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Background: SARS-CoV-2 evolution has contributed to successive waves of infections and severely compromised the efficacy of available SARS-CoV-2 monoclonal antibodies. Decaying vaccine-induced immunity, vaccine hesitancy, and limited vaccine protection in older and immunocompromised populations further compromises vaccine efficacy at the population level. Early antiviral treatments, including intravenous remdesivir (RDV), reduce hospitalization and severe disease due to COVID-19. An orally bioavailable RDV analog could facilitate earlier widespread administration to non-hospitalized COVID-19 patients. Method(s): We synthesized monoalkyl glyceryl ether phosphodiesters of GS-441524 (RVn), lysophospholipid analogs which allow for oral bioavailability and stability in plasma. We evaluated the in vivo efficacy of our lead compound, 1-O-octadecyl-2-O-benzyl-sn-glyceryl-3-phospho-RVn (V2043), in an oral treatment model of murine SARS-CoV-2 infection. We then synthesized numerous phospholipid analogs of RVn and determined which modifications enhanced in vitro antiviral activity and selectivity. The most effective compounds against SARS-CoV-2 were then evaluated for antiviral activity against other RNA viruses. Result(s): Oral treatment of SARS-CoV-2 infected BALB/c mice with V2043 (60 mg/kg once daily for 5 days, starting 12 hrs after infection) reduced lung viral load by more than 100-fold versus vehicle at day 2 and to below the LOD at day 5. V2043 inhibited previous and contemporary SARS-CoV-2 Variants of concern to a similar degree, as measured by the half maximal effective concentration (EC50) in a human lung epithelial cell line (Calu-3). Evaluation of multiple RVn analogs with hydrophobic esters at the sn-2 of glycerol revealed that in vitro antiviral activity was improved by the introduction of a 3-fluoro-4-methoxysubstituted benzyl or a 3-or 4-cyano-substituted benzyl. These compounds showed a 2-to 6-fold improvement in antiviral activity compared to analogs having an unsubstituted benzyl, such as V2043, and were more active than RDV. These compounds also showed enhanced antiviral activity against multiple contemporary and emerging RNA viruses. Conclusion(s): Collectively, our data support the development of RVn phospholipid prodrugs as oral antiviral agents for prevention and treatment of SARS-CoV-2 infections and as preparation for future outbreaks of pandemic RNA viruses.
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Shift workers are known to have poorer metabolic health outcomes compared to day workers,(1) whilst those who work in rotating shift work roles have the highest risk.(2) To date, overall energy intake in shift workers has been found to be similar to day workers,(3) but it is unknown whether energy intake in workers on rotating shift schedules may be a contributing factor to the observed higher chronic disease risk. A systematic review and meta-analysis were conducted to explore how rotating shift work schedules impact total energy intake compared to fixed day/morning work schedules. Intra-person differences in energy intake amongst rotating shift workers on day/morning versus night shifts was also examined. Searches were conducted on CINAHL, Cochrane, Embase, MEDLINE PsycINFO and Scopus databases to identify articles reporting energy intake for rotating shift workers and fixed day workers. Articles were screened in duplicate against inclusion criteria using Covidence software. Data were extracted by one reviewer and checked independently by one of three reviewers. Quality assessment of included studies was assessed in duplicate using the American Dietetic Association (ADA) Quality Criteria Checklist for Primary Research. Meta-analyses were performed in RevMan using a random effects model, to compare mean difference in 24-hour energy intake with 95% confidence intervals. Heterogeneity was assessed with the I-squared test (I2). Thirty-one studies (n = 18196 participants) met the inclusion criteria and were included in the review with data for the two meta-analyses comprising 18 studies and seven studies, respectively. Overall, rotating shift workers had significantly higher average 24-hour energy intake compared to fixed day or morning work schedules (weighted mean difference [WMD] = 264 kJ;95% CI [70, 458], p < 0.008;I2 = 63%). Within rotating shift workers, the mean difference in 24-hour energy intake across morning/day shifts compared to night shifts was not statistically significant (WMD = 101 kJ;95% CI [-651, 852];p = 0.79;I2 = 77%). Results indicate workers on rotating shift schedules had a higher average 24-hour energy intake compared to their fixed day schedule counterparts. However, energy intake across shift schedules did not differ for individuals working this pattern. A higher 24-hour energy intake in rotating shift workers can contribute to gradual weight gain and higher metabolic risk in rotating shift work populations.
