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2.
European Journal of Public Health ; 31, 2021.
Article in English | ProQuest Central | ID: covidwho-1514681

ABSTRACT

Background Mobilizing real world data from multiple data hubs in multiple countries to carry out policy-oriented research, requires orchestrating the governance of workflows, being compliant with legal and ethical requirements, and semantic harmonization and technological interoperability. In the context of PHIRI, policy-oriented research has to provide insight to policy-makers to cope with pandemics. Methods PHIRI builds this concept on the deployment of four use cases throughout a federated research infrastructure. A central hub orchestrates all the elements encompassing the development of such an infrastructure;so, a common governance model, common methodology pursuing semantic interoperability, and the development and deployment of technological solution containing ETL processes, data quality assessment solutions and data analyses, all packaged to be rolled out in the different data hubs composing the federation. Results A prototype orchestrating those workflows is being followed in four use cases: indirect effects of the pandemic on vulnerable populations, delayed breast cancer treatments due to the pandemic, perinatal health affections along the COVID19 crisis, effects of the pandemic on mental health care. A prototype of the technological platform supporting interoperable federated analyses has been prepared. Conclusions It is pertinent, feasible and reliable using a federated research infrastructure leveraging real world data from many data hubs in many countries to answer research queries on the COVID19 pandemic.

3.
European Journal of Public Health ; 31, 2021.
Article in English | ProQuest Central | ID: covidwho-1514584

ABSTRACT

Background Wide variations in COVID-19 infection and outcomes exist across Europe and within countries. PHIRI will look at COVID-19 impacts in specific subgroups by conducting research through use cases of immediate relevance for public health policies focusing on indirect effects of the pandemic related to healthcare and other policies to contain the pandemic. Furthermore, the use cases represent pilot activities for the benefits and added value of a research infrastructure by bringing together data from different European countries. Methods Four research use cases will focus on selected aspects of vulnerable population groups and risk factors, delayed medical care in cancer, perinatal health outcomes, as well as mental health outcomes and are selected based on public health importance, geographic coverage, feasibility of producing actionable insights and relevance for the PHIRI infrastructure. The use cases will demonstrate how a broad variety of secondary data (e.g. administrative and survey data) can be pooled and/or reused in a distributed way across Europe. Results The outputs of the use cases will be processed by formalizing data models, data management processes and analytical pipelines in an interoperable way to feed in the federated research infrastructure. The use cases facilitate research by making scalable, reproducible methods available within PHIRI and by publishing the FAIRified use cases analysis results on the Health Information Portal. They will provide outcomes to guide policy makers in preparedness and response scenarios and will ensure the development of a format for the timely dissemination of use case results to the targeted groups. Conclusions PHIRI will provide insights in real life use cases to generate immediate results on key health impacts of COVID-19 on population health to underpin decision making and will drive the development of the federated research infrastructure that allows rapid cycle analysis.

4.
Topics in Antiviral Medicine ; 29(1):205-206, 2021.
Article in English | EMBASE | ID: covidwho-1250108

ABSTRACT

Background: We compared the characteristics and clinical outcomes of hospitalized patients with COVID-19 with and without HIV infection (HIV-pos and HIV-neg) in Spain during the first wave of the pandemic. Methods: HIV-pos were identified by reviewing clinical records and laboratory registries of 10,922 patients in active-follow-up within the Spanish HIV Research Network (CoRIS) up to June 30, 2020. Each HIV-pos was matched with 5 HIV-neg of the same age and sex randomly selected from COVID-19@Spain, a multicenter cohort of 4,035 patients hospitalized with PCR confirmed COVID-19 in Spain (Clin Microbiol Infect 2020;26:1525-36). Data were collected with the ISARIC-WHO Core case report form (https://isaric.org/document/COVID-19-crf/). The COVID-19 SEIMC score (predictive of 30-day mortality), based on age, sex, dyspnea, O2 saturation, neutrophil-to-lymphocyte ratio, and estimated glomerular filtration rate, was calculated at admission in all patients (ESCMID Conference on Coronavirus Disease, 2020, Abstract#00513). Outcomes included the need for mechanical ventilation and all-cause in-hospital mortality. Results: Forty-five patients with PCR confirmed COVID-19 were identified in CoRIS, 21 of which were hospitalized. A total of 105 age/sex-matched controls were selected from COVID-19@Spain. The median age in both groups was 53 (Q1-Q3, 46-56) years, and 90.5% were men. In HIV-pos, 19.1% were IDUs, 95.2% were on ART, 94.4% had HIV-RNA < 50 copies/mL, and the median (Q1-Q3) CD4+ count was 595 (349-798) cells/mm3. No statistically significant differences were found between groups in number and type of comorbidities, presenting signs and symptoms, laboratory parameters, and radiology findings. The median (Q1-Q3) COVID-19 SEIMC score on admission was 4 (2-7) and 5 (3-7) in HIV-pos and HIV-neg, respectively;P=.890. Corticosteroids were administered to 33.3% and 27,4% HIV-pos and HIV-neg, respectively;P=.58. Remdesivir was administered to 0 and 2.9% of HIV-pos and HIV-neg, respectively;P=.426. During admission, 9.5% HIV-pos and 23.3% HIV-neg underwent mechanical ventilation;P=.158. In-hospital mortality was 9.5% in HIV-pos and 11.4% in HIV-neg;P=.800. Conclusion: Our findings suggest that well-controlled HIV infection does not modify the clinical presentation or worsen clinical outcomes in patients hospitalized with COVID-19. (Figure Presented).

