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Introduction: COVID-19 vaccination substantially reduces morbidity and mortality associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and severe illness. However, despite effective COVID-19 vaccines many questions remain about the efficacy of vaccines and the durability and robustness of immune responses, especially in immunocompromised persons. The NCI-funded Serological Sciences Network (SeroNet) is a coordinated effort including 11 sites to advance research on the immune response to SARS-CoV-2 infection and COVID-19 vaccination among diverse and vulnerable populations. The goals of the Pooling Project are: (1) to conduct real-world data (RWD) analyses using electronic medical records (EMR) data from four health care systems (Kaiser Permanente Northern California, Northwell Health, Veterans Affairs-Case Western, and Cedars-Sinai) to determine vaccine effectiveness in (a) cancer patients;(b) autoimmune diseases and (c) solid organ transplant recipients (SOTR);(2) to conduct meta-analyses of prospective cohort studies from eight SeroNet institutions (Cedars-Sinai, Johns Hopkins, Northwell Health, Emory University, University of Minnesota, Mount Sinai, Yale University) to determine post-vaccine immune responses in (a) lung cancer patients;(b) hematologic cancers/hematopoietic stem cell transplant (HSCT) recipients;(c) SOTR;(d) lupus. Method(s): For our RWD analyses, data is extracted from EMR using standardized algorithms using ICD-10 codes to identify immunocompromised persons (hematologic and solid organ malignancy;SOTR;autoimmune disease, including inflammatory bowel disease, rheumatoid arthritis, and SLE). We use common case definitions to extract data on demographic, laboratory values, clinical co morbidity, COVID-19 vaccination, SARS-CoV-2 infection and severe COVID-19, and diseasespecific variables. In addition, we pool individual-level data from prospective cohorts enrolling patients with cancer and other immunosuppressed conditions from across network. Surveys and biospecimens from serology and immune profiling are collected at pre-specified timepoints across longitudinal cohorts. Result(s): Currently, we have EMR data extracted from 4 health systems including >715,000 cancer patients, >9,500 SOTR and >180,000 with autoimmune conditions. Prospective cohorts across the network have longitudinal data on >450 patients with lung cancer, >1,200 patients with hematologic malignancies, >400 SOTR and >400 patients with lupus. We will report results examining vaccine effectiveness for prevention of SARS-CoV-2 infection, severe COVID-19 and post-acute sequelae of COVID-19 (PAS-C or long COVID) in cancer patients compared to other immunocompromised conditions. Conclusion(s): Our goal is to inform public health guidelines on COVID-19 vaccine and boosters to reduce SARS-CoV-2 infection and severe illness in immunocompromised populations.
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In an environment characterized by turmoil and unpredictability, by the digital transition and transformation, and by the economic and social effects caused by the global public crisis (COVID19), this study aims to analyze the motivations for using the internet and making online purchases, identifying the perceived benefits and consumer satisfaction. For this, an exploratory study with descriptive design was carried out, through the administration of a questionnaire (google forms). 385 consumers responded. The data show that there are significant differences between groups (buyers and non-buyers) in terms of motivation, perceptions of benefits and satisfaction. The use of online shopping platforms fosters a relationship that favors efficiency and enhances feelings of control and freedom in purchasing behavior. The experiences lived through technological intermediation, given the possibility of interaction and personalization, add value to brands, create an innovative identity, while contributing to obtaining a memorable and satisfying experience. © 2023, ICST Institute for Computer Sciences, Social Informatics and Telecommunications Engineering.