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OBJECTIVES: Early in the COVID-19 pandemic, outpatient visits were adapted for the virtual setting, forcing laryngologists to presume certain diagnoses without the aid of laryngoscopy, solely based on history and the limited physical exam available via video visit. This study aims to examine the accuracy of presumptive diagnoses made via telemedicine, compared to subsequent in-person follow up, where endoscopic examination could confirm or refute suspected diagnoses. METHODS: A retrospective chart review was conducted of 38 patients evaluated for voice-related issues at NYU Langone Health and the University of California-San Francisco. Presumptive diagnoses at the initial telemedicine encounter were noted, along with diagnostic cues used for clinical reasoning and recommended treatment plans. These presumptive diagnoses were compared to diagnoses and plans established following laryngoscopy at follow-up in-person visits. RESULTS: After laryngoscopy at the first in-person visit, 38% of presumptive diagnoses changed, as did 37% of treatment plans. The accuracy varied among conditions. Muscle tension dysphonia and Reinke's edema were accurately diagnosed without laryngoscopy, but other conditions, including vocal fold paralysis and subglottic stenosis, were not initially suspected, relying on laryngoscopy for diagnosis. CONCLUSIONS: While some laryngologic conditions may be reasonably identified without in-person examination, laryngoscopy remains central to definitive diagnosis and treatment. Telemedicine can increase access to care, but it may provide more utility as a screening tool, triaging which patients should present more urgently for in-person laryngoscopy. LEVEL OF EVIDENCE: 4.
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Introduction: Spatial neglect (SN) is a debilitating neuropsychological syndrome defined as a failure to respond to stimuli in the side of space opposite to the side of the brain injury. Despite the impact, there are currently no clinically effective rehabilitation methods. Computerised rehabilitation can increase enjoyment and feelings of independence (Morse et al.,2020), thus we developed computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT) which can remotely record adherence and facilitate self-administration. SIGHT, or visuomotor feedback training, or (grasping-to-lift and balance rods) has been shown to be effective in reducing SN (Rossit et al., 2019). Method(s): This research aims to investigate the feasibility of a randomized controlled trial using c-SIGHT vs. an attentional control, while also exploring experiences of self-administering the therapy at home. This is a two-arm, double-blinded feasibility study intends to recruit 46 stroke survivors with SN and allocate them using minimisation to self-administer c-SIGHT or an attentional control for 30 minutes, twice a day for 10 days at home. Participants complete a set of neuropsychological tests and questionnaires at three time points (baseline, post-training, one-month follow-up) and one semi-structured interview after using c-SIGHT. Primary outcomes are feasibility parameters (recruitment, blinding success, adherence, follow-up rates). Secondary outcomes are changes in neglect, cognition and activities of daily living. Result(s): Since May 2021, the study has opened up at five NHS sites in the East of England. Despite COVID-19 delays, 20 stroke survivors have been recruited, 11 completed baseline assessments, and four have completed the study. Conclusion(s): Other preliminary results (e.g., usability) will be presented.
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Despite years of recruitment efforts, women remain significantly underrepresented throughout engineering. While research into precollege engineering education has expanded, it has primarily focused on formal learning settings, even though students spend significantly more time outside of the classroom. The COVID-19 pandemic changed everything, including the time spent outside of the classroom in informal environments. Specifically, programs had to evolve to provide online content and at-home activities. Some programs even shut down completely. Within this context, our study sought to understand the impact of one informal engineering learning experience, a Girl Scout engineering badge, which also shifted online due to the COVID-19 pandemic. Specifically, we examined the impact on middle school girls' engineering identity development to understand how these experiences supported the development of an engineering identity. Before and after a Girl Scout engineering badge experience, 15 girls (grades 4–7) were interviewed about their knowledge and perception of engineering. The Draw-an-Engineer Test was used as a focal artifact, and we studied the girls' engineering identity through the lens of Possible Selves Theory. The engineering badge activities were facilitated online. Completely virtual and hybrid meetings were employed allowing additional insight into how outcomes differ with delivery method. Most participants showed an increase in their understanding of engineering and some developed engineering possible selves. Through our work, we noted that informal engineering experiences can improve pre-college students' understanding and perception of engineering;however, differences in program delivery, such as those caused by the pandemic, can have an impact. Therefore, significant additional research is needed to better understand the scope of the impact of informal programs particularly regarding how impacts differ across delivery modes and contexts. These discoveries can be used to shape evidence-based recommendations for impactful informal experiences. © 2022, Purdue University Press. All rights reserved.