5.
Topics in Antiviral Medicine ; 29(1):208, 2021.
Article in English | EMBASE | ID: covidwho-1249949

ABSTRACT

Background: Within a prospective cohort of people with HIV (PWH) in Spain, we assessed the prevalence of SARS-CoV-2 antibodies (Ab), the proportion of asymptomatic COVID-19, and identified predictors of infection. Methods: We determined SARS-CoV-2 Ab in plasma samples collected from April 1st to September 30th, 2020, from enrollees in the Spanish HIV Research Network Cohort (CoRIS), a prospective national cohort of PWH, naive to ART at study entry, seen for the first time from January 1st, 2004. Samples were stored at-80°C in the Spanish HIV BioBank, and serology was performed using the Platelia SARS-CoV-2 Total Ab assays (BioRad, Hercules, CA, USA). Illness severity (NIH criteria) was assessed by medical records review and, if needed, participant interviews. Multivariable logistic regression analysis was used to identify predictors of seropositivity among the following variables: sex, age, country of birth, education level, comorbidities (hypertension, chronic heart disease, diabetes, non-AIDS related cancer, chronic kidney disease, cirrhosis), route of HIV acquisition, prior AIDS, CD4+ cell count, HIV viral load, and N(t)RTI backbone. Results: During the study period, blood samples were collected and stored in the HIV BioBank from 1,076 consecutive PWH in CoRIS: 88.0% male at birth, median age 43 yr., 72.3% MSM, 97.7% on ART, median CD4+ 688 cells/mm3, 91.4% undetectable HIV viral load. SARS-CoV-2 Ab were detected in 91 PWH, for a seroprevalence of 8.5% (95%CI: 6.9%-10.3%). A total of 41 PWH (45.0%) had asymptomatic infections;the disease was mild in 43 (47.3%), moderate in 4 (4.4%), severe in 3 (3.3%), and 0 critical. Seven PWH (7.7%) were hospitalized. COVID-19 was confirmed by RT-PCR in 22 (24.2%) PWH. Variables independently associated with SARS-CoV-2 seropositivity were birth in Latin American (LA) Countries vs. Spain (adjusted odds ratio [aOR]: 2.34, 95%CI: 1.42-3.85;P=.001);arterial hypertension (aOR: 1.63, 95%CI: 1.00-2.67;P=.050);and therapy with tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) vs tenofovir alafenamide (TAF)/FTC as the N(t)RTI backbone (aOR: 0.32, 95%CI: 0.12-0.84;P=.021). (Table). Conclusion: A large proportion of SARS-CoV-2 infections among PWH were asymptomatic. Birth in LA-countries and arterial hypertension were associated with increased risk of SARS-CoV-2 seropositivity. Our analysis, adjusted by comorbidities and other variables, suggest that TDF/FTC may prevent SARS-CoV-2 infection among PWH. (Figure Presented).

6.
European Journal of Hospital Pharmacy ; 28(SUPPL 1):A143, 2021.
Article in English | EMBASE | ID: covidwho-1186341

ABSTRACT

Background and importance Tocilizumab (TCZ) has been proposed to mitigate the cytokine storm syndrome associated with SARS-CoV-2. However, acute administration of this drug has been shown to cause serious adverse effects at the level of the liver, including acute liver failure. Aim and objectives To evaluate the liver toxicity profile associated with the acute use of TCZ in patients with SARS-CoV-2 infection. Material and methods A retrospective single centre study, lasting 2 months (March to April 2020), was conducted in all patients with a clinical suspicion/diagnosis confirmed of SARSCoV-2 infection and who had received treatment with TCZ. The following variables were collected: age, sex, posology scheme of TCZ, admission to the intensive care unit (ICU), need for orotracheal intubation (OTI) and death during the hospital stay. The hepatic profile was analysed for levels of hepatic transaminases (GOT/AST and GPT/ALT) and total bilirubin (TOT BL) pre and post completion of treatment with TCZ. Alteration of liver parameters was classified as mild (1- 3 × upper limit of normality (UPN)), moderate (3-5 × UPN) and severe (≥5 × UPN). Results During the study period, 44 patients with SARS-CoV-2 infection were treated with TCZ (65.9% men (n=29);mean age 62.3 years (31-82)). The posology scheme of TCZ used was the following: single dose (68.2%, n=30), double dose (18.2%, n=8) and triple dose (11.6%, n=6). Two patients (4.5%) received a 50% reduced dose because of previous liver failure. During admission, 56.8% (n=25) of patients required a stay in the ICU. 36.4% (n=16) needed OTI. 9.1% (n=4) died during admission. Liver profile analysis showed that 72.7% of patients (n=32) presented with normal levels of GPT/ALT and GOT/AST before treatment. 59.1% (n=26) presented with normal levels of BL TOT and 4.5% (n=2) had high levels. In 34.1% (n=15) there were no data. After treatment with TCZ, 86.3% (n=38) developed hepatotoxicity. Elevation of GPT/ALT was observed: mild (42.1%), moderate (28.9%) and severe (28.9%);elevation of GOT/AST: mild (44.7%), moderate (31.6%) and severe (13.2%). 42.9% (n=12) presented with high levels of BL TOT after receiving TCZ. Conclusion and relevance The study showed how a high proportion of patients with SARS-CoV-2 infection developed severe liver toxicity after the use of the drug. However, future studies will be needed to clarify the involvement of SARSCoV-2 itself in the development of hepatotoxicity.

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