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Background & Aim: Immunocompromised patients are susceptible to high-risk opportunistic infections and malignant diseases. If available, most antiviral and antifungal drugs are quite toxic, relatively ineffective, and induce resistance in the long term. Methods, Results & Conclusion(s): We have previously demonstrated the safety of adoptive cell therapy for COVID-19 patients with CD45RA negative cells containing SARS-CoV-2-specific T cells from a donor, chosen based on HLA compatibility and cellular response to SARS-CoV-2 peptide pools. After finishing a Phase 2 randomized multicenter clinical trial (RELEASE, NCT04578210), we concluded that the infusion is safe, effective, accelerates lymphocyte recovery and shows hallmarks of an immune response. To use adoptive cell therapy to treat COVID-19 it would be necessary to develop a biobank of living drugs. For that, we examined the immune evolution performing a longitudinal analysis from previously SARS-CoV-2 infected and infection- naive individuals covering 21 months from infection. Cellular responses were maintained over time while humoral responses increased after vaccination but were gradually lost. Therefore, the best donors would be recovered individuals and two months after vaccination. We also evaluated the effect of dexamethasone (current standard of care treatment for COVID-19 and other infections involving lymphopenia) and Interleukin-15 (cytokine involved in T-cell maintenance and survival) on CD45RA negative. Dexamethasone did not alter cell functionality, proliferation or phenotype at a clinical-practice concentration, while interleukin-15 increased the memory T-cell and T-regulatory cell activation state, and interferon gamma release. Furthermore, we applied the adoptive passive transfer of CD45RA negative cells containing pathogen-specific memory T-cells to other infectious diseases characterized by sustained lymphopenia. We infused six immunocompromised patients with Cytomegalovirus, BK virus, Aspergillus, and Epstein-Barr virus lymphoproliferative disease. Patients experienced pathogen clearance, resolution of symptoms and lymphocyte increase. Transient microchimerism was detected in three patients. The use of CD45RA negative cells containing specific memory T cells of a third-party donor for treating severe pathogenic diseases in immunocompromised patients is feasible, safe, and effective, and has an advantage over other cell therapies such as lower costs and a less complex regulatory environment.Copyright © 2023 International Society for Cell & Gene Therapy
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The purpose of the study is to examine the moderation of the Fourth Industrial Revolution/Industry 4.0 (I4.0) in the relationship between Total Quality Management (TQM) and the improvement of operational performance within nanostores (neighborhood stores, markets, pulperías) in Honduras, under the conditions of a developing economy. The owner of each of the 143 nanostores under study completed a survey on I4.0 and TQM, with some operational performance indicators, during the Covid pandemic. As this study was based on the contingency theory, multivariate data analyses were performed, measuring whether I4.0 positively moderates the effect of TQM on operating performance. With I4.0, some nanostores have been channeling their efforts towards higher performance through advancing levels of interconnectivity. Eventually, approaches such as TQM will integrate technologies that, in turn, can harm or enhance operational performance. I4.0 seems to have a positive and significant effect (according to previous studies), but especially, a moderator effect. The authors point out several options for further study in different socioeconomic contexts. This study shows that technological implementation will lead to a better performance in nanostores. The implementation of TQM favors this improvement, supporting nanostores towards I4. 0. © 2022 Latin American and Caribbean Consortium of Engineering Institutions. All rights reserved.
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Background: The third wave of COVID-19 in Mexico produced a high demand for hospital care, which is why it was created a multidisciplinary group to optimize decision-making: the Interinstitutional Command for the Health Sector (COISS, according to its initials in Spanish). So far, there is no scientific evidence of the COISS processes or their effect on the behavior of epidemiological indicators and the hospital care needs of the population in the context of COVID-19 in the entities involved. Objectives: To analyze the trend on epidemic risk indicators throughout the COISS group's management in the third wave of COVID-19 in Mexico. Material and methods: Mixed study: 1) non-systematic review of information from technical documents issued by COISS, 2) secondary analysis of open-access institutional databases through the description of healthcare needs of cases notified with COVID-19 symptoms, and an ecological analysis by each Mexican state on the behavior of hospital occupancy, RT-PCR positivity, and COVID-19 mortality in two-time points. Results: The COISS activity in identifying states with epidemic risk generated actions aimed at a reduction in hospital occupancy of beds, positivity by RT-PCR, and mortality from COVID-19. Conclusions : The decisions of the COISS group reduced the indicators of epidemic risk. Continuing the work of the COISS group is an urgent need. Conclusions: The decisions of the COISS group reduced the indicators of epidemic risk. Continuing the work of the COISS group is an urgent need. Copyright © 2023 Revista Medica del Instituto Mexicano del Seguro Social.
