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  • Open Access English
    Authors: 
    Arévalos, Victor; Ortega Paz, Luis; Fernandez Rodríguez, Diego; Jiménez Díaz, Víctor Alfonso; Bañeras Rius, Jordi; Campo, Gianluca; Rodríguez Santamarta, Miguel; Pérez de Prado, Armando; Gómez Menchero, Antonio; Díaz Fernández, José Francisco; +13 more
    Publisher: Public Library of Science (PLoS)
    Country: Spain

    Background Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes. Study and design This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee. Conclusion The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

  • Open Access English
    Authors: 
    Steve Simpson-Yap; Edward De Brouwer; Tomas Kalincik; Nick Rijke; J. Hillert; Clare Walton; Gilles Edan; Yves Moreau; Tim Spelman; Lotte Geys; +37 more
    Publisher: Wolters Kluwer Health
    Countries: Belgium, United Kingdom

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Esclerosi múltiple Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Esclerosis múltiple Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Multiple Sclerosis Background and Objectives People with multiple sclerosis (MS) are a vulnerable group for severe coronavirus disease 2019 (COVID-19), particularly those taking immunosuppressive disease-modifying therapies (DMTs). We examined the characteristics of COVID-19 severity in an international sample of people with MS. Methods Data from 12 data sources in 28 countries were aggregated (sources could include patients from 1–12 countries). Demographic (age, sex), clinical (MS phenotype, disability), and DMT (untreated, alemtuzumab, cladribine, dimethyl fumarate, glatiramer acetate, interferon, natalizumab, ocrelizumab, rituximab, siponimod, other DMTs) covariates were queried, along with COVID-19 severity outcomes, hospitalization, intensive care unit (ICU) admission, need for artificial ventilation, and death. Characteristics of outcomes were assessed in patients with suspected/confirmed COVID-19 using multilevel mixed-effects logistic regression adjusted for age, sex, MS phenotype, and Expanded Disability Status Scale (EDSS) score. Results Six hundred fifty-seven (28.1%) with suspected and 1,683 (61.9%) with confirmed COVID-19 were analyzed. Among suspected plus confirmed and confirmed-only COVID-19, 20.9% and 26.9% were hospitalized, 5.4% and 7.2% were admitted to ICU, 4.1% and 5.4% required artificial ventilation, and 3.2% and 3.9% died. Older age, progressive MS phenotype, and higher disability were associated with worse COVID-19 outcomes. Compared to dimethyl fumarate, ocrelizumab and rituximab were associated with hospitalization (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI] 1.01–2.41; aOR 2.43, 95% CI 1.48–4.02) and ICU admission (aOR 2.30, 95% CI 0.98–5.39; aOR 3.93, 95% CI 1.56–9.89), although only rituximab was associated with higher risk of artificial ventilation (aOR 4.00, 95% CI 1.54–10.39). Compared to pooled other DMTs, ocrelizumab and rituximab were associated with hospitalization (aOR 1.75, 95% CI 1.29–2.38; aOR 2.76, 95% CI 1.87–4.07) and ICU admission (aOR 2.55, 95% CI 1.49–4.36; aOR 4.32, 95% CI 2.27–8.23), but only rituximab was associated with artificial ventilation (aOR 6.15, 95% CI 3.09–12.27). Compared to natalizumab, ocrelizumab and rituximab were associated with hospitalization (aOR 1.86, 95% CI 1.13–3.07; aOR 2.88, 95% CI 1.68–4.92) and ICU admission (aOR 2.13, 95% CI 0.85–5.35; aOR 3.23, 95% CI 1.17–8.91), but only rituximab was associated with ventilation (aOR 5.52, 95% CI 1.71–17.84). Associations persisted on restriction to confirmed COVID-19 cases. No associations were observed between DMTs and death. Stratification by age, MS phenotype, and EDSS score found no indications that DMT associations with COVID-19 severity reflected differential DMT allocation by underlying COVID-19 severity. Discussion Using the largest cohort of people with MS and COVID-19 available, we demonstrated consistent associations of rituximab with increased risk of hospitalization, ICU admission, and need for artificial ventilation and of ocrelizumab with hospitalization and ICU admission. Despite the cross-sectional design of the study, the internal and external consistency of these results with prior studies suggests that rituximab/ocrelizumab use may be a risk factor for more severe COVID-19. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. The operational costs linked to this study are funded by the Multiple Sclerosis International Federation (MSIF) and the Multiple Sclerosis Data Alliance (MSDA), acting under the umbrella of the European Charcot Foundation. The MSDA receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Canopy Growth Corp, Genzyme, Icometrix, Merck, Mylan, Novartis, QMENTA, Quanterix, and Roche. MSIF receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Genzyme, Med-Day, Merck, Mylan, Novartis, and Roche. This work was supported by the Flemish government under the Onderzoeksprogramma Artificiële Intelligentie Vlaanderen programme and the Research Foundation Fladers (FWO) for ELIXIR Belgium–Flanders (FWO) for ELIXIR Belgium. The central platform was provided by QMENTA, and the computational resources used in this work were provided by Amazon. The statistical analysis was carried out at CORe, The University of Melbourne, with support from the National Health and Medical Research Council (NHMRC; 1129189 and 1140766).

  • Open Access
    Authors: 
    Cristiana Sessa; Jorge Cortes; Pierfranco Conte; Fatima Cardoso; Toni K. Choueiri; Reinhardt Dummer; Patricia LoRusso; Oliver G. Ottmann; Bettina Ryll; Tony Mok; +5 more
    Publisher: Elsevier BV
    Country: Switzerland

    COVID-19; Cancer care; Clinical research COVID-19; Cura del càncer; Recerca clínica COVID-19; Cuidado del cancer; Investigación clínica The coronavirus disease-19 (COVID-19) pandemic promises to have lasting impacts on cancer clinical trials that could lead to faster patient access to new treatments. In this article, an international panel of oncology experts discusses the lasting impacts of the pandemic on oncology clinical trials and proposes solutions for clinical trial stakeholders, with the support of recent data on worldwide clinical trials collected by IQVIA. These lasting impacts and proposed solutions encompass three topic areas. Firstly, acceleration and implementation of new operational approaches to oncology trials with patient-centric, fully decentralized virtual approaches that include remote assessments via telemedicine and remote devices. Geographical differences in the uptake of remote technology, including telemedicine, are discussed in the article, focusing on the impact of the local adoption of new operational approaches. Secondly, innovative clinical trials. The pandemic has highlighted the need for new trial designs that accelerate research and limit risks and burden for patients while driving optimization of clinical trial objectives and endpoints, while testing is being minimized. Areas of considerations for clinical trial stakeholders are discussed in detail. In addition, the COVID-19 pandemic has exposed the underrepresentation of minority groups in clinical trials; the approach for oncology clinical trials to improve generalizability of efficacy and outcomes data is discussed. Thirdly, a new problem-focused collaborative framework between oncology trial stakeholders, including decision makers, to leverage and further accelerate the innovative approaches in clinical research developed during the COVID-19 pandemic. This could shorten timelines for patient access to new treatments by addressing the cultural and technological barriers to adopting new operational approaches and innovative clinical trials. The role of the different stakeholders is described, with the aim of making COVID-19 a catalyst for positive change in oncology clinical research and eventually in cancer care.

  • Open Access English
    Authors: 
    Jaber S Alqahtani; Tope Oyelade; Abdulelah M Aldhahir; Renata Gonçalves Mendes; Saeed M Alghamdi; Marc Miravitlles; Swapna Mandal; John R. Hurst;
    Publisher: Public Library of Science