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Background. Previous scoring systems have been proposed to predict COVID19 outcomes, however none have been universally adopted. Two scoring systems of interest are Monoclonal Antibody Screening Score (MASS) and Oral Antiviral and Monoclonal Antibody Screening Score (OMASS).MASS prioritized patientsfor outpatient monoclonal antibody treatment based on risk of hospitalization, and OMASS was a modified version of MASS used to prioritize outpatient oral antivirals. We created a modified scoring system (UCH2021) incorporating vaccination status. These scores (table 1) have not been used to predict in-hospital clinical outcomes. We investigate these systems' abilities to predict mortality and oxygen requirements in hospitalized COVID19 patients. They do not require blood tests and allow for more rapid triage. Table 1: MASS, OMASS, UCH2021 Scoring Criteria Methods. A retrospective chart review was performed on 133 patients in two tertiary care centers between March and Sept. 2020 with RT-PCR confirmed SARS CoV2. Baseline risk factors were collected and MASS, OMASS, and UCH2021 were calculated. Primary outcomes included mortality, need for intubation, and need for supplemental oxygen >6L during hospitalization. Secondary analysis assessed if any individual risk factors were associated with those outcomes. These systems were evaluated via area under the curve calculations. Two groups based on an outcome were compared using two-sample t-tests for continuous variables and Fisher's exact tests for categorical variables. Results. All three systems demonstrated some discriminative power for mortality (table 2), but not for oxygen and intubation requirements. There was statistically significant difference in age between survivors and deceased (table 3), and BMI for oxygen requirements (table 4). Other risk factors were not predictive of mortality or oxygen requirement. Table 2: MASS, OMASS, UCH2021 Scores and Mortality in Hospitalized COVID19 Patients Table 3: Age and Mortality in Hospitalized COVID19 Patients Table 4: BMI and Oxygen Requirements in Hospitalized COVID19 Patients Conclusion. The MASS, OMASS, and UCH2021 score all had predictive power in determining in-hospital mortality, with moderate accuracy, however none were predictive of oxygen requirements. Age and BMI were also good predictors of mortality and oxygen requirements respectively. This study was completed prior to vaccine distribution in the US. Further studies would be helpful to assess if UCH2021 score has greater discriminative power in samples with vaccinated patients.
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Background:Symptoms after SARS-CoV-2 primary vaccination among patients with inflammatory bowel disease (IBD) are generally similar to the general population,although symptoms after the second dose are more frequent and severe than after the first dose.Postvaccination symptoms after a 3rd mRNA vaccine dose in the predominantly immune-compromised IBD population is unknown.Methods:Adults with IBD participating in the prospective Coronavirus Risk Associations and Longitudinal Evaluation in IBD (CORALE-IBD) vaccine registry who received a 3rd mRNA vaccine dose were asked to complete a detailed symptom survey 1 week after vaccination.Symptoms were assessed across 11 organ systems,and graded as mild,moderate,or severe,or requiring hospitalization.“Severe+” referred to those with severe symptoms or who required hospitalization.We stratified by age (<or> 50 years) given prior distinct symptom profiles after dose 2 (D2).We also evaluated whether severe+ symptoms after D2 predicted severe+ symptoms after dose 3 (D3).Results:We included 524 participants (70% female, mean age 45 years) who received a 3rd mRNA vaccine through October 11, 2021.Most had Crohn's disease (71%), and 89% were on biologic therapies.Most (58%) had received primary vaccination with BNT562b2,and only 3.5% reported prior COVID infection at the time of initial vaccination.Overall, 97% of subjects received a 3rd dose with the same mRNA vaccine as in their initial series with the remainder receiving the other mRNA vaccine type.No participants received a 3rd dose with the Ad26.CoV.2 (J&J) vaccine. Overall, 41% reported symptoms after a 3rd dose,with symptoms generally more frequent and severe among those <55 years (Table).The most frequent postvaccination symptom was injection site pain (39%).Common systemic symptoms included fatigue/malaise (34%),headache (23%),and muscle, bone or joint symptoms (13%).These were all less frequent after D3 than after D2 (Figure).Gastrointestinal symptoms were reported by 8.8%, which