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IRCT20200414047072N1 IRCT 2020-04-28 Hilton Pharma Pvt. Ltd. Use of Convalescent Plasma in the treatment of COVID-19 Experimental Use of COVID-19 Convalescent Plasma for the Purpose Of Passive Immunization in Current COVID-19 Pandemic 2020-04-14 anticipated 357 Complete https://irct.ir/trial/47163 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Other. N/A COVID-19. Intervention group: Convalescent Plasma, Frozen Solution for infusion (FFP) for the prevention and treatment of Covid-19. Human plasma protein. The dosage depends upon the clinical situation and underlying disorder, use within 24 hours, administration based on ABO-blood group compatibility. Avoid shaking. It should be frozen within 8 hours after collection, stored at -18C or colder and have an expiration date one year from the date of collection. Not to exceed IV infusion rate of 1 mL/kg/min, emergency IND (eIND) approved by FDA. provided by Blood bank of the hospital mentioned in the IRB.. 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 Dr. Arshi Naz
ST 2/A,Block 17,Gulshan-e-Iqbal, KDA Scheme 24, Karachi, Pakistan.
Karachi Pakistan 75300 +92 21 34821502 labarshi@yahoo.com National Institute Of Blood Disease and Bone Marrow Transplantation scientific Dr. Arshi Naz
ST 2/A,Block 17,Gulshan-e-Iqbal, KDA Scheme 24, Karachi, Pakistan.
Karachi Pakistan 75300 +92 21 34821502 labarshi@yahoo.com National Institute Of Blood Disease and Bone Marrow Transplantation Pakistan Inclusion Criteria for Donors; Volunteer enrollment (Informed consent will be obtained; Annexures-2A & 2B). All the regulations related to ICH-GCP and Blood Transfusion Authority (BTA) Pakistan will be followed. Should fulfill all the criteria of a healthy blood donor (with the exception of history of COVID-19 during last 4-8 weeks. History of COVID-19 during last 4-8 weeks. RT-PCR negative for SARS-CoV-2 RNA (carried out on nasopharyngeal or oropharyngeal specimen). Age cutoff: 18-55 years. Body weight cut off: >50 kg for men and > 45 kg for women. At least a week been passed since last use of glucocorticoids. A minimum of 2-week duration been passed since complete recovery. Inclusion Criteria for Recipients: Volunteer enrollment (Informed consent will be obtained; Annexures-3A & 3B). Confirmed COVID-19 cases confirmed by RT-PCR laboratory tests. Severe or Critical COVID-19 related features (8): (a) Severe COVID-19, defined by the presence of any of the following features: i.Shortness of breath. ii.Respiratory rate ≥ 30/min, iii. Arterial blood oxygen saturation ≤ 93%, iv. Lung infiltrates > 50% within 24 to 48 hours (b) Critical COVID-19, defined by the presence of any of the following features: i.Respiratory failure, ii.Shock iii.Multiple organ dysfunction 18 years 55 years Both Allergy history for 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 multi organ failure. U07.1 COVID-19, virus identified Other Intervention group: Convalescent Plasma, Frozen Solution for infusion (FFP) for the prevention and treatment of Covid-19. Human plasma protein. The dosage depends upon the clinical situation and underlying disorder, use within 24 hours, administration based on ABO-blood group compatibility. Avoid shