ABSTRACT
Organizations, such as universities, face a variety of adversities, challenges, or disruptions that call for resilience to be enacted. Resilience is an important communicative process that relies on organizations and their stakeholders to collaboratively make sense of and respond to a given adversity, such as the COVID-19 pandemic. In order to identify the shared characteristics that organizations use in their communication surrounding adversity, we completed a genre analysis of the messages created by Big 10 Universities to welcome stakeholders to the 2020–2021 academic year. Through our analysis we uncovered commonalities that make organization-stakeholder resilience discourse distinct—(1) defining a shared relationship, (2) detailing steps to regain a sense of normalcy, and (3) describing the outcome of enacting resilience. Based on these findings, we propose a genre of organization-stakeholder resilience by highlighting the role of communication in cultivating resilience through the emphasis on discursive relationships that exist between organizations and stakeholders. © The Author(s) 2022.
ABSTRACT
The World Health Organization has declared the novel coronavirus disease 2019 (COVID-19) a global public health emergency. Despite the predominating respiratory symptoms occurring in COVID-19, thrombosis can occur in some patients, with morbidity and mortality increase due to the respiratory worsening. This article reports the case of a 62-year-old man with a flu-like illness that was diagnosed as COVID-19 by RT-PCR of SARS-CoV-2. After three weeks, he subsequently developed abdominal pain in addition to bloating, nausea, and vomiting. He underwent exploratory laparotomy after imaging tests suggested mesenteric ischemia. Intestinal ischemia was evident, due to the absence of flow in the superior mesenteric artery and jejunal branches. Embolectomy and enterectomy were performed and they resulted in a favorable outcome, with clinical improvement. This case adds data to the limited literature on extrapulmonary complications of COVID-19, notably those related to thromboembolic events.
La Organización Mundial de la Salud ha declarado la enfermedad del nuevo coronavirus 2019 (COVID-19) una emergencia de salud pública mundial. A pesar de los síntomas respiratorios predominantes en COVID-19, la trombosis puede ocurrir en algunos pacientes, con un aumento de la morbimortalidad debido al empeoramiento respiratorio. Presentamos el caso de un hombre de 62 años con enfermedad similar a la gripe que fue diagnosticada como COVID-19 por RT-PCR de SARS-CoV-2. Después de tres semanas, desarrolló dolor abdominal además de hinchazón, náuseas y vómitos. Fue sometido a laparotomía exploradora luego de que las pruebas de imagen sugirieran isquemia mesentérica. Se evidenció isquemia intestinal por ausencia de flujo en la arteria mesentérica superior y ramas yeyunales. Se realizó embolectomía y enterectomía con evolución favorable, con mejoría clínica. Este caso añade datos a la limitada literatura sobre las complicaciones extrapulmonares del COVID-19, en particular las relacionadas con eventos tromboembólicos.
Subject(s)
COVID-19 , Thromboembolism , Thrombosis , COVID-19/complications , Humans , Male , Mesenteric Artery, Superior/diagnostic imaging , Middle Aged , SARS-CoV-2 , Thromboembolism/complications , Thromboembolism/etiology , Thrombosis/diagnostic imagingABSTRACT
A rapid home-diagnostic test for SARS-CoV-2 was developed that automates the reagent delivery and washing steps required for an enzyme-linked immunosorbent assay (ELISA). The device is made of inexpensive polyethylene film and double-sided adhesive that is patterned, cut, and laminated together to create hollow channels. After sample is added, sample, reagents, and washing buffer are sequentially delivered to and washed from a detection zone on a nitrocellulose test strip, giving the end-user a visual readout in <15 minutes. A smartphone camera was used to capture images, and an analytical limit of detection of 35 PFU/mL was determined. When 22 untrained end-users were asked to visually identify a positive result, 95% correctly identified 150 PFU/mL and above as positive. © 2021 MicroTAS 2021 - 25th International Conference on Miniaturized Systems for Chemistry and Life Sciences. All rights reserved.
