Preprint / Version 1

The Brazilian ongoing intervention studies for COVID-19: Clinical trials protocols

##article.authors##

  • Tatiane Bomfim Ribeiro Universidade de São Paulo, Faculdade de Medicina https://orcid.org/0000-0003-4434-748X
  • Talita Aona Mazotti NA
  • Moacyr R Cuce Nobre Instituto  do Coração, HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, BR.
  • Airton Stein Universidade Federal de Ciências da Saúde de Porto Alegre
  • Daniela Oliveira de Melo Universidade Federal de São Paulo. São Paulo, SP, BR https://orcid.org/0000-0001-8613-7953

DOI:

https://doi.org/10.1590/SciELOPreprints.45

Keywords:

COVID-19, treatment outcome, Brazil, clinical protocols

Abstract

Clinical trials investigating COVID-19 treatments have been carried out worldwide, and also in Brazil. Public registration of research protocols promotes transparency and follows the legislation. Objective: To describe the research protocols under development in Brazil for COVID-19 treatment, and to evaluate the publication after registration in Plataforma Brasil/CONEP. Method: A comprehensive search on the databases ClinicalTrials.gov, ReBEC (Brazilian database) and the International Clinical Trials Registry Platform, was performed on April 11, 2020. The CONEP Bulletin was consulted on April 7, 2020 to assess intervention studies elected for public registration. Results: Our study shows that there are sixteen intervention studies in progress about COVID-19 in Brazil (CONEP registry), however, only six are available in the protocol registry databases. Brazilian open access research protocols investigated interventions with: hydroxychloroquine associated with azithromycin or monotherapy; chloroquine; dexamethasone; mesenchymal stem cells. Five studies (83%) are open and include patients with suspected or confirmed COVID-19 diagnosis. Three studies are multicenter and all include clinically relevant outcomes. Conclusion: Brazil has research protocols in progress for COVID-19 treatment, however only 1/3 of these studies has public protocols available.

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Author Biographies

Tatiane Bomfim Ribeiro, Universidade de São Paulo, Faculdade de Medicina

MSc em Saúde Coletiva, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR. Membro The International Society for Pharmacoepidemiology (ISPE). Pesquisadora independente em Farmacoepidemiologia e Avaliação de Tecnologias em Saúde.

Talita Aona Mazotti, NA

Esp. em Farmácia Clínica e Atenção Farmacêutica, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, BR

Moacyr R Cuce Nobre , Instituto  do Coração, HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, BR.

MD, PhD. InCor, Instituto  do Coração, HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, BR.

Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, BR.

Airton Stein, Universidade Federal de Ciências da Saúde de Porto Alegre

MD, PhD. Professor Titular de Saúde Coletiva da Universidade Federal de Ciências da Saúde de Porto Alegre; Médico de Família e Comunidade do Grupo Hospitalar Conceição. Porto Alegre, RS, BR.

Daniela Oliveira de Melo, Universidade Federal de São Paulo. São Paulo, SP, BR

PhD. Professor Ajunto do Departamento de Ciências Farmacêuticas da Universidade Federal de São Paulo. São Paulo, SP, BR

Posted

04/14/2020

How to Cite

Bomfim Ribeiro, T., Aona Mazotti, T., R Cuce Nobre , M., Stein, A., & Oliveira de Melo, D. (2020). The Brazilian ongoing intervention studies for COVID-19: Clinical trials protocols. In SciELO Preprints. https://doi.org/10.1590/SciELOPreprints.45

Section

Health Sciences

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