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IRCT20200312046749N1 IRCT 2020-03-28 Tehran University of Medical Sciences Efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19 Evaluation the efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19 outcomes: a prospective clinical trial study. 2020-03-27 anticipated 80 Complete https://irct.ir/trial/46551 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 COVID-19. Intervention 1: Intervention group: altebrel 50mg by aryogen company subcutaneously in two dose with2-3 days duration in one week. Intervention 2: Control group: In control group, supportive care and protocol without any injection. Yes - There is a plan to make this available What will be shared: Study protocol When: After finished sampling and data analysis To whom: The researchers in university Conditions: Help in managing of patients Where to obtain: The principal investigator How to obtain: Contact with the chief Comments:
public Vahid Ziaee
Markaz Tebi Atfal hospital, Dr. Gharib street
tehran Iran (Islamic Republic of) 1419733151 +98 21 6692 0981 ziaee@tums.ac.ir Tehran University of Medical Sciences scientific Raheleh Assari
Children Medical Center, Dr Gharib St.
Tehran Iran (Islamic Republic of) 1971844458 +98 21 6694 8443 r1assari@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Confirmed the COVID-19 disease with one or more of these: fever, dry cough, dyspnea and one or more of below: positive SARS-COV2 PCR • Characteristic changes of SARS-COV2 in chest CT scan such as bilateral ground grass opacity in bases of the lungs ( confirmation with the radiologist) Age>18 years old Signing inform consent from the patient or patient̓ s accompaniment No manifestations of bacterial infection No history of rheumatologic disorders No history of cancer for the last 1 year.No history of immunodeficiency (primary or acquired) No manifestations, history and radiologic parameters according to active or latent TB No diabetes or autoimmune hepatitis No uveitis No history of immunosuppressive treatment in the last 6 months No history of growth hormone, Testosterone and any Anabolic steroids in the last one month No history of Corticosteroid therapy (>30 mg/m2) for > 5 days in the last one month No history of Corticosteroid pulses or IVIG treatments for last one month No history of Biologics treatment for the last 6 months 18 years no limit Both Administration of corticosteroids pulses and/or IVIG in the disease process or one month after anti-TNF prescription. Unwillingness of involved patients to continue this research. U07.1 COVID-19 Treatment - Drugs Rehabilitation Intervention group: altebrel 50mg by aryogen company subcutaneously in two dose with2-3 days duration in one week. Control group: In control group, supportive care and protocol without any injection Improvement of pulmonary manifestations and the duration. Timepoint: One week, two weeks and 6 months after. Method of measurement: physical examination, labratory data and CT scan. Improvement the radiologic parameters. Timepoint: after 7-10 days. Method of measurement: computed tomography. Necessity and Duration to ICU admission and hospitalization. Timepoint: One to two weeks later. Method of measurement: Questionnaire. Mortality. Timepoint: One month later. Method of measurement: Number. The three months outcomes: complete improvement; improvement with transient complication; improvement with persistent complication. Timepoint: After three months. Method of measurement: Physical examination and history. vice chancellor for research Approved 2020-03-24 Tehran University of Medical Sciences Tehran University of Medical Sciences, Qods St., Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)