Disparities in COVID-19 Related Outcomes in the United States By Race and Ethnicity: An Umbrella Review of Meta-Analyses

Objectives: Meta-analyses have investigated associations between race and ethnicity and COVID-19 outcomes. However, there is uncertainty about these associations' existence, magnitude, and level of evidence. We, therefore, aimed to synthesize, quantify, and grade the strength of evidence of race and ethnicity and COVID-19 outcomes in the US. Method(s): In this umbrella review, we searched four databases (Pubmed, Embase, the Cochrane Database of Systematic Reviews, and Epistemonikos) from database inception to April 2022. The methodological quality of each meta-analysis was assessed using the Assessment of Multiple Systematic Reviews, version 2 (AMSTAR-2). The strength of evidence of the associations between race and ethnicity with outcomes was ranked according to established criteria as convincing, highly suggestive, suggestive, weak, or non-significant. The study protocol was registered with PROSPERO, CRD42022336805 Results: Of 880 records screened, we selected seven meta-analyses for evidence synthesis, with 42 associations examined. Overall, 10 of 42 associations were statistically significant (p <= 0.05). Two associations were highly suggestive, two were suggestive, and two were weak, whereas the remaining 32 associations were non-significant. The risk of COVID-19 infection was higher in Black individuals compared to White individuals (risk ratio, 2.08, 95% Confidence Interval (CI), 1.60-2.71), which was supported by highly suggestive evidence;with the conservative estimates from the sensitivity analyses, this association remained suggestive. Among those infected with COVID-19, Hispanic individuals had a higher risk of COVID-19 hospitalization than non-Hispanic White individuals (odds ratio, 2.08, 95% CI, 1.60-2.70) with highly suggestive evidence which remained after sensitivity analyses. Conclusion(s): Individuals of Black and Hispanic groups had a higher risk of COVID-19 infection and hospitalization. These associations of race and ethnicity and COVID-19 outcomes existed more obviously in the pre-hospitalization stage. More consideration should be given in this stage for addressing health inequity.Copyright © 2023

The use of hotels/motels to address homelessness among veterans during the COVID-19 pandemic: lessons from the supportive services for veteran families program

The objective of this exploratory mixed methods study is to assess the use of hotels/motels among Veterans experiencing housing instability during the COVID-19 pandemic to inform policy and programmatic responses to homelessness during such emergencies. We analyzed qualitative interviews conducted with national-level homeless services leadership and Supportive Services for Veteran Families (SSVF) program providers during October 2020-May 2021 and quantitative data for Veterans who enrolled in SSVF during March-August 2020. A multivariable two-part regression model identified factors associated with receiving hotel/motel-specific financial assistance and associated costs. Qualitative interviews indicated that the use of hotels/motels during COVID-19 offered protection from a contagious disease and a novel mechanism to accommodate high-need Veterans who may have previously been unsheltered or resistant to services. Quantitative analyses found that Veteran households' stays in hotels/motels increased sharply following the onset of the COVID-19 pandemic;this assistance tended to flow to a more vulnerable group (i.e. older, no income, and extensive histories of homelessness). COVID-19 and homelessness are ongoing public health concerns;strategies such as the use of hotels/motels to reduce homelessness and ensure safe options for isolation and quarantine are needed to prevent poor health outcomes for a vulnerable population.

Mitigating an Infodemic: Can The Professions Still Regulate Themselves?

"Information disorder is a crisis that exacerbates all other crises. When bad information becomes as prevalent, persuasive, and persistent as good information, it creates a chain reaction of harm.” (Commission on Information Disorder, 2021, p. 1) There is no better demonstration of this chain reaction than the harm that is being inflicted across the globe by the COVID-19 infodemic. The term infodemic may be new for some readers. © 2022,Online Journal of Issues in Nursing. All Rights Reserved.

Correcting Disparities in Adolescent Access to Medicines by Promoting Age-Inclusive Research

