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IRCT20151228025732N53 IRCT 2020-04-10 Semnan University of Medical Sciences Therapeutic effects of plasma of recovered people from COVID-19 on hospitalized patients with this disease Evaluation of the therapeutic effects of Convalescent Plasma (CP) of recovered people from Covid-19 in improving clinical and laboratory symptoms of hospitalized patients 2020-04-20 anticipated 12 Complete https://irct.ir/trial/46931 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 COVID-19. Intervention 1: Intervention group: Administration of 2 units of CP (Convalescent Plasma obtained from COVID-19 recovered people thorough plasmapheresis) (IV). Each unit of plasma that is collected from one different donor will be given over 2 h with an interval of 1 h between the two units. Intervention 2: Control group: Patients with COVID-19 will receive conventional treatment. 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 Parviz Kokhaei
Semnan University of Medical Sciences, Basij boulevard, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 p_kokha@yahoo.com Semnan University of Medical Sciences scientific Parviz Kokhaei
Semnan University of Medical Sciences, Basij boulevard, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 p_kokha@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) (As a plasma donor): Complete resolution of COVID-19 disease symptoms at least 14 days prior to donation. (As a plasma donor): Donors do not have a history of blood or blood product transfusion (As a plasma donor): COVID-19 neutralizing antibody titers be greater than 1:320 (If possibly checked) (As a plasma donor): The donor's age be between 25 and 55 years old (As a plasma donor): Negative results for COVID-19 by PCR (As a plasma donor): Be in suitable general health condition for plasmapheresis (As a plasma recipient): Patients admitted to the ICU who is receipt of mechanical invasive or non-invasive ventilation, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300mmHg (93%). Current receipt of intravenous vasoactive medications to maintain mean arterial pressure >65 mmHg (As a plasma recipient): Respiratory frequency ≥ 30/min (As a plasma recipient): Laboratory-confirmed COVID-19 infection (by real time PCR). 25 years 55 years Both (As a plasma recipient): Negative real-time PCR from respiratory secretions or blood within 48 h prior to CP transfusion (As a plasma recipient): History of allergic reaction to blood or plasma products (As a plasma recipient): Known IgA deficiency U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Administration of 2 units of CP (Convalescent Plasma obtained from COVID-19 recovered people thorough plasmapheresis) (IV). Each unit of plasma that is collected from one different donor will be given over 2 h with an interval of 1 h between the two units. Control group: Patients with COVID-19 will receive conventional treatment. Checking the amount of ventilation. Timepoint: Before intervention, 30 minutes after each step of intervention and daily. Method of measurement: Artificial respirator or ventilator. White blood cell count, CRP in patients with COVID-19. Timepoint: Every 24 hours (Before and after intervention). Method of measurement: Cell counter. Percentage of T CD8 in peripheral blood. Timepoint: Before and after the intervention. Method of measurement: Evaluation of T CD8 percentage by Flow cytometry. Percentage of T CD4 in peripheral blood. Timepoint: Before and after the intervention. Method of measurement: Evaluation of T CD4 percentage by Flow cytometry. C-Reactive Protein (CRP) in patients with COVID-19. Timepoint: Every 24 hours (Before and after intervention). Method of measurement: Rapid test. Semnan University of Medical Sciences Approved 2020-04-04 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)