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The nanostores known in Latin America as pulperias are an important player in the generation of resources and wealth. Currently, they represent more than 50 million points of sale around the world, where two-thirds of the population go to these centers for retail products and services. The pulperias explain at least 60% of the sales and success of the distribution channels of Mass Consumption companies. However, the literature that describes the pulperias operations with empirical evidence is still lacking. Also, no study describes the pulperias operation in Honduras. Therefore, the purpose of the study is to characterize the pulperias in Honduras, as a first exploratory study that allows to description, determinate variables and establishes the state of this sector during the COVID19 pandemic, 2020-2022 period. Hence, an exploratory investigation was carried out, collecting empirical evidence in 472 pulperias. The results show that competitiveness and infrastructure are low, and technological inclusion and financing are limited. Finally, they have a high market share, and the level of adaptability and agility are medium, being a sector threatened by security and the supermarket and hypermarket chains. © 2023, University of Cienfuegos, Carlos Rafael Rodriguez. All rights reserved.
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Researchers have contributed to the supply chain (SC) field in terms of agility and adaptability. However, it is not well known if the operations of nanostores in technology, innovation, infrastructure, and market impact agility, adaptability, and operational performance in nanostores and even less in emerging markets, where small distributors manage to a certain degree the practices of nanostores operations. A literature review was done to identify variables and their items to design a structured questionnaire that was pretested with supply chain experts. We conducted an empirical study on a sample of 472 nanostores from Honduras. Data were collected during the COVID-19 pandemic in 2022. The hypotheses of the research model were tested using the mediation effect by the Serial Multiple Mediator Model method proposed steps. We further checked the mediation significance using the Bootstrapping test. Results show that agility is a strong determinant (i.e., mediator or intervening effect) between SC and performance: nanostores are reacting in an accelerated way to the market. Adaptability is found not to mediate between supply chain and performance: nanostores do not reach adaptability due to technology limitations, changes in structures, innovation, and technification. To improve nanostore adaptability, technological inclusion, predictive programs, and a better understanding of the market must be increased. © 2022 Latin American and Caribbean Consortium of Engineering Institutions. All rights reserved.
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An important criterion that must be known in the nanostore sector (bodega, warehouse, kiosk, grocery store) is the way that the competitive environment (EC) is related to adaptability. The study of adaptability and EC in this field is a new topic that requires research, due to the importance of the type of competitive strategy adopted by an organization, since new adaptability practices can be integrated as a result. There are some studies with frequently applied theories in supply chain management, logistics and adaptability of nanostores, focused on the challenges they currently face. Our research is based on the fit contingency theory, to identify the extent to which the variables of adaptability and EC are related to the performance of Honduran nanostores. The research considers 143 nanostores implementing adaptability, as an important operations program for CE and performance. This study presents new insights and offers guidance for nanostore owners, managers, and academics, especially that adaptability can positively intervene the relationship between EC and performance in nanostores.
