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1.
Acta Paediatr ; 2022.
Article in English | Web of Science | ID: covidwho-2019132

ABSTRACT

AIM: Our aim was to describe the epidemiology of multisystem inflammatory syndrome in children (MIS-C) in the Republic of Ireland, in the context of all cases of COVID-19 in children, during the first year of the SARS-CoV-2 pandemic. METHODS: Cases of MIS-C were identified by prospective surveillance in Irish hospitals from April 2020 to April 2021. Paediatric COVID-19 cases and outbreaks in schools or childcare facilities were notified to and routinely investigated by Public Health. Univariate and bivariate analyses were carried out in Excel, Stata and JMP statistical package. RESULTS: Fifty-four MIS-C cases (median age 7.58 years;males 57%) were identified over the study period. MIS-C incidence was higher in certain ethnicities ('black' 21.3/100,000 [95% CI 4.3-38.4];and 'Irish Traveller' 14.7/100,000 [95% CI -5.7-35.1]) than those of 'white' ethnicity (3.4 /100,000). MIS-C cases occurred in three temporal clusters, which followed three distinct waves of community COVID-19 infection, irrespective of school closures. Formal contact tracing identified an epidemiological link with a COVID-19-infected family member in the majority of MIS-C cases (77%). In contrast, investigation of COVID-19 school outbreaks demonstrated no epidemiological link with MIS-C cases during the study period. CONCLUSION: Efforts at controlling SARS-CoV-2 transmission in the community may be a more effective means to reduce MIS-C incidence than school closures. Establishing a mandatory reporting structure for MIS-C will help delineate the role of risk factors such as ethnicity and obesity and the effect of vaccination on MIS-C incidence.

3.
Gastroenterology ; 162(7):S-1008, 2022.
Article in English | EMBASE | ID: covidwho-1967396

ABSTRACT

BACKGROUND: Immune-modulating medications for inflammatory bowel diseases (IBD) have been associated with suboptimal vaccine responses. There is conflicting data with SARS-CoV-2 vaccination. METHODS: We measured SARS-CoV-2 vaccine immunogenicity at 2 weeks post 2nd mRNA vaccine in IBD patients as compared to normal healthy donors (NHD). We measured humoral immune responses to SARS-CoV-2: anti-spike Immunoglobulin G (IgG) and anti-receptor binding domain (RBD) IgG were measured by ELISA, and neutralizing antibody titers were measured using recombinant, reporter SARS-CoV-2. Antigen specific memory B cells were measured using recombinant SARS-CoV-2 proteins. Activation induced marker T cell (AIM) assays were performed using SARS-CoV-2 spike megapools. Immunophenotyping was performed by flow cytometry. RESULTS: We enrolled 29 patients with IBD (19 with Crohn's disease, 10 with ulcerative colitis) on infliximab (IFX) monotherapy (N=9), IFX combination therapy with a thiopurine (N=9), vedolizumab monotherapy (N= 11) as compared to matched NHD (N=12). At 2 weeks post vaccination, all subjects made detectable anti-spike IgG and anti-RBD IgG. There were no differences in anti-spike IgG titers among the different groups. IBD patients on IFX monotherapy, but not IBD patients on IFX combination therapy or vedolizumab monotherapy, had lower anti-RBD and neutralization titers as compared to NHD (p-value: 0.041 and 0.023, respectively) (Fig. 1). There were no significant differences in the percentage of spike-specific or RBD-specific memory B cells in IBD patients as compared to NHD (Fig. 1). There were no differences in the percentage of spike-specific CD4+ or CD8+ T cells in all IBD patients as compared to NHDs (Fig. 2). CONCLUSIONS: We demonstrate overall comparable and perserved cell-mediated immunity to SARS-CoV-2 vaccination in a small cohort of IBD patients treated with a range of different immune-modulating medications as compared to healthy controls. Larger numbers of patients are needed to validate these findings.

