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

• Autor(a) principal: Bomfim Ribeiro, Tatiane
• Data de Publicação: 2020
• Outros Autores: Aona Mazotti, Talita, R Cuce Nobre , Moacyr, Stein, Airton, Oliveira de Melo, Daniela
• Tipo de documento: preprint
• Idioma: por
• Título da fonte: SciELO Preprints
• Texto Completo: https://preprints.scielo.org/index.php/scielo/preprint/view/45
• topic: COVID-19; Ensaios clínicos; Brasil; Protocolos Clínicos; Pesquisa clínica; COVID-19; treatment outcome; Brazil; clinical protocols

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.