was slightly more frequent than after D2 (7.8%).Among those with postvaccination symptoms, the proportion with severe symptoms after D3 was lower than D2 for fatigue/ malaise, headache, dizziness and lightheadedness, fever/chills, and rheumatologic symptoms, but was slightly higher than D2 for gastrointestinal symptoms.Severe+ symptoms were seen in 17% after D2 and in 14% after D3. Of those with severe+ symptoms after D2, 34% had severe+ symptoms after D3.In contrast, about 22% had severe+ symptoms after D3 but did not report severe+ symptoms after D2.Conclusion:The frequency and severity of symptoms after a 3rd mRNA vaccine dose are generally similar or lower than those after a second dose.Furthermore, prior severe+ symptoms after D2 do not necessarily predict severe+ symptoms after D3. Further evaluation of postvaccination gastrointestinal symptoms in this population is warranted. (Figure Presented) (Table Presented)
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This work aimed to evaluate social vulnerability based on popu-lation characteristics as a means to indicate the possible intra-ur-ban spaces with greater chances of dispersion and contagion by COVID-19. Based on variables that explain social characteristics and increase the vulnerability of individuals, information from IBGE was selected, treated by factor analysis and mapped, accord-ing to the adaptation of the methodology developed by the Centre for Social Studies in Coimbra. The scale of coverage chosen was that of census sectors, from three municipalities in the state of Rio Grande do Sul/Brazil. The analysis resulted in 21 variables that make it possible to classify five dimensions of the vulnerability of the populations, indicating the places where actions to prevent contagion should be more incisive, given the population character-istics, and the vulnerability of urban peripheries was evidenced. The grouping of information expressed social dimensions that de-note aspects auxiliary to understanding the territory and social vul-nerability on a local scale. The methodology demonstrated can be easily adopted in different scales and regions of Brazil, and also in other countries. This study will make it possible to make decisions aimed at avoiding contagion, and to subsidize with information the elaboration of plans for the gradual resumption of economic and social activities.
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Background. Antimicrobial stewardship programs (ASP) have been essential during the coronavirus disease 2019 (COVID-19) pandemic response. Use of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has proven difficult to operationalize, despite being available through emergency use authorization (EUA). Utilizing existing ASP and multidisciplinary approach to lead the effort, we aim to describe our experience in operationalizing monoclonal antibody therapy. Methods. Retrospective study of SARS-CoV-2 infected adults receiving monoclonal antibody therapy under EUA (December 2020-April 2021). An algorithm developed by the ASP provided education and an interactive online tool allowing referring physicians and patients to assess eligibility prior to hospital arrival. Patients were screened and approved by existing ASP which included;Infectious Disease (ID) physicians, pharmacist, and ID Nurse. A multidisciplinary approach with ER staff and development of pharmacy workflow with order set were utilized as eligible patients received infusion in dedicated ER location. Data such as demographics, co-morbid condition, infusion related complications, hospitalization, and death were reviewed and collected regularly by the ASP team with frequent monitoring and regulatory reporting. Primary patient outcome was preventing hospitalization. Results. 107 patients received monoclonal antibody therapy. 47% patients were male, 50% White, and 79% non-Hispanic. 87% received monotherapy (bamlanivimab) and 13% received dual therapy (bamlanivimab/etesevimab). 17 patients required hospitalization post infusion. 1 death occurred. COVID-19 related hospitalization within 30-days was avoided in 84% of treated patients. No adverse event directly related to infusion were seen. Conclusion. Use of monoclonal antibody therapy under EUA for patients for SARS-CoV-2 infection led to decrease in hospitalization in this cohort. An existing ASP using an algorithmic approval process, frequent monitoring, and multidisciplinary approach successfully operationalized the use of monoclonal antibody therapy. ASP's provide benefit and versatility beyond monitoring of antimicrobials alone and should continue to receive support by hospital leadership.
