Rapid analysis of local data to inform off-label tocilizumab use early in the COVID-19 pandemic.
Ontology highlight
ABSTRACT:
SUBMITTER: Morgan CE
PROVIDER: S-EPMC8493269 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The ongoing coronavirus disease 2019 (COVID-19) pandemic has heightened discussion of the use of mobile phone data in outbreak response. Mobile phone data have been proposed to monitor effectiveness of non-pharmaceutical interventions, to assess potential drivers of spatiotemporal spread, and to support contact tracing efforts. While these data may be an important part of COVID-19 response, their use must be considered alongside a careful understanding of the behaviors and populations they capture. Here, we review the different applications for mobile phone data in guiding and evaluating COVID-19 response, the relevance of these applications for infectious disease transmission and control, and potential sources and implications of selection bias in mobile phone data. We also discuss best practices and potential pitfalls for directly integrating the collection, analysis, and interpretation of these data into public health decision making.
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Project description:We evaluated adverse drug events (ADEs) by chart review in a random national sample of 428 veterans with coronavirus disease 2019 (COVID-19) who received tocilizumab (n = 173 of 428). ADEs (median time, 5 days) occurred in 51 of 173 (29%) and included hepatoxicity (n = 29) and infection (n = 13). Concomitant medication discontinuation occurred in 22% of ADE patients; mortality was 39%.
| S-EPMC8160489 | biostudies-literature
Project description:BackgroundThe effectiveness of the best combination between different antiviral and anti-inflammatory drugs stills an interest in the treatment of COVID19 infection.Patients and methodsA prospective randomized cohort study comprised 108 adult patients with confirmed PCR COVID 19 infection with systemic hyper inflammation state, divided into two groups according to the treatment regimen, 56 in the tocilizumab- hydroxychloroquine (TCZ-HCQ) treatment, and 52 in the tocilizumab-remdesivir (TCZ-RMV) treatment. The first group received a combination of I.V. TCZ (400-800 mg every 24 h for only two doses) and HCQ (400 mg twice in the first day then 200 mg twice for 5 days) while the second group of patients received I.V. RMV of 200 mg on day 1 followed by 100 mg once daily infused over 60 min for 5 days with the same TCZ regimen used in the first group. All clinical parameters and laboratory investigations were assessed before and after treatment.ResultsThe CRP was significantly decreased while PaO2/FiO2 (P/F) ratio post-treatment was significantly improved in both treatment groups. TCZ-HCQ group showed a significant decrease in the ferritin, LDH, and D. Dimer levels. The median days of hospitalization with interquartile range (IQR) were 10 (6-16) and 8 (5-12) for TCZ-HCQ and TCZ-RMV groups, respectively. The numbers of mechanically ventilated patients were 25 and 43 for TCZ-HCQ and TCZ-RMV groups, respectively. Therapeutic failure was about 26.8% in the TCZ-HCQ group and 30.8% in the TCZ-RMV group but there was no significant difference between both groups. Some complications were recognized only in TCZ-RMV following treatment including secondary bacterial infections (42.3%), myocarditis (15.4%), and finally pulmonary embolism (7.7%).ConclusionEfficacy of both TCZ-RMV and TCZ-HCQ combinations are observed in the treatment of severe COVID-19 patients; however the increased need for ICU or mechanical ventilation in the TCZ-RMV arm contributed to the appearance of cardiac and thrombotic events. The study was registered at the Clinical Trials registry (ClinicalTrials.gov; NCT04779047).
| S-EPMC8562044 | biostudies-literature
Project description:Acute respiratory distress syndrome associated with coronavirus infection is related to a cytokine storm with large interleukin-6 (IL-6) release. The IL-6-receptor blocker tocilizumab may control the aberrant host immune response in patients with coronavirus disease 2019 (COVID-19) . In this pandemic, kidney transplant (KT) recipients are a high-risk population for severe infection and showed poor outcomes. We present a multicenter cohort study of 80 KT patients with severe COVID-19 treated with tocilizumab during hospital admission. High mortality rate was identified (32.5%), related with older age (hazard ratio [HR] 3.12 for those older than 60 years, P = .039). IL-6 and other inflammatory markers, including lactic acid dehydrogenase, ferritin, and D-dimer increased early after tocilizumab administration and their values were higher in nonsurvivors. Instead, C-reactive protein (CRP) levels decreased after tocilizumab, and this decrease positively correlated with survival (mean 12.3 mg/L in survivors vs. 33 mg/L in nonsurvivors). Each mg/L of CRP soon after tocilizumab increased the risk of death by 1% (HR 1.01 [confidence interval 1.004-1.024], P = .003). Although patients who died presented with worse respiratory situation at admission, this was not significantly different at tocilizumab administration and did not have an impact on outcome in the multivariate analysis. Tocilizumab may be effective in controlling cytokine storm in COVID-19 but randomized trials are needed.
