Clinical trials developed in brazil on COVID-19: What is being researched?

Abstract

Background: The coronavirus disease 2019 pandemic (COVID-19) has brought great public health challenges into our lives. To date, there has been no specific therapeutic protocol for this disease, which requires a study with high-quality evidence. Objectives: To analyze clinical trials on COVID-19 in Brazil. Methods: Documentary research was conducted on the clinical trial registration platform. For the search strategy, the “COVID-19” keyword was established in the “condition or disease” section and “Brazil” in the “country” section. No limit on the search period was considered. Data were analyzed and presented using descriptive statistics. Results: Of the 81 registered clinical trials, 48 met the eligibility criteria. The sample size ranged from 10 to 3,000 individuals. Most studies recruited individuals aged 18-64 years (48.5%) and > 65 years (48.5%). Regarding the study design, randomized (91.6%), parallel (89.5%), quadruple-blind (39.6%), and therapeutic (97.9%) types were more frequent. Most studies used standard two-arm trial (70.8%), used drugs (79.2%), placebo (58.3%), and were sponsored by pharmaceutical/biotechnology companies and universities with 33.3% and 29.2%, respectively. Conclusions: Clinical trials under development in Brazil on COVID-19 are mostly carried out with adult and elderly participants, and regarding the study design, have a predominance of randomized allocation, parallel model, quadruple-blind masking with a therapeutic purpose. Most studies use antithrombotic agents or combinations of antithrombotic agents.