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COVID-19 , Neoplasms , COVID-19 Vaccines , Humans , Neoplasms/drug therapy , SARS-CoV-2 , Vaccination/adverse effectsABSTRACT
Background: Cancer patients are at increased risk of severe COVID-19 illness because of their systemic immunosuppressive state. The potential effects of cancer and/or anticancer treatments on COVID-19 vaccine response, adverse events and progression are unknown. Moreover, the impacts of financial, familial and societal stressors during the pandemic on health-related quality of life are unclear. To address these concerns, we report data from the ongoing U.S. NCI-funded SeroNet COVID-19 Risk Associations and Longitudinal Evaluation Study (CORALE) at a large health care system in Los Angeles. Methods: Cancer patients are invited to complete questionnaires, donate blood specimens and engage in long-term follow-up with repeat questionnaires and biosampling. Patient-reported outcomes are assessed at baseline, post-vaccination, 6, 12 and 24 months. Clinical information on cancer type, stage, treatment, dates, medications and outcomes (adverse events, SARS-CoV-2 infection, COVID-19 vaccination and cancer-related outcomes) are extracted from electronic medical records. Results: From December 2019-May 2020, we enrolled 317 patients with malignancies or hematologic disorders (70.0% response rate). The median age was 63 (interquartile range (IQR)=54-73) years, 47% were women, 30% self-identified as non-White minorities and 18% were unable to work due to health status. 3% were known to been infected with SARS-CoV-2. An overall COVID-19 vaccine acceptance rate of 80% was reported. Among unvaccinated patients, women expressed more hesitancy than men (p=0.045). Concerns about adverse events (56%), rushed vaccine development (44%), and insufficient knowledge (44%) were reported. Self-reported symptoms after the first dose included injection site pain (21%) and fatigue (11%). We observed low levels of depression and high emotional support. Enrollment is ongoing. Conclusions: Individuals with cancer are a complex and extremely diverse population with a multitude of considerations for both immediate clinical care and long-term survivorship. Updated results including findings on antibody response to vaccination across cancer types/treatment protocols will be presented. Legal entity responsible for the study: Cedars-Sinai Medical Center. Funding: U.S. National Cancer Institute. Disclosure: All authors have declared no conflicts of interest.
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IntroductionThe confinement associated with COVID-19 pandemic was an experience with significant physical and mental health implications, including higher stress levels, decreased sleep quality, pain symptoms and changes in lifestyle behaviours.ObjectivesThe main goal of this study was to analyze the relationship between stress and health variables (sleep, health symptoms, health perception, and lifestyle behaviours) in a Portuguese university during COVID-19 home confinement.MethodsA cross-sectional online survey design was conducted. A sample of 263 Portuguese workers (64.3% females), with mean age of 48.3 years (sd=8.9), filled in the PSS10, answering questions concerning health symptoms (perceived health, pain symptoms and fatigue), lifestyle behaviours (sleep and eating habits, use of alcohol and tobacco) during COVID-19 home confinement. A descriptive statistical analysis, a Pearson correlation analyses and the t Student test, for independent samples, were performed.ResultsThe results showed significant correlations between stress and perceived health (r=-.404;p<.0001), arms pain (r=.212;p=.002), legs pain (r=.201;p=.003), back pain (r=.219;p=.001), headache (r=.289;p<.0001) and fatigue (r=.295;p<.0001). Concerning lifestyle behaviours, the results showed significant correlations between stress and sleep (r=-.552;p<.0001) and stress is significantly higher (p<.0001) in individuals who have changed their eating habits.ConclusionsDuring the COVID-19 home confinement, higher stress levels are associated with a worse perception of health, more pain symptoms (legs, arms, back, headache), worse sleep quality and more fatigue. Moreover, the individuals with higher levels of stress have changed their eating habits. Lastly, health promotion interventions are needed in order to minimize the impact of home confinement in health.
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Ivermectin is a potent antiparasitic which has activity against a large amount of viroses and was highlighted in 2020 as a drug with potential effectiveness for the treatment of Covid-2019. The work published by Caly (2020) leveraged the off-label use of ivermectin by the population by showing the drug from a test done with cells in vitro infected with the SARS-CoV-2 virus isolated. The present study aimed to quantify the content of ivermectin in manipulated and industrialized drugs, comparing the results with the value indicated on the label. As it does not have a method already pre-established by the Brazilian Pharmacopoeia, the dosage was performed according to the methodology adapted by Costa and Pereira Netto (2019), using the spectrophotometry method in UV/VIS, which is recommended by the Regulatory Agency for the quantification of substances. The results showed that four of the six analyzed were not within the parameters required by the American regulatory agency in relation to the active ingredient content. It is intended to highlight the importance of quality control of medications in addition to warning of possible health risks associated with the administration of medications which indication differs from what appears in the package insert.