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Study aim: Using COVID-19 convalescent plasma for the purpose of passive immunization in current COVID-19 pandemic Design: Single arm, open label, clinical trial employing WHO recognized monitored emergency use of unregistered and experimental interventions (MEURI) study design. Sample size is 357 Settings and conduct: The places of the study: National Institute of Blood Disease & Bone Marrow Transplantation, Karachi; Liaquat University of Medical and Health Sciences, Jamshoro, Sindh; University of Health Science and children hospital, Lahore. Blinding in this study: Not Blinded. Participants/Inclusion and exclusion criteria: Inclusion Criteria: informed consent must have been obtained, confirmed COVID-19 cases confirmed by RT-PCR laboratory tests, moderately severe or severe life-threatening COVID-19 related features: Shortness of breath, respiratory rate ≥ 30/min, arterial blood oxygen saturation ≤ 92%, and/or lung infiltrates > 25% within 24 to 48 hours, Severe Life-threatening disease Exclusion Criteria: Allergy history of plasma, sodium citrate and methylene blue; For patients with history of autoimmune system diseases or selective IgA deficiency, the application of convalescent plasma should be evaluated cautiously by clinicians. Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multiorgan failure. Intervention groups: Convalescent plasma: Plasmapheresis, 900 - 1000 mL each time. Standard apheresis plasma collection protocol using Haemonetics MCS+ intermittent blood flow system or Terumo Optia, Cobe-Spectra, Trima or Fresenius continuous flow system to be used. Isovolumic saline replacement should be done. Each donor can donate convalescent plasma again after an interval of every 2 weeks. Main outcome variables: Shortness of breath, Respiratory rate, Arterial blood oxygen saturation, Lung infiltrates, Respiratory failure, Shock, Multiple organ dysfunction
IRCTID: IRCT20200414047072N1
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