ABSTRACT
As the COVID-19 pandemic continues, there remains a need for fast, accurate and low-cost diagnostic tests to prevent outbreaks. We have developed an electrochemical capillary-flow driven immunoassay (eCaDI) capable of detecting SARS-CoV-2 nucleocapsid (N) protein in self-administered nasal samples at the point of care (POC). The low-cost device is made of polyester and adhesive films and provides sequential delivery of sample and reagents to a detection zone integrating a screen-printed carbon electrode (SPCE) modified with anti-N protein antibodies from a single addition of sample, automating the steps of an ELISA. The modified electrodes are highly sensitive and selective for COVID-19 N protein and were successfully applied to test clinical samples. The novelty of this work resides in the integration of sensitive electrochemical detection with pump-free capillary-flow assay, providing accuracy at the POC. Previously reported systems are slow and/or require multiple user steps reducing the utility for POC applications relative to the system reported here. © 2021 MicroTAS 2021 - 25th International Conference on Miniaturized Systems for Chemistry and Life Sciences. All rights reserved.
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Background: NT-proBNP was added to our emergency department (ED) triage blind 'shortness of breath (SOB) orderset' for presenters aged >70. Evidence-based thresholds for acute heart failure (HF) diagnosis are >900/1800 pg/ml for ages 50-75/>75 respectively (1.2);their utility in contemporary practice is uncertain. Purpose: To assess the relation between blind NT-proBNP testing in this setting and (1) coded discharge diagnosis stratified by age, and (2) all-cause mortality at medium-term follow-up. Methods:We retrieved all ED 'SOB' blood ordersets (1.1.2019-31.12.2019), including NT-proBNP, Hb, electrolytes, creatinine, troponin, CRP, d-dimer, and coded discharge diagnoses. Multivariate logistic regression models for all-cause survival (at 9.9.2021) were assessed. Results: There were 638 presentations (median age 76.1), unexpectedly including 198 <70 years. Modal and median lengths of stay were 0 and 1 day respectively. Stratified by age (<60, 60-69, 70-74, 75-79, 80-84, ≥85y), the proportion with HF coded as primary discharge diagnosis (5, 7, 9, 17, 18, 25% respectively) and all-comer all-cause mortality at 2.2±0.3 years (13, 42, 40, 48, 48, 49%) steadily increased (Table;orderset variables presented as median (inter-quartile range)). Median NT-proBNP was 3672, 2667, and 321 pg/ml when HF was in the primary, secondary, or neither coded discharge diagnosis field respectively;2.2-year-all-cause mortality was 54%, 60%, and 35%. In those with a primary HF discharge code, 77% of 349 presenters ≥75y and 88% of 231 aged 50-74 had NT-proBNP >1800/900 pg/ml respectively. In those without an HF code, 26% in both age cohorts had NT-proBNP >1800/900 pg/ml (dotted lines in Figure, panels A/B, respectively represent NT-proBNP thresholds). Independent predictors of all-cause mortality for patients with a primary or secondary HF code were ln(NT-proBNP) (OR 1.26, 95% CI 1-1.59) and serum Na+ (OR 0.93, 0.88-0.99);for patients without an HF code, these were serum K+ (1.87, 1.21-2.88), ln(NT-proBNP) (1.35, 1.15-1.58), ln(CRP) (1.18, 1.02-1.36), length of stay (1.08, 1.03-1.12), and age (1.03, 1.01-1.06). (Figure Presented) Conclusion: HF detection with NT-proBNP in a blind SOB orderset showed increasing sensitivity with age with the best specificity >75 years. Most presenters stayed ≤1 day, so blind testing at triage facilitates HF detection. NT-proBNP independently predicted 2.2-year-all-cause mortality irrespective of discharge HF coding. This is notable as the commonest non-HF causes of acute SOB are prognostically important at >70 years and follow-up occurred through the Covid-19 pandemic. The findings may reflect disease severity in patients without HF, but also suggest that discharge HF coding status does not identify all those with prognostically relevant HF.