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Malaltia pulmonar obstructiva crònica; Factors de risc mèdics Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Enfermedad pulmonar obstructiva crónica; Factores de riesgo médicos Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Chronic obstructive pulmonary disease; Medical risk factors Background Reports have suggested a reduction in exacerbations of chronic obstructive pulmonary disease (COPD) during the coronavirus disease 2019 (COVID-19) pandemic, particularly hospital admissions for severe exacerbations. However, the magnitude of this reduction varies between studies. Method Electronic databases were searched from January 2020 to May 2021. Two independent reviewers screened titles and abstracts and, when necessary, full text to determine if studies met inclusion criteria. A modified version of the Newcastle-Ottawa Scale was used to assess study quality. A narrative summary of eligible studies was synthesised, and meta-analysis was conducted using a random effect model to pool the rate ratio and 95% confidence intervals (95% CI) for hospital admissions. Exacerbation reduction was compared against the COVID-19 Containment and Health Index. Results A total of 13 of 745 studies met the inclusion criteria and were included in this review, with data from nine countries. Nine studies could be included in the meta-analysis. The pooled rate ratio of hospital admissions for COPD exacerbations during the pandemic period was 0.50 (95% CI 0.44–0.57). Findings on the rate of community-treated exacerbations were inconclusive. Three studies reported a significant decrease in the incidence of respiratory viral infections compared with the pre-pandemic period. There was not a significant relationship between exacerbation reduction and the COVID-19 Containment and Health Index (rho = 0.20, p = 0.53). Conclusion There was a 50% reduction in admissions for COPD exacerbations during the COVID-19 pandemic period compared to pre-pandemic times, likely associated with a reduction in respiratory viral infections that trigger exacerbations. Future guidelines should consider including recommendations on respiratory virus infection control measures to reduce the burden of COPD exacerbations beyond the pandemic period. The author(s) received no specific funding for this work.

  • Open Access
    Authors: 
    Jacob D. Galson; Sebastian Schaetzle; Rachael J. M. Bashford-Rogers; Rachael J. M. Bashford-Rogers; Matthew I. J. Raybould; Aleksandr Kovaltsuk; Gavin J. Kilpatrick; Ralph Minter; Donna K. Finch; Jorge Dias; +12 more
    Publisher: Apollo - University of Cambridge Repository
    Country: United Kingdom

    Repertori de cèl·lules B; SARS-CoV-2; Anticòs Repertorio de células B; SARS-CoV-2; Anticuerpo B-cell repertoire; SARS-CoV-2; Antibody Deep sequencing of B cell receptor (BCR) heavy chains from a cohort of 31 COVID-19 patients from the UK reveals a stereotypical naive immune response to SARS-CoV-2 which is consistent across patients. Clonal expansion of the B cell population is also observed and may be the result of memory bystander effects. There was a strong convergent sequence signature across patients, and we identified 1,254 clonotypes convergent between at least four of the COVID-19 patients, but not present in healthy controls or individuals following seasonal influenza vaccination. A subset of the convergent clonotypes were homologous to known SARS and SARS-CoV-2 spike protein neutralizing antibodies. Convergence was also demonstrated across wide geographies by comparison of data sets between patients from UK, USA, and China, further validating the disease association and consistency of the stereotypical immune response even at the sequence level. These convergent clonotypes provide a resource to identify potential therapeutic and prophylactic antibodies and demonstrate the potential of BCR profiling as a tool to help understand patient responses. MR is supported by an Engineering and Physical Sciences Research Council (EPSRC) and Medical Research Council (MRC) grant (EP/L016044/1). AK is supported by a Biotechnology and Biological Sciences Research Council (BBSRC) grant (BB/M011224/1).

  • Open Access English
    Authors: 
    Milena Soriano Marcolino; Magda Carvalho Pires; L. E. F. Ramos; Rafael Guimarães Tavares da Silva; Luana Martins Oliveira; Rafael Lima Rodrigues de Carvalho; Rodolfo Lucas Silva Mourato; Adrián Sánchez-Montalvá; Berta Raventós; Fernando Anschau; +108 more
    Publisher: Elsevier
    Country: Netherlands