4.
Neurology ; 98(18 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1925309

ABSTRACT

Objective: We are investigating whether COVID-19 infection increases the propensity of developing Guillain-Barré Syndrome (GBS) or affects the clinical outcome of GBS. Background: During the pandemic, there have been many case reports and case series of GBS following COVID-19 infection. The causality of COVID-19 in these cases is not clear. There are conflicting reports regarding the incidence of GBS during the pandemic. In prior literature, clinical and electrophysiologic characteristics of GBS in COVID-19 associated cases did not differ from the previously described natural history. Design/Methods: Longitudinal electronic health record database for Optum, which included more than 4.4 million patients who underwent testing for COVID-19, was queried in May 2021 for ICD-9 and ICD-10 codes for GBS. Clinical information based on billing codes was acquired. GBS cases within 60 days of the first positive PCR test for COVID-19 were further analyzed. We also evaluated the presence of GBS in patients who tested negative for COVID 19 during the same time frame. Results: There were 725,347 patients in the database with COVID-19 diagnosis. We analyzed 844 patients with GBS, 86 of which occurred within 60 days of COVID-19 diagnosis. The incidence of GBS was not increased among the patients with recent COVID 19 diagnosis, compared to the GBS cases without COVID 19 in the same time frame. In our preliminary analysis, COVID-19 associated cases had higher mortality, intubation rates, and need for posthospital rehabilitation at a facility. Conclusions: Our preliminary analysis of this large database did not show any evidence that COVID-19 increases the propensity for developing GBS. However, when associated with COVID-19 infection, the outcomes for GBS seem to be worse. Further ongoing analyses considering covariates of age, comorbidities, and month of COVID-19 diagnosis is planned.

5.
British Journal of Haematology ; 197(SUPPL 1):153-154, 2022.
Article in English | EMBASE | ID: covidwho-1861228

ABSTRACT

An explosion of research has occurred since the advent of the COVID-19 pandemic relating to its effect on the NHS, health consciousness and vaccine side effects, such as vaccine-induced thrombocytopenia and thrombosis (VITT). This project sought to establish the effects of the UK's national lockdowns and media coverage of VITT on the rate of referrals and outcomes of DVT clinic appointments at our hospital. There was a suspicion among nurses running the DVT clinic that referrals were lower, but rates of positive scans higher, during the first national lockdown and that the reverse was true following media reporting of the first cases of VITT, with large numbers of patients testing negative for DVT. We report the findings of a retrospective, observational case-control study of 3550 patients presenting to Norfolk and Norwich University Hospital outpatient DVT clinic from any referral source (usually GP or A + E) between 2/3/2020 and 10/5/2021. Data from 2015 to 2019 were also obtained, providing 5-year averages for comparison. Outcomes were classified as positive (for DVT), negative (including those where Doppler ultrasound scan was not indicated due to low Wells score and negative D-dimer) and DNA (did not attend). Chi-squared (χ2 ) analyses were undertaken to determine heterogeneity of weekly referrals during specific periods of the pandemic. With 2 degrees of freedom (2df), a χ2 result above 5.9 suggests heterogeneity. T -tests were run to compare the outcomes driving the χ2 results with the data from the preceding 5 years. Compared to the non-lockdown period, there was a significant reduction in the number of referrals seen during the dates of the 1st national lockdown (χ2 = 20.01, 2df, p = <0.01). This was primarily due to a reduction in the number of patients subsequently found to be negative for DVT (31.0 vs. 45.4, p = <0.01). The difference was less marked and did not reach statistical significance during the 2nd and 3rd lockdowns. A significant increase in total weekly referrals was observed during the period immediately following media reporting of the first cases of VITT related to the AstraZenaca COVID-19 vaccine (55.1 vs. 73.1, p = <0.01). This was driven by an increase in patients subsequently found to be negative for DVT (39.2 vs. 57.2 p = <0.01). The weekly number of positive patients during this time was not significantly higher than the preceding 5-year average for the same dates (9.7 vs. 10.2, p = 0.30). Comparison with 5-year averages confirmed that the pattern seen in different parts of the pandemic year described above did not follow the usual pattern of referrals across the year. Finally, throughout the observed period, there was a below average rate of DNA outcomes when compared to the preceding 5-year average. These findings suggest several phenomena unique to the COVID-19 pandemic. First, measures to prevent the spread of COVID-19 were associated with fewer patients without DVT being referred to the DVT clinic. Second, media reporting of VITT was associated with a higher rate of referral of patients without a DVT to the DVT clinic without any change in the number of positive patients compared to the preceding 5 years. Third, during the COVD-19 pandemic, there were fewer patients failing to attend their clinic appointment, which we hypothesise is as a result of increased awareness of the need not to waste NHS resources..