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Project description:Background. The COVID-19 pandemic has popularized computer-based decision-support models, which are commonly used to inform decision making amidst complexity. Understanding what organizational decision makers prefer from these models is needed to inform model development during this and future crises. Methods. We recruited and interviewed decision makers from North Carolina across 9 sectors to understand organizational decision-making processes during the first year of the COVID-19 pandemic (N = 44). For this study, we identified and analyzed a subset of responses from interviewees (n = 19) who reported using modeling to inform decision making. We used conventional content analysis to analyze themes from this convenience sample with respect to the source of models and their applications, the value of modeling and recommended applications, and hesitancies toward the use of models. Results. Models were used to compare trends in disease spread across localities, estimate the effects of social distancing policies, and allocate scarce resources, with some interviewees depending on multiple models. Decision makers desired more granular models, capable of projecting disease spread within subpopulations and estimating where local outbreaks could occur, and incorporating a broad set of outcomes, such as social well-being. Hesitancies to the use of modeling included doubts that models could reflect nuances of human behavior, concerns about the quality of data used in models, and the limited amount of modeling specific to the local context. Conclusions. Decision makers perceived modeling as valuable for informing organizational decisions yet described varied ability and willingness to use models for this purpose. These data present an opportunity to educate organizational decision makers on the merits of decision-support modeling and to inform modeling teams on how to build more responsive models that address the needs of organizational decision makers. Highlights Organizations from a diversity of sectors across North Carolina (including public health, education, business, government, religion, and public safety) have used decision-support modeling to inform decision making during COVID-19. Decision makers wish for models to project the spread of disease, especially at the local level (e.g., individual cities and counties), and to help estimate the outcomes of policies. Some organizational decision makers are hesitant to use modeling to inform their decisions, stemming from doubts that models could reflect nuances of human behavior, concerns about the accuracy and precision of data used in models, and the limited amount of modeling available at the local level.
| S-EPMC9340948 | biostudies-literature
Project description:As of May 14, 2020, the World Health Organization has reported approximately 4.3 million cases of the novel Coronavirus Disease (COVID-19) with approximately 294,046 deaths worldwide [1]. Solid organ transplant recipients who are on chronic immunosuppressants fall within a special population of COVID-19 patients since they are more susceptible to complications secondary to COVID-19. Currently, we do not have data on treating COVID-19 patients with solid organ transplants with tocilizumab, an interleukin-6 (IL-6) inhibitor. We report a case of COVID-19 in a patient with a kidney and liver transplant and discuss the early use of tocilizumab to prevent the cytokine storm and attempt to reduce the likelihood of progression to Acute Respiratory Distress Syndrome (ARDS). In addition, we present other COVID-19 related transplant cases reported in the literature outlining the presenting clinical signs and outcomes.
| S-EPMC7318948 | biostudies-literature
Project description:While the use of social media by local governments has gained relevance in recent years, crises are critical situations that reinforce the need to reach citizens to disclose information, demonstrate the government's commitment, and increase the citizens' level of preparedness and awareness of resources. This paper examines the factors that influenced local governments' e-disclosure during the first wave of the COVID-19 pandemic. To accomplish this objective, we systematically tracked every post published by the official Facebook page of 304 Portuguese municipalities between March 2 and July 5, 2020. The findings show that financial autonomy is the main predictor of e-disclosure, factors varied on the different phases of the pandemic's first wave, and sociodemographic factors became more prevalent as explanatory factors when the crisis worsened. Our study may help increase the level of preparedness during possible future crises. In particular, establishing communication strategies for prolonged public health crises, making financial resources available for the accomplishment of such strategies, and reducing the digital divide can contribute to more effective disclosure. Future research should explore the dynamics of disclosure during public health crises. This study also highlights the need to incorporate time in research that focuses on the determinants of e-disclosure that could also be tested in normal times.
