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IRCT20220112053701N1 IRCT 2022-02-26 Kerman University of Medical Sciences Evaluation of the effect of subcutaneous adalimumab on the prognosis of patients with COVID-19: a pilot study Evaluation of the effect of subcutaneous adalimumab on the prognosis of patients with COVID-19: a pilot study in patients admitted to Afzalipour hospital in Kerman 2022-02-19 anticipated 20 Complete https://irct.ir/trial/61234 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 COVID-19. Intervention 1: On the first day of hospitalization of this study, which will be performed non-blindly, patients of the intervention group will receive 40 mg subcutaneous adalimumab made by Sinagen factory. In the intervention group, as in the control group, adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol. Intervention 2: Control group: adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mehrdad farrokhnia
Haft-Bagh Highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 8000 Aha6765@yahoo.com Kerman University of Medical Sciences scientific Mehrdad farrokhnia
Haft-Bagh Highway.
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 8000 Aha6765@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Severe COVID-19 (respiratory rate more than 30 per minute or oxygen saturation less than 90% or more than 50% lung parenchyma involvement on the patient's CT scan) Patient's consent Age: 60_70 years old 60 years 70 years Both Fever (body temp above 40°C) Any active bacterial or fungal infection Positive blood and urine culture History of chronic obstructive pulmonary disease History of tuberculosis Heart failure Infectious skin wounds History of multiple sclerosis Very severe/critical stage of the disease (shock, encephalopathy, myocardial lesion, coagulation, and renal impairment) abnormal liver tests in the form of liver enzymes more than 2 times normal GFR less than or equal to 30 U07.1 COVID-19, virus identified Treatment - Drugs Other On the first day of hospitalization of this study, which will be performed non-blindly, patients of the intervention group will receive 40 mg subcutaneous adalimumab made by Sinagen factory. In the intervention group, as in the control group, adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol. Control group: adjuvant therapies such as vitamins C and D along with remedsivir and heparin will be prescribed according to the treatment protocol. C-reactive protein (CRP). Timepoint: First and 5th day. Method of measurement: using latex agglutination tests and a bionic CRP quantitative detection kit. Lactate Dehydrogenase (LDH). Timepoint: First and 5th day. Method of measurement: routine commercial kits (Pars Azmoon Co.,Iran). SpO2 level. Timepoint: First and 5th day. Method of measurement: by pulse oximeter. Respiratory rate per minute. Timepoint: First and 5th day. Method of measurement: Counting the number of breaths for one minute by counting how many times the chest rises. Hospitalization stay. Timepoint: discharge time. Method of measurement: Counting the number of days hospitalized. Kerman University of Medical Sciences Approved 2022-02-11 Ethics committee of Kerman University of Medical Sciences Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)