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Research suggests that COVID-19-related restrictions affected individuals' ability to engage in relationship maintenance behaviors and have led to poorer romantic relationship quality. Poor relationship quality may be especially problematic for lesbian, gay, bisexual, transgender, queer or questioning, and otherwise non-heterosexual or-cisgender (LGBTQ+) college students, who often lack family support and are at greater risk for mental health issues. We used a social exchange theory lens to examine correlates of relationship satisfaction for LGBTQ+ college students during the early months of the pandemic. The analytic sample consists of 175 LGBTQ+ students (Mage = 20.5) who completed an online survey and reported being in a romantic relationship. Our findings demonstrate that LGBTQ+ students with more supportive partners were more satisfied with their relationships. These results can inform clinicians how to better support LGBTQ+ college couples when they experience relationship stress. © 2023 Society for the Study of Emerging Adulthood and SAGE Publishing.
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BACKGROUND: The SARS-CoV-2 pandemic and corresponding acute respiratory syndrome have affected all populations and led to millions of deaths worldwide. The pandemic disproportionately affected immunocompromised and immunosuppressed adult patients who had received solid organ transplants (SOTs). With the onset of the pandemic, transplant societies across the world recommended reducing SOT activities to avoid exposing immunosuppressed recipients. Due to the risk of COVID-19-related outcomes, SOT providers adapted the way they deliver care to their patients, leading to a reliance on telehealth. Telehealth has helped organ transplant programs continue treatment regimens while protecting patients and physicians from COVID-19 transmission. This review highlights the adverse effects of COVID-19 on transplant activities and summarizes the increased role of telehealth in the management of solid organ transplant recipients (SOTRs) in both pediatric and adult populations. METHODS: A comprehensive systematic review and meta-analysis were conducted to accentuate the outcomes of COVID-19 and analyze the efficacy of telehealth on transplant activities. This in-depth examination summarizes extensive data on the clinical detriments of COVID-19 in transplant recipients, advantages, disadvantages, patient/physician perspectives, and effectiveness in transplant treatment plans via telehealth. RESULTS: COVID-19 has caused an increase in mortality, morbidity, hospitalization, and ICU admission in SOTRs. Telehealth efficacy and benefits to both patients and physicians have increasingly been reported. CONCLUSIONS: Developing effective systems of telehealth delivery has become a top priority for healthcare providers during the COVID-19 pandemic. Further research is necessary to validate the effectiveness of telehealth in other settings.
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COVID-19 , Organ Transplantation , Telemedicine , Adult , Child , Humans , COVID-19/epidemiology , Organ Transplantation/adverse effects , Pandemics , SARS-CoV-2 , Transplant RecipientsABSTRACT
Background. The CLUSTER trial assessed the impact of prospective identification of clusters coupled with a response protocol on the containment of hospital clusters. Methods. This 82-hospital CRT in 16 states compared clusters of bacterial and fungal healthcare pathogens using a statistical outbreak detection tool (WHONET-SaTScan) coupled with a standardized response protocol (automated cluster detection arm) compared to routine surveillance with the response protocol (control arm). Trial periods: 24 mo Baseline (2/17-1/19);5 mo Phase-in (2/19-6/ 19);30 mo Intervention (7/19-1/22). The primary outcome was the number of additional cases occurring after initial cluster detection. Analyses used generalized linear mixed models to assess differences in additional cases between the intervention vs baseline periods across arms, clustering by hospital. Results were assessed overall and, to account for the effect of COVID-19 on hospital operations, stratified into pre-COVID-19 (7/19-6/20) and during COVID-19 (7/20-1/22) intervention periods. We also assessed the probability that a patient was in a cluster. Results. In the baseline period, the automated cluster detection and control arms had 0.09 and 0.07 additional cluster cases/1000 admissions, respectively. The automated cluster detection arm had a 22% greater relative reduction in additional cluster cases in the intervention vs baseline period compared to control (P=0.5). Within the intervention period, the automated cluster detection arm had a significant 64% relative reduction pre-COVID-19 (P< 0.05) and a non-significant 6% relative reduction during COVID-19 (P=0.9) compared to control (Figure). When evaluating patient risk of being part of a cluster across the entire intervention period, the automated cluster detection arm had a significant 35% relative reduction vs control (P< 0.01). Conclusion. A statistical automated tool coupled with a response protocol improved cluster containment by 64% pre-COVID-19 but not during COVID-19;there were no significant differences between the arms when using the entire intervention period. Automated cluster detection may substantially improve outbreak containment in non-pandemic periods when infection prevention programs are able to optimize containment protocols. (Figure Presented).