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Hospitalitzacions; Mortalitat Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Hospitalizaciones; Mortalidad Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Hospitalizations; Mortality Objectives The majority of available scores to assess mortality risk of coronavirus disease 2019 (COVID-19) patients in the emergency department have high risk of bias. Therefore, this cohort aimed to develop and validate a score at hospital admission for predicting in-hospital mortality in COVID-19 patients and to compare this score with other existing ones. Methods Consecutive patients (≥ 18 years) with confirmed COVID-19 admitted to the participating hospitals were included. Logistic regression analysis was performed to develop a prediction model for in-hospital mortality, based on the 3978 patients admitted between March–July, 2020. The model was validated in the 1054 patients admitted during August–September, as well as in an external cohort of 474 Spanish patients. Results Median (25–75th percentile) age of the model-derivation cohort was 60 (48–72) years, and in-hospital mortality was 20.3%. The validation cohorts had similar age distribution and in-hospital mortality. Seven significant variables were included in the risk score: age, blood urea nitrogen, number of comorbidities, C-reactive protein, SpO 2 /FiO 2 ratio, platelet count, and heart rate. The model had high discriminatory value (AUROC 0.844, 95% CI 0.829–0.859), which was confirmed in the Brazilian (0.859 [95% CI 0.833–0.885]) and Spanish (0.894 [95% CI 0.870–0.919]) validation cohorts, and displayed better discrimination ability than other existing scores. It is implemented in a freely available online risk calculator (https://abc2sph.com/). Conclusions An easy-to-use rapid scoring system based on characteristics of COVID-19 patients commonly available at hospital presentation was designed and validated for early stratification of in-hospital mortality risk of patients with COVID-19. This study was supported in part by Minas Gerais State Agency for Research and Development ( Fundação de Amparo à Pesquisa do Estado de Minas Gerais – FAPEMIG ) [grant number APQ-00208-20], National Institute of Science and Technology for Health Technology Assessment ( Instituto de Avaliação de Tecnologias em Saúde – IATS )/ National Council for Scientific and Technological Development ( Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq ) [grant number 465518/2014-1], and CAPES Foundation ( Coordenação de Aperfeiçoamento de Pessoal de Nível Superior ) [grant number 88887.507149/2020-00]. AS was supported by a postdoctoral grant “Juan Rodés” (JE18/00022) from Instituto de Salud Carlos III through the Ministry of Economy and Competitiveness, Spain.

  • Open Access Catalan; Valencian
    Publisher: Servei Català de la Salut

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Activitats; Contenció; Mesures de seguretat Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Actividades; Contención; Medidas de seguridad Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Activities; Containment; Security measures Cartell adreçat a la ciutadania informant de les mesures de protecció destinades a la contenció de la COVID-19 que seran d'aplicació a partir del 8 de març a Catalunya. Cartel dirigido a la ciudadanía informando de las medidas de protección destinadas a la contención de la Covid-19 que serán de aplicación a partir del 8 de marzo en Catalunya. Poster addressed to the public informing of the protection measures intended for the containment of the COVID-19 that will be applicable from March 8 in Catalonia.

  • Open Access
    Authors: 
    Baldassarri M.; Picchiotti N.; Fava F.; Fallerini C.; Benetti E.; Daga S.; Valentino F.; Doddato G.; Furini S.; Giliberti A.; +155 more
    Publisher: Elsevier BV
    Countries: Spain, Spain, Spain, Spain, Spain, Italy, Spain

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Gen receptor d'andrògens; Infecció vírica i genoma de l’hoste Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Gen receptor de andrógenos; Infección viral y genoma del huésped Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Androgen receptor gene; Viral infection and host genome Background While SARS-CoV-2 similarly infects men and women, COVID-19 outcome is less favorable in men. Variability in COVID-19 severity may be explained by differences in the host genome. Methods We compared poly-amino acids variability from WES data in severely affected COVID-19 patients versus SARS-CoV-2 PCR-positive oligo-asymptomatic subjects. Findings Shorter polyQ alleles (≤22) in the androgen receptor (AR) conferred protection against severe outcome in COVID-19 in the first tested cohort (both males and females) of 638 Italian subjects. The association between long polyQ alleles (≥23) and severe clinical outcome (p = 0.024) was also validated in an independent cohort of Spanish men <60 years of age (p = 0.014). Testosterone was higher in subjects with AR long-polyQ, possibly indicating receptor resistance (p = 0.042 Mann-Whitney U test). Inappropriately low serum testosterone level among carriers of the long-polyQ alleles (p = 0.0004 Mann-Whitney U test) predicted the need for intensive care in COVID-19 infected men. In agreement with the known anti-inflammatory action of testosterone, patients with long-polyQ and age ≥60 years had increased levels of CRP (p = 0.018, not accounting for multiple testing). Interpretation We identify the first genetic polymorphism that appears to predispose some men to develop more severe disease. Failure of the endocrine feedback to overcome AR signaling defects by increasing testosterone levels during the infection leads to the polyQ tract becoming dominant to serum testosterone levels for the clinical outcome. These results may contribute to designing reliable clinical and public health measures and provide a rationale to test testosterone as adjuvant therapy in men with COVID-19 expressing long AR polyQ repeats. MIUR project “Dipartimenti di Eccellenza 2018-2020” to Department of Medical Biotechnologies University of Siena, Italy (Italian D.L. n.18 March 17, 2020) and “Bando Ricerca COVID-19 Toscana” project to Azienda Ospedaliero-Universitaria Senese. Private donors for COVID-19 research and charity funds from Intesa San Paolo.

