| Title {1} | Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in hospitalized patients with pneumonia caused by Covid-19 virus infection: a study protocol for a phase II, open-label, three-armed, randomized, single-center, active control superiority trial. |
| Trial registration {2a and 2b} |
Brazilian Clinical Trials Registry (ReBec): RBR-5s2mqg Universal Trial Number (UTN): U1111-1250-1843 |
| Protocol version [1] |
Version 2.0 Nov. 18, 2020 |
| Funding {4} |
Funded by: Emergency project - Rapid Implementation Supplements Against COVID-19 of the Sao Paulo Research Foundation (FAPESP 2020/04522-5). Research, Inovation and Dissemination Center – Obesity and Comorbidities Research Center of the Sao Paulo Research Foundation (FAPESP 2013/07607-8). |
| Author details {5a} |
Obesity and Comorbidities Research Center, University of Campinas, Campinas, São Paulo, Brazil. Department of Internal Medicine, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil. Department of Surgery, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil. Department of Radiology, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil. Clinical Hospital, University of Campinas, Campinas, São Paulo, Brazil. School of Nursing, University of Campinas, Campinas, São Paulo, Brazil. |
| Name and contact information for the trial sponsor {5b} | Clinics Hospital, University of Campinas, Campinas, São Paulo, Brazil, R. Vital Brasil, 251 - Cidade Universitária, Campinas - SP, 13083-888 |
| Role of sponsor {5c} | The study sponsor and funders have no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. |