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Study aim: Evaluating the efficacy and safety of Adalimumab as a treatment option for patients with COVID-19 Design: Prospective clinical trial with parallel randomized control and treatment, open-label groups, phase 2 trial on 60 patients. Block randomization was done using online website (www.sealedenvelope.com/simple-randomiser/v1/lists). Settings and conduct: Place of study: Masih Daneshvari Hospital. How to do the study: 60 patients with COVID-19, using block randomization will be divided in to intervention and control group. This is an open-label study. Participants/Inclusion and exclusion criteria: Patients between 18 and 65 years old who have laboratory confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction) or CT scan and are sever or critically ill, are included in the study. Furthermore, patients must have CRP rise two times the normal value and IL-6 above 7 pg/ml. Study exclusion criteria is as follows: acute or chronic renal failure (creatinine rise above 3 mg/dL during the last 48 hours or GFR les than 30 mL/min), liver failure (LFT rise five times the upper limit or three time rise in symptomatic patients or Child Pugh C or D), allergic reaction while injecting adalimimab with severe extravasation or anaphylactic reaction, patient with mild disease. Intervention groups: Patients in treatment group received single dose of adalimumab ampule (CinnoRA, CinnaGen), 40 mg subcutaneously with supportive treatments according to national guideline. Furthermore, patients in control group received supportive care according national guideline. Main outcome variables: Hospital discharge, need for oxygen support, need for mechanical ventilation, and 28 days mortality.
IRCTID: IRCT20151227025726N23
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