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Background. Pulse glucocorticoid therapy is used in COVID-19 infection. We evaluated the effectiveness of methylprednisolone 250 mg/d for 3 days vs. dexamethasone 6 mg/ d for 10 days in patients with severe but not critical COVID-19 pneumonia. Methods. A multicentre, randomized, open-label, controlled trial was conducted between February 2021 and August 2021 at 4 hospitals in Spain and included 128 hospitalized adults with confirmed COVID-19 pneumonia needing oxygen therapy but not critically ill. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 once daily for 10 days or methylprednisolone 250 mg once daily for 3 days. The primary outcome was 28-day mortality. Results. Of the 128 randomized patients, 125 were analysed (mean age 60 +/- 17 years;82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group vs. 4.8 % in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, -8.8 to 9.1%];P=0.98). The post-hoc added composite outcome of mortality at 90 days or intubation was 15.9% in the 250 mg methylprednisolone group vs. 15% in the 6 mg dexamethasone group (absolute risk difference, -0.9% [95% CI, -13.8 to 12.3%];P=0.83). Hyperglycaemia was more frequent in the methylprednisolone group, at 27.0 vs. 8.1 % (absolute risk difference, -18.9% [95% CI, -31.8 to - 5.6%];P=0.007). Conclusion. Among severe but not critical patients with COVID-19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation.
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Background. The COVID-19 pandemic has strained healthcare systems worldwide and is now a leading cause of death. Remdesivir is the first antiviral shown to decrease time to recovery in a randomized placebo-controlled trial. Other studies have conflicting results and the World Helath Organization does not recommend the routine use of Remdesivir in hospitalized patients. The herogeneity of these studies and their populations makes interpretation of the available data difficult, with standard of care in different countries as the main confounding factor. Thus, it is imperative for low and middle income countries to study the role of remdesivir within their healthcare systems. We seek to further understand the impact of COVID-19 in a cohort in the Dominican Republic. Methods. This is a retrospective review of patients admitted for COVID-19 to a tertiary center in the DR between August 2020 to March. 2021. Patients with clinical findings consistent with COVID-19 pneumonia and a positive molecular test for SARS-CoV-2 were included in the study. Results. A total of 59 cases were reviewed, of which 40 were treated with remdesivir and 19 with remdesivir plus tocilizumab. Patients were more commonly male (69.5%) and ages ranged from 71-80 years (34.5%), 61-70 (20.7%), 51-60 (20.7%), 41-50 (10%), >81 (8.6%) and 18-30 (1.7%). Hypertension was the most common comorbidity (Figure 1). The average length of stay was 16.5 days, and 2.1 days. Mechanical ventilation was needed in 33.9%. Tocilizumab was administered in 32%. Mortality for the cohort was 29% (Figure 2). Mortality in patients treated with remdesivir alone was 22%, compared to 6.8% in those receiving tocilizumab and remdesivir. Comorbidities Mortality by length of stay Conclusion. In our cohort, the use of remdesivir was associated with higher mortality than remdesivir in combination with tocilizumab. The mortality in our cohort was high (29%) compared to the 11.9% reported in in the placebo group of the ACTT-1 study. Furthermore, studies have consistently shown benefit earlier in the disease course and with lower oxygen needs. Our cohort had high rates of mechanical ventilation. Thus, the modest benefit seen in developed countries may be harder to show in resource limited settings and the number needed to treat is likely much higher. Remdesivir did not appear to have an impact in our cohort.
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Introduction: Collection media of clinical samples with the capacity to denature viruses reduce the risk of contagion during transportation and processing. Objective(s): To use the nucleic acids transport media (NATM) in nasopharyngeal swab samples collected for the diagnosis of SARS-CoV-2. Method(s): An experimental study was conducted to demonstrate the medium capacity to inactivate viral infectivity. Zika virus (ZIKV), of biosafety level 2, was used as an enveloped virus model. The clinical performance of the NATM for the diagnosis of SARS-CoV-2 was evaluated. A ZIKV strain propagated in the Vero cell line was used and, prior to cells infection, ZIKV was in contact at different intervals (2;15, and 30 min) with pure NATM;subsequently, serial dilutions (10-1-10-4) were performed. Viral inactivation was evaluated by RT-PCR in the supernatant and the collected cells when the propagation period was completed. CITOSWAB VTM was used as reference to estimate the clinical performance of the NATM in 30 nasopharyngeal swabs collected for the diagnosis of SARS-CoV-2 infection. Result(s): ZIKV remained infectious at inoculum dilutions of >= 10-2, regardless of contact time. Clinical specificity and sensitivity of the NATM for the diagnosis of SARS-CoV-2 were 100%, respectively. Conclusion(s): Results suggest that ZIKV positive clinical samples at dilutions <= 10-1 of the NATM can be safely handled, which could potentially be applied to the molecular diagnosis of SARS-CoV-2. Copyright © 2022, Editorial Ciencias Medicas. All rights reserved.
