ABSTRACT
A tremendous number of studies describe results on the evolution of the COVID-19 impact on infected patients, hospital admissions, deaths, mental health and well-being of the population. However, there are hardly any reports on its impact and evolution since the beginning of the pandemic with clinical, contextual and individual perception information. Our work describes the research project called Health Care and Social Survey (ESSOC, Encuesta Sanitaria y SOCial). It arises from the need to provide specific, reliable, early, and timely data on the impact of COVID-19 that can be considered when making decisions to prepare and provide an effective Public Health response in the different affected populations. It is linked to official statistical operations included in the Andalusian Regional Government and has also been granted a favorable opinion by the Research Ethics Committee. The ESSOC is based on a Real-World Data design. It integrates observational data extracted from multiple sources including information based on surveys and clinical, epidemiological, population, and environmental registries. The surveys have an overlapping panel design with a total of over 22,000 effective interviews being carried out over three years from the beginning of the state of alarm in Spain. Their geographical scope is the Autonomous Region of Andalusia (8.4MM people, the fifth most populated region in Europe), and the population scopes are general population, population residing in disadvantaged areas, and population over the age of 55. The conceptual approach of this study encompasses all aspects affecting health that will contribute to an extraordinary increase in the current knowledge of the impact of the COVID-19 pandemic. Its results will be very useful for cross-disciplinary comparisons in population-based studies, and the methodology developed will serve as a model to be applied in other epidemiological studies. Key messages It is needed to provide specific, reliable, early, and timely data on the impact of COVID-19 that can be considered when making decisions to prepare and provide an effective Public Health response. Our research project integrates observational data extracted from multiple sources including information based on surveys and clinical, epidemiological, population, and environmental registries.
ABSTRACT
Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) enters into target cells by exploiting the cellular transmembrane protease serine 2 (TMPRSS2) for spike protein cleavage. Male gender, age, obesity, diabetes, hypertension are some of the factors related to coronavirus disease 2019 (COVID-19) severity and mortality. Prostate cancer (PCa) patients (pts) are expected to be at higher risk for COVID-19 due to age and disease related comorbidities. TMPRSS2 transcription depends on androgens and androgen receptor and it is significantly downregulated by hormone therapies commonly used to treat PCa in different settings. Supposing that in PCa pts androgen deprivation therapy (ADT) could hamper SARS-CoV-2 cell entry, we aim to evaluate if the presence of single nucleotide polymorphisms (SNPs) in the androgen responsive elements (AREs) in the TMPRSS2 promoter is associated to COVID-19 outcomes. Trial design: The present exploratory biological study is part of an ongoing retrospective-prospective multicenter cohort trial designed to verify whether PCa pts on ADT develop milder clinical presentation of COVID-19 than the general male population. The cohort trial collects real world data since February 2020 through regional databases that identified 200,000 potential pts to be enrolled to compare the clinical outcome of COVID-19 between PCa pts on active therapy (Study Group) and non-PCa pts (Control Group). Within the Study Group, we will compare the COVID-19 outcome between treatment subgroups: ADT alone, ADT plus antiandrogens, CYP17 inhibitors or chemotherapy. To identify SNPs in AREs of the TMPRSS2 gene and to describe possible associations with COVID-19 outcome, blood samples will be collected from 50 PCa pts treated at selected centers. Pts will participate voluntarily and sign an informed consent approved by local ethical committees. We will centrally perform PBMCs isolation and DNA extraction by using quiagen QIAamp DNA Mini Kit. SNPs will be evaluated with the Axiom™ Human Genotyping SARS-CoV-2 array. The effect of ADT will be corrected depending on identified SNPs and associated to COVID-19 outcome. The study is ongoing: we processed blood samples from 21 pts. Final results are awaited by the end of 2021. Legal entity responsible for the study: The authors. Funding: Fondazione IRCCS Istituto Nazionale Tumori di Milano. Disclosure: All authors have declared no conflicts of interest.