The average time between regulatory approval and labeling of an innovative medicine for adults and children is nearly a decade.1 Often this is the result of poorly integrated adult and pediatric studies within medicines development programs, which consequently leads to prolonged off-label pediatric use. Furthermore, the conduct of studies in children after adult market approval becomes difficult if not impossible. Experiences during the SARS-CoV-2 pandemic have heightened awareness of this disparity. The fact that most children have been less severely affected by COVID-19 combined with reluctance to include children in early phases of investigational research has contributed to delays in evaluation of potential treatments for those children who present with more severe forms of the disease.2 Our study sought to understand how adolescent inclusion in adult trials is positioned in regulatory guidance since such documents set critical expectations for trial design and regulatory decision-making for innovative medicines. The authors conducted multiple sequential PubMed searches in November 2019 (and repeated in August 2021) utilizing a variety of grouped search terms-including ''pediatric,'' ''paediatric,'' ''adolescent,'' ''adolescence,'' ''regulatory guidance,'' ''guidance,'' ''FDA guidance,'' ''regulatory guideline,'' ''guideline,'' ''EMA guideline,'' and/or ''meta-analysis.'' The searches failed to return any results showing that an analysis of regional regulatory guidance specific to age-inclusive research has been published. It is our understanding that this study represents the first comprehensive analysis of age-inclusive language within regulatory guidance for two globally important health agencies, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The study utilized a qualitative analysis approach to review FDA and EMA regulatory guidance documents assessing their recommendations about adolescent inclusion in clinical trials. The study found that regulatory guidance contained recommendations supporting adolescent inclusion in 32% of FDA and 15% of EMA documents, while 14% and 21%, respectively, were found to be exclusionary. In both regions, more than half of all guidance documents were silent regarding the applicability of adolescentinclusive trial methodologies. Analysis by therapeutic area revealed FDA guidance for infectious diseases and EMA guidance for conditions requiring blood products was the most permissive. A more inclusive approach was identified to disease guidance published by the FDA Oncology Center of Excellence. Our study has identified important opportunities for enhancement of regulatory guidance which, if addressed, can facilitate inclusion of adolescent patients in adult trials to accelerate adolescent access to life-changing medicines. Regulatory guidance plays a critical role in improving the type and the quality of data generated in clinical trials which inform medicines use in diverse patient populations. As pediatric policy reforms have led to significant experience with pediatric medicines development, this should be leveraged to update existing regulatory guidance, fostering scientifically justified inclusion of adolescents in adult clinical trials.

Social inclusion through the urban lens: a comparative analysis of neighbourhoods of residential racial homogeneity and heterogeneity in Cape Town, South Africa

The world is increasingly urbanising, more than half of the global population live within cities. The impact of COVID-19 is having devastating effects. The United Nations estimates that the pandemic will most likely elevate poverty and inequalities at a global scale. The World Bank's twin goals of ending extreme poverty and promoting prosperity and the United Nations' Sustainable Development Goals have deemed inclusive, resilient, and sustainable cities as global imperatives. Despite wide recognition, building inclusive cities remains a challenge. Many studies of social inclusion are conducted at an individual or household scale, with little emphasis on the interaction between human dynamics and the spatial characteristics of cities. This article proposes a data driven framework for examining urban social inclusion through the profiling of neighbourhoods by combining spatial network measurements, transport, land use and socio-economic indicators in Cape Town, South Africa. The spatial unit of the neighbourhood is considered an important building block within cities and has especially historically important social and cultural connotations in South Africa. The results show that there are 4 types of neighbourhoods, Economically disadvantaged and marginalised, Affluent and exclusive, Semi residentially heterogeneous and Residentially heterogeneous. Neighbourhoods with increased residential racial heterogeneity, additionally, have access to higher levels of mixed land use, transport, and global closeness centrality. Furthermore, neither extremely high nor low-income neighbourhoods are found to be related to racial heterogeneity. The results enable the profiling and comparison of neighbourhoods, and it is envisioned that this evidence-based approach could support policy makers and urban planners within decision making processes. © 2022 Proceedings 13th International Space Syntax Symposium, SSS 2022. All rights reserved.

A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cytotoxicity may involve inhibition of peroxisome proliferator-activated receptor alpha. Fenofibrate activates peroxisome proliferator-activated receptor alpha and inhibits SARS-CoV-2 replication in vitro. Whether fenofibrate can be used to treat coronavirus disease 2019 (COVID-19) infection in humans remains unknown. Here, we randomly assigned inpatients and outpatients with COVID-19 within 14 d of symptom onset to 145 mg of oral fenofibrate nanocrystal formulation versus placebo for 10 d, in a double-blinded fashion. The primary endpoint was a severity score whereby participants were ranked across hierarchical tiers incorporating time to death, mechanical ventilation duration, oxygenation, hospitalization and symptom severity and duration. In total, 701 participants were randomized to fenofibrate (n = 351) or placebo (n = 350). The mean age of participants was 49 ± 16 years, 330 (47%) were female, mean body mass index was 28 ± 6 kg/m2 and 102 (15%) had diabetes. Death occurred in 41 participants. Compared with placebo, fenofibrate had no effect on the primary endpoint. The median (interquartile range) rank in the placebo arm was 347 (172, 453) versus 345 (175, 453) in the fenofibrate arm (P = 0.819). There was no difference in secondary and exploratory endpoints, including all-cause death, across arms. There were 61 (17%) adverse events in the placebo arm compared with 46 (13%) in the fenofibrate arm, with slightly higher incidence of gastrointestinal side effects in the fenofibrate group. Overall, among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes ( NCT04517396 ).