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Purpose: The evidence regarding the clinical effectiveness of COVID-19 vaccination in kidney transplant (KT) recipients is limited so far. Our purpose is to analyze the characteristics and outcomes of a large series of KT with COVID-19 breakthrough infection and compare them with unvaccinated patients. As a secondary objective, we analyzed the evolution according to the type of mRNA vaccine administered. Method(s): From April to October 2021, KT recipients with COVID-19, included in the COVID-19 registry of the Spanish Society of Nephrology, were analyzed. Data regarding vaccination status and type of vaccine were collected and outcomes of unvaccinated or partially vaccinated patients were compared with fully vaccinated patients. Result(s): Clinical picture was similar and survival analysis showed no differences between groups: 21.7% of fully vaccinated patients and 20.8% of unvaccinated or partially vaccinated died (p=.776). In multivariable analysis age and pneumonia were independent risk factors for death, while vaccination status was not related to mortality. These results remained similar when we excluded patients with partial vaccination as well as when we analyzed exclusively hospitalized patients. Patients vaccinated with mRNA-1273 (Moderna) (n=213) showed a significantly lower mortality than those who received BNT162b2 (Pfizer-BioNTech) vaccine (n=121) (16.4% vs. 28.8%, p=.002) (HR: 0.52, CI 95% 0.31-0.85, p=.010). Conclusion(s): COVID-19 severity in KT patients has remained high and has not improved despite receiving 2 doses of an mRNA vaccine, but the mRNA-1273 vaccine shows higher clinical effectiveness than BNT162b2 in KT recipients with breakthrough infection, so it could be considered as the first option in these patients.
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The study shows an overview of school experiences after implementing the distance learning modality derived from the COVID-19 health emergency from the perspective of 25 elementary school students from urban and rural schools in Chiapas, Mexico. We built our research on an interpretative, hermeneutic approach while conducting semi-structured interviews based on the children's schoolwork. This combination made possible the configuration of three analytical categories: "The pandemic as a bat's broth," which examines the conception of the health emergency, the process of disease and death;"I learn by being glued to the screen," about distance school work and the personal and family vicissitudes behind this dynamic;and "The confinement and the habitation of psychic space," which reflects on the experiences of students about their family relationships, the demands and emerging alterations in the face of confinement. These approaches make us reflect on whether the pandemic amplified children's education problems since the discursive evidence and school performance indicate tension and conflict in the study participants. Finally, we discuss the alternative of managing these experiences through words since symbolizing them can be a means of containment.
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Objective: To describe the elapsed time between vaccination against SARS-COV2 and development of COVID19 pneumonia. To analyse the relation between COVID19 pneumonia and the time between doses as well as with patient profile. Material and/or methods: Cross-sectional descriptive study of patients diagnosed with COVID19 pneumonia and correctly vaccinated who have been notified to SEFV-h. The search for cases was carried out using the FEDRA 3 application between January and September 2021. Results: 99 cases of pneumonia in correctly vaccinated patients were identified;of these, 75 were vaccinated with Comirnaty, 12 with Janssen, 9 with Vaxzevria and 3 with Spikevax. Fifty-seven percent of pneumonias occurred 60 to 129 days after vaccination with a maximum ranging from 90 to 99 days (median 96). For analysis of the time between doses, the 87 cases that required two doses to complete vaccination schedule were considered. Nine of them had more than 2 months between doses, while 78 had less than 1 month (in 54% of the 87 cases 21 days had passed). There was no apparent association with the frequency of developing pneumonia. Thirty-seven percent were women and 60% men. To assess age, the cases were distributed by decade. Thus, the age group >79 had the highest number of cases (52), while the groups 60-69 and 70-79 comprised 18 cases each. The least cases were in the remaining groups: 8 (50-59), 2 (40-49) and 1 (30-39). There was none in the lower age groups. Conclusions: The data indicate that most cases of vaccine failure with severe disease occur 3 months after vaccination. Compared to pre-vaccination data collected from other sources, a decrease in severe cases was observed, with unchanged patient profile in terms of age and sex.
