JMIR Research Protocols (Mar 2021)

Molecular and Cellular Biomarkers of COVID-19 Prognosis: Protocol for the Prospective Cohort TARGET Study

  • Kurizky, Patricia,
  • Nóbrega, Otávio T,
  • Soares, Alexandre Anderson De Sousa Munhoz,
  • Aires, Rodrigo Barbosa,
  • Albuquerque, Cleandro Pires De,
  • Nicola, André Moraes,
  • Albuquerque, Patrícia,
  • Teixeira-Carvalho, Andréa,
  • Naves, Luciana Ansaneli,
  • Fontes, Wagner,
  • Luz, Isabelle Souza,
  • Felicori, Liza,
  • Gomides, Ana Paulo Monteiro,
  • Mendonça-Silva, Dayde Lane,
  • Espindola, Laila Salmen,
  • Martins-Filho, Olindo Assis,
  • de Lima, Sheila Maria Barbosa,
  • Mota, Licia Maria Henrique,
  • Gomes, Ciro Martins

DOI
https://doi.org/10.2196/24211
Journal volume & issue
Vol. 10, no. 3
p. e24211

Abstract

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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-62zdkk International Registered Report Identifier (IRRID)DERR1-10.2196/24211