neytman, Gene, Hoover, Keila, Jana, Atasi, Hart, Phil A, Greninger, Alexander L, Szurgot, Bob, Eron, Joseph J, Currier, Judith S, Hughes, Michael D, Smith, Davey M, Li, Jonathan Z, Chew, Kara, Smith, David, Daar, Eric, Wohl, David, Currier, Judith, Eron, Joseph, Hughes, Michael, Giganti, Mark, Ritz, Justin, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Li, Jonathan, Fletcher, Courtney, Fischer, William, Evering, Teresa, Coombs, Robert, Ignacio, Rachel Bender, Cardoso, Sandra, Corado, Katya, Jagannathan, Prasanna, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Singh, Upinder, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, and Shahkolahi, Akbar
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Emerging Infectious Diseases ,Infectious Diseases ,Coronaviruses Therapeutics and Interventions ,Coronaviruses ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Humans ,Adult ,COVID-19 ,SARS-CoV-2 ,RNA ,Viral ,Time Factors ,Treatment Outcome ,camostat ,outpatient ,phase 2 ,ACTIV-2/A5401 Study Team ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Clinical sciences - Abstract
BackgroundCamostat inhibits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vitro. We studied the safety and efficacy of camostat in ACTIV-2/A5401, a phase 2/3 platform trial of therapeutics for COVID-19 in nonhospitalized adults.MethodsWe conducted a phase 2 study in adults with mild-to-moderate COVID-19 randomized to oral camostat for 7 days or a pooled placebo arm. Primary outcomes were time to improvement in COVID-19 symptoms through day 28, proportion of participants with SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) from nasopharyngeal swabs through day 14, and grade ≥3 treatment-emergent adverse events (TEAEs) through day 28.ResultsOf 216 participants (109 randomized to camostat, 107 to placebo) who initiated study intervention, 45% reported ≤5 days of symptoms at study entry and 26% met the protocol definition of higher risk of progression to severe COVID-19. Median age was 37 years. Median time to symptom improvement was 9 days in both arms (P = .99). There were no significant differences in the proportion of participants with SARS-CoV-2 RNA ConclusionsIn a phase 2 study of nonhospitalized adults with mild-to-moderate COVID-19, oral camostat did not accelerate viral clearance or time to symptom improvement, or reduce hospitalizations or deaths. Clinical Trials Registration. ClinicalTrials.gov identifier: NCT04518410.
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- 2023
20. The public health impact of COVID-19 variants of concern on the effectiveness of contact tracing in Vermont, United States
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Castonguay, François M., Borah, Brian F., Jeon, Seonghye, Rainisch, Gabriel, Kelso, Patsy, Adhikari, Bishwa B., Daltry, Daniel J., Fischer, Leah S., Greening, Jr., Bradford, Kahn, Emily B., Kang, Gloria J., and Meltzer, Martin I.
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- 2024
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21. Estimated public health impact of concurrent mask mandate and vaccinate-or-test requirement in Illinois, October to December 2021
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Castonguay, François M., Barnes, Arti, Jeon, Seonghye, Fornoff, Jane, Adhikari, Bishwa B., Fischer, Leah S., Greening, Jr., Bradford, Hassan, Adebola O., Kahn, Emily B., Kang, Gloria J., Kauerauf, Judy, Patrick, Sarah, Vohra, Sameer, and Meltzer, Martin I.
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- 2024
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22. Problematic Alcohol Use Trajectories in U.S. Military Veterans during a Public Health Crisis: Results from a 3-year, Nationally Representative, Longitudinal Study
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Na, Peter J., Fischer, Ian C., Petrakis, Ismene L., and Pietrzak, Robert H.
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- 2024
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23. The public health impact of COVID-19 variants of concern on the effectiveness of contact tracing in Vermont, United States
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François M. Castonguay, Brian F. Borah, Seonghye Jeon, Gabriel Rainisch, Patsy Kelso, Bishwa B. Adhikari, Daniel J. Daltry, Leah S. Fischer, Bradford Greening, Emily B. Kahn, Gloria J. Kang, and Martin I. Meltzer
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Case investigation ,Contact tracing ,Cases averted ,COVID-19 ,Modeling ,Medicine ,Science - Abstract
Abstract Case investigation and contact tracing (CICT) are public health measures that aim to break the chain of pathogen transmission. Changes in viral characteristics of COVID-19 variants have likely affected the effectiveness of CICT programs. We estimated and compared the cases averted in Vermont when the original COVID-19 strain circulated (Nov. 25, 2020–Jan. 19, 2021) with two periods when the Delta strain dominated (Aug. 1–Sept. 25, 2021, and Sept. 26–Nov. 20, 2021). When the original strain circulated, we estimated that CICT prevented 7180 cases (55% reduction in disease burden), compared to 1437 (15% reduction) and 9970 cases (40% reduction) when the Delta strain circulated. Despite the Delta variant being more infectious and having a shorter latency period, CICT remained an effective tool to slow spread of COVID-19; while these viral characteristics did diminish CICT effectiveness, non-viral characteristics had a much greater impact on CICT effectiveness.
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- 2024
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24. Evaluation of Psychosomatic, Respiratory, and Neurocognitive Health in COVID-19 Survivors 12 Months after ICU Discharge
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Nicolas Germann, Daria Amozova, Kristina Göhl-Freyn, Tim Fischer, Manuel Frischknecht, Gian-Reto Kleger, Urs Pietsch, Miodrag Filipovic, Martin H. Brutsche, Thomas Frauenfelder, Christian R. Kahlert, Dagmar A. Schmid, and Werner C. Albrich
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COVID-19 ,intensive unit care ,ICU ,predictive model ,psychosomatic health ,Specialties of internal medicine ,RC581-951 - Abstract
Patients who survive critical COVID-19 frequently report post-acute sequelae of COVID-19 (PASC) such as psychosomatic and neurocognitive health problems. The goal of this study was to identify clinical risk factors and other predictors for such long-term consequences in severely ill COVID-19 patients. Adult COVID-19 intensive care unit (ICU) survivors from August 2020 to May 2021 were enrolled. A broad range of clinical, laboratory and chest computed tomography (CT) data was collected during their ICU stays. The association between ICU predictors and psychosomatic, respiratory, and neurocognitive assessments 12 months after ICU discharge was analyzed using univariate regression analysis. In 17 patients (mean age 58.9 ± 11.4 years), laboratory markers (CRP, lymphocytes, hemoglobin), ICU severity (SOFA, SAPS II, need for mechanical ventilation), complications (ARDS), and lung CT data (ground-glass opacity) were promising predictors of depressive and anxiety symptoms, fatigue, and sleep problems. Recovery of psychosomatic health such as fatigue, depression, and anxiety correlated with lower levels of inflammation and high hemoglobin levels. ARDS, mechanical ventilation, and worse SOFA and SAPS II scores were further risk factors for depressive and anxiety symptoms. Our study identified novel associations such as pulmonary ground-glass opacity being positively associated with depression, anxiety, fatigue, and insomnia levels.
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- 2024
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25. Mortality and morbidity associated with new onset acute kidney injury in critically ill COVID-19 infection patients
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Nina Fischer, Xinfei Miao, Danielle Weck, Jacob Matalon, Cameron C. Neeki, Troy Pennington, Fanglong Dong, Sarkis Arabian, and Michael M. Neeki
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Acute renal injury ,Covid-19 ,Dialysis ,Chronic renal failure ,Mortality ,Medical emergencies. Critical care. Intensive care. First aid ,RC86-88.9 - Abstract
Abstract Background The recent global pandemic due to severe acute respiratory syndrome coronavirus-2 resulted in a high rate of multi-organ failure and mortality in a large patient population across the world. As such, a possible correlation between acute kidney injury (AKI) and increased mortality rate in these patients has been suggested in literature. Methods This is a two-year retrospective study of critically ill adult patients infected with COVID-19 that were admitted to the intensive care unit (ICU) on ventilatory support. Two groups of patients were identified in this study, those who were directly admitted to the ICU or those who were initially admitted to the Medical Floor and were later transferred to the ICU due to either worsening respiratory status or change in their hemodynamic conditions. Within each group, three subgroups were created based on the status of AKI, namely, those who did not develop AKI, those who developed AKI, and those who with previous history of dialysis dependent AKI. Results The AKI subgroup had the highest mortality rate in the ICU and Floor patients. Of note, those patients who were directly admitted to the Floor and were later transferred to the ICU for worsening conditions also experienced a higher mortality rate if they had developed AKI during their course of hospital stay. Conclusions This study identified a statistically significant higher mortality in patients who developed AKI than those who did not develop AKI among critically ill patients. Trial registration Clinicaltrials.gov registration number NCT05964088. Date of registration: July 24 2023.