6.
Mobile Medicine: Overcoming People, Culture, and Governance ; : 237-246, 2021.
Article in English | Scopus | ID: covidwho-1841609

ABSTRACT

Race-related tragedies in America in 2020 and 2021, coupled with the COVID-19 global pandemic, have amplified awareness of deep racial inequity in our society and ignited intense national dialogue about systemic racism. Healthcare leaders in hospitals, health systems, enterprise healthcare technology companies, and mobile medicine start-ups have a unique opportunity and responsibility to address diversity, equity, and inclusion in their organizations and drive a sense of belonging and access among patients and employees. Effective DEI practices will be required to attract the best talent and to secure the biggest and most influential customer segments. Formally, healthcare leaders are responsible for both setting the strategy for diversity, equity, and inclusion efforts, as well as executing on the organizational vision and delivering results supported by data. Healthcare leaders at future-ready, marquee organizations drive diversity, equity, and inclusion with both a governance and talent lens. © 2022 selection and editorial matter, Sherri Douville;individual chapters, the contributors.

8.
Clin Infect Dis ; 2021 Sep 01.
Article in English | MEDLINE | ID: covidwho-1700720

ABSTRACT

BACKGROUND: Coronavirus Disease 2019 (Covid-19) requiring hospitalization is characterized by robust antibody production, dysregulated immune response and immunothrombosis. Fostamatinib, is a novel spleen tyrosine kinase inhibitor we hypothesize will ameliorate Fc activation and attenuate harmful effects of the anti-COVID-19 immune response. METHODS: We conducted a double-blind, randomized, placebo-controlled trial in hospitalized adults requiring oxygen with Covid-19 where patients receiving standard of care were randomized to receive fostamatinib or placebo. The primary outcome was serious adverse events by day 29. RESULTS: A total of 59 patients underwent randomization (30 to fostamatinib and 29 to placebo). Serious adverse events occurred in 10.5% of patients in the fostamatinib group compared to 22% in placebo (P = .2). Three deaths occurred by day 29, all receiving placebo. The mean change in ordinal score at day 15 was greater in the fostamatinib group (-3.6 ± 0.3 vs. -2.6 ± 0.4, P = .035) and the median length in the ICU was 3 days in the fostamatinib group vs. 7 days in placebo (P = .07). Differences in clinical improvement were most evident in patients with severe or critical disease (median days on oxygen, 10 vs. 28, P = .027). There were trends towards more rapid reductions in C-reactive protein, D-dimer, fibrinogen and ferritin levels in the fostamatinib group. CONCLUSION: For COVID-19 requiring hospitalization, the addition of fostamatinib to standard of care was safe and patients were observed to have improved clinical outcomes compared to placebo. These results warrant further validation in larger confirmatory trials.

9.
Journal of University Teaching and Learning Practice ; 18(8):17, 2021.
Article in English | Web of Science | ID: covidwho-1663271

ABSTRACT

At a time of transition into adulthood, tertiary study places additional stresses on the mental wellbeing of students. The continual assessment, long teaching hours, and expectation of professionalism that is expected from students within clinical programmes places even more burden on these students. Then in 2020, with the COVID-19 lockdown, there were significant changes to how these programs were delivered. We surveyed the mental wellbeing of our undergraduate students in the Bachelor of Optometry and Bachelor of Pharmacy programmes at the University of Auckland in 2019 and 2020. Using validated screening questionnaires, we found a high level of anxiety and depression in both years, however, in 2020 following the lockdown, anxiety levels in our students decreased. We found that the leading stressor was academic stress, and levels of anxiety were inversely correlated with perceived academic success. Therefore, we believe the lockdown, which provided both a break from clinical stresses and a change in teaching modality to online delivery, provided a period of relief, despite the potential stressful environment regarding COVID-19. To help alleviate the high level of distress in our students, lessons could be learned to decrease the stress levels in our students by continuing with alternative teaching and assessment styles. Practitioner Notes 1. A substantial proportion of tertiary clinical students face experience anxiety and depression 2. Most of the stress derives from academic pressures 3. During the COVID-19 lockdown, with enforced changes to teaching and evaluation, students experienced a significant reduction in anxiety 4. Modifications to standard clinical teaching methods to include more online and asynchronous assessment methods may improve the mental wellbeing of students

10.
Asia-Pacific Journal of Clinical Oncology ; 17(SUPPL 9):88-89, 2021.
Article in English | EMBASE | ID: covidwho-1591401