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This conclusion of the compendium of essays by Anthony E. Clark summarizes the content and significance of his research on the history of Catholicism in China. It was written as the COVID-19 virus was sweeping across the globe, and Clark reflects upon the comparisons between the virus' outbreak at Wuhan in 2019 and two French Catholic missionaries, François-Régis Clet, and Jean-Gabriel Perboyre, who were martyred in the Wuchang district of Wuhan in the mid-nineteenth century. Also considered in this conclusion is the trend among scholars to depict China's relationship with the West and Christianity as one of "conflict” or "cooperation,” highlighting the two extremes of either irreconcilable difference or congruous sameness. Clark concludes this collection of essays with the suggestion that the historical exchange between China and the West has been rather an admixture of conflict and cooperation, but defined mostly as a relationship of friendship. © 2020, The Author(s).
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Background: The COVID-19 pandemic has caused unprecedented health care challenges mandating surgical service reconfiguration. Within our hospital, emergency and elective streams were separated and self-contained Protected Elective Surgical Units were developed to mitigate against infection-related morbidity. Aims of this study were to determine the risk of COVID-19 transmission and mortality and whether the development of Protected Elective Surgical Units can result in significant reduction in risk. Methods: A retrospective observational study of consecutive patients from 18 specialties undergoing elective or emergency surgery under general, spinal, or epidural anaesthetic over a 12-month study period was undertaken. Primary outcome measures were 30-day postoperative COVID-19 transmission rate and mortality. Secondary adjusted analyses were performed to ascertain hospital and Protected Elective Surgical Unit transmission rates. Results: Between 15 March 2020 and 14 March 2021, 9,925 patients underwent surgery: 6,464 (65.1%) elective, 5,116 (51.5%) female, and median age 57 (39-70). A total of 69.5% of all procedures were performed in Protected Elective Surgical Units. Overall, 30-day postoperative COVID-19 transmission was 2.8% (3.4% emergency vs 1.2% elective Pâ¯<â¯.001). Protected Elective Surgical Unit postoperative transmission was significantly lower than non-Protected Elective Surgical Unit (0.42% vs 3.2% Pâ¯<â¯.001), with an adjusted likely in-hospital Protected Elective Surgical Unit transmission of 0.04%. The 30-day all-cause mortality was 1.7% and was 14.6% in COVID-19-positive patients. COVID-19 infection, ageâ¯>â¯70, male sex, American Society of Anesthesiologists grade > 2, and emergency surgery were all independently associated with mortality. Conclusion: This study has demonstrated that Protected Elective Surgical Units can facilitate high-volume elective surgical services throughout peaks of the COVID-19 pandemic while minimising viral transmission and mortality. However, mortality risk associated with perioperative COVID-19 infection remains high.
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Mirroring the trend of the growth of Computer Science (CS) programs nation and worldwide, the CS program in the College of Engineering at Tennessee Technological University has experienced similar growth in the number of students enrolling in its B.S., M.S., and Ph.D. programs. This growth of enrollment in CS has been accompanied by a growth in another student population at the university that is often overlooked: Interdisciplinary Studies - Interest in Computer Science (ICSC) majors. This population represents students who have qualified for admission at Tennessee Tech, but have not qualified for entry into the CS program. Indeed, just as the freshman class of CS has grown 44%, the ICSC program has grown 63%. To address the problem of retention and migration into CS from ICSC, we have developed the pre-CS Redshirt program, which is aimed at providing increased advising, peer mentoring, tutoring, and connections to faculty. Launched in Fall 2020, the challenges facing these students have been compounded by COVID-19. In order to study initial effectiveness, we measured Fall-Spring retention, comparative GPAs for students in the CS and ICSC programs, and conducted a survey of students to measure students' sense of belongingness with the measured population including students of all levels currently enrolled in the CS program as well as the pre-CS Redshirt students.
