Abstract
Introduction: This study aims to assess the effectiveness and safety of infliximab in hospitalized patients with severe COVID-19.
Patients and Methods: This double blind, randomized controlled trial was conducted on 48 patients with COVID-19 at Hajar hospital in Shahrekord, Iran, from December 2020 to June 2021, to evaluate the efficacy and safety of infliximab in hospitalized patients with severe COVID-19. Eligible adults with confirmed severe COVID-19 were randomized to receive a single intravenous dose of infliximab (4 mg/kg) plus standard care (infliximab-treated group n = 24), or the control group (n = 24) received standard care alone. Data on demographics, clinical signs, radiologic findings, laboratory markers, and clinical outcomes were systematically collected at admission and during hospitalization. The primary outcomes included comparison of duration of hospital stay, mortality rate, mechanical ventilation requirement, and laboratory parameters between the two groups.
Results: The results indicate that infliximab treatment in patients was associated with better clinical outcomes, including reduced hospital stay, lower mortality rates, decreased need for mechanical ventilation, and experiencing of better oxygen saturation. Laboratory parameters showed that the infliximab group experienced improved immune cell profiles marked by increased lymphocytes and decreased neutrophils and white blood cells. Additionally, inflammatory and coagulation markers such as D-dimer, lactate dehydrogenase (LDH), and C-reactive protein (CRP) were more effectively reduced in the infliximab-treated group, reflecting better control of inflammation; however, infliximab treatment indicated no significant difference in platelet levels between groups.
Conclusion: Infliximab treatment in COVID-19 patients is associated with improved clinical outcomes, highlighting its potential as an effective immunomodulatory therapy.
Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20201229049873N1; https://irct.behdasht.gov.ir/trial/53791), and ethical code from Shahrekord University of Medical Sciences (IR.SKUMS.REC.1399.227; https://ethics.research.ac.ir/EthicsProposalView.php?id=169921).