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Haematological cancer is a risk factor for severe COVID-19, and multiple myeloma (MM) patients may have further risk due to older age and susceptibility to infections. This study aims to understand the pandemic's psychosocial impact on people with haematological cancers, and investigate whether MM patients experience extra stress compared to non-MM patients. The IMPaCCT survey was an international, longitudinal online survey, open to cancer patients. The first survey captured the period April-July 2020 and used quantitative and qualitative measures of quality of life (QoL), including validated tools (WHOQOL-BREF and EQ-5D-5L). Overall, 944 blood cancer patients responded (173 MM, 93 leukaemia, 117 lymphoma, 561 myeloproliferative neoplasm). Most were female, resided in the United Kingdom and did not live alone. Patients with MM were older ( p < 0.001), and more of them had received their cancer diagnosis within the last 5 years ( p < 0.001) than non-MM patients. Only three participants had a COVID diagnosis and none of them had MM. In both MM and non-MM groups, most participants said they would be less concerned about COVID if they did not have cancer. Although 70% of respondents reported their QoL as good/ very good, QoL scores on WHOQOL-BREF were lower in the physical, psychological and social domains than healthy prepandemic UK norms 7 . Respondents reported more satisfaction with environmental factors, such as living arrangements and access to services, however, than prepandemic norms. In both groups there were high rates of anxiety/depression (67%, severe in 5%). MM patients reported more issues with pain and mobility than non-MM patients. Overall 84% of the respondents reported COVID had changed their lives, and 63% of them found this hard to manage. Patients' most trusted sources for information about COVID-19 were healthcare providers and scientists for MM and non-MM participants (90% and 86% with high levels of trust respectively). MM patients had more trust in their friends and family for COVID information than non-MM patients (58% with high level of trust vs. 41%;p < 0.001). Regarding services, 43% of participants had used telemedicine, with more MM than non-MM patients using this service (61% of MM vs. 39% of non-MM). Most reported it was a positive experience. Most participants experienced a changed format for their health appointments, particularly MM patients (69% of MM vs. 52% of non-MM). Appointments with oncologists or haematologists were most often affected. Thirty-four per cent of MM patients reported their treatments were changed or delayed, compared to 11% of non-MM blood cancer patients. This study summarises the self-reported impact of COVID on psychosocial health and care access during the early pandemic in vulnerable patient groups. Results indicate that MM patients are especially vulnerable. Better understanding the needs of these patients will enable healthcare providers to properly support them..
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Complications of extrinsic compression on an inflatable penile prosthesis (IPP) due to prone positioning for COVID-19 pneumonia have not been described. Patients with an IPP present a unique challenge for managing compression injuries secondary to proning due to the dependent position of the penis and ability of the device to restrict blood flow to the distal penis when externally compressed for long periods of time. We present two patients with previous IPP placement who experienced glans and penile ischemia secondary to extrinsic compression of the penis from proning, who were monitored conservatively and avoided urgent explantation. To describe two patients with IPPs who were intubated and proned for COVID-19 pneumonia who experienced IPP-related complications due to pressure injury, one of whom survived for follow-up. Two male patients, ages 68 and 74 years, who developed penile injury following proning for COVID-19 pneumonia. The first patient presented with skin breakdown of the ventral aspect of the penis and scrotum without exposed implant. The second patient presented with a pale and dusky glans. The first patient was managed by scrotal elevation with bacitracin application to the wound twice daily. There was no surgical intervention or debridement of the penile and scrotal wounds. The patient was then followed on an outpatient basis without need for explantation at 4-months from initial consultation (Figure 1). He underwent a CT of the abdomen and pelvis as well as a CT Urogram as an outpatient that confirmed appropriate positioning of all components of the device without evidence of underlying infection. On exam, the penile prosthesis was well-positioned and cycled normally, with a freely mobile pump within the scrotum. The second patient expired during hospitalization from COVID-19 respiratory failure, but was monitored for six days without glans necrosis (Figure 2) once external pressure was removed. Patients with IPPs who require prone positioning are a unique population that are at risk for extrinsic compression injury of the penis. In contrast to ischemia related to instrinsic compression, such