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- 2024
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26. Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19
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Giganti, Mark J, Chew, Kara W, Eron, Joseph J, Li, Jonathan Z, Pinilla, Mauricio, Moser, Carlee, Javan, Arzhang Cyrus, Fischer, William A, Klekotka, Paul, Margolis, David, Wohl, David Alain, Coombs, Robert W, Daar, Eric S, Smith, Davey M, Currier, Judith S, Hughes, Michael D, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Greninger, Alexander, Degli-Angeli, Emily, Goecker, Erin, Daza, Glenda, Harb, Socorro, Dragavon, Joan, Aldrovandi, Grace, Murtaugh, William, Science, Frontier, Cooper, Marlene, Gutzman, Howard, Knowles, Kevin, Bowman, Rachel, Erhardt, Bill, Waring, Lorraine, Hessinger, Diane, and Adams, Stacey
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Emerging Infectious Diseases ,Coronaviruses ,Clinical Trials and Supportive Activities ,Infectious Diseases ,Good Health and Well Being ,Adult ,Humans ,Antibodies ,Monoclonal ,COVID-19 ,Hospitalization ,RNA ,Viral ,SARS-CoV-2 ,hospitalization ,outpatient ,SARS-CoV-2 RNA ,surrogate marker ,ACTIV-2/A5401 Study Team ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Biological sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundThere is little information regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA as a predictor for clinical outcomes in outpatients with mild-to-moderate coronavirus disease 2019 (COVID-19).MethodsAnterior nasal (AN) and plasma SARS-CoV-2 RNA data from 2115 nonhospitalized adults who received monoclonal antibodies (mAbs) or placebo in the ACTIV-2/A5401 trial were analyzed for associations with hospitalization or death.ResultsOne hundred two participants were hospitalized or died through 28 days of follow-up. Higher day 0 (pretreatment) AN RNA was associated with increasing risk of hospitalization/death (risk ratio [RR], 1.24 per log10 copies/mL [95% confidence interval {CI}, 1.04-1.49]) among placebo recipients, ranging from 3% to 16% for
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- 2023
27. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trialResearch in context
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Teresa H. Evering, Carlee Moser, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Kara W. Chew, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, William Fischer, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Prasanna Jagannathan, Alan Perelson, Sandy Pillay, Cynthia Riviere, Upinder Singh, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Verónica Lacal, Diego Salusso, Sebastian Nuñez, Marcelo Rodrigo Rodriguez, Luciana Laborde, Marcelo Papasidero, Luis Wehbe, Mariana Gonzalez, Felicitas Fernandez Voena, Tomas Alvarez, Amaru Lopez, Virginia Huhn, Ulises D'Andrea Nores, Pablo Dieser, Fernando Bordese, Marisa Mussi, Rodrigo de Carvalho Santana, Adriana Aparecida Tiraboschi Bárbaro, Breno Santos, Rita de Cássia Alves Lira, Andre Luiz Machado da Silva, Sandra Wagner Cardoso, Maria Pia Diniz Ribeiro, Nathália Soliva, Eduardo Vasconcellos, Jorge Eurico Ribeiro, Miriam Amaral Enéas, Jorge Pinto, Julia Fonseca de Morais Caporali, Flávia Gomes Faleiro Ferreira, Norma Erendira Rivera Martinez, Victor Casildo Bohorquez Lopez, Melchor Victor Frias, Krystle Fetalvero, Alyxzza Maranan, Jennifer Rosa, Thomas Coetzer, Maureen Mohata, Sr., Umesh Lalloo, Penelope Madlala, Larisha Pillay-Ramaya, Jaclyn Ann Bennet, Noluthando Mwelase, Nokuphiwa Mbhele, Frederick Petrick, Leonard Joubert, Rose Mbali, Sr., Natasha Joseph, Mmatsie Manentsa, Eugene van der Walt, Mduduzi Sandile Lawrance Masilela, Zinhle Zwane, Tendai Chiperera, Lerato Mohapi, Suri Moonsamy, Usha Singh, Kirsten McHarry, Elizma Snyman, Pieter Lennox, James Craig Innes, Oteng Letlape, Olebogeng Jonkane, William Brumskine, Tania Adonis, Ni Ni Sein, Modulakgotla Sebe, Yacoob Vahed, Nazreen Jeewa Hussen, Ismail Mitha, Vasundhara Cheekati, Purna Cheekati, Christie Lummus, Samuel Idarraga, Andrew Kim, David N. Pham, Wei-Hsin Kao, Michael M. Pfeffer, Miriam Batule Dominguez, Anju Malik, Anna Bryan, Melanie Arnold, Idania Fernandez, Cinzia Karpf, Aniuska Ruiz, David Taylor, Eric Folkens, Jennifer Manne, Sigal Yawetz, Cheryl Keenan, Emeka Eziri, Carl Fichtenbaum, Jenifer Baer, Sarah Trentman, Robert Call, Leroy Vaughan, Aaron Milstone, Jamie Alex Slandzicki, Jessica Wallan, Clinton Guillory, Nancy Andrews, Leslie Hughes, Jonathan Berardi, Celine Arar, Randall Quinn, Jorge P. Amaya, Marissa Gomez-Martinez, Luis Cantu, Monica Betancourt-Garcia, Nwora Lance Okeke, Charles M. Burns, Fadi Haddad, Victoria Haddad, Augusto Focil, Griselda Rosas, Susana Moyano, Yaneicy Gonzalez Rojas, Ahmad Aswad, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Humam Farah, Rebekah McClain, Sadia Shaik, Timothy Hatlen, Deepa Gotur, Joseph Surber, Jeffrey Kingsley, April Pixler, Alex Zopo, Jack Herman, Craig Herman, Ramon Leon, Boris Nikolov, Fernando Gonzalez Vergara, Ana I. Gonzalez, Noemi Gonzalez, Michael Gelman, Olga Andriunas, Zarema Jagizarov, Jan Westerman, David Davis, Donna Sherer, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Bharat Mocherla, Kelly Beck, Valarie Maldonado, Jennifer Veltman, Rajesh Gandhi, Katrina Shea, Matthew Planchon, Laura Bogan Herpel, Kaushlendra K. Tripathi, Donald C. Day, John Pullman, Sr., Erin Williams-Leber, Misty Johnson, Michelle Hecker, Ann Avery, Keila Hoover, George W. Monlux, Elizabeth Juneja, Jr., Arthur Wernick, Karelia Ruiz, Maureen Hernández, Yadilys Pérez, Babafemi O. Taiwo, Claudia Hawkins, Baiba Berzins, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Edwin DeJesus, Charlotte-Paige Rolle, Almena L. Free, Sallie D. Pulliam, Debra Weinstein, Rosa M. Suarez, Ezequiel Socorro, Estefania Socorro, Gene Neytman, Raymond Easley, Mariam Aziz, Joan Swiatek, Avish Nagpal, Breanna Kompelien, Kathryn McEvoy, Susan E. Hoover, Allison Lutz, Jessica Just, Manuel Hernandez, Yanly B. Victoria, Gabriel Rodriguez, Divya Pathak, Joshua J. Ordway, Megan Heffner, Patrick Weston, Khalilah Weston, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Brian Clemency, Renoj Varughese, Joshua Lynch, Aleen Khodabakhshian, Samantha Fortier, Christopher Coyne, Alexandrea Cronin, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mobeen Rathore, Saniyyah Mahmoudi, Amna Riaz, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Michael P. Dube, Saahir Khan, Luis M. Mendez, Sarah McGuffin, Chris Jonsson, Mamta K. Jain, Smruthi Senthil, Kimberly Turner-Gray, Sanjay Mehta, Mary Lewinski, Masoud Azizad, Christopher Chow, Lisa Nakatani, Derrick Williamson, Hisham Atriss, Matthew Caloura, Midhun Malla, Hannah Hazard-Jenkins, Aimee Wilkin, Jamraus Fayssoux, Hannah Seagle, Rachel Presti, and Alem Haile
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COVID-19 ,Monoclonal antibodies ,Outpatient treatment ,Clinical trial ,Post COVID conditions ,Long COVID ,Medicine (General) ,R5-920 - Abstract
Summary: Background: It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Methods: Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Findings: Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53–0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Interpretation: Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. Funding: National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.
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- 2024
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28. Comparative Aerosol and Surface Stability of SARS-CoV-2 Variants of Concern.
