Trial design and oversight
BeeCovid2 was a randomized, double-blind, placebo-controlled clinical trial to evaluate safety and efficacy of EPP-AF in hospitalized patients with COVID-19 who were not in mechanical ventilation. The study was conducted at Hospital São Rafael, a tertiary 600-bed hospital in Salvador, Bahia, northeastern Brazil, from April to August 2021. The protocol was approved by the local Ethics Committee (registration number 43265321.9.0000.0048) on February 25, 2021, and the trial was registered on March 16, 2021, on ClinicalTrials.gov (NCT04800224). More details can be found in the previously published study protocolThe study was conducted in accordance with the principles of the Declaration of Helsinki and the guidelines of Good Clinical Practice of the International Harmonization Conference. All participating patients and/or their legal representatives were duly informed about objectives and risks of participation before signing the informed consent form. The informed consent form is electronically signed, stored on the Research Electronic Data Capture (REDCap) platform, and automatically made available to participants via download. The electronic informed consent form was evaluated and approved by the local Ethics Committee.All authors guarantee data integrity and fidelity to the study protocol. This study was an initiative of the principal investigator and correspondent. An independent commission from D’Or Institute for Education and Research, an institutional platform to support research, monitored the research documents, ensuring greater information security and fidelity. Any novel information arising from the study were promptly reported to the Ethics Committee during the study.