as with the sliding technique, which results in glans necrosis and necessitates urgent explantation, conservative treatment and serial examination in the setting of external compression from prone intubation was a viable and safe option to immediate explantation in these patients. Prevention, in the form of proper padding and minimization of external compression, remains paramount as we obtain more long term data from this unique patient population. No [ FROM AUTHOR] Copyright of Journal of Sexual Medicine is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Background. The burden of Respiratory Syncytial Virus (RSV)-associated hospitalization in adults is incompletely understood. The COVID-19 pandemic has resulted in multiple public health measures (e.g., social distancing, handwashing, masking) to decrease SARS-CoV-2 transmission, which could impact RSV-associated hospitalizations. We sought to compare RSV-associated hospitalizations from 2 pre- and one mid-COVID-19 winter viral respiratory seasons. Methods. We conducted an IRB-approved prospective surveillance at two Atlanta-area hospitals during the winter respiratory viral seasons from Oct 2018-Apr 2021 for adults ≥ 50 years of age admitted with acute respiratory infections (ARI) and adults of any age with COPD or CHF-related admissions. Adults were eligible if they were residents of an 8 county region surrounding Atlanta, Georgia. Those with symptoms > 14 days were excluded. Standard of care test results were included. Asymptomatic adults ≥ 50 years of age were enrolled as controls in Seasons 1 and 2. Nasopharyngeal swabs from cases and controls were tested for RSV using BioFireR FilmArrayR Respiratory Viral Panel (RVP). We compared the demographic features and outcomes of RSV+ cases and controls. Results. RSV was detected in 71/2,728 (2.6%) hospitalized adults with ARI, CHF, or COPD and 4/466 (0.9%) controls. In Season 1, RSV occurred in 5.9% (35/596 patients), in Season 2 3.6% (35/970 patients), but in only 0.09% (1/1,162 patients) in Season 3 (P < 0.001 for both seasons). RSV detection in Season 3 was similar to RSV detection among controls during Seasons 1 and 2 (P=0.6). Median age of cases and controls was 67 years (Table 1). Of cases with RSV 11% were admitted to the ICU and two required mechanical ventilation. The majority of hospitalized patients were discharged home (95.8%) with a median length of hospitalization of three days (IQR 2-7). Conclusion. Over 3 seasons, RSV was detected in 2.6% of adults admitted to the hospital with ARI, CHF or COPD. The rate of RSV dramatically declined during the 2020-21 winter respiratory viral season, likely due to public health measures implemented in response to COVID-19.
ABSTRACT
Background. A significant burden of disease exists for adults infected with influenza (flu) and SARS-CoV-2, which causes COVID-19. However, data are limited comparing outcomes between hospitalized adults infected with these viruses. Methods. Over the course of 3 consecutive winter respiratory viral seasons, adults ≥ 50 years of age admitted with acute respiratory tract infections (ARI) and adults of any age with COPD or CHF-related admissions were enrolled from 2 Atlanta area hospitals. For the 2018-19 and 2019-20 seasons, participants were approached in the hospital. If the participant enrolled, nasopharyngeal (NP) and oropharyngeal (OP) swabs were collected and tested using BioFire® FilmArray® respiratory panel. Due to the COVID-19 pandemic in 2020-21 and limitations involving participant contact, only NP standard of care (SOC) swabs were collected. A comprehensive medical chart review was completed for each subject which encompassed data on their hospitalization, past medical history, and vaccination history. Co-infected patients were excluded from the analyses. Results. Of the eligible participants, 118 were flu positive (three RSV-influenza co-infections were excluded) and 527 were COVID-19 positive. Median age was lower for the flu cohort at 62 (IQR 56-71) than those with COVID-19 (67, IQR 59-77) (p < 0.0001). Length of stay (LOS) was shorter in flu-infected patients (median 3 d, IQR 2-6), but was longer for COVID-19 patients (median 5 d, IQR 3-10). ICU admission occurred in 20% of those with flu, and among those admitted to the ICU mechanical ventilation (MV) occurred in 12.5%. ICU admission and MV was significantly higher for those with COVID-19, with 28% of patients admitted to the ICU and 47% of those requiring MV. Among patients with COVID-19, 8.9% died. This was significantly higher than that of flu (3.4%) (p=0.008). Hospital discharge occurred more frequently to a nursing home or LTCF with COVID-19 (10.3%) than with flu (0%) (p< 0.0001). Table 1. Breakdown of age, hospitalization course, and discharge disposition for participants diagnosed with influenza or COVID-19 during hospitalization. Conclusion. COVID-19 resulted in a longer hospital admission, a greater chance of ICU admission and MV as compared to flu. Additionally, COVID-19 participants had a high rate of discharge to a nursing home/LTCF and a significantly higher risk of death. While the clinical course was not as severe as COVID-19, influenza contributed a significant burden.