Enhanced recovery after surgery-a trainee approach to consistent perioperative colorectal care

Aim: Re-establishing Colorectal elective surgery within COVID-19 recovery has been challenging.The publication of updated Enhanced Recovery After Surgery guidelines following colorectal resection (2018), builds on a surgical continuum of evidence-based domains for perioperative optimisation.Aiming to evaluate adherence to ERAS guidelines promoting awareness and use through educational sessions for improved patient outcomes. Method(s): An audit of 24 patients were compared against ERAS recommendations with complete data sets of 14 (December 2021 -February 2022).Compliance against 24 domains encompassing pre, intra and post-operative care were assessed.An ERAS multidisciplinary focus group of clinicians and nursing staff highlighted key areas to increase adherence to ERAS recommendations.A didactic teaching intervention was introduced.Pre and post intervention questionnaire explored ERAS baseline knowledge, confidence and barriers to implementation. Result(s): Eleven of 24 ERAS domains were completed after the initial audit. Following intervention compliance increased to 19 domains. Average inpatient stay was 11 days with 64% of patients undergoing a laparoscopic resection. Response rate for pre and post intervention questionnaire was 75%.Median self-reported knowledge increased from 2.8 to 4.3 out of 5 post-intervention. Eighty one percent of junior doctors reported high importance of ERAS in elective patient journey but challenge of time constraints, lack of awareness and communication were barriers to its implementation.At 3 months post intervention, 80% of doctors reported a positive impact on both their confidence and management of ERAS patients. Conclusion(s): By embracing an evidence-based ERAS approach through integrated multidisciplinary working utilising educational sessions to increase stakeholder confidence and knowledge, we can deliver standardised, equitable and optimised patient care.

Barring Freedom: Art, Abolition and the Museum in Pandemic Times

Barring Freedom, a travelling exhibition featuring artworks engaging the histories and current conditions of prisons and policing in the United States, was to open in April 2020. While COVID-19 disrupted that plan, the realities of inequity in the United States placed into stark relief by the pandemic and the uprisings of summer 2020 brought urgency to rethinking the curatorial vision of the exhibition to reach audiences beyond the gallery walls. Buoyed by the idea that, in the words of Angela Davis, art can ‘propel people towards social emancipation’, the exhibition and related programming was reconceived as an ongoing, interdiscipli-nary, public scholarship initiative reaching across the borders normally perceived between museums, prisons and universities. Opportunities arose for expanded forms of community building and participation that welcomed different forms of knowledge, furthering the political and aesthetic aims of the project to shift the social attachment to prisons. © 2022 Intellect Ltd Curatorial Reflection. English language.

How Expensive Are Hospitalizations by COVID-19? Evidence From Colombia.

OBJECTIVES: This study aimed to estimate the direct medical costs due to hospitalizations by COVID-19 in Colombia and to identify their cost drivers in Colombia. METHODS: This is a retrospective cost-of-illness study of COVID-19 in Colombia. We estimated direct medical costs using data from patients insured to a Benefit Plan Administrator Company, between March 15, 2020 and May 29, 2020. Absolute and relative frequencies, averages, medians, and interquartile ranges (IQRs) were used to characterize the population and estimate the costs of hospitalized patients with COVID-19. We stratified the cost analysis by sex, age groups, comorbidities, and type of hospitalization (general ward and intensive care unit [ICU]). Cost drivers were calculated from a generalized linear model. RESULTS: We studied 113 confirmed patients, 51.3% men. On average, the hospital length of stay was 7.3 (± 6.2) days. A person hospitalized with COVID-19 reported median costs of $1688 (IQR 788-2523). In women, this cost was $1328 (IQR 463-2098); in men, this was 1.4 times greater. The median cost for ICU was $4118 (IQR 2069-5455), 3 times higher than those hospitalized only in the general ward. Admission to the ICU, having 1 comorbidity, length of stay, high blood pressure, having 5 comorbidities, and being treated in the city of Cartagena were statistically significant with direct medical costs. CONCLUSIONS: Our study provides an idea of the magnitude of costs needed to hospitalize a COVID-19 case in Colombia. Other studies in Colombia have assessed the costs of hospitalization for infectious diseases such as influenza, costs significantly lower than those described here.

