A randomized clinical trial study on the efficacy and safety of adalimumab and methylprednisolone pulse therapy in the treatment of COVID-19 patients with acute respiratory distress syndrome

Abstract

Introduction: Adalimumab reduces the expression of the angiotensin-converting enzyme (ACE2) receptor at the cell surface, therefore it is thought to be effective in treating patients with COVID-19. Objectives: The present study was conducted to evaluate the effectiveness of adalimumab and pulsed corticosteroids in treating patients with severe acute respiratory failure due to COVID-19. Patients and Methods: The present double-blind clinical trial study was carried out on patients with COVID-19 referred to Imam Reza hospital, Tehran. Patients were randomly divided into two groups of intervention (patients under standard treatment according to the national protocol of Iran + methylprednisolone + adalimumab) and control (patients under standard treatment according to the national protocol of Iran + methylprednisolone). Results: The patients’ hospitalization information shows that the duration of patients’ hospitalization in the intervention group was significantly shorter than their counterparts in the control group (P=0.041). Serum levels of total bilirubin on the ninth day (P=0.043) and GCS (Glasgow coma scale) on the ninth day (P=0.041) and tenth (P=0.039) in the adalimumab group were significantly increased compared to the control group. However, the direct bilirubin value on the eighth day (P=0.031), serum creatinine on the 8th (P=0.047), 9th (P=0.047) and 10th (P=0.047) days and also PEEF (pericarditis/pericardial effusion) on the tenth day were significantly lower in the intervention group than the control group. Conclusion: The administration of adalimumab significantly increases the GCS of COVID-19 patients and reduces the length of hospital stay. Trial Registration: This study is designed as a double-blind clinical trial (identifier: IRCT20200406046963N2, https://www.irct.ir/trial/55011), and has been approved by the ethics committee in biomedical research of AJA University of Medical Sciences (#IR.AJAUMS.REC.1400.032).