ABSTRACT

Purpose: The COVID-19 pandemic has accelerated the rapid expansion and adoption at scale of telehealth, where previously reserved in use to remote communities. This afforded a novel opportunity to study the impact of telehealth delivery on oncology care. Our study aimed to qualitatively explore current physician and patient perspectives on the utility of telehealth in oncology care. Materials and Methods: Semi-structured interviews of seven physicians and eleven patients, recruited from an oncology department in an Australian tertiary teaching hospital, were conducted. Two authors independently coded the transcripts and emerging themes were identified and refined in an iterative process of thematic analysis. Results : Telehealth offered broadened possibilities by allowing continuity of care in the pandemic and enabling patients and physicians to discover novel advantages. It also brought to the fore often overlooked elements of in-person care unavailable on telehealth. These included the information communicated physically through formal and informal physical examination, the collaboration between patient and physician in shaping outcomes and building rapport, and the confidence in decisions made and physician performance. While patients and physicians envisioned the continuation of telehealth post-pandemic, logistical steps are necessary to address these challenges. Conclusion: This study highlights the unprecedented opportunities that telehealth presents in widening access and diversifying oncology care. However, it also demonstrates that telehealth, particularly in a 'one-size-fits-all' approach, cannot always reach equivalence in quality of care. Further research is required to identify when and for whom telehealth is most acceptable, to maximise its potential benefits in a potential hybrid model of care.

