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IRCT20200611047735N2 IRCT 2021-02-13 Bandare-abbas University of Medical Sciences The effect of Plasmapheresis in the treatment of patients with COVID-19 Study of the therapeutic role of plasmapheresis in patients with COVID-19 and its effect on serum levels of inflammatory factors 2020-10-22 anticipated 45 Complete https://irct.ir/trial/52426 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 COVID-19. Intervention group: Plasmapheresis will be performed in 3 sessions at intervals of 24 to 36 hours based on the daily evaluation of the patient in the dialysis ward of Shahid Mohammadi Hospital in Bandar Abbas. Plasmapheresis will be performed by MSC + device is one of the types of apheresis devices of blood components including platelets, WBC, RBC, stem cells with high efficiency of plasmapheresis, with minimal platelet loss. Disposable single-needle sets will also used during plasmapheresis.. 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 There is no further information
public Mehdi Hassani Azad
Jomhouri Eslami Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3333 7192 mehdi.hassaniazad@gmail.com Bandare-abbas University of Medical Sciences scientific Mehdi Hassani Azad
Jomhouri Eslami Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3333 7192 mehdi.hassaniazad@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) COVID-19 patients with positive Realtime PCR test for COVID-19 tachypnea> Respiratory Rate 30 per minute and dyspnea, Oxygen saturation lower than 88% and fraction of inspired oxygen/ PaO2 ratio lower to equal 300, and increased lung involvement by more than 50% on CT scan. Patient with symptoms of respiratory failure, patient in need or under mechanical ventilation, patient with multiple organ failure and patient with shock symptoms Presence of two positive inflammatory markers including: Ferritin greater than 1000 or CRP above 50 mg/dl or ′ ′ +++ ′ ′ or Lactate dehydrogenase greater than 1000 Lack of proper response to antiviral and corticosteroid therapy and hypoxia during hospitalization no limit no limit Both Low blood pressure lower than normal range, which causes a further decrease in blood pressure during plasmapheresis. Coagulation disorders that cause bleeding during plasmapheresis. Decreased blood platelets below the normal range, which may increase bleeding during plasmapheresis. U07.1 COVID-19 Treatment - Devices Intervention group: Plasmapheresis will be performed in 3 sessions at intervals of 24 to 36 hours based on the daily evaluation of the patient in the dialysis ward of Shahid Mohammadi Hospital in Bandar Abbas. Plasmapheresis will be performed by MSC + device is one of the types of apheresis devices of blood components including platelets, WBC, RBC, stem cells with high efficiency of plasmapheresis, with minimal platelet loss. Disposable single-needle sets will also used during plasmapheresis. Serum IL-6 levels. Timepoint: Before plasmapheresis and after the last stage of plasmapheresis. Method of measurement: ELISA technique. Serum IL-1β levels. Timepoint: Before plasmapheresis and after the last stage of plasmapheresis. Method of measurement: ELISA technique. Serum TNF-α levels. Timepoint: Before plasmapheresis and after the last stage of plasmapheresis. Method of measurement: ELISA technique. Serum IFN-γ levels. Timepoint: Before plasmapheresis and after the last stage of plasmapheresis. Method of measurement: ELISA technique. Clinical manifestation. Timepoint: Before plasmapheresis and after the last stage of plasmapheresis. Method of measurement: Clinical examination and completion of a questionnaire. Inflammatory factors of peripheral blood. Timepoint: Before plasmapheresis and after the last stage of plasmapheresis. Method of measurement: Peripheral blood test. Bandare-abbas University of Medical Sciences Approved 2020-09-26 Ethics committee of Hormozgan University of Medical Sciences Jomhouri Eslami Blvd Bandar Abbas Hormozgan Iran (Islamic Republic of)