  • Publication . Article . Other literature type . 2021
    Open Access English
    Authors: 
    Concetta Elisa Onesti; Marco Tagliamento; Giuseppe Curigliano; Nadia Harbeck; Rupert Bartsch; Hans Wildiers; Vivianne C. G. Tjan-Heijnen; Miguel Martin; Sylvie Rottey; Daniele Generali; +10 more
    Countries: Belgium, Netherlands

    PURPOSE The COVID-19 pandemic has affected healthcare systems globally, leading to reorganization of medical activities. We performed an international survey aimed to investigate the medium- and long-term impact on oncology units. MATERIALS AND METHODS An 82-item survey was distributed from June 17 to July 14, 2020 among medical oncologists worldwide. RESULTS One hundred nine medical oncologists from 18 countries in Europe (n = 93), United States (n = 5), and Latin America (n = 11) answered the survey. A systematic tracing of COVID-19–positive patients was continued in the postacute phase by 77.1% of the centers; 64.2% of the respondents participated in a local registry and 56% in international or national registries of infected patients. Treatment adaptations were introduced, and surgery was the most affected modality being delayed or canceled in more than 10% of patients in 34% of the centers, whereas early cessation of palliative treatment was reported in 32.1% of the centers; 64.2% of respondents reported paying attention to avoid undertreatments. The use of telemedicine has been largely increased. Similarly, virtual tools are increasingly used particularly for medical education and international or national or multidisciplinary meetings. 60.6% of the participants reduced clinical activity, and 28.4% compensated by increasing their research activity. Significant reduction of clinical trial activities is expected in 37% of centers this year. The well-being of healthcare staff would not recover by the end of the year according to 18% of the participants. CONCLUSION The COVID-19 outbreak has had a major impact on oncologic activity, which will persist in the future, irrespective of geographical areas.

  • Open Access English
    Authors: 
    Fabian Eibensteiner; Valentin Ritschl; Tanja Stamm; Asil Cetin; Claus Peter Schmitt; Gema Ariceta; Sevcan A. Bakkaloglu; Augustina Jankauskiene; Günter Klaus; Fabio Paglialonga; +10 more
    Countries: Turkey, Lithuania

    ObjectivesIn a previously published Delphi exercise the European Pediatric Dialysis Working Group (EPDWG) reported widely variable counteractive responses to COVID-19 during the first week of statutory public curfews in 12 European countries with case loads of 4–680 infected patients per million. To better understand these wide variations, we assessed different factors affecting countermeasure implementation rates and applied the capability, opportunity, motivation model of behaviour to describe their determinants.DesignWe undertook this international mixed methods study of increased depth and breadth to obtain more complete data and to better understand the resulting complex evidence.SettingThis study was conducted in 14 paediatric nephrology centres across 12 European countries during the COVID-19 pandemic.ParticipantsThe 14 participants were paediatric nephrologists and EPDWG members from 12 European centres.Main outcome measures52 countermeasures clustered into eight response domains (access control, patient testing, personnel testing, personal protective equipment policy, patient cohorting, personnel cohorting, suspension of routine care, remote work) were categorised by implementation status, drivers (expert opinion, hospital regulations) and resource dependency. Governmental strictness and media attitude were independently assessed for each country and correlated with relevant countermeasure implementation factors.ResultsImplementation rates varied widely among response domains (median 49.5%, range 20%–71%) and centres (median 46%, range 31%–62%). Case loads were insufficient to explain response rate variability. Increasing case loads resulted in shifts from expert opinion-based to hospital regulation-based decisions to implement additional countermeasures despite increased resource dependency. Higher governmental strictness and positive media attitude towards countermeasure implementation were associated with higher implementation rates.ConclusionsCOVID-19 countermeasure implementation by paediatric tertiary care centres did not reflect case loads but rather reflected heterogeneity of local rules and of perceived resources. These data highlight the need of ongoing reassessment of current practices, facilitating rapid change in ‘institutional behavior’ in response to emerging evidence of countermeasure efficacy.