Impact of School Opening Model on Cases of SARS-CoV-2 in Surrounding Communities: A Nationwide, Retrospective Cohort Study

Background. Early in the COVID-19 pandemic, elementary and secondary schools were closed. There was variation in school opening mode (traditional, hybrid, remote) in fall 2020.The aim of this national, retrospective cohort study is to evaluate the impact of in-person learning on community incidence of SARS-CoV-2 and COVID-19-related deaths. Methods. Data were extracted from several data sources. School opening mode was collected from the Burbio school tracker, which tracks school openings in a sample of school districts across the US. Incidence of SARS-CoV-2 and COVID-19 related deaths were obtained from the CDC. Data on community-level SARS-CoV-2 mitigation measures were obtained from the Oxford University COVID-19 Government Response Tracker. The effect of school mode on SARS-CoV-2 cases and deaths/100,000 during the 12-weeks following the start of school was estimated using a log-linear model with state, week, and state-week fixed effects. Models were stratified by 9 US Census divisions and adjusted for variables determined a priori to be potentially associated with the outcome. Results. 519 US counties were included (Figure 1);mean cases of COVID-19 were increasing across all regions during the weeks following the start of school, regardless of school mode. Adjusted absolute differences in COVID-19 cases in counties with hybrid and traditional school opening modes relative to fully remote learning models are presented in Figure 2. In the Northeast and Midwest regions of the country, COVID-19 case rates were not statistically different between different school modes. However, in the South and West regions, there was a statistically significant increase in cases per week among counties that opened in an in-person relative to remote learning model, ranging from 17.1 (95% CI: 0.3-33.8) to 24.4 (95% CI: 7.3-41.5) in the South and from 19.0 (95% CI: 8.8-29.3) to 109.2 (95% CI: 50.4-168.0) in the West. There was no impact of school opening mode on COVID-19-related deaths. Conclusion. Impact of school mode on community case-rates of SARS-CoV-2 varied across the US. In some areas of the country, traditional school mode was associated with increases in case rates relative to virtual while there were no differences in other regions.

COVID-19 in the Perioperative Period of Cardiovascular Surgery: the Brazilian Experience.

INTRODUCTION: We investigated the clinical course and outcomes of patients submitted to cardiovascular surgery in Brazil and who had developed symptoms/signs of coronavirus disease 2019 (COVID-19) in the perioperative period. METHODS: A retrospective multicenter study including 104 patients who were allocated in three groups according to time of positive real time reverse transcriptase-polymerase chain reaction (RT-PCR) for the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2): group 1, patients who underwent cardiac surgery > 10 days after positive RT-PCR; group 2, patients with a positive RT-PCR within 10 days before or after surgery; group 3, patients who presented positive RT-PCR > 10 days after surgery. The primary outcome was mortality and secondary outcomes were postoperative complications, intensive care unit (ICU) length of stay, and postoperative days of hospitalization. RESULTS: The three groups were similar with respect to age, the European System of Cardiac Operative Risk Evaluation score, and comorbidities, except hypertension. Postoperative complications and death were significantly higher in groups 2 and 3 than in group 1, and no significant difference between groups 2 and 3 was seen. Group 2 showed a high prevalence of surgery performed as an urgent procedure. Although no significant differences were observed in ICU length of stay, total postoperative hospitalization time was significantly higher in group 3 than in groups 1 and 2. CONCLUSION: COVID-19 affecting the postoperative period of patients who underwent cardiovascular surgery is associated with a higher rate of morbidity and mortality. Delaying procedures in RT-PCR-positive patients may help reduce risks of perioperative complications and death.

Minimizing clinician exposure to SARSCoV2 during otologic surgery

Session Description: The COVID-19/SARS-CoV2 pandemic has highlighted concerns regarding disease transmission to both surgeons and assisting staff during procedures that generate droplets and aerosols. Aerosol and droplet formation is known to occur during otologic and lateral skull base surgery, particularly when powered instrumentation is used. This expert panel will review both the basic science and clinical studies regarding risk identification. Recommendations regarding minimization of these risks will be thoroughly discussed in both scientific and practical terms that can be utilized by practicing otolaryngologists in real-life scenarios. In addition, the panel will address controversies regarding these risks and mitigation schemes and address real-life situations using case-based examples relevant to both the general otolaryngologist and neurotologic specialist. The discussion will focus not only on mitigation of spread of SARS-CoV2 virus but also on other currently identified pathogens of the middle ear and mastoid and future threats. This panel will address emerging pathogens that have not yet become threats in the United States and Western Europe but have affected otolaryngologists in other areas of the world. It will also provide guidance for hypothetical novel future threats that have not yet presented in clinical practice. This presentation is highly relevant to practicing otolaryngologists, including general otolaryngologists, pediatric otolaryngologists, and neurotologists and will provide the attendee with a thorough update clinical practice patterns, potential spread of contagion, and strategies of spread mitigation. Outcome Objectives: (1) Examine the basic and clinical science of pathogens of the middle ear, mastoid, and cerebrospinal fluid and the patterns of spread of these pathogens during otologic and lateral skull base procedures. (2) Understand and implement strategies to mitigate spread of currently known pathogens in otologic and lateral skull base procedures, including limitation of the spread of SARS/CoV2. (3) Understand a framework of strategies and best practices for mitigation of spread of emerging pathogens and future pathogens.