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Introduction: Primary tracheal tumors are rare with an incidence of 0.2/100,000 persons, accounting for 0.6% of all pulmonary tumors. Only 10-20% of these tumors are benign with the most common being recurrent respiratory papillomatosis. Other benign tracheobronchial tumors include hamartoma, fibroma, lipoma and hemangioma among others. Due to the slow growing nature of these tumors, patients may present with progressive exertional dyspnea, cough and recurrent pneumonia, though rarely these tumors are identified incidentally in asymptomatic patients. This case describes a patient with an who underwent successful resection with flexible bronchoscopy and snare electrocautery. Case Report: A 66-year-old male with a history of former tobacco use was admitted to the medical intensive care unit (ICU) in 11/2020 with COVID-19 pneumonia, and incidentally found to have a tracheal tumor noted on CT imaging. His ICU course was complicated by submassive pulmonary embolism, pneumothorax requiring chest tube, and acute hypoxemic respiratory failure requiring heated high-flow nasal cannula. He was successfully discharged to home after 4 weeks and evaluated in the ambulatory clinic for follow-up 2 months later. Review of his imaging from an outside facility demonstrated a 1-cm polypoid lesion arising from the right tracheal wall (Figure 1A). Pulmonary function testing demonstrated a moderate restrictive defect with normal flow-volume loops. He was referred to interventional pulmonology for further evaluation and management. Flexible bronchoscopy revealed a 50% partially obstructing polypoid mass 6-cm distal to the vocal cords (Figure 1B). The mass was excised using snare electrocautery with subsequent cryotherapy for destruction of abnormal tissue at the base of the lesion and argon plasma coagulation for hemostasis. Pathology revealed tracheal lipoma. Repeat flexible bronchoscopy 12 weeks later revealed no evidence of recurrence at the site of the previously resected tracheal lipoma (Figure 1C). Discussion: Among benign tracheobronchial tumors, lipoma is an extremely rare diagnosis representing only 3-9% of cases. Airway lipomas very rarely involve the trachea and are infrequently found incidentally in asymptomatic patients. Epidemiological risk factors are thought to include male gender, obesity, middle age, and smoking. Flexible tracheobronchoscopy remains the gold standard for diagnosis, also allowing for excisional treatment with electrocautery, cryotherapy, or laser therapy. Given the rare incidence of these tumors, follow-up evaluation is recommended, though to-date there are no reports of local recurrence after bronchoscopic treatment. This case highlights the importance for diagnostic evaluation of incidental tracheobronchial tumors given the rare incidence of benign diagnoses.
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Background and Aims: The objective of this study was to evaluate the impact of virtual care for gestational diabetes (GDM) in the context of the COVID-19 pandemic. Methods: This mixed methods program evaluation used the quadruple aim framework. The impact on patient and provider satisfaction and costs was assessed with surveys and interviews. Chi-square tests of independence compared clinical outcomes before (April 2019-Feb 2020) to after (May 2020-March 2021) the shift to virtual care. Results: 82 women completed a patient experience questionnaire. The majority rated their virtual care experience as good or excellent (93%) with a preference to continue visits in the future (84%). Most respondents felt virtual care saved them money (90%) and time (98%). Providers all felt the switch to virtual care was positive but there was concern about the loss of non-verbal cues and personal connections. Physicians noted increased efficiency however more difficulty with assessing glucose trends. Nurses noted an increased work load, concerns about adequacy of patient education and delays in insulin initiation. When comparing outcomes for women who received in-person and virtual care there were no significant difference in rates of insulin initiation, C-sections, macrosomia or NICU admissions. There was a decreased rate of missed appointments after the switch to virtual care (6.1% vs 1.1%, p-value < .01). Conclusions: There has been high patient and provider satisfaction for virtual GDM care with no difference in clinical outcomes and less missed appointments. Virtual GDM care should remain an option in the future.