ABSTRACT
Background. Acute respiratory tract infections (ARIs) are a significant cause of morbidity in adults. Influenza is associated with about 490,600 hospitalizations and 34,200 deaths in the US in the 2018-2019 season. The burden of rhinovirus among adults hospitalized with ARI is less well known. We compared the burden of influenza and rhinovirus from 2 consecutive winter respiratory viral seasons in hospitalized adults and healthy controls pre-COVID-19 and one season mid-COVID-19 to determine the impact of rhinovirus as a pathogen. Methods. From Oct 2018 to Apr 2021, prospective surveillance of adults ≥50 years old admitted with ARI or COPD/CHF exacerbations at any age was conducted at two Atlanta hospitals. Adults were eligible if they lived within an eightcounty region around Atlanta and if their symptom duration was < 14 days. In the seasons from Oct 2018 to Mar 2020, asymptomatic adults ≥50 years old were enrolled as controls. Standard of care test results were included and those enrolled contributed nasopharyngeal swabs that were tested for respiratory pathogens using BioFire® FilmArray® Respiratory Viral Panel (RVP). Results. During the first two seasons, 1566 hospitalized adults were enrolled. Rhinovirus was detected in 7.5% (118) and influenza was detected in 7.7% (121). Rhinovirus was also detected in 2.2% of 466 healthy adult controls while influenza was detected in 0%. During Season 3, the peak of the COVID-19 pandemic, influenza declined to 0% of ARI hospitalizations. Rhinovirus also declined (p=0.01) but still accounted for 5.1% of all ARIs screened (Figure 1). Rhinovirus was detected at a greater rate in Season 3 than in asymptomatic controls in the first 2 seasons (p=0.008). In the first two seasons, Influenza was detected in 8.6% (24/276) of those admitted to the ICU. Rhinovirus was detected in 6.1% (17/276) of those admitted to the ICU but declined to 3.1% (8/258) in Season 3. Conclusion. Dramatic declines occurred in influenza in adults hospitalized with ARI, CHF, or COPD in Atlanta during the COVID-19 pandemic and with enhanced public health measures. Although rhinovirus declined during the COVID-19 pandemic, it continued to be identified at a rate higher than in historical controls. Additional data are needed to understand the role of rhinovirus in adult ARI, CHF, and COPD exacerbations.
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BACKGROUND: Various studies have examined the general impact of the COVID-19 outbreak on children's health behaviours. The impact of public health measures practised by children during COVID-19 is relatively unknown. OBJECTIVES: The primary objective was to determine the association between physical and social distancing measures and children's outdoor time, sleep duration, and screen time during COVID-19. DESIGN/METHODS: A longitudinal study using repeated measures of exposures and outcomes was conducted in healthy children (0 to 10 years) between April 14 and July 15, 2020. Parents were asked to complete questionnaires about isolation, physical distancing practices, and children's health behaviours. The primary exposure was the average number of days that children practised physical and social distancing measures per week. The three outcomes were children's outdoor time, total screen time, and sleep duration during COVID-19. Linear mixed effects models were fitted using repeated measures of primary exposure and outcomes. RESULTS: This study included 554 observations from 265 children. Physical and social distancing measures were associated with shorter outdoor time (-17.2;95% CI-22.07,-12.40;p < 0.001) and longer total screen time (11.3;95% CI 3.88, 18.79;p = 0.003) during COVID-19. The association with outdoor time was stronger in younger children (< 5 years), and the associations with total screen time were stronger in females and in older children (= 5 years). CONCLUSION: Physical and social distancing measures during COVID-19 have resulted in negative impacts on the health behaviours of Canadian children living in a large metropolitan area.
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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.