Allogeneic Stem Cell Transplantation in a Large Urban Cohort of North-American Adult T-Cell Leukemia/Lymphoma

Introduction: Adult T-cell leukemia lymphoma (ATLL) is a rare hematologic malignancy caused by human T-cell lymphotropic virus (HTLV-1) with dismal cure rates and poor response to conventional chemotherapy. Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) is the only therapeutic option which may offer the chance of long-term remission and cures in a subset of patients. We sought to investigate the outcomes of transplantation in one of the largest cohorts in North America. Methods: A retrospective chart review study was conducted using the North-American ATLL and the Hematopoietic Precursor Cell transplantation databases at Montefiore Medical Center from 2011 to 2020. Variables collected include age, sex, ethnicity, ATLL subtype, molecular profile, previous treatments, conditioning regimens, type of transplant, immunosuppressive regimen, progression free survival (PFS) post-transplant and overall survival (OS) post-transplant. Results: Fourteen patients with ATLL who received an AlloSCT from 2011-2020 were identified. Fifty-seven percent (8/14) of patients were male. Seventy-one percent (10/14) of patients were African American and twenty-nine percent (4/14) were Hispanic. Median age was 51 years. Sixty-four percent (9/14) of patients had Stage IV disease at the time of diagnosis. Forty-three percent (6/14) patients had acute and fifty-seven percent (8/14) had lymphomatous ATLL. Almost all patients (92%) were treated initially with EPOCH combination chemotherapy. Twenty-eight percent (4/14) of patients received interferon/zidovudine as bridge-to-transplant. Fifty-seven percent (8/14) of patients achieved complete remission (CR) prior to AlloSCT, 7% (1/14) were in partial remission, and 28% (4/14) were relapsed or refractory. Forty-three percent (6/14) of patients received SCT from a matched-related donor (MRD), 36% (5/14) from a haplo-identical donor and 21% (3/14) from a matched-unrelated donor (MUD). Ninety-three percent (13/14) of patients received a reduced-intensity conditioning (RIC) regimen pre-transplantation. Seven percent (1/14) received a myeloablative conditioning (MAC) regimen. RIC regimens consisted of fludarabine with melphalan +/- anti-thymocyte globulin (ATG) or fludarabine with cyclophosphamide with total-body irradiation in doses less than 500 cGy. Patients receiving haplo-identical SCT also received post-transplant cyclophosphamide (PTCy) for prevention of graft vs host disease (GVHD). The MAC regimen used included busulfan with cyclophosphamide at myeloablative doses. Twenty-eight percent (4/14) of patients relapsed post-alloSCT with a median relapse-free survival of 6 months (range 4-18 months). The median OS of the whole cohort was 27 months (8-82 months). Graft-versus-host disease (GVHD) developed in 28% (4/14) percent of patients. The most common manifestation was skin GVHD. Fifty-percent (7/14) of the patients are surviving to-date. Transplant-related mortality (TRM) at day 100 was 21% (3/14) of patients. Causes of death were complex and included several diagnoses in certain patients. The most frequent diagnoses associated with death were infection (28%), graft failure (14%), GVHD (14%), veno-occlusive disease of the liver (VOD) (7%), disease progression (14%) and unknown due to patient lost to follow-up (14%). The main infectious events included fungal (2), bacterial (1), and COVID-19 (1) infection. Forty-three percent (6/14) of patients remain in complete remission to date. Conclusions: Allogeneic Stem Cell Transplantation offers long-term survival with a TRM of 21% in a disease with an inherently dismal prognosis. AlloSCT using several graft sources, is thus, a safe and well tolerated treatment modality and offers long term remissions. Disclosures: Steidl: Pieris Pharmaceuticals: Consultancy;Aileron Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;Bayer Healthcare: Research Funding;Stelexis Therapeutics: Consultancy, Current equity holder in private company, Membership on an entity's Board of Directors or advi ory committees. Verma: BMS: Consultancy, Research Funding;acceleron: Consultancy, Honoraria;Janssen: Research Funding;Medpacto: Research Funding;stelexis: Current equity holder in private company. Janakiram: ADC Therapeutics, FATE therapeutics, TAKEDA pharmaceuticals: Research Funding.

