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

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

doi:10.2196/24211

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

JMIR Res Protoc. 2021 Mar 4;10(3):e24211. doi: 10.2196/24211.

Authors

Patricia Kurizky^#^{1

2}, Otávio T Nóbrega^#¹, Alexandre Anderson De Sousa Munhoz Soares^#¹, Rodrigo Barbosa Aires^#¹, Cleandro Pires De Albuquerque^#^{1

2}, André Moraes Nicola^#¹, Patrícia Albuquerque^#³, Andréa Teixeira-Carvalho^#⁴, Luciana Ansaneli Naves^#^{1

2}, Wagner Fontes^#⁵, Isabelle Souza Luz⁵, Liza Felicori^#⁶, Ana Paulo Monteiro Gomides^#⁷, Dayde Lane Mendonça-Silva^#^{2

8}, Laila Salmen Espindola^#^{1

8}, Olindo Assis Martins-Filho^#⁴, Sheila Maria Barbosa de Lima^#⁹, Licia Maria Henrique Mota^#^{1

2}, Ciro Martins Gomes^#^{1

2}

Affiliations

¹ Programa de Pós-graduação em Ciências Médicas da Faculdade de Medicina, University of Brasília, Brasilia, Brazil.
² Hospital Universitário de Brasília, University of Brasília, Brasília, Brazil.
³ Faculdade de Ceilândia, University of Brasília, Brasília, Brazil.
⁴ Fundação Oswaldo Cruz, FIOCRUZ-Minas, Belo Horizonte, Brazil.
⁵ Instituto de Ciências Biológicas, University of Brasília, Brasília, Brazil.
⁶ Instituto de Ciências Biológicas, Federal University of Minas Gerais, Belo Horizonte, Brazil.
⁷ Centro Universitário de Brasília, Brasília, Brazil.
⁸ Faculdade de Ciências da Saúde, University of Brasília, Brasília, Brazil.
⁹ Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, FIOCRUZ, Rio de Janeiro, Brazil.

^# Contributed equally.

PMID: 33661132
PMCID: PMC7935398
DOI: 10.2196/24211

Abstract

Background: 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.

Objective: In 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.

Methods: To 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.

Results: The 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.

Conclusions: This 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 registration: Brazilian Registry of Clinical Trials RBR-62zdkk; https://ensaiosclinicos.gov.br/rg/RBR-62zdkk.

International registered report identifier (irrid): DERR1-10.2196/24211.

Keywords: COVID-19; TARGET; biomarker; cohort; cytokine profile; design; genetics; immune system; immunology; metabolomics; neutralizing antibodies; neutrophil function; prognosis; proteomics; thromboelastometry; virus.

©Patricia Kurizky, Otávio T Nóbrega, Alexandre Anderson De Sousa Munhoz Soares, Rodrigo Barbosa Aires, Cleandro Pires De Albuquerque, André Moraes Nicola, Patrícia Albuquerque, Andréa Teixeira-Carvalho, Luciana Ansaneli Naves, Wagner Fontes, Isabelle Souza Luz, Liza Felicori, Ana Paulo Monteiro Gomides, Dayde Lane Mendonça-Silva, Laila Salmen Espindola, Olindo Assis Martins-Filho, Sheila Maria Barbosa de Lima, Licia Maria Henrique Mota, Ciro Martins Gomes. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.03.2021.