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Bushmaker, Trenton, Yinda, Claude, Morris, Dylan, Holbrook, Myndi, Gamble, Amandine, Adney, Danielle, Bushmaker, Cara, van Doremalen, Neeltje, Fischer, Robert, Plowright, Raina, Lloyd-Smith, James, and Munster, Vincent
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COVID-19 ,Omicron ,SARS-CoV-2 ,United States ,aerosol ,coronavirus disease ,environmental stability ,respiratory infections ,severe acute respiratory syndrome coronavirus 2 ,transmission ,variants of concern ,viruses ,zoonoses ,Humans ,SARS-CoV-2 ,COVID-19 ,Respiratory Aerosols and Droplets - Abstract
SARS-CoV-2 transmits principally by air; contact and fomite transmission may also occur. Variants of concern are more transmissible than ancestral SARS-CoV-2. We found indications of possible increased aerosol and surface stability for early variants of concern, but not for the Delta and Omicron variants. Stability changes are unlikely to explain increased transmissibility.
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- 2023
29. Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19
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Evering, Teresa H, Chew, Kara W, Giganti, Mark J, Moser, Carlee, Pinilla, Mauricio, Wohl, David Alain, Currier, Judith S, Eron, Joseph J, Javan, Arzhang Cyrus, Bender Ignacio, Rachel, Margolis, David, Zhu, Qing, Ma, Ji, Zhong, Lijie, Yan, Li, D’Andrea Nores, Ulises, Hoover, Keila, Mocherla, Bharat, Choudhary, Manish C, Deo, Rinki, Ritz, Justin, Fischer, William A, Fletcher, Courtney V, Li, Jonathan Z, Hughes, Michael D, Smith, Davey, Daar, Eric S, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Cardoso, Sandra, Corado, Katya, Jagannathan, Prasanna, Jilg, Nikolaus, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Singh, Upinder, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, Shahkolahi, Akbar, Lacal, Verónica, Salusso, Diego, Nuñez, Sebastian, Rodrigo Rodriguez, Marcelo, Laborde, Luciana, Papasidero, Marcelo, Wehbe, Luis, Gonzalez, Mariana, Fernandez Voena, Felicitas, Alvarez, Tomas, Lopez, Amaru, Huhn, Virginia, Dieser, Pablo, Bordese, Fernando, Mussi, Marisa, de Carvalho Santana, Rodrigo, Bárbaro, Adriana Aparecida Tiraboschi, Santos, Breno, de Cássia Alves Lira, Rita, da Silva, Andre Luiz Machado, Ribeiro, Maria Pia Diniz, Soliva, Nathália, Vasconcellos, Eduardo, Ribeiro, Jorge Eurico, Enéas, Miriam Amaral, and Pinto, Jorge
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Patient Safety ,Infectious Diseases ,Clinical Trials and Supportive Activities ,Vaccine Related ,Lung ,Emerging Infectious Diseases ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Good Health and Well Being ,Adult ,Humans ,Female ,Middle Aged ,Male ,COVID-19 ,SARS-CoV-2 ,Antibodies ,Monoclonal ,Antibodies ,Viral ,Double-Blind Method ,ACTIV-2/A5401 Study Team ,Medical and Health Sciences ,General & Internal Medicine ,Clinical sciences - Abstract
BackgroundDevelopment of safe and effective SARS-CoV-2 therapeutics is a high priority. Amubarvimab and romlusevimab are noncompeting anti-SARS-CoV-2 monoclonal antibodies with an extended half-life.ObjectiveTo assess the safety and efficacy of amubarvimab plus romlusevimab.DesignRandomized, placebo-controlled, phase 2 and 3 platform trial. (ClinicalTrials.gov: NCT04518410).SettingNonhospitalized patients with COVID-19 in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines.PatientsAdults within 10 days onset of symptomatic SARS-CoV-2 infection who are at high risk for clinical progression.InterventionCombination of monoclonal antibodies amubarvimab plus romlusevimab or placebo.MeasurementsNasopharyngeal and anterior nasal swabs for SARS-CoV-2, COVID-19 symptoms, safety, and progression to hospitalization or death.ResultsEight-hundred and seven participants who initiated the study intervention were included in the phase 3 analysis. Median age was 49 years (quartiles, 39 to 58); 51% were female, 18% were Black, and 50% were Hispanic or Latino. Median time from symptom onset at study entry was 6 days (quartiles, 4 to 7). Hospitalizations and/or death occurred in 9 (2.3%) participants in the amubarvimab plus romlusevimab group compared with 44 (10.7%) in the placebo group, with an estimated 79% reduction in events (P
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- 2023
30. Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection
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Deo, Rinki, Choudhary, Manish C, Moser, Carlee, Ritz, Justin, Daar, Eric S, Wohl, David A, Greninger, Alexander L, Eron, Joseph J, Currier, Judith S, Hughes, Michael D, Smith, Davey M, Chew, Kara W, Li, Jonathan Z, Javan, Arzhang Cyrus, Giganti, Mark, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Fletcher, Courtney, Fischer, William, Evering, Teresa, Ignacio, Rachel Bender, Cardoso, Sandra, Corado, Katya, Jagannathan, Prasanna, Jilg, Nikolaus, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Singh, Upinder, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, and Shahkolahi, Akbar
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Biomedical and Clinical Sciences ,Clinical Sciences ,Emerging Infectious Diseases ,Clinical Trials and Supportive Activities ,Clinical Research ,Brain Disorders ,Infectious Diseases ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Good Health and Well Being ,Humans ,COVID-19 ,SARS-CoV-2 ,Retrospective Studies ,RNA ,Viral ,ACTIV-2/A5401 Study Team ,Medical and Health Sciences ,General & Internal Medicine ,Clinical sciences - Abstract
BackgroundAlthough symptom and viral rebound have been reported after nirmatrelvir-ritonavir treatment, the trajectories of symptoms and viral load during the natural course of COVID-19 have not been well described.ObjectiveTo characterize symptom and viral rebound in untreated outpatients with mild to moderate COVID-19.DesignRetrospective analysis of participants in a randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT04518410).SettingMulticenter trial.Patients563 participants receiving placebo in the ACTIV-2/A5401 (Adaptive Platform Treatment Trial for Outpatients With COVID-19) platform trial.MeasurementsParticipants recorded the severity of 13 symptoms daily between days 0 and 28. Nasal swabs were collected for SARS-CoV-2 RNA testing on days 0 to 14, 21, and 28. Symptom rebound was defined as a 4-point increase in total symptom score after improvement any time after study entry. Viral rebound was defined as an increase of at least 0.5 log10 RNA copies/mL from the immediately preceding time point to a viral load of 3.0 log10 copies/mL or higher. High-level viral rebound was defined as an increase of at least 0.5 log10 RNA copies/mL to a viral load of 5.0 log10 copies/mL or higher.ResultsSymptom rebound was identified in 26% of participants at a median of 11 days after initial symptom onset. Viral rebound was detected in 31% and high-level viral rebound in 13% of participants. Most symptom and viral rebound events were transient, because 89% of symptom rebound and 95% of viral rebound events occurred at only a single time point before improving. The combination of symptom and high-level viral rebound was observed in 3% of participants.LimitationA largely unvaccinated population infected with pre-Omicron variants was evaluated.ConclusionSymptom or viral relapse in the absence of antiviral treatment is common, but the combination of symptom and viral rebound is rare.Primary funding sourceNational Institute of Allergy and Infectious Diseases.
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- 2023
31. Learning to spend time in unusual times: An inquiry into the potential for sustainability learning during COVID-19-induced school closures
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Grauer, Claire, Frank, Pascal, and Fischer, Daniel
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- 2023
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32. Estimated public health impact of concurrent mask mandate and vaccinate-or-test requirement in Illinois, October to December 2021
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François M. Castonguay, Arti Barnes, Seonghye Jeon, Jane Fornoff, Bishwa B. Adhikari, Leah S. Fischer, Bradford Greening, Adebola O. Hassan, Emily B. Kahn, Gloria J. Kang, Judy Kauerauf, Sarah Patrick, Sameer Vohra, and Martin I. Meltzer
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Masks ,Vaccines ,Cases and hospitalizations averted ,COVID-19 ,Modeling ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Facing a surge of COVID-19 cases in late August 2021, the U.S. state of Illinois re-enacted its COVID-19 mask mandate for the general public and issued a requirement for workers in certain professions to be vaccinated against COVID-19 or undergo weekly testing. The mask mandate required any individual, regardless of their vaccination status, to wear a well-fitting mask in an indoor setting. Methods We used Illinois Department of Public Health’s COVID-19 confirmed case and vaccination data and investigated scenarios where masking and vaccination would have been reduced to mimic what would have happened had the mask mandate or vaccine requirement not been put in place. The study examined a range of potential reductions in masking and vaccination mimicking potential scenarios had the mask mandate or vaccine requirement not been enacted. We estimated COVID-19 cases and hospitalizations averted by changes in masking and vaccination during the period covering October 20 to December 20, 2021. Results We find that the announcement and implementation of a mask mandate are likely to correlate with a strong protective effect at reducing COVID-19 burden and the announcement of a vaccinate-or-test requirement among frontline professionals is likely to correlate with a more modest protective effect at reducing COVID-19 burden. In our most conservative scenario, we estimated that from the period of October 20 to December 20, 2021, the mask mandate likely prevented approximately 58,000 cases and 1,175 hospitalizations, while the vaccinate-or-test requirement may have prevented at most approximately 24,000 cases and 475 hospitalizations. Conclusion Our results indicate that mask mandates and vaccine-or-test requirements are vital in mitigating the burden of COVID-19 during surges of the virus.
