Perfil dos protocolos de ensaios clínicos sobre Covid-19 com participação da Fiocruz.

Objective: To identify Fiocruz's performance in clinical studies related to Covid-19. Analyze the different terminologies used to refer to Fiocruz participation. Map the region of these studies. Measure the number of studies approved on clinical study registration platforms and regulatory ethical bases. Analyze the methodological characteristics and good practices of the interventional study protocols. Methods: We reviewed databases of Brazilian National Research Ethics Committee, databases of Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) and Brazilian National Institute of Industrial Property (Instituto Nacional de Propriedade Industrial-INPI). Results: 53 clinical studies on Covid-19 were found with the participation of Fiocruz in 39 of them as a proponent institution. Among the 53 studies, 19 are on registration platforms. Of the registered interventional studies, 5 are for prevention and 9 for treatment. The intervention most frequently evaluated in these studies was chloroquine/hydroxychloroquine. There was also a greater concentration of clinical studies in the southeastern region, with a total of 37 studies. Conclusion: Some limitations in the methodological design were analyzed, which may affect the scope of the studies. It is expected that the data obtained will be used to guide future clinical studies on Covid-19 with Fiocruz participation. [ABSTRACT FROM AUTHOR]