Abstract
BackgroundSince the beginning of the COVID-19 pandemic, the world’s attention has been focused on better understanding the relation between the human host and the SARS-CoV-2 virus, as its action has led to hundreds of thousands of deaths.ObjectiveIn this context, we decided to study certain consequences of the abundant cytokine release over the innate and adaptive immune systems, inflammation, and hemostasis, comparing mild and severe forms of COVID-19.MethodsTo accomplish these aims, we will analyze demographic characteristics, biochemical tests, immune biomarkers, leukocyte phenotyping, immunoglobulin profile, hormonal release (cortisol and prolactin), gene expression, thromboelastometry, neutralizing antibodies, metabolic profile, and neutrophil function (reactive oxygen species production, neutrophil extracellular trap production, phagocytosis, migration, gene expression, and proteomics). A total of 200 reverse transcription polymerase chain reaction–confirmed patients will be enrolled and divided into two groups: mild/moderate or severe/critical forms of COVID-19. Blood samples will be collected at different times: at inclusion and after 9 and 18 days, with an additional 3-day sample for severe patients. We believe that this information will provide more knowledge for future studies that will provide more robust and useful clinical information that may allow for better decisions at the front lines of health care.ResultsThe recruitment began in June 2020 and is still in progress. It is expected to continue until February 2021. Data analysis is scheduled to start after all data have been collected. The coagulation study branch is complete and is already in the analysis phase.ConclusionsThis study is original in terms of the different parameters analyzed in the same sample of patients with COVID-19. The project, which is currently in the data collection phase, was approved by the Brazilian Committee of Ethics in Human Research (CAAE 30846920.7.0000.0008).Trial RegistrationBrazilian Registry of Clinical Trials RBR-62zdkk; https://ensaiosclinicos.gov.br/rg/RBR-62zdkkInternational Registered Report Identifier (IRRID)DERR1-10.2196/24211
Highlights
COVID-19 emerged in the city of Wuhan, Hubei, China and spread worldwide over the several months [1]
This study is original in terms of the different parameters analyzed in the same sample of patients with COVID-19
The etiologic agent was identified as a new coronavirus of the Betacoronavirus genus, named SARS-CoV-2, due to its structural similarity to severe acute respiratory syndrome–related coronavirus (SARS-CoV), which accounted for an outbreak in China in 2002-2003 [3]
Summary
COVID-19 emerged in the city of Wuhan, Hubei, China and spread worldwide over the several months [1]. Reported by the World Health Organization (WHO) as a pneumonia outbreak of undetermined origin, COVID-19 had its epidemiological status revised by the WHO as a Public Health Emergency of International Concern by the end of January 2020 and as a pandemic at the beginning of March 2020 [2]. Angiotensin converting enzyme-2 (ACE2) mediates SARS-CoV-2 (and other coronaviruses) entry via clathrin-mediated endocytosis into type-2 pneumocytes and macrophages of the lung milieu [5,6]. SARS-CoV-2 binding markedly impairs ACE2 catalytic activity by competitive inhibition, with increased in situ pulmonary inflammation and coagulation as detrimental outcomes of weakened counter regulation of the angiotensin II/AT1 receptor axis [7]. Since the beginning of the COVID-19 pandemic, the world’s attention has been focused on better understanding the relation between the human host and the SARS-CoV-2 virus, as its action has led to hundreds of thousands of deaths
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