11.
Blood ; 138:2321, 2021.
Article in English | EMBASE | ID: covidwho-1582311

ABSTRACT

Background Based on early evidence of a high rate of coronavirus mortality in patients with acute myeloid leukaemia (AML) undergoing intensive chemotherapy (IC), the national health service (NHS) in the United Kingdom temporarily made venetoclax available as an alternative therapy, with the aim of reducing both mortality and healthcare resource use. From late April 2020, venetoclax was available to patients aged >16y with NPM1 mutation without FLT3 internal tandem duplication (ITD), patients aged >50y with NPM1, IDH1 or IDH2 mutations (regardless of FLT3 status) and patients aged >60y without favourable-risk cytogenetics. Venetoclax could be given with either azacitidine or low-dose cytarabine (LDAC), with the latter recommended mainly for patients with NPM1 mutation. We report a health-system-wide real world data collection for toxicity and patient outcomes across 65 NHS Hospitals. Methods Each patient was registered on a central NHS database. Clinicians certified that their patient met the above criteria, had not received previous AML treatment, and was fit for induction chemotherapy. Anonymised data were retrospectively collected by treating physicians. Venetoclax dose, duration and toxicity information was requested for the first 4 cycles of therapy. Response definitions were as per European Leukaemia Network (ELN) guidelines. A total of 870 patients have been registered on the scheme, with outcomes reported here for those with follow-up information at a data cut on 1st August 2021. Results There were 301 patients, median age 72y (range 34 - 90) with 62% male. The majority (81%) had an ECOG performance status of 0-1. AML was secondary to a previous haematological disorder in 33%, therapy-related in 10% and de novo in the remaining 57%. MRC cytogenetic risk was intermediate in 70% and adverse in 27%. NPM1 mutations were detected in 28% and FLT3-ITD in 12%. Next-generation sequencing results were available in 86% of patients, which detected mutations in IDH1 or IDH2 in 28%, ASXL1 in 20%, RUNX1 in 17% and TP53 in 12%. The ELN risk was favourable for 23%, intermediate for 30% and adverse for 44%. A majority received venetoclax in combination with azacitidine (85%), with the remaining 15% receiving LDAC. The LDAC cohort was enriched for de novo AML (76% vs 54%) and NPM1-mutated disease (56% vs 23%). Most patients (81%) followed the recommended initial schedule of venetoclax 100mg daily for 28 days in combination with posaconazole or voriconazole. Patients spent a median 14 days in hospital in cycle 1, then a median of 0 days for cycles 2-4. In cycles 1, 2, 3 and 4, the median number of days for recovery of neutrophils to >0.5x10 9/L was 33, 25, 24 and 14 respectively, and the median number of days to recovery of platelets to >50x10 9/L was 22, 3, 0 (no drop below 50) and 0. The composite complete remission (CR) / CR with incomplete haematological recovery (CRi) rate was 70%. MRD data is being collected. The best response was morphological leukaemia free state (MLFS) in 2%, partial remission in 7% and refractory disease in 11%. CR/CRi was higher in de novo (78%) compared to secondary AML (57%, p=0.02);NPM1 mutated (78% vs 67%, p=0.02) and IDH1/IDH2 mutated disease (85% vs 62%, p=0.02). ELN favourable risk patients had the highest CR/CRi rate (85%, intermediate 71%, adverse 60%, p=0.01). Median follow-up was 8.2 months (95%CI 7.8 - 9.0) with median overall survival (OS) 12.8 months (95%CI 10.9 - not reached). Mortality at day 30 was 5.7% and day 60 was 8.4%. 12-month overall survival was 51%, increasing to 71% in those who achieved CR/CRi. Survival was poorer in secondary (HR 1.9, p <0.01) and therapy-related AML (HR 2.1, p=0.02), better in NPM1 mutated (HR 0.6, p=0.02) and IDH mutated (HR 0.5, p=0.02) disease and poorer with TP53 mutation (HR 2.0, p=0.01). Overall survival did not differ for patients treated with LDAC compared to azacitidine (HR 1.1, p=0.7). Conclusion This large real-world study demonstrates CR/CRi and survival rates comparable to those reported in prospective clinical trials. Importantly, during t e COVID-19 pandemic, the adoption of venetoclax regimens permitted the great majority of treatment to be delivered as an outpatient with significant resource saving at a time of critically constrained inpatient resources. The data support prospective comparisons of venetoclax-based regimens to IC in fit adults with AML particularly in older patients with de novo AML, NPM1-mutated and IDH-mutated disease. [Formula presented] Disclosures: Belsham: Celgene: Other: meeting attendance;Abbvie: Other: meeting attendance. Khan: Abbvie: Honoraria;Astellas: Honoraria;Takeda: Honoraria;Jazz: Honoraria;Gilead: Honoraria;Novartis: Honoraria. Khwaja: Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Astellas: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Latif: Kite: Consultancy, Honoraria, Speakers Bureau;Jazz: Consultancy, Honoraria;Daiichi Sankyo: Consultancy, Honoraria;Novartis: Consultancy, Honoraria;Amgen: Consultancy, Honoraria;Abbvie: Consultancy, Honoraria;Astellas: Consultancy, Honoraria, Speakers Bureau;Takeda UK: Speakers Bureau. Loke: Pfizer: Honoraria;Amgen: Honoraria;Janssen: Honoraria;Novartis: Other: Travel;Daichi Sankyo: Other: Travel. Murthy: Abbvie: Other: support to attend educational conferences. Smith: ARIAD: Honoraria;Pfizer: Speakers Bureau;Daiichi Sankyo: Speakers Bureau. Whitmill: Daiichi-sankyo: Other: travel fees;EHA in stockholm: Other: conference support. Craddock: Novartis Pharmaceuticals: Other: Advisory Board;Celgene/BMS: Membership on an entity's Board of Directors or advisory committees, Research Funding. Dillon: Shattuck Labs: Membership on an entity's Board of Directors or advisory committees;Jazz: Other: Education events;Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: educational events;Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Session chair (paid to institution), Speakers Bureau;Menarini: Membership on an entity's Board of Directors or advisory committees;Astellas: Consultancy, Other: Educational Events, Speakers Bureau;Amgen: Other: Research support (paid to institution);Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Research Support, Educational Events.

12.
Performance Measurement and Metrics ; ahead-of-print(ahead-of-print):13, 2021.
Article in English | Web of Science | ID: covidwho-1494241