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Objective: To assess the safety of high-dose bolus methylprednisolone versus intermediate-dose dexamethasone in COVID-19 patients with non-critical respiratory failure (RF). Material and/or methods: Low-intervention, phase IV, open-label, randomized 1:1, low-intervention clinical trial (CT): • Arm 1: Dexamethasone 6 mg/24 h/10 days. • Arm 2: Methylprednisolone boluses 250 mg/24 h/3 days Safety preliminary results are presented for 127 patients. This CT has been approved by the Spanish Medicines Agency and the Medicines Ethics Committee of the Salamanca Health Area. EudraCT Number: 2020-005026-28. Results: 127 hospitalized patients, diagnosed with acutephase SARS-CoV-2 infection and non-critical RF, were recruited between January and August 2021. The mean age was 59.5 years and 66.14% were male. The 93.70% were in stage 5 disease according to WHO criteria and 6.30% in stage 4. There were 55 serious adverse events (SAEs) (32 patients, 78% men) and 7 of them (12.7%) were considered serious adverse reactions (SARs), all of them expected. Six patients died (three in the methylprednisolone group). Of these seven SARs, two (28.5%) belonged to the methylprednisolone group, all in men (mean age 67.5 years) and none resulted in death. The classification by organ and system (SOC) of the registered 55 AEs and SAEs, was as follows: 5 vascular disorders cases (methylprednisolone arm: 2), 21 respiratory, thoracic and mediastinal disorders cases (methylprednisolone arm: 12), 2 gastrointestinal disorders cases (methylprednisolone arm: 0), 1 nervous system disorders case (methylprednisolone arm), 26 infections and infestations cases (methylprednisolone arm: 13) and 1 cardiac disorders case no related with methylprednisolone. For the seven adverse reactions reported, the classification by SOC was as follows: one infections and infestations case and one gastrointestinal disorders case no related with methylprednisolone and five vascular disorders cases (methylprednisolone arm: 2). Conclusions: Based on the results obtained, there is no evidence of safety risks associated with high-dose methylprednisolone bolus versus intermediate-dose dexamethasone in patients with COVID-19 with non-critical respiratory failure.
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Background. Literature on SARS-CoV-2 infection in cancer patients is scarce in Latin America. This population seems to have a higher risk for adverse outcomes. This study aims to correlate clinical characteristics with outcomes in patients with cancer in a referral center in Mexico. Methods. We included patients with cancer and confirmed SARS-CoV-2 infection, from April, 19 to December 30, 2020, at the Instituto Nacional de Cancerologia, Mexico. Clinical information was obtained from medical and epidemiological records. We conducted a descriptive analysis. For the association between variables with hospitalization, invasive mechanical ventilation (IMV), and mortality;univariate and multivariate logistic regression was performed;odds ratios and 95% confidence intervals were calculated. Results. Four hundred thirty-three patients were included;268 (62%) were female, the median age was 55 years. One hundred thirty-five (31%), 130 (30%), and 93 (21%) patients had obesity, hypertension, and diabetes mellitus (DM), respectively. Three hundred forty-one (79%) had solid cancer;82 (19%) hematological malignancy (HM), and 10 (2%) were under evaluation for cancer diagnosis. One hundred seventy (39%) had advanced or metastatic cancer. One hundred ninety-eight (46%) patients were hospitalized. Risk factors were: age (p= 0.001);woman (p=0.019);HM (p=0.050) and advanced or metastatic cancer (p= 0.041). Fourty-five (10%) patients required IMV. Age (p=0.018);DM (p=0.041);C-Reactive Protein (p= 0.002), and LDH (p= 0.033) were associated with invasive mechanical ventilation. Mortality within 30-days after diagnosis was 19% (82 cases). Associated characteristics were: age (p=0.041);lymphocytes (p=0.049);creatinine (p=0.005) and albumin (p=0.001). Conclusion. In this study, patients with cancer showed higher mortality, need of hospitalization, and invasive mechanical ventilation compared with groups of patients without cancer. We did not find an increased risk in mortality for hematological malignancies. Although our cohort was younger than others previously reported, age was a strong predictor of adverse outcomes. Variables associated with IMV and death were similar to those previously described in cancer patients with COVID-19.