Dynamics of Leukocyte Subpopulations Reconstitution Predict Infection Propensity in a Multiethnic Real World Cohort Treated with Anti-CD19 CAR-T Cell Therapy (Axicabtagene-Ciloleucel)

Background: Adoptive immunotherapy using CD19-targeted Chimeric Antigen Receptor T-cells (CAR-T) has revolutionized the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). We have demonstrated the efficacy of FDA-approved axicabtagene ciloleucel (Yescarta) in a multiethnic New York City underserved population with 80% complete response (CR) rate in the first ten patients treated at our institution (Abbasi et al., 2020). There is limited data on the propensity of infections and lymphohematopoietic reconstitution after Day 30 (D30) following CAR-T cell therapy. In this study, we evaluated the prevalence and nature of infectious complications in an expanded cohort of DLBCL patients treated with CD19 CAR-T therapy and its association with the dynamics of leukocyte subpopulation reconstitution post-CAR-T cell therapy. Methods: We conducted a retrospective study of patients who received CAR-T therapy at our institution between 2018-2020. Variables collected include patient demographics, absolute neutrophil (ANC), lymphocyte (ALC) and monocyte counts (AMC) at Day 30, hematologic reconstitution (ANC≥ 1500/µL) at Day 90 (D90), presence or absence of infections after D30 by clinical and/or microbiological parameters. Associations between presence of infection and D30 ANC, ALC, AMC, ANC/ALC ratio, AMC/ALC ratio were assessed using Kruskal-Wallis test. Association between infection and hematologic reconstitution at D90 was done using Chi-square test. Kaplan-Meier curves with log-rank test were used to evaluate overall survival (OS) and progression-free survival (PFS). Results: Nineteen patients were evaluated in our study, consisting of 42% (8) Hispanic, 32% (6) Caucasian, 21% (4) African-American, and 5% (1) Asian subjects. Based on clinical and microbiologic data, 47% (9) developed an infection after D30 (infection group) while 53% (10) of subjects remained infection-free after D30 (non-infection group). The most common infection type observed was viral (11 patients) followed by bacterial (8 patients) and fungal (3 patients) (Table 1). Of 25 total infectious events, 44% (11) were grade 1 or 2 and 48% (12) were grade 3 with 10 being viral in etiology. Two deaths occurred due to an infectious process. Three patients tested SARS-CoV-2 positive and were hospitalized with COVID-19 pneumonia. Median OS and PFS has not been reached in either group. To determine the kinetics of lymphohematopoietic reconstitution and its association with infection risk, we evaluated the relationship between cytopenias and rates of infection after D30. Notably, compared to non-infection group, infection group had a higher median ALC (1000/µL vs 600/µL p=0.04), a lower median ANC/ALC ratio (1.4 vs 4.5 p<0.01) and a lower median AMC/ALC at D30 (0.36 vs 1.33, p=0.01) (Table 2). In addition, patients in the infection group had a lower rate of hematologic reconstitution (ANC >1500/µL) at D90. We observed that only 22% (2) of patients had recovered ANC > 1500/µLin the infection group as opposed to 80% (8) in the non-infection group at D90 (p= 0.038). Rates of cytokine release syndrome (CRS) were comparable between the two groups (55.6% vs 70% p=0.52). Surprisingly, rates of immune-effector cell associated neurotoxicity syndrome (ICANS) was lower (55.6%) in the infection group compared to (90%) non-infection group (p=0.09). Fourteen of 19 patients had follow-up over one year, of which 8 (57%) remained in complete remission (CR). Conclusions: We demonstrate an infection rate of 47% (9) beyond D30 in patients undergoing CD19 CAR-T. Increased ALC, lower ANC/ALC and AMC/ALC ratios at D30 may be predictive of infectious complications. Median OS has not been reached in our cohort. Given the potential clinical impact, our observations should be corroborated using larger datasets. [Formula presented] Disclosures: Steidl: Pieris Pharmaceuticals: Consultancy;Bayer Healthcare: Research Funding;Stelexis Therapeutics: Consultancy, Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees;Ai eron Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Janakiram: ADC Therapeutics, FATE therapeutics, TAKEDA pharmaceuticals: Research Funding. Verma: BMS: Consultancy, Research Funding;acceleron: Consultancy, Honoraria;Janssen: Research Funding;stelexis: Current equity holder in private company;Medpacto: Research Funding.