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- 2024
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33. The UCSC Genome Browser database: 2023 update
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Nassar, Luis R, Barber, Galt P, Benet-Pagès, Anna, Casper, Jonathan, Clawson, Hiram, Diekhans, Mark, Fischer, Clay, Gonzalez, Jairo Navarro, Hinrichs, Angie S, Lee, Brian T, Lee, Christopher M, Muthuraman, Pranav, Nguy, Beagan, Pereira, Tiana, Nejad, Parisa, Perez, Gerardo, Raney, Brian J, Schmelter, Daniel, Speir, Matthew L, Wick, Brittney D, Zweig, Ann S, Haussler, David, Kuhn, Robert M, Haeussler, Maximilian, and Kent, W James
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Biological Sciences ,Bioinformatics and Computational Biology ,Genetics ,Biotechnology ,Networking and Information Technology R&D (NITRD) ,Human Genome ,1.5 Resources and infrastructure (underpinning) ,2.6 Resources and infrastructure (aetiology) ,Humans ,COVID-19 ,Databases ,Genetic ,Genomics ,Internet ,Phylogeny ,SARS-CoV-2 ,Software ,Web Browser ,Environmental Sciences ,Information and Computing Sciences ,Developmental Biology ,Biological sciences ,Chemical sciences ,Environmental sciences - Abstract
The UCSC Genome Browser (https://genome.ucsc.edu) is an omics data consolidator, graphical viewer, and general bioinformatics resource that continues to serve the community as it enters its 23rd year. This year has seen an emphasis in clinical data, with new tracks and an expanded Recommended Track Sets feature on hg38 as well as the addition of a single cell track group. SARS-CoV-2 continues to remain a focus, with regular annotation updates to the browser and continued curation of our phylogenetic sequence placing tool, hgPhyloPlace, whose tree has now reached over 12M sequences. Our GenArk resource has also grown, offering over 2500 hubs and a system for users to request any absent assemblies. We have expanded our bigBarChart display type and created new ways to visualize data via bigRmsk and dynseq display. Displaying custom annotations is now easier due to our chromAlias system which eliminates the requirement for renaming sequence names to the UCSC standard. Users involved in data generation may also be interested in our new tools and trackDb settings which facilitate the creation and display of their custom annotations.
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- 2023
34. Survey on Management of Unilateral Axillary Lymphadenopathy after Recent Ipsilateral COVID-19 Vaccination
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Wilsen, Craig B, Ikeda, Debra M, Ojeda-Fournier, Haydee, Hovanessian Larsen, Linda J, Trinh, Long, Joe, Bonnie N, Fischer, Cheryce P, Sheth, Pulin A, Sohlich, Rita E, Rosen, Eric L, Downey, John R, Aminololama-Shakeri, Shadi, Yamashita, Mary W, Tsai, Irene S, and Chalfant, James S
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lymphadenopathy ,vaccination ,breast imaging ,COVID-19 - Abstract
Background: In the setting of widespread COVID-19 vaccination and booster administration, there is an increased incidence of axillary lymphadenopathy identified during breast imaging.Purpose: To investigate how breast imaging radiologists manage unilateral axillary lymphadenopathy (UAL) after a recent ipsilateral COVID-19 vaccination.Methods: A 26-question survey was distributed to 12 California breast imaging facilities in June 2022. Results: There were 10 responses to the survey (83% response rate). All respondents considered recent ipsilateral COVID-19 vaccination relevant to the interpretation of UAL. Seven respondents (70%) also considered non-COVID-19 vaccinations relevant. All respondents documented recent COVID-19 vaccinations, but 4 (40%) had no information for other vaccines. Eight respondents (80%) delayed screening after COVID-19 vaccination during initial vaccination efforts, and 3 (30%) still required or suggested delaying screening at the time of the survey. Breast Imaging Reporting and Data System (BI-RADS) categorization for UAL with no abnormal findings in the ipsilateral breast varied by facility and modality. BI-RADS categorization for UAL previously assigned to BI-RADS 0 or associated with suspicious ipsilateral breast findings varied, but practices tended to demonstrate a high level of suspicion unless the UAL showed improvement on follow-up imaging. For unchanged UAL on initial follow-up, 7 (70%) assign BI-RADS 3, and 3 (30%) assign BI-RADS 4.Conclusion: Despite available guidelines, there was no consensus approach to managing UAL after vaccination among academic and community-based breast imaging radiologists in California. Management was more uniform for a subset of patients perceived to be at higher risk for lymph node metastases, with most or all respondents recommending biopsy when there was a suspicious finding in the ipsilateral breast, concurrent ipsilateral breast cancer, or concurrent malignant tumors not in the breast known to metastasize to the axilla.
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- 2023
35. Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design
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Horwitz, Leora I, Thaweethai, Tanayott, Brosnahan, Shari B, Cicek, Mine S, Fitzgerald, Megan L, Goldman, Jason D, Hess, Rachel, Hodder, SL, Jacoby, Vanessa L, Jordan, Michael R, Krishnan, Jerry A, Laiyemo, Adeyinka O, Metz, Torri D, Nichols, Lauren, Patzer, Rachel E, Sekar, Anisha, Singer, Nora G, Stiles, Lauren E, Taylor, Barbara S, Ahmed, Shifa, Algren, Heather A, Anglin, Khamal, Aponte-Soto, Lisa, Ashktorab, Hassan, Bassett, Ingrid V, Bedi, Brahmchetna, Bhadelia, Nahid, Bime, Christian, Bind, Marie-Abele C, Black, Lora J, Blomkalns, Andra L, Brim, Hassan, Castro, Mario, Chan, James, Charney, Alexander W, Chen, Benjamin K, Chen, Li Qing, Chen, Peter, Chestek, David, Chibnik, Lori B, Chow, Dominic C, Chu, Helen Y, Clifton, Rebecca G, Collins, Shelby, Costantine, Maged M, Cribbs, Sushma K, Deeks, Steven G, Dickinson, John D, Donohue, Sarah E, Durstenfeld, Matthew S, Emery, Ivette F, Erlandson, Kristine M, Facelli, Julio C, Farah-Abraham, Rachael, Finn, Aloke V, Fischer, Melinda S, Flaherman, Valerie J, Fleurimont, Judes, Fonseca, Vivian, Gallagher, Emily J, Gander, Jennifer C, Gennaro, Maria Laura, Gibson, Kelly S, Go, Minjoung, Goodman, Steven N, Granger, Joey P, Greenway, Frank L, Hafner, John W, Han, Jenny E, Harkins, Michelle S, Hauser, Kristine SP, Heath, James R, Hernandez, Carla R, Ho, On, Hoffman, Matthew K, Hoover, Susan E, Horowitz, Carol R, Hsu, Harvey, Hsue, Priscilla Y, Hughes, Brenna L, Jagannathan, Prasanna, James, Judith A, John, Janice, Jolley, Sarah, Judd, SE, Juskowich, Joy J, Kanjilal, Diane G, Karlson, Elizabeth W, Katz, Stuart D, Kelly, J Daniel, Kelly, Sara W, Kim, Arthur Y, Kirwan, John P, Knox, Kenneth S, Kumar, Andre, Lamendola-Essel, Michelle F, Lanca, Margaret, Lee-Lannotti, Joyce K, Lefebvre, R Craig, and Levy, Bruce D
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Coronaviruses ,Infectious Diseases ,Clinical Research ,Emerging Infectious Diseases ,2.1 Biological and endogenous factors ,Infection ,Good Health and Well Being ,Humans ,COVID-19 ,Observational Studies as Topic ,Post-Acute COVID-19 Syndrome ,Prospective Studies ,Retrospective Studies ,SARS-CoV-2 ,Adolescent ,Adult ,Multicenter Studies as Topic ,General Science & Technology - Abstract
ImportanceSARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis.MethodsRECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms.DiscussionRECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.RegistrationNCT05172024.