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ImageCLEF s part of the Conference and Labs of the Evaluation Forum (CLEF) since 2003. CLEF 2022 will take place in Bologna, Italy. ImageCLEF is an ongoing evaluation initiative which promotes the evaluation of technologies for annotation, indexing, and retrieval of visual data with the aim of providing information access to large collections of images in various usage scenarios and domains. In its 20th edition, ImageCLEF will have four main tasks: (i) a Medical task addressing concept annotation, caption prediction, and tuberculosis detection;(ii) a Coral task addressing the annotation and localisation of substrates in coral reef images;(iii) an Aware task addressing the prediction of real-life consequences of online photo sharing;and (iv) a new Fusion task addressing late fusion techniques based on the expertise of the pool of classifiers. In 2021, over 100 research groups registered at ImageCLEF with 42 groups submitting more than 250 runs. These numbers show that, despite the COVID-19 pandemic, there is strong interest in the evaluation campaign.
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Introduction: The COVID-19 pandemic ushered in a rapid, transformative adoption of telemedicine to maintain patient access to care. As clinicians made the shift from in-person to virtual practice, they faced a paucity of established and reliable clinical examination standards for virtual care settings. In this systematic review, we summarize the accuracy and reliability of virtual assessments compared with traditional in-person examination tools. Methods: We searched PubMed, Embase, Web of Science, and CINAHL from inception through September 2019 and included additional studies from handsearching of reference lists. We included studies that compared synchronous video (except allowing for audio-only modality for cardiopulmonary exams) with in-person clinical assessments of patients in various settings. We excluded behavioral health and dermatological assessments. Two investigators abstracted data using a predefined protocol. Results: A total of 64 studies were included and categorized into 5 clinical domains: neurological (N = 41), HEENT (head, eyes, ears, nose, and throat; N = 5), cardiopulmonary (N = 5), musculoskeletal (N = 8), and assessment of critically ill patients (N = 5). The cognitive assessment within the neurological exam was by far the most studied (N = 19) with the Mini-Mental Status Exam found to be highly reliable in multiple settings. Most studies showed relatively good reliability of the virtual assessment, although sample sizes were often small (<50 participants). Conclusions: Overall, virtual assessments performed similarly to in-person exam components for diagnostic accuracy but had a wide range of interrater reliability. The high heterogeneity in population, setting, and outcomes reported across studies render it difficult to draw broad conclusions on the most effective exam components to adopt into clinical practice. Further work is needed to identify virtual exam components that improve diagnostic accuracy.
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Aim: The COVID-19 pandemic has caused unprecedented healthcare challenges mandating surgical service reconfiguration. Within our hospital, emergency and elective streams were separated and self contained Protected Elective Surgical Units (PESU) were developed to mitigate against infection related morbidity. Aims of this study were to determine the risk of COVID-19 transmission and mortality and whether the development of PESUs can result in significant reduction in risk. Method: A retrospective observational study of consecutive patients from 18 specialties, undergoing elective or emergency surgery under general, spinal, or epidural anaesthetic over a 12-month study period was undertaken. Primary outcome measures were 30-day postoperative COVID-19 transmission rate and mortality. Secondary adjusted analyses were performed to ascertain hospital and PESU transmission rates. Results: Between 15th March 2020 and 14th March 2021, 9,925 patients underwent surgery, 6,464 (65.1%) elective, 5,116 (51.5%) female and median age 57 (39-70). 69.5% of all procedures were performed in PESUs. Overall, 30-day post-operative COVID-19 transmission was 2.8% (3.4% emergency vs 1.2% elective p<0.001). PESU post-operative transmission was significantly lower than non-PESU (0.42% vs 3.2% p<0.001), with an adjusted likely in-hospital PESU transmission of 0.04%. The 30-day all-cause mortality was 1.7%, and 14.6% in COVID-19 positive patients. COVID-19 infection, age >70, male gender, ASA >2 and emergency surgery were all independently associated with mortality. Conclusions: This study has demonstrated the value of PESUs in minimising COVID-19 viral transmission and associated mortality with additional relevance to protected elective services going forward (possibilities of reduced cancellations due to bed shortages and transmission of other nosocomial infections).