Venezuela: Background and U.S. relations

Venezuela remains in a deep crisis under the authoritarian rule of Nicolas Maduro of the United Socialist Party of Venezuela. Maduro, narrowly elected in 2013 after the death of Hugo Chavez (president, 1999-2013), began a second term on January 10, 2019, that is widely considered illegitimate. Since January 2019, Juan Guaido, president of Venezuela's democratically elected, opposition-controlled National Assembly, has sought to form a transition government to serve until internationally observed elections can be held. The United States and 57 other countries recognize Guaido as interim president, but he has been unable to harness that diplomatic support to wrest Maduro from power. Venezuela's economy has collapsed. The country is plagued by hyperinflation, severe shortages of food and medicine, and a dire humanitarian crisis that has further deteriorated in 2020 as a result of gasoline shortages, an outbreak of Coronavirus Disease 2019 (COVID-19), and strengthened U.S. sanctions. Maduro has blamed U.S. sanctions for the economic crisis, but many observers cite economic mismanagement and corruption as the main factors. U.N. agencies estimate that 5.1 million Venezuelans have fled the country as of August 2020, primarily to neighboring countries. U.S. Policy Since recognizing the Guaido government in January 2019, the United States has coordinated its efforts with Interim President Guaido. U.S. strategy has emphasized diplomatic efforts to bolster support for Guaido;targeted sanctions and visa revocations to increase pressure on Maduro officials;broader sanctions on the state oil company, other state-controlled companies and institutions, and the government;and humanitarian aid ($534 million to countries sheltering Venezuelans and $76 million for Venezuela from FY2017 through May 2020). In October 2019, the U.S. Agency for International Development (USAID) signed an agreement with the Guaido government enabling the provision of development assistance and increased democracy assistance. In 2020, the Administration has sanctioned companies that have transported Venezuelan oil and seized Venezuela-bound ships carrying Iranian petroleum products in violation of sanctions. U.S. officials have vowed to keep "maximum pressure" on Maduro and his foreign backers until he agrees to allow a transition government to convene free and fair legislative and presidential elections. Congressional Action Congress has supported the Administration's efforts to support a restoration of democracy in Venezuela without U.S. military intervention in the country and to provide humanitarian support to Venezuelans, although some Members have expressed concerns about the humanitarian impact of sanctions. In December 2019, Congress enacted P.L. 116-94, which appropriates $30 million in FY2020 assistance for democracy programs in Venezuela and incorporates the Senate-reported version of the VERDAD Act (S. 1025), a comprehensive bill to address the crisis in Venezuela. The VERDAD Act incorporated House-passed measures authorizing FY2020 humanitarian aid to Venezuela (H.R. 854), restricting the export of defense articles to Venezuela (H.R. 920), and requiring a U.S. strategy to counter Russian influence in Venezuela (H.R. 1477). In December 2019, Congress also enacted P.L. 116-92, which prohibits federal contracting with persons who do business with the Maduro government. In July 2019, the House passed H.R. 549, designating Venezuela as a beneficiary country for temporary protected status;however, a Senate effort to pass H.R. 549 by unanimous consent failed. For FY2021, the Administration requested $200 million in democracy aid aimed to support a democratic transition in Venezuela and $5 million in global health assistance;the House-passed version of the measure (H.R. 7608, H. Rept. 116-444) would provide $30 in democracy aid for Venezuela and support the provision of additional aid if a democratic transition occurs. The House-passed version of the FY2021 National Defense Authorization Act (H.R. 6395, H. Rept. 116-442) would require a report on he crises in Venezuela and its impacts on U.S. and regional security. © 2021 Nova Science Publishers, Inc.

Continuation versus discontinuation of renin-angiotensin system inhibitors in patients admitted to hospital with COVID-19: a prospective, randomised, open-label trial.

BACKGROUND: Biological considerations suggest that renin-angiotensin system inhibitors might influence the severity of COVID-19. We aimed to evaluate whether continuing versus discontinuing renin-angiotensin system inhibitors (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) affects outcomes in patients admitted to hospital with COVID-19. METHODS: The REPLACE COVID trial was a prospective, randomised, open-label trial done at 20 large referral hospitals in seven countries worldwide. Eligible participants were aged 18 years and older who were admitted to hospital with COVID-19 and were receiving a renin-angiotensin system inhibitor before admission. Individuals with contraindications to continuation or discontinuation of renin-angiotensin system inhibitor therapy were excluded. Participants were randomly assigned (1:1) to continuation or discontinuation of their renin-angiotensin system inhibitor using permuted block randomisation, with allocation concealed using a secure web-based randomisation system. The primary outcome was a global rank score in which participants were ranked across four hierarchical tiers incorporating time to death, duration of mechanical ventilation, time on renal replacement or vasopressor therapy, and multiorgan dysfunction during the hospitalisation. Primary analyses were done in the intention-to-treat population. The REPLACE COVID trial is registered with ClinicalTrials.gov, NCT04338009. FINDINGS: Between March 31 and Aug 20, 2020, 152 participants were enrolled and randomly assigned to either continue or discontinue renin-angiotensin system inhibitor therapy (continuation group n=75; discontinuation group n=77). Mean age of participants was 62 years (SD 12), 68 (45%) were female, mean body-mass index was 33 kg/m2 (SD 8), and 79 (52%) had diabetes. Compared with discontinuation of renin-angiotensin system inhibitors, continuation had no effect on the global rank score (median rank 73 [IQR 40-110] for continuation vs 81 [38-117] for discontinuation; ß-coefficient 8 [95% CI -13 to 29]). There were 16 (21%) of 75 participants in the continuation arm versus 14 (18%) of 77 in the discontinuation arm who required intensive care unit admission or invasive mechanical ventilation, and 11 (15%) of 75 participants in the continuation group versus ten (13%) of 77 in the discontinuation group died. 29 (39%) participants in the continuation group and 28 (36%) participants in the discontinuation group had at least one adverse event (χ2 test of adverse events between treatment groups p=0·77). There was no difference in blood pressure, serum potassium, or creatinine during follow-up across the two groups. INTERPRETATION: Consistent with international society recommendations, renin-angiotensin system inhibitors can be safely continued in patients admitted to hospital with COVID-19. FUNDING: REPLACE COVID Investigators, REPLACE COVID Trial Social Fundraising Campaign, and FastGrants.