ABSTRACT

Purpose The project was conducted to learn how the services of the digital media commons (DMC) impact and support student success. Data were collected to learn how faculty perceive the instructional support program, how patrons perceive the quality of the services and how students use the services, technology and the space that the DMC occupies. The results will be used to improve services and instruction and to inform the future direction of our instruction support service post-COVID-19. Design/methodology/approach The project included three phases. First, a survey was sent to faculty who had brought their class for an instruction session to gain input on how they perceived the impact of the instruction and follow-up services on the quality of media projects. The second phase was a customer service survey implemented in the area to learn how patrons used the spaces and technology, what types of projects they completed in the DMC and their satisfaction with the assistance they received. The third phase employed student focus groups that followed up on the information from the survey to pinpoint how students perceive that the DMC impacts their academic success. Findings The data gained from the research indicated that (1) the teaching program provides important instruction for media projects, (2) the DMC provides important services and technology that contribute to student success and (3) The DMC space is an important destination for students as a learning space. Research limitations/implications The scope of this case study is limited by the size of sample groups surveyed and the presumed veracity of their responses. The implications of our results do, however, align with reported trends experienced by peer institutions. Practical implications This case study can be used by colleagues from other university's and learning environments to improve their space and instructional support offerings. Social implications Digital learning and work environments are increasing across the country due to society's demand for multimedia literacy instruction and technical support. This research will serve as a reference point for institutions starting and/or assessing the direct impact of digital spaces on student success and learning outcomes. Originality/value Although there are many studies on the impact of academic libraries' services, space and resources on student success, few specifically address the contributions of academic library digital media services on student achievement. This project fills that gap and will serve as a model for future research.

13.
Palliative Medicine ; 35(1 SUPPL):58, 2021.
Article in English | EMBASE | ID: covidwho-1477017

ABSTRACT

Background: The COVID-19 pandemic restrictions have led to extended usage of virtual communication technology in healthcare, especially via mobile applications. Understanding the adoption of mobile applicationenabled communication in end-of-life care in particular is important to improve its usage for patients and carers. This is a pertinent topic in light of the pandemic and the higher health risks of this population group. Aims: To explore the use of mobile application-enabled communication for end-of-life care patients and their carers. Methods (design, data collection, analysis): A realist synthesis approach is being adopted, using six databases and other information sources from 2005 to present. Data screening and quality assessment will be carried out by two reviewers independently. Discrepancies and disagreements will be discussed and resolved by a third reviewer. Data abstraction will use the context, mechanism, and outcome approach to capture specific information about the theories around the development, adoption, and use of mobile application-enabled technologies in end-of-life care. (https:// www.crd.york.ac.uk/prospero/display-record.php?RecordID=231535) Results: A total of 666 abstracts were screened and 218 full texts are being analysed. The project is ongoing, and the results will be presented at the meeting. A summary table of the theories around the development, adoption, and use of mobile application-enabled technologies in end-of-life care will be used to create a logic model of the link between empirical data and theories. Conclusion / Discussion: The study will highlight the theories which explain the adoption of technology use in end-of-life care. The realist synthesis uses the available theories as a starting point and the empirical findings to build on these. The results will help to inform the applicability of a blended model of face-to-face and virtual communication after the end of the pandemic.

14.
American Journal of Respiratory and Critical Care Medicine ; 203(9):1, 2021.
Article in English | Web of Science | ID: covidwho-1407089
15.
Clin Infect Dis ; 2021 Sep 01.
Article in English | MEDLINE | ID: covidwho-1381001

ABSTRACT

BACKGROUND: Coronavirus Disease 2019 (Covid-19) requiring hospitalization is characterized by robust antibody production, dysregulated immune response and immunothrombosis. Fostamatinib, is a novel spleen tyrosine kinase inhibitor we hypothesize will ameliorate Fc activation and attenuate harmful effects of the anti-COVID-19 immune response. METHODS: We conducted a double-blind, randomized, placebo-controlled trial in hospitalized adults requiring oxygen with Covid-19 where patients receiving standard of care were randomized to receive fostamatinib or placebo. The primary outcome was serious adverse events by day 29. RESULTS: A total of 59 patients underwent randomization (30 to fostamatinib and 29 to placebo). Serious adverse events occurred in 10.5% of patients in the fostamatinib group compared to 22% in placebo (P = .2). Three deaths occurred by day 29, all receiving placebo. The mean change in ordinal score at day 15 was greater in the fostamatinib group (-3.6 ± 0.3 vs. -2.6 ± 0.4, P = .035) and the median length in the ICU was 3 days in the fostamatinib group vs. 7 days in placebo (P = .07). Differences in clinical improvement were most evident in patients with severe or critical disease (median days on oxygen, 10 vs. 28, P = .027). There were trends towards more rapid reductions in C-reactive protein, D-dimer, fibrinogen and ferritin levels in the fostamatinib group. CONCLUSION: For COVID-19 requiring hospitalization, the addition of fostamatinib to standard of care was safe and patients were observed to have improved clinical outcomes compared to placebo. These results warrant further validation in larger confirmatory trials.

