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Submitted: 02 Nov 2021
Accepted: 04 Dec 2021
ePublished: 18 Dec 2021
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Immunopathol Persa. 2023;9(2): 30322.
doi: 10.34172/ipp.2022.30322

Scopus ID: 85164622468
  Abstract View: 1449
  PDF Download: 644

Clinical Trial

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

Omid Yazdani 1 ORCID logo, Ramin Hamidi Farahani 2 ORCID logo, Reza Mosaed 3 ORCID logo, Amir Nezami Asl 4, Ebrahim Hazrati 5,6* ORCID logo

1 Department of Medical, School of Medicine, AJA University of Medical Sciences, Tehran, Iran
2 Department of Infectious Diseases, School of Medicine, AJA University of Medical Sciences, Tehran, Iran
3 Faculty Medicine, AJA University of Medical Sciences, Tehran, Iran
4 Faculty of Aerospace and Subaquatic Medicine, AJA University of Medical Sciences, Tehran, Iran
5 Department of Anesthesiology and Critical Care, AJA University of Medical Sciences, Tehran, Iran
6 Trauma and Surgery Research Center, AJA University of Medical Sciences, Tehran, Iran
*Corresponding Author: Ebrahim Hazrati, Email: dr.hazrati.e@ajaums.ac.ir, , Email: dr.hazrati.e@gmail.com

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).


Citation: Yazdani O, Hamidi Farahani R, Mosaed R, Nezami Asl A, Hazrati E. 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. Immunopathol Persa. 2023;9(2):e30322. DOI:10.34172/ ipp.2022.30322.
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