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- 2023
36. Exploring individual's public trust in the NHS Test and Trace System – A pragmatic reflexive thematic analysis
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C.M. Babbage, H. Wagner, L. Dowthwaite, V. Portillo, E. Perez, and J. Fischer
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COVID-19 ,Digital contact tracing ,Public trust ,Reflexive thematic analysis ,Responsible research and innovation ,Patient and public involvement ,Information technology ,T58.5-58.64 ,Psychology ,BF1-990 - Abstract
Context: Digital contact tracing uses automated systems and location technology embedded on smartphone software for efficient identification of individuals exposed to COVID-19. Such systems are only effective with high compliance, yet compliance is mediated by public trust in the system. This work explored the perception of individual's trust and expectation of the broader Test and Trace system in the United Kingdom (UK) with the upcoming release of the National Health Service's (NHS) COVID-19 app as a case example. Methods: Twelve adults underwent online semi-structured interviews in August 2020, prior to public availability of the COVID-19 app. Pragmatic reflexive thematic analysis was applied inductively to explore common themes between participants, using an organic and recursive process (Braun & Clarke, 2019). Results: Themes highlighted features of the technology that would be perceived to be trustworthy (Theme 1), and concerns relating to i) whether users would comply with a T&T system (Theme 2) and ii) how a T&T system would handle user's personal data (Theme 3). Two further themes built on aspects of automation within a T&T system and its impact on trust (Theme 4) and how the media altered perceptions of the T&T system (Theme 5). Conclusions: Participants outlined the need for different user requirements that could be built into the NHS COVID-19 app that would support increased adherence. Concurrently, participants raised questions surrounding personal data and privacy of their data, plus the level of automated versus manual tasks, which impacted perception of trust in the app and wider system. Additionally, themes highlighted that T&T systems do not happen within a vacuum, but within a pre-existing environment influenced by variables such as the media and perception of other's compliance to T&T. Implications: Since it's roll-out, controversies surrounding the UK T&T system include concerns about privacy, stigma and uptake. Considering the current piece of work, which anticipated similar concerns prior to public access to COVID-19 app, engaging with the public may have been an important step in improving the perception and compliance with the app. Principles fundamental to patient and public involvement (PPI) and Responsible Research and Innovation (RRI) such as the inclusion of the public in the early development of research and aligning the outcomes of research and innovation with broader societal values and expectations would have been well-applied to this system and should be applied to future autonomous systems requiring high public uptake.
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- 2024
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37. Deaths in Immigration and Customs Enforcement (ICE) detention: A Fiscal Year (FY) 2021–2023 update
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Cara Buchanan, Sameer Ahmed, Joseph Nwadiuko, Annette M. Dekker, Amy Zeidan, Eva Bitrán, Thomas Urich, Briah Fischer, Elizabeth R.E. Burner, Parveen Parmar, and Sophie Terp
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immigration detention ,immigration health ,covid-19 ,correctional health ,public health ,Public aspects of medicine ,RA1-1270 - Abstract
Background: This study describes the deaths of individuals in Immigration and Customs Enforcement (ICE) detention between FY2021–2023, updating a report from FY2018–2020, which identified an increased death rate amidst the COVID-19 pandemic. Methods: Data was extracted from death reports published online by ICE. Causes of deaths were recorded, and death rates per 100,000 admissions were calculated using population statistics reported by ICE. Reports of individuals released from ICE custody just prior to death were also identified and described. Results: There were 12 deaths reported from FY2021–2023, compared to 38 deaths from FY2018–2020. The death rate per 100,000 admissions in ICE detention was 3.251 in FY2021, 0.939 in FY2022, and 1.457 in FY2023, compared with a pandemic-era high of 10.833 in FY2020. Suicide caused 1 of 12 (8.3%) deaths in FY2021–2023 compared with 9 of 38 (23.7%) deaths in FY2018–2020. COVID-19 was contributory in 3 of 11 (25%) medical deaths in FY2021–2023, compared with 8 of 11 (72.7%) in the COVID-era months of FY2020 (p = 0.030). Overall, 4 of 11 (36.3%) medical deaths in FY2021–2023 resulted from cardiac arrest in detention facilities, compared with 6 of 29 (20.3%) in FY2018–2020. Three deaths of hospitalized individuals released from ICE custody with grave prognoses were identified. Conclusions: The death rate among individuals in ICE custody decreased in FY2021–2023, which may be explained in part by the release of vulnerable individuals following recent federal legal determinations (e.g., Fraihat v. ICE). Identification of medically complex individuals released from ICE custody just prior to death and not reported by ICE indicates that reported deaths underestimate total deaths associated with ICE detention. Attentive monitoring of mortality outcomes following release from ICE custody is warranted.
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- 2024
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38. Adapting COVID-19 Contact Tracing Protocols to Accommodate Resource Constraints, Philadelphia, Pennsylvania, USA, 2021
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Seonghye Jeon, Lydia Watson-Lewis, Gabriel Rainisch, Chu-Chuan Chiu, François M. Castonguay, Leah S. Fischer, Patrick K. Moonan, John E. Oeltmann, Bishwa B. Adhikari, Hannah Lawman, and Martin I. Meltzer
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COVID-19 ,contact tracing ,cases averted ,resource efficiency ,staff hours ,coronavirus disease ,Medicine ,Infectious and parasitic diseases ,RC109-216 - Abstract
Because of constrained personnel time, the Philadelphia Department of Public Health (Philadelphia, PA, USA) adjusted its COVID-19 contact tracing protocol in summer 2021 by prioritizing recent cases and limiting staff time per case. This action reduced required staff hours to prevent each case from 21–30 to 8–11 hours, while maintaining program effectiveness.
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- 2024
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39. Third dose of the BNT162b2 vaccine in cardiothoracic transplant recipients: predictive factors for humoral response
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Costard-Jäckle, Angelika, Schramm, René, Fischer, Bastian, Rivinius, Rasmus, Bruno, Raphael, Müller, Benjamin, Zittermann, Armin, Boeken, Udo, Westenfeld, Ralf, Knabbe, Cornelius, and Gummert, Jan
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- 2023
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40. Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection
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Boucau, Julie, Chew, Kara W, Choudhary, Manish C, Deo, Rinki, Regan, James, Flynn, James P, Crain, Charles R, Hughes, Michael D, Ritz, Justin, Moser, Carlee, Dragavon, Joan A, Javan, Arzhang C, Nirula, Ajay, Klekotka, Paul, Greninger, Alexander L, Coombs, Robert W, Fischer, William A, Daar, Eric S, Wohl, David A, Eron, Joseph J, Currier, Judith S, Smith, Davey M, team, the POSITIVES study, Li, Jonathan Z, Barczak, Amy K, and Team, the ACTIV-2 A5401 Study
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Research ,Infectious Diseases ,Vaccine Related ,Biodefense ,Biotechnology ,Lung ,Immunization ,Prevention ,Emerging Infectious Diseases ,Pneumonia ,Pneumonia & Influenza ,Clinical Trials and Supportive Activities ,Infection ,Good Health and Well Being ,Antibodies ,Monoclonal ,Antibodies ,Monoclonal ,Humanized ,Antibodies ,Neutralizing ,Humans ,SARS-CoV-2 ,COVID-19 Drug Treatment ,POSITIVES study team ,ACTIV-2/A5401 Study Team ,COVID ,COVID therapies ,COVID-19 ,mAbs ,monoclonal antibodies ,resistance ,viral culture ,Biomedical and clinical sciences - Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies (mAbs) are among the treatments recommended for high-risk ambulatory persons with coronavirus 2019 (COVID-19). Here, we study viral culture dynamics post-treatment in a subset of participants receiving the mAb bamlanivimab in the ACTIV-2 trial (ClinicalTrials.gov: NCT04518410). Viral load by qPCR and viral culture are performed from anterior nasal swabs collected on study days 0 (day of treatment), 1, 2, 3, and 7. Treatment with mAbs results in rapid clearance of culturable virus. One day after treatment, 0 of 28 (0%) participants receiving mAbs and 16 of 39 (41%) receiving placebo still have culturable virus (p
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- 2022
41. Risk of subsequent lower respiratory tract infection (LRTI) after hospitalization for COVID-19 LRTI and non-COVID-19 LRTI: a retrospective cohort study
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Bruxvoort, Katia J., Fischer, Heidi, Lewnard, Joseph A., Hong, Vennis X., Pomichowski, Magdalena, Grant, Lindsay R., Jódar, Luis, Gessner, Bradford D., and Tartof, Sara Y.