17.
American Journal of Respiratory and Critical Care Medicine ; 203(9), 2021.
Article in English | EMBASE | ID: covidwho-1277314

ABSTRACT

Rationale:The outbreak of COVID-19 in March of 2020 led to the emergent search for treatment options. Passive immune therapy with COVID-19 convalescent plasma (CCP) therapy was utilized as an investigational therapy. We designed an open label study and received an investigational new drug (IND) number from the Food and Drug Administration for the study on April 11, 2020. Methods:Patients with severe COVID-19 were enrolled and identical ABO CCP was administered. CCP was collected from recovered COVID-19 patients by our hospital blood donor services in line with FDA guidelines. Patients could receive up to three doses of CCP and each dose came from a different donor to potentiate therapeutic response. Subjects were followed for 28 days after infusion of COVID-19 convalescent plasma (CCP) in hospital or with weekly phone calls if discharged home. Results:45 patients received CCP through the study period of April 24th through August 21st. The median age was 60 (range: 16-87), and two thirds were male (n=30) with Hispanic predominance (58%). Patients also received supplemental therapies such as remdesivir, tocilizumab, dexamethasone, and inhaled nitric oxide. Twenty-six recipients received 1 dose, 12 received 2 doses, and 7 received 3 doses of CCP all of which were collected internally by the hospital blood donor center. 22 recipients were O positive, 17 were A positive, and 6 were B positive. During their hospital course, 18 patients were on mechanical ventilation, 3 of which were on ECMO, 19 were on high-flow nasal cannula, and 8 were on low-flow nasal cannula as the highest level of oxygen therapy. At the 28 day follow up, 14 patients were deceased (31%), 4 (9%) were still hospitalized, and 27 (60%) were discharged home. Two patients had a suspected transfusion related reaction that resolved with supportive care including diphenhydramine and furosemide. Conclusion:We designed and implemented a pragmatic study to provide a treatment option for patients hospitalized with COVID-19. Sixty percent of our very sick study population survived to hospital discharge and there were only two transient infusion reactions. While larger studies with a control group are necessary to more clearly evaluate the benefit of CCP in COVID-19, our study lays the foundation for the rapid implementation of a Convalescent Plasma Program for possible future pandemics as a bridge to vaccine and therapeutic trials.

18.
Public Health ; 195: 158-160, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1270625

ABSTRACT

OBJECTIVES: Schools in the Republic of Ireland reopened to students and staff in late August 2020. We sought to determine the test positivity rate of close contacts of cases of coronavirus disease 2019 (COVID-19) in schools during the first half-term of the 2020/2021 academic year. METHODS: National-level data from the schools' testing pathway were interrogated to determine the positivity rate of close contacts of cases of COVID-19 in Irish primary, postprimary and special schools during the first half-term of 2020/2021 academic year. The positivity rates among adult and child close contacts were compared and the proportion of national cases of COVID-19 who were aged 4-18 years during the observation period was calculated to assess whether this proportion increased after schools reopened. RESULTS: Of all, 15,533 adult and child close contacts were tested for COVID-19 through the schools' testing pathway during the first half-term of the 2020/2021 academic year. Three hundred and ninety-nine close contacts tested positive, indicating a positivity rate of 2.6% (95% confidence interval: 2.3-2.8%). The positivity rates of child and adult close contacts were similarly low (2.6% vs 2.7%, P = 0.7). The proportion of all national cases of COVID-19 who were aged 4-18 years did not increase during the first half-term of the 2020/2021 school year. CONCLUSIONS: The low positivity rate of close contacts of cases of COVID-19 in schools indicate that transmission of COVID-19 in Irish schools during the first half-term of the 2020/2021 academic year was low. These findings support policies to keep schools open during the pandemic.


Subject(s)
COVID-19/epidemiology , COVID-19/transmission , Contact Tracing , Disease Outbreaks/prevention & control , Pandemics , Students/statistics & numerical data , Adult , COVID-19/prevention & control , Child , Disease Transmission, Infectious/prevention & control , Family , Humans , Ireland/epidemiology , Male , SARS-CoV-2 , Schools
19.
American Journal of Obstetrics and Gynecology ; 224(2):S383-S384, 2021.
Article in English | Web of Science | ID: covidwho-1141045
20.
American Journal of Obstetrics and Gynecology ; 224(2):S383-S383, 2021.
Article in English | Web of Science | ID: covidwho-1141044
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