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Study aim:
Evaluation of the efficacy and safety of Adalimumab and Methylprednisolone pulse therapy in treatment of Covid-19 patients with ARDS
Design:
This study is a two arm parallel group, randomized clinical trial in phase 2 which will be carried out on 40 hospitalized COVID-19 patients. Patients randomly divided into two groups.
Settings and conduct:
This clinical trial will be carried out on 40 hospitalized COVID-19 patients in Intensive care unit of imam Reza hospital of AJA university of medical sciences, Iran. Patients will be received 1000mg Methylprednisolone pulse for 3 days and single 40 mg dose of Adalimumab.
Participants/Inclusion and exclusion criteria:
Inclusion Criteria: Patients admitted to ICU with moderate to severe Covid-19 infection needs respiratory support PaO2/FiO2 less than 300 Progression of disease severity and not responding to standard treatment Prediction of intubation need in next 24 hours and LDH more than 450 Exclusion Criteria: Uncontrolled diabetes mellitus Active bacterial, fungal infection Procalcitonin more than 0.5 History of hypersensitivity to corticosteroids Active GI bleeding
Intervention groups:
Control group: receive standard regimen for COVID-19 Intervention group: receive standard regimen for COVID-19 plus Methylprednisolone (1000 mg for 3 days) and Adalimumab (single stat 40 mg dose).
Main outcome variables:
Changes in respiratory distress Changes in O2 Saturation Extubation Discharge from ICU Mortality