Analysis of adverse events of Heparin and Tocilizumab combination therapy in patients with severe COVID-19 infection

• Grant number: 22/02084-6
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• Start date: August 01, 2022
• End date: July 31, 2025
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Ludhmila Abrahão Hajjar
• Grantee: Cecília Chie Sakaguchi Barros
• Host Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

Severe COVID-19 infection is characterized by intense inflammation and thrombogenesis, related to the elevation of markers such as C-reactive protein, IL-6, D-dimer and ferritin. For these cases, there is a potential benefit of anticoagulant therapies with Heparin and immunomodulatory therapies with Tocilizumab in terms of patient prognosis. Thus, in view of the wide applicability of this therapy, it is important to analyze the adverse events of these drugs in the context of the treatment of severe COVID-19. Methods: A sub-study of the HEPMAB-COVID TRIAL, which is a multicenter, randomized, open-label, clinical trial will be performed in adult patients with severe COVID-19 infection who have hypoxemia requiring oxygen supplementation. In the study, patients were divided into 4 treatment groups: group 1 (therapeutic Heparin), group 2 (prophylactic Heparin), group 3 (therapeutic Heparin and Tocilizumab), group 4 (prophylactic Heparin and Tocilizumab). 308 patients were included. The primary objective of the substudy will be the analysis of adverse events of Heparin and Tocilizumab treatment in the context of patients with severe COVID-19. The secondary objective will be to evaluate changes in the clinical course of patients after the occurrence of adverse events. (AU)