ABSTRACT
Background: The risk of severe COVID-19 is increased in patients (pts) with hematologic malignancies, with a reported risk of death of 34% (Vijenthira et al, 2020). The ASH-ASTCT COVID-19 vaccine guidelines indicate that certain immunocompromised patient populations could have an attenuated response to the SARS-CoV-2 vaccine. However, most SARS-CoV-2 vaccine trials required pts to be off immune suppression to be eligible and therefore excluded most pts with hematologic malignancies. Little is known about the efficacy of SARS-CoV-2 vaccines in pts with hematologic malignancies. In this study, we aimed to evaluate the serological response of Pfizer and Moderna vaccination after two doses given in pts with hematologic malignancies with a focus on pts with myeloid malignancies. Methods: Patients with a history of hematologic malignancies treated at the University of Texas Southwestern Medical Center and received two doses of vaccination with quantitative measurement of SARS-CoV-2 IgG Spike antibody to assess vaccination response were included in this study. Baseline patient and disease characteristics including disease status and therapy given at the time of vaccination were collected. Time to vaccine response was defined as having a positive quantifiable spike IgG antibody titer per the lab reference range. The development of COVID-19 infection as well as antibody titer levels were collected. Categorical variables were compared using Chi-square and Fisher's exact tests and student t-test and ANOVA test were used to compare continuous variables. Results: A total of 61 pts with hematologic malignancies had spike IgG antibody testing after receiving 2 doses of the vaccine were included in this study. The median age at the time of vaccination was 72 (22-85) and 46% of pts were female. Eighty five percent of pts were Caucasian. The majority of pts (67.3%) had a myeloid malignancy (MDS/CMML 29.5%, AML 14.8%, myelofibrosis 16.4%, CML 6.6%), followed by chronic lymphocytic leukemia (16.4%), and others (6.6%). The median time from hematologic malignancy diagnosis to the first vaccine dose was 51 months (0.4-337 months). At the time of vaccine administration, 46 (75%) of pts were on active therapy and 39 (64%) of pts had active disease. Median time from the second vaccine dose to IgG spike antibody testing was 64 days (26-268 days). Most pts (75%) mounted a serological response with quantifiable COVID-IgG spike antibodies, 85% and 56% in myeloid and lymphoid malignancy, respectively. All pts with MDS/CMML/CCUS and CML mounted an immune response (100%), followed by acute myeloid leukemia (n: 7/9, 78%) and myelofibrosis (n: 6/10, 60%). Eight (13%) of pts were receiving hypomethylating agent therapy at the time of vaccination and all (100%) had a positive IgG response. Only one patient developed COVID-19 infection post vaccination with a documented IgG response and 2 pts had COVID-19 infection prior to the first dose of vaccination, both of these pts had IgG titers >10,000. Sixty percent of pts (9/15) with negative IgG response received treatment with either CD20 monoclonal antibodies or BTK inhibitors within 12 months of the first vaccine dose. Two out of three pts (67%) receiving Ruxolitinib had negative serology. Seven pts were on treatment with hydroxyurea, interestingly, all but the 2 pts with polycythemia vera had a negative antibody titer while on treatment with hydroxyurea. There was a strong positive correlation between vaccine titer and absolute lymphocyte count (r 2=0.27, p<0.001) (Figure). Conclusions: In this retrospective study, we demonstrate a higher rate of COVID-19 vaccine efficacy in pts with myeloid malignancy with varying responses per treatment and disease subtype compared to pts with B-cell malignancy with variable anti-CD20 or BTK inhibitor therapy. Pts with myelodysplastic syndromes, overlap syndromes of clonal cytopenia of undetermined significance all developed spike antibodies irrespective of hypomethylating therapy or Hydrea as did pts with chronic myeloid leukemia. However, pts with polycythemia vera nd those on treatment with Ruxolitinib had an attenuated response to the vaccine. Albeit this single center study, pts with myelodysplastic syndromes should be offered COVID vaccines irrespective of their blood counts or ongoing treatment. Our findings should be validated in a larger group of patients. [Formula presented] Disclosures: Patel: Agios: Membership on an entity's Board of Directors or advisory committees;Celgene-BMS: Membership on an entity's Board of Directors or advisory committees;PVI: Honoraria. Anderson: Celgene, BMS, Janssen, GSK, Karyopharm, Oncopeptides, Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Awan: Cardinal Health: Consultancy;BMS: Consultancy;Dava Oncology: Consultancy;Karyopharm: Consultancy;Merck: Consultancy;Johnson and Johnson: Consultancy;Incyte: Consultancy;Beigene: Consultancy;Verastem: Consultancy;MEI Pharma: Consultancy;Celgene: Consultancy;Kite pharma: Consultancy;Gilead sciences: Consultancy;Pharmacyclics: Consultancy;Janssen: Consultancy;Abbvie: Consultancy;ADCT therapeutics: Consultancy;Astrazeneca: Consultancy;Genentech: Consultancy. Madanat: Blue Print Pharmaceutical: Honoraria;Onc Live: Honoraria;Stem line pharmaceutical: Honoraria;Geron Pharmaceutical: Consultancy.