A novel eHealth model of care to effectively manage chronic hepatitis C in community and prison-based settings

Background and Aim: The rising burden of chronic disease in the developed world has resulted in an accumulation of patients requiring long-term specialist input in care, despite relatively stagnant capacity in tertiary hospital services. Newer models of care, incorporating specialist input while empowering and enabling community-based treatment in the more cost-effective primary care setting, are urgently needed. Digital health technologies have been proposed as one such novel model. The evolving digital technology paradigm shift instigated by the coronavirus 2019 pandemic has placed further emphasis on the need for evidence-based eHealth interventions. Chronic hepatitis C virus (HCV) represents a model disease in which rapid treatment advances have allowed care to shift from tertiary to community-based treatment models;however, barriers remain in achieving elimination targets and scaling up treatment to at-risk populations. We aimed to explore the efficacy, acceptability, and feasibility of an eHealth model to connect community and prison-based clinicians with specialist teams for HCV treatment. Methods: We conducted a multicenter quasi-experimental pre-post study using a hybrid effectiveness-implementation design with referring community and prison-based clinicians, in consultation with eight tertiary centers in Australia. The pre-intervention control group was treated through existing paper, fax, or remote consultation methods between 1 March 2016 and 28 February 2017. The eHealth model of care (using the HealthELink system) was prospectively implemented from 1 August 2017 to 30 April 2019. Key elements of the web-based eHealth model include HCV-specific clinical decision support, including University of Liverpool drug-drug interaction integration, secure electronic messaging, task management, email alerts, and an electronic patient portal. The primary outcome was sustained virological response at 12 weeks after treatment (SVR12), based on intention-to-treat analysis. Secondary outcomes included an implementation analysis comprising usability, acceptability, quality, safety, and uptake/utilization measures. Results: In total, 249 patients (180 community, 69 prison) were treated in the eHealth group, and 681 (588 community, 87 prison) in the control group. Sixty-one general practitioners, 12 specialists, 24 nurses, and four prison systems registered to use the eHealth system. In the community-based group, SVR12 was confirmed in 106/180 patients (59%), compared with 383/588 (65%) in the control group (P = 0.13), and 44/69 (64%) versus 61/87 (70%) in the prison-based group (P = 0.32). Completion of repeat liver biochemistry at the time of SVR12 testing (88% vs 51%, P = 0.01) and adherence to guideline-based treatment (100% vs 98%, P = 0.03) were higher in the eHealth group. Timeto specialist approval (median, 1 vs 7 days;P < 0.01) and SVR12 confirmation from the intention to treat when adjusted for treatment duration (175 vs 208 days, P = 0.05) were both significantly reduced in the eHealth group. Uptake of the eHealth model was greatest in nurse-led and prison-based cohorts. Low uptake was found among GP users, primarily due to few HCV patients encountered during the study. High levels of usability (median system usability score, 76) and acceptability were found among most users, with the clinical decision support features found to be most useful. Low technological failure rates were seen, with browser compatibility the most frequent issue encountered, in less than 5% of users. Conclusion: This eHealth model of care resulted in similar clinical outcomes to the current standard of care. However, treatment efficiency and adherence to guideline-based care were improved using eHealth. The model was acceptable and displayed good usability for most users. This study shows that a multifaceted eHealth system is a valuable and scalable model to manage HCVand serves as a blueprint for other chronic diseases.

Navigating a "New Normal" During the COVID-19 Pandemic: College Student Perspectives of the Shift to Remote Learning

The current COVID-19 pandemic has rapidly shifted institutions of higher education to remote learning environments, which has impacted student learning in unknown ways. The authors surveyed college students to determine how learning was impacted by the shift to remote learning during the COVID-19 pandemic, and to identify both the factors that created barriers and the factors that helped students succeed. Results indicate four primary factors-instructional design, instructor interactions, student autonomy and responsibility, and life/environmental factors-intersected to create the student learning environment. Implications for addressing barriers and increasing student success are discussed.