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Introduction: Venous (VTE) and arterial thromboembolic events are one of the most common complications in the Sars-Cov2 infection. Incidence of these complications ranges from 5% to 45%, as found among studies. Cancer is an established risk factor of thromboembolic events. However, it is not well known the incidence of thromboembolic events among cancer patients with COVID-19. Aim: To determine the incidence of venous and arterial thromboembolic complications between hospitalized cancer patients with covid-19. Materials and Methods: We performed a retrospective analysis of cancer patients with COVID-19 admitted to “Gregorio Marañón General University Hospital” from March to June 2020. Eligibility criteria required a positive polymerase chain reaction or IgG/IgM serology test for Sars-Cov2. The main objective is to obtain the incidence of thrombosis between hospitalized cancer patients with COVID-19. The secondary objective is to determine the mortality. Results: We included 79 patients, 64.6% male, with a mean age of 67.9 years old (range 31-94). The median follow-up of the patients was 110 days. Seventy-one patients (89.9%) had active cancer and 72.2% received oncology treatment in the previous 3 months. Sixty-six patients (83.5%) received therapeutic or prophylactic anticoagulation. Baseline characteristics of the patients are summarised in Table 1 overleaf. Five patients (6.3%) suffered a venous thrombosis, and no episodes of arterial thromboembolic events were reported at the end of the study. 3 patients (60%) developed a pulmonary embolism and 2 patients (40%) a deep venous thrombosis. Thirty patients died: 17 patients (56.7%) because of Covid-19, 10 patients (33.3%) due to tumour progression and 3 patients (10%) as a result of other causes. Mortality rate did not significantly differ among patients who developed thrombosis: 38% non-thrombosis vs 33.3% thrombosis;p=0.684. Conclusions: In our study the incidence of venous thromboembolic events among cancer patients with Covid-19 was found to be 6.3% and no arterial thromboembolic event was noticed. This figure is similar to the incidence reported in general population. Mortality was not higher among patients with thromboembolic events. (Table presented.)
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Background : A recent meta-analysis found a strong relationship between COVID-19 and venous thromboembolism (VTE) in hospitalized patients. Findings on cancer patients and VTE risk remain controversial, mostly in outpatient setting. CATS-MICA score (CMS) was developed as a simple tool (normogram), with only two variables (tumor-site and D-dimer concentration), to calculate predicted 6 month risk of venous thromboembolism (P6RV). Aims : Assessing the prediction capability of VTE risk in SARS-CoV-2-infected cancer patients (inpatients and outpatients) using CMS normogram. Methods : We performed an observational, retrospective, singlecenter study. Consecutive SARS-CoV-2-infected cancer patients attended in Hospital General Universitario Gregorio Marañón Madrid, Spain, in the first wave from March 2020 to June 2020, were included in the analysis. According to tumor location and D-Dimer value, CMS was individually calculated based on the online risk calculator (available at http://catsc ore.medun iwien.ac.at/ ) at COVID-19 diagnosis. Data were collected from electronic medical records. Results : 80 patients were included (Table 1). Median follow-up was 117 days. There was no statistically significant association between CMS and VTE (median CMS for VTE patients was 6.18% and for non VTE patients was 4.93%, P = 0.6). There was a statistical significant difference between the CMS of death cases and survivors . Survival analysis (Figure 1) showed a significant difference between low (<5%) and high (≥5%) risk groups ( P 0.02). Conclusions : Limitations such as sample size and heterogeneity, plus use of anticoagulation on most patients at the moment of COVID-19 diagnosis blur the results. Further studies are required to demonstrate the usefulness of the CMS for prediction of VTE in this specific setting. Regardless, there were significant differences in mortality between high and low risk groups of P6RV values at survival analysis, suggesting a valuable relationship between this tool and mortality, that could be more thoroughly investigated.