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- 2023
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42. Different COVID-19 treatments’ impact on hospital length of stay
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Iwamoto, Satori, Muhar, Bahaar Kaur, Chen, Hao, Chu, Harrison, Johnstone, Mason, Sidhu, Ashwin, Chu, Hillary, Fischer, Joseph, and Chu, Gary
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- 2023
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43. High titers of neutralizing SARS-CoV-2 antibodies six months after symptom onset are associated with increased severity in COVID-19 hospitalized patients
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Sejdic, Adin, Frische, Anders, Jørgensen, Charlotte Sværke, Rasmussen, Lasse Dam, Trebbien, Ramona, Dungu, Arnold, Holler, Jon G., Ostrowski, Sisse Rye, Eriksson, Robert, Søborg, Christian, Nielsen, Thyge L., Fischer, Thea K., Lindegaard, Birgitte, Franck, Kristina Træholt, and Harboe, Zitta Barrella
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- 2023
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44. Standing the test of COVID-19: charting the new frontiers of medicine
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Simon Cauchemez, Giulio Cossu, Nathalie Delzenne, Eran Elinav, Didier Fassin, Alain Fischer, Thomas Hartung, Dipak Kalra, Mihai Netea, Johan Neyts, Rino Rappuoli, Mariagrazia Pizza, Melanie Saville, Pamela Tenaerts, Gerry Wright, Philippe Sansonetti, and Michel Goldman
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COVID-19 ,precision medicine ,public health ,digital health ,clinical trial ,pandemic ,Science - Abstract
The COVID-19 pandemic accelerated research and innovation across numerous fields of medicine. It emphasized how disease concepts must reflect dynamic and heterogeneous interrelationships between physical characteristics, genetics, co-morbidities, environmental exposures, and socioeconomic determinants of health throughout life. This article explores how scientists and other stakeholders must collaborate in novel, interdisciplinary ways at these new frontiers of medicine, focusing on communicable diseases, precision/personalized medicine, systems medicine, and data science. The pandemic highlighted the critical protective role of vaccines against current and emerging threats. Radical efficiency gains in vaccine development (through mRNA technologies, public and private investment, and regulatory measures) must be leveraged in the future together with continued innovation in the area of monoclonal antibodies, novel antimicrobials, and multisectoral, international action against communicable diseases. Inter-individual heterogeneity in the pathophysiology of COVID-19 prompted the development of targeted therapeutics. Beyond COVID-19, medicine will become increasingly personalized via advanced omics-based technologies and systems biology—for example targeting the role of the gut microbiome and specific mechanisms underlying immunoinflammatory diseases and genetic conditions. Modeling proved critical to strengthening risk assessment and supporting COVID-19 decision-making. Advanced computational analytics and artificial intelligence (AI) may help integrate epidemic modeling, clinical features, genomics, immune factors, microbiome data, and other anthropometric measures into a “systems medicine” approach. The pandemic also accelerated digital medicine, giving telehealth and digital therapeutics critical roles in health system resilience and patient care. New research methods employed during COVID-19, including decentralized trials, could benefit evidence generation and decision-making more widely. In conclusion, the future of medicine will be shaped by interdisciplinary multistakeholder collaborations that address complex molecular, clinical, and social interrelationships, fostering precision medicine while improving public health. Open science, innovative partnerships, and patient-centricity will be key to success.
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- 2024
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45. Decoding the historical tale: COVID-19 impact on haematological malignancy patients—EPICOVIDEHA insights from 2020 to 2022Research in context
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Jon Salmanton-García, Francesco Marchesi, Francesca Farina, Barbora Weinbergerová, Federico Itri, Julio Dávila-Valls, Sonia Martín-Pérez, Andreas Glenthøj, Ditte Stampe Hersby, Maria Gomes da Silva, Raquel Nunes Rodrigues, Alberto López-García, Raúl Córdoba, Yavuz M. Bilgin, Iker Falces-Romero, Shaimaa El-Ashwah, Ziad Emarah, Caroline Besson, Milena Kohn, Jaap Van Doesum, Emanuele Ammatuna, Monia Marchetti, Jorge Labrador, Giovanni Paolo Maria Zambrotta, Luisa Verga, Ozren Jaksic, Marcio Nucci, Klára Piukovics, Alba Cabirta-Touzón, Moraima Jiménez, Elena Arellano, Ildefonso Espigado, Ola Blennow, Anna Nordlander, Stef Meers, Jens van Praet, Tommaso Francesco Aiello, Carolina Garcia-Vidal, Nicola Fracchiolla, Mariarita Sciumè, Guldane Cengiz Seval, Pavel Žák, Caterina Buquicchio, Carlo Tascini, Stefanie K. Gräfe, Martin Schönlein, Tatjana Adžić-Vukičević, Valentina Bonuomo, Chiara Cattaneo, Summiya Nizamuddin, Martin Čerňan, Gaëtan Plantefeve, Romane Prin, Tomas Szotkovski, Graham P. Collins, Michelina Dargenio, Verena Petzer, Dominik Wolf, Natasha Čolović, Lucia Prezioso, Toni Valković, Francesco Passamonti, Gustavo-Adolfo Méndez, Uluhan Sili, Antonio Vena, Martina Bavastro, Alessandro Limongelli, Rafael F. Duarte, Marie-Pierre Ledoux, Milche Cvetanoski, Zlate Stojanoski, Marina Machado, Josip Batinić, Gabriele Magliano, Monika M. Biernat, Nikola Pantić, Christian Bjørn Poulsen, Annarosa Cuccaro, Maria Ilaria Del Principe, Austin Kulasekararaj, Irati Ormazabal-Vélez, Alessandro Busca, Fatih Demirkan, Marriyam Ijaz, Nikolai Klimko, Igor Stoma, Sofya Khostelidi, Noemí Fernández, Ali S. Omrani, Rui Bergantim, Nick De Jonge, Guillemette Fouquet, Milan Navrátil, Ghaith Abu-Zeinah, Michail Samarkos, Johan Maertens, Cristina De Ramón, Anna Guidetti, Ferenc Magyari, Tomás José González-López, Tobias Lahmer, Olimpia Finizio, Natasha Ali, László Imre Pinczés, Esperanza Lavilla-Rubira, Alessandra Romano, Maria Merelli, Mario Delia, Maria Calbacho, Joseph Meletiadis, Darko Antić, José-Ángel Hernández-Rivas, Joyce Marques de Almeida, Murtadha Al-Khabori, Martin Hoenigl, Maria Chiara Tisi, Nina Khanna, Aleksandra Barać, Noha Eisa, Roberta Di Blasi, Raphaël Liévin, Carolina Miranda-Castillo, Nathan C. Bahr, Sylvain Lamure, Mario Virgilio Papa, Ayel Yahya, Avinash Aujayeb, Jan Novák, Nurettin Erben, María Fernández-Galán, José-María Ribera-Santa Susana, Ikhwan Rinaldi, Rita Fazzi, Monica Piedimonte, Rémy Duléry, Yung Gonzaga, Andrés Soto-Silva, Giuseppe Sapienza, Alexandra Serris, Ľuboš Drgoňa, Ana Groh, Laura Serrano, Eleni Gavriilaki, Athanasios Tragiannidis, Juergen Prattes, Nicola Coppola, Vladimir Otašević, Miloš Mladenović, Mirjana Mitrović, Bojana Mišković, Pavel Jindra, Sofia Zompi, Maria Vittoria Sacchi, Carolin Krekeler, Maria Stefania Infante, Daniel García-Bordallo, Gökçe Melis Çolak, Jiří Mayer, Marietta Nygaard, Michaela Hanáková, Zdeněk Ráčil, Matteo Bonanni, Philipp Koehler, Laman Rahimli, Oliver A. Cornely, Livio Pagano, Francisco Javier Martín-Vallejo, Przemyslaw Zdziarski, Hossein Zarrinfer, Jana Wittig, Sein Win, Vivien Wai-Man, Benjamín Víšek, Donald C. Vinh, Maria Vehreschild, Gina Varricchio, Panagiotis Tsirigotis, Ana Torres-Tienza, Alina Daniela Tanase, Agostino Tafuri, Maria Stamouli, Jiří Sramek, Carole Soussain, Ayten Shirinova, Jörg Schubert, Enrico Schalk, Mohammad Reza Salehi, Modar Saleh, Giorgio Rosati, Elisa Roldán, Florian Reizine, Mayara Rêgo, Isabel Regalado-Artamendi, Marina Popova, Fernando Pinto, Laure Philippe, Hans Martin Orth, Hans-Beier Ommen, Aleš Obr, Lucía Núñez-Martín-Buitrago, Nicolas Noël, Julia Neuhann, Gianpaolo Nadali, Julia A. Nacov, Ana M. Munhoz Alburquerque, Maria Enza Mitra, Malgorzata Mikulska, Sibylle Mellinghoff, Ben Mechtel, Juan-Alberto Martín-González, Sandra Malak, Jorge Loureiro-Amigo, Lisset Lorenzo De La Peña, Giulia Liberti, Marianne Landau, Ira Lacej, Martin Kolditz, Chi Shan Kho, Reham Abdelaziz Khedr, Meinolf Karthaus, Linda Katharina Karlsson, María-Josefa Jiménez-Lorenzo, Macarena Izuzquiza, Baerbel Hoell-Neugebauer, Raoul Herbrecht, Christopher H. Heath, Fabio Guolo, Jan Grothe, Antonio Giordano, Sergey Gerasymchuk, Ramón García-Sanz, Nicole García-Poutón, Vaneuza Araújo Moreira Funke, Monica Fung, Charlotte Flasshove, Luana Fianchi, Jenna Essame, Matthias Egger, Bernard Drenou, Giulia Dragonetti, Maximilian Desole, Roberta Della Pepa, Bénédicte Deau Fischer, Elizabeth De Kort, Erik De Cabo, François Danion, Etienne Daguindau, Tania Cushion, Louise Cremer, Marianna Criscuolo, Gregorio Cordini, Antonella Cingolani, Fabio Ciceri, Fazle Rabbi Chowdhury, Ekaterina Chelysheva, Adrien Chauchet, Louis Yi Ann Chai, M. Mansour Ceesay, Elena Busch, Mathias Brehon, Davimar M.M. Borducchi, Stephen Booth, Serge Bologna, Caroline Berg Venemyr, Rebeca Bailén-Almorox, Anastasia Antoniadou, Amalia N. Anastasopoulou, and Fevzi Altuntaş