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Background. The profound changes wrought by COVID-19 on routine hospital operations may have influenced performance on hospital measures, including healthcare-associated infections (HAIs). Objective. Evaluate the association between COVID-19 surges and HAI or cluster rates Methods. Design: Prospective cohort study Setting. 148 HCA Healthcare-affiliated hospitals, 3/1/2020-9/30/2020, and a subset of hospitals with microbiology and cluster data through 12/31/2020 Patients. All inpatients Measurements. We evaluated the association between COVID-19 surges and HAIs, hospital-onset pathogens, and cluster rates using negative binomial mixed models. To account for local variation in COVID-19 pandemic surge timing, we included the number of discharges with a laboratory-confirmed COVID-19 diagnosis per staffed bed per month at each hospital. Results. Central line-associated blood stream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia increased as COVID-19 burden increased (P ≤ 0.001 for all), with 60% (95% CI, 23 to 108%) more CLABSI, 43% (95% CI, 8 to 90%) more CAUTI, and 44% (95% CI, 10 to 88%) more cases of MRSA bacteremia than expected over 7 months based on predicted HAIs had there not been COVID-19 cases. Clostridioides difficile infection (CDI) was not significantly associated with COVID-19 burden. Microbiology data from 81 of the hospitals corroborated the findings. Notably, rates of hospital-onset bloodstream infections and multidrug resistant organisms, including MRSA, vancomycin-resistant enterococcus and Gram-negative organisms were each significantly associated with COVID-19 surges (P < 0.05 for all). Finally, clusters of hospital-onset pathogens increased as the COVID-19 burden increased (P = 0.02). Limitations. Variations in surveillance and reporting may affect HAI data. Table 1. Effect of an increase in number of COVID-19 discharges on HAIs and hospital-onset pathogens Figure 1. Predicted mean HAI rates as COVID-19 discharges increase Predicted mean HAI rate by increasing monthly COVID-19 discharges. Panel a. CLABSI, Panel b, CAUTI Panel c. MRSA Bacteremia, Panel d. CDI. Data are stratified by small, medium and large hospitals. Figure 2. Monthly comparison of COVID discharges to clusters COVID-19 discharges and the number of clusters of hospital-onset pathogens are correlated throughout the pandemic. Conclusion. COVID-19 surges adversely impact HAI rates and clusters of infections within hospitals, emphasizing the need for balancing COVID-related demands with routine hospital infection prevention.
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Background. BRIGHTE is an ongoing global study evaluating the gp120 attachment inhibitor fostemsavir (FTR) in heavily treatment-experienced (HTE) adults with multidrug resistant (MDR) HIV-1 unable to form a viable antiretroviral (ARV) regimen. An estimated 2 million people living with HIV-1 have been infected with SARS-CoV-2. Those with HIV viremia and/or low CD4+ counts are at increased risk of serious adverse outcome. We describe the reported COVID cases in a clinical trial population of people living with MDR HIV and immune suppression. Methods. At the start of the COVID pandemic, all ongoing BRIGHTE subjects had achieved ≥ 192 weeks on FTR and optimized background ARVs;results through Week 96 were presented previously. Investigators used WHO guidelines for COVID diagnosis and reported exposure, testing results and symptom presence. Figure 1. BRIGHTE Study Design Results. 371 subjects [272 Randomized Cohort (RC), 99 Non-Randomized Cohort (NC)] were enrolled;44% were ≥ 50 years of age and 86% had an AIDS history. Median CD4+ count at study start of was 80 cells/mm3 (IQR 11-202);30% with ≤ 20 cells/mm3. 250 subjects remained in BRIGHTE at pandemic start. By April 2021, 17 subjects (14 RC, 3 NC) had confirmed COVID infection (positive PCR test). Severity was Grade 1-3, all cases resolved with no deaths. Six subjects were hospitalized (Table 1);most recent CD4+ count prior to COVID were 293-1641 cells/mm3 and 5/6 subjects were virologically suppressed. Treatments often included prophylactic anticoagulants and supplemental oxygen;no cART changes were made. The remaining 11/17 confirmed cases were managed outpatient. Five more subjects had suspect COVID not confirmed by PCR and 2 subjects had negative PCR tests. Table 1. Characterization of Participants with Serious AEs of Confirmed COVID-19 Infections - All Hospitalizations Conclusion. A total of 22/250 COVID-19 cases (17 confirmed, 5 unconfirmed) have been reported in BRIGHTE. Outcomes were reassuring with no deaths or known persistent sequelae, despite having advanced HIV and comorbid diseases at baseline associated with poorer COVID outcomes. Outcomes may have benefitted from immunologic improvement during the trial.