| S-EPMC8517969 | biostudies-literature
Project description:In Ontario on March 16, 2020, a directive was issued to all acute care hospitals to halt nonessential procedures in anticipation of a potential surge in COVID-19 patients. This included scheduled outpatient cardiac surgical and interventional procedures that required the use of intensive care units, ventilators, and skilled critical care personnel, given that these procedures would draw from the same pool of resources required for critically ill COVID-19 patients. We adapted the COVID-19 Resource Estimator (CORE) decision analytic model by adding a cardiac component to determine the impact of various policy decisions on the incremental waitlist growth and estimated waitlist mortality for 3 key groups of cardiovascular disease patients: coronary artery disease, valvular heart disease, and arrhythmias. We provided predictions based on COVID-19 epidemiology available in real-time, in 3 phases. First, in the initial crisis phase, in a worst case scenario, we showed that the potential number of waitlist related cardiac deaths would be orders of magnitude less than those who would die of COVID-19 if critical cardiac care resources were diverted to the care of COVID-19 patients. Second, with better local epidemiology data, we predicted that across 5 regions of Ontario, there may be insufficient resources to resume all elective outpatient cardiac procedures. Finally in the recovery phase, we showed that the estimated incremental growth in waitlist for all cardiac procedures is likely substantial. These outputs informed timely data-driven decisions during the COVID-19 pandemic regarding the provision of cardiovascular care.
| S-EPMC7241392 | biostudies-literature
Project description:Tocilizumab, an anti-interleukin-6 (IL-6) agent, is indicated as a treatment for several autoimmune or inflammatory diseases, including rheumatoid arthritis and juvenile idiopathic arthritis (JIA). IL-6 plays roles in both immune system dysregulation and inflammation, and thus efforts to extend the utility of tocilizumab in patients with autoinflammatory conditions are ongoing. Here, we survey the literature on the off-label use of tocilizumab in patients with juvenile-onset rheumatic diseases including juvenile systemic lupus erythematosus (SLE), juvenile dermatomyositis (DM), vasculitis, juvenile scleroderma, and other autoinflammatory diseases. There is no real evidence that tocilizumab is useful for patients with SLE and juvenile DM, but several cases of childhood Takayasu arteritis have experienced promising outcomes. In juvenile-onset scleroderma, for which no therapy that can halt disease progression is available, tocilizumab may stop progression and the associated functional impairment. Tocilizumab prevents systemic inflammation in patients with Kawasaki's disease, but may develop coronary aneurysms. Tocilizumab has been used to treat several pediatric autoinflammatory diseases, including JIA-associated uveitis and Castleman's disease. Further work in larger populations is necessary to confirm the effects of tocilizumab in patients with pediatric rheumatic diseases.
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Project description:BACKGROUND:Tocilizumab, a humanized monoclonal antibody, targets IL-6 receptors blocking downstream pro-inflammatory effects of IL-6. In preliminary reports it was suggested to be beneficial in patients with severe COVID-19. METHODS:In this open-label prospective study we describe clinical characteristics and outcome of 51 patients hospitalized with confirmed and severe COVID-19 pneumonia treated with tocilizumab intravenously. All patients had elevated IL-6 plasma level (>40 pg/mL) and oxygen saturation <93% in ambient air. Clinical outcomes, oxygen support, laboratory data and adverse events were collected over a follow-up of 30 days. RESULTS:Forty-five patients (88%) were on high-flow oxygen supplementation, six of whom with invasive ventilation. From baseline to day 7 after tocilizumab we observed a dramatic drop of body temperature and CRP value with a significant increase in lymphocyte count (p<0.001). Over a median follow-up time of 34 days from tocilizumab, 34 patients (67%) showed an improvement in their clinical severity class; 31 were discharged; 17 (33%) showed a worsening of their clinical status, of these 14 died (27%). The mortality rate was significantly associated with mechanical ventilation at baseline (83.3% vs 20% of patients on non-invasive oxygen support; p=0.0001). The most frequent side effects were an increase of hepatic enzymes (29%), thrombocytopenia (14%), and serious bacterial and fungal infections (27%). CONCLUSION:Tocilizumab exerts a rapidly beneficial effect on fever and inflammatory markers, although no significant impact on the clinical outcome can be inferred by our results. Critically ill patients seem to have a high risk of serious infections with this drug.
| S-EPMC7241995 | biostudies-literature