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Vaccination ,ICU ,COVID-19 ,Haematological malignancy ,Immunosuppression ,Medicine (General) ,R5-920 - Abstract
Summary: Background: The COVID-19 pandemic heightened risks for individuals with hematological malignancies due to compromised immune systems, leading to more severe outcomes and increased mortality. While interventions like vaccines, targeted antivirals, and monoclonal antibodies have been effective for the general population, their benefits for these patients may not be as pronounced. Methods: The EPICOVIDEHA registry (National Clinical Trials Identifier, NCT04733729) gathers COVID-19 data from hematological malignancy patients since the pandemic's start worldwide. It spans various global locations, allowing comprehensive analysis over the first three years (2020–2022). Findings: The EPICOVIDEHA registry collected data from January 2020 to December 2022, involving 8767 COVID-19 cases in hematological malignancy patients from 152 centers across 41 countries, with 42% being female. Over this period, there was a significant reduction in critical infections and an overall decrease in mortality from 29% to 4%. However, hospitalization, particularly in the ICU, remained associated with higher mortality rates. Factors contributing to increased mortality included age, multiple comorbidities, active malignancy at COVID-19 onset, pulmonary symptoms, and hospitalization. On the positive side, vaccination with one to two doses or three or more doses, as well as encountering COVID-19 in 2022, were associated with improved survival. Interpretation: Patients with hematological malignancies still face elevated risks, despite reductions in critical infections and overall mortality rates over time. Hospitalization, especially in ICUs, remains a significant concern. The study underscores the importance of vaccination and the timing of COVID-19 exposure in 2022 for enhanced survival in this patient group. Ongoing monitoring and targeted interventions are essential to support this vulnerable population, emphasizing the critical role of timely diagnosis and prompt treatment in preventing severe COVID-19 cases. Funding: Not applicable.
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- 2024
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46. Changes to Peroxyacyl Nitrates (PANs) Over Megacities in Response to COVID‐19 Tropospheric NO2 Reductions Observed by the Cross‐Track Infrared Sounder (CrIS)
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Madison J. Shogrin, Vivienne H. Payne, Susan S. Kulawik, Kazuyuki Miyazaki, and Emily V. Fischer
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PAN ,COVID‐19 ,megacities ,satellite ,CrIS ,photochemistry ,Geophysics. Cosmic physics ,QC801-809 - Abstract
Abstract The COVID‐19 pandemic perturbed air pollutant emissions as cities shut down worldwide. Peroxyacyl nitrates (PANs) are important tracers of photochemistry that are formed through the oxidation of non‐methane volatile organic compounds in the presence of nitrogen oxide radicals (NOx = NO + NO2). We use satellite measurements of free tropospheric PANs from the Suomi‐National Polar‐orbiting Partnership Cross‐track Infrared Sounder (CrIS) over eight of the world's megacities. We quantify the seasonal cycle of PANs over these megacities and find seasonal maxima in PANs correspond to seasonal peaks in local photochemistry. CrIS is used to explore changes in PANs in response to the COVID‐19 lockdowns. Statistically significant changes to PANs occurred over four megacities: with decreases over Los Angeles and Delhi, and increases over Mexico City and Beijing in the winter. Our analysis suggests that large perturbations in NOx may not result in significant declines in NOx export potential of megacities.
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- 2024
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47. Towards Equity and Decolonization? - An Introduction into the Blog Debate on the World Health System after the Pandemic
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Lilli Hasche, Jelena von Achenbach, and Andreas Fischer-Lescano
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COVID-19 ,Global Health ,Pandemic Treaty ,WHO ,Law - Abstract
The COVID-19 pandemic exposed systemic problems in the global health system. It revealed that the global health system perpetuates global health inequalities rather than effectively reducing them: The international community, particularly the countries of the Global North, failed to make COVID-19 vaccines widely available to the populations of the world's poorest countries. This blog debate takes stock of the reform debate about a just and decolonizing transformation of the health system. Bringing together scholars from various disciplines, the contributions of this debate ask what a fair global health system could look like and what role the law plays in it.
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- 2024
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48. Defining the risk of SARS-CoV-2 variants on immune protection
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DeGrace, Marciela M, Ghedin, Elodie, Frieman, Matthew B, Krammer, Florian, Grifoni, Alba, Alisoltani, Arghavan, Alter, Galit, Amara, Rama R, Baric, Ralph S, Barouch, Dan H, Bloom, Jesse D, Bloyet, Louis-Marie, Bonenfant, Gaston, Boon, Adrianus CM, Boritz, Eli A, Bratt, Debbie L, Bricker, Traci L, Brown, Liliana, Buchser, William J, Carreño, Juan Manuel, Cohen-Lavi, Liel, Darling, Tamarand L, Davis-Gardner, Meredith E, Dearlove, Bethany L, Di, Han, Dittmann, Meike, Doria-Rose, Nicole A, Douek, Daniel C, Drosten, Christian, Edara, Venkata-Viswanadh, Ellebedy, Ali, Fabrizio, Thomas P, Ferrari, Guido, Fischer, Will M, Florence, William C, Fouchier, Ron AM, Franks, John, García-Sastre, Adolfo, Godzik, Adam, Gonzalez-Reiche, Ana Silvia, Gordon, Aubree, Haagmans, Bart L, Halfmann, Peter J, Ho, David D, Holbrook, Michael R, Huang, Yaoxing, James, Sarah L, Jaroszewski, Lukasz, Jeevan, Trushar, Johnson, Robert M, Jones, Terry C, Joshi, Astha, Kawaoka, Yoshihiro, Kercher, Lisa, Koopmans, Marion PG, Korber, Bette, Koren, Eilay, Koup, Richard A, LeGresley, Eric B, Lemieux, Jacob E, Liebeskind, Mariel J, Liu, Zhuoming, Livingston, Brandi, Logue, James P, Luo, Yang, McDermott, Adrian B, McElrath, Margaret J, Meliopoulos, Victoria A, Menachery, Vineet D, Montefiori, David C, Mühlemann, Barbara, Munster, Vincent J, Munt, Jenny E, Nair, Manoj S, Netzl, Antonia, Niewiadomska, Anna M, O’Dell, Sijy, Pekosz, Andrew, Perlman, Stanley, Pontelli, Marjorie C, Rockx, Barry, Rolland, Morgane, Rothlauf, Paul W, Sacharen, Sinai, Scheuermann, Richard H, Schmidt, Stephen D, Schotsaert, Michael, Schultz-Cherry, Stacey, Seder, Robert A, Sedova, Mayya, Sette, Alessandro, Shabman, Reed S, Shen, Xiaoying, Shi, Pei-Yong, Shukla, Maulik, Simon, Viviana, Stumpf, Spencer, Sullivan, Nancy J, Thackray, Larissa B, and Theiler, James
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Medical Microbiology ,Biomedical and Clinical Sciences ,Biological Sciences ,Emerging Infectious Diseases ,Pneumonia ,Vaccine Related ,Pneumonia & Influenza ,Infectious Diseases ,Biodefense ,Immunization ,Biotechnology ,Prevention ,Lung ,Prevention of disease and conditions ,and promotion of well-being ,2.1 Biological and endogenous factors ,3.4 Vaccines ,Aetiology ,Infection ,Good Health and Well Being ,Animals ,Biological Evolution ,COVID-19 ,COVID-19 Vaccines ,Humans ,National Institute of Allergy and Infectious Diseases (U.S.) ,Pandemics ,Pharmacogenomic Variants ,SARS-CoV-2 ,United States ,Virulence ,General Science & Technology - Abstract
The global emergence of many severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants jeopardizes the protective antiviral immunity induced after infection or vaccination. To address the public health threat caused by the increasing SARS-CoV-2 genomic diversity, the National Institute of Allergy and Infectious Diseases within the National Institutes of Health established the SARS-CoV-2 Assessment of Viral Evolution (SAVE) programme. This effort was designed to provide a real-time risk assessment of SARS-CoV-2 variants that could potentially affect the transmission, virulence, and resistance to infection- and vaccine-induced immunity. The SAVE programme is a critical data-generating component of the US Government SARS-CoV-2 Interagency Group to assess implications of SARS-CoV-2 variants on diagnostics, vaccines and therapeutics, and for communicating public health risk. Here we describe the coordinated approach used to identify and curate data about emerging variants, their impact on immunity and effects on vaccine protection using animal models. We report the development of reagents, methodologies, models and notable findings facilitated by this collaborative approach and identify future challenges. This programme is a template for the response to rapidly evolving pathogens with pandemic potential by monitoring viral evolution in the human population to identify variants that could reduce the effectiveness of countermeasures.
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- 2022
49. Prevention of Coronavirus Disease 2019 Among Older Adults Receiving Pneumococcal Conjugate Vaccine Suggests Interactions Between Streptococcus pneumoniae and Severe Acute Respiratory Syndrome Coronavirus 2 in the Respiratory Tract
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Lewnard, Joseph A, Bruxvoort, Katia J, Fischer, Heidi, Hong, Vennis X, Grant, Lindsay R, Jódar, Luis, Gessner, Bradford D, and Tartof, Sara Y
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Vaccine Related ,Pneumonia ,Infectious Diseases ,Lung ,Immunization ,Pneumonia & Influenza ,Prevention ,Infection ,Good Health and Well Being ,Aged ,Anti-Bacterial Agents ,COVID-19 ,COVID-19 Testing ,Humans ,Pneumococcal Infections ,Pneumococcal Vaccines ,Respiratory System ,SARS-CoV-2 ,Streptococcus pneumoniae ,Vaccines ,Conjugate ,pneumococcal conjugate vaccine ,older adults ,polymicrobial infection ,Streptococcus pneumoniae ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
BackgroundWhile secondary pneumococcal pneumonia occurs less commonly after coronavirus disease 2019 (COVID-19) than after other viral infections, it remains unclear whether other interactions occur between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Streptococcus pneumoniae.MethodsWe probed potential interactions between these pathogens among adults aged ≥65 years by measuring associations of COVID-19 outcomes with pneumococcal vaccination (13-valent conjugate vaccine [PCV13] and 23-valent pneumococcal polysaccharide vaccine [PPSV23]). We estimated adjusted hazard ratios (aHRs) using Cox proportional hazards models with doubly robust inverse-propensity weighting. We assessed effect modification by antibiotic exposure to further test the biologic plausibility of a causal role for pneumococci.ResultsAmong 531 033 adults, there were 3677 COVID-19 diagnoses, leading to 1075 hospitalizations and 334 fatalities, between 1 March and 22 July 2020. Estimated aHRs for COVID-19 diagnosis, hospitalization, and mortality associated with prior PCV13 receipt were 0.65 (95% confidence interval [CI], .59-.72), 0.68 (95% CI, .57-.83), and 0.68 (95% CI, .49-.95), respectively. Prior PPSV23 receipt was not associated with protection against the 3 outcomes. COVID-19 diagnosis was not associated with prior PCV13 within 90 days following antibiotic receipt, whereas aHR estimates were 0.65 (95% CI, .50-.84) and 0.62 (95% CI, .56-.70) during the risk periods 91-365 days and >365 days, respectively, following antibiotic receipt.ConclusionsReduced risk of COVID-19 among PCV13 recipients, transiently attenuated by antibiotic exposure, suggests that pneumococci may interact with SARS-CoV-2.
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- 2022
50. Multiple early factors anticipate post-acute COVID-19 sequelae
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Su, Yapeng, Yuan, Dan, Chen, Daniel G, Ng, Rachel H, Wang, Kai, Choi, Jongchan, Li, Sarah, Hong, Sunga, Zhang, Rongyu, Xie, Jingyi, Kornilov, Sergey A, Scherler, Kelsey, Pavlovitch-Bedzyk, Ana Jimena, Dong, Shen, Lausted, Christopher, Lee, Inyoul, Fallen, Shannon, Dai, Chengzhen L, Baloni, Priyanka, Smith, Brett, Duvvuri, Venkata R, Anderson, Kristin G, Li, Jing, Yang, Fan, Duncombe, Caroline J, McCulloch, Denise J, Rostomily, Clifford, Troisch, Pamela, Zhou, Jing, Mackay, Sean, DeGottardi, Quinn, May, Damon H, Taniguchi, Ruth, Gittelman, Rachel M, Klinger, Mark, Snyder, Thomas M, Roper, Ryan, Wojciechowska, Gladys, Murray, Kim, Edmark, Rick, Evans, Simon, Jones, Lesley, Zhou, Yong, Rowen, Lee, Liu, Rachel, Chour, William, Algren, Heather A, Berrington, William R, Wallick, Julie A, Cochran, Rebecca A, Micikas, Mary E, Unit, the ISB-Swedish COVID-19 Biobanking, Wrin, Terri, Petropoulos, Christos J, Cole, Hunter R, Fischer, Trevan D, Wei, Wei, Hoon, Dave SB, Price, Nathan D, Subramanian, Naeha, Hill, Joshua A, Hadlock, Jennifer, Magis, Andrew T, Ribas, Antoni, Lanier, Lewis L, Boyd, Scott D, Bluestone, Jeffrey A, Chu, Helen, Hood, Leroy, Gottardo, Raphael, Greenberg, Philip D, Davis, Mark M, Goldman, Jason D, and Heath, James R
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Clinical Research ,Prevention ,Infectious Diseases ,Good Health and Well Being ,Adaptive Immunity ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Autoantibodies ,Biomarkers ,Blood Proteins ,CD8-Positive T-Lymphocytes ,COVID-19 ,Convalescence ,Disease Progression ,Female ,Humans ,Immunity ,Innate ,Longitudinal Studies ,Male ,Middle Aged ,Risk Factors ,SARS-CoV-2 ,Transcriptome ,Young Adult ,Post-Acute COVID-19 Syndrome ,ISB-Swedish COVID-19 Biobanking Unit ,PASC ,RNAemia ,antibodies ,auto-antibodies ,computational biology ,immune system ,immunology ,long COVID ,metabolomics ,multi-omics ,proteomics ,single cell ,single-cell CITE-seq ,single-cell RNA-seq ,single-cell TCR-seq ,single-cell secretome ,symptoms ,transcriptome ,viremia ,Biological Sciences ,Medical and Health Sciences ,Developmental Biology - Abstract
Post-acute sequelae of COVID-19 (PASC) represent an emerging global crisis. However, quantifiable risk factors for PASC and their biological associations are poorly resolved. We executed a deep multi-omic, longitudinal investigation of 309 COVID-19 patients from initial diagnosis to convalescence (2-3 months later), integrated with clinical data and patient-reported symptoms. We resolved four PASC-anticipating risk factors at the time of initial COVID-19 diagnosis: type 2 diabetes, SARS-CoV-2 RNAemia, Epstein-Barr virus viremia, and specific auto-antibodies. In patients with gastrointestinal PASC, SARS-CoV-2-specific and CMV-specific CD8+ T cells exhibited unique dynamics during recovery from COVID-19. Analysis of symptom-associated immunological signatures revealed coordinated immunity polarization into four endotypes, exhibiting divergent acute severity and PASC. We find that immunological associations between PASC factors diminish over time, leading to distinct convalescent immune states. Detectability of most PASC factors at COVID-19 diagnosis emphasizes the importance of early disease measurements for understanding emergent chronic conditions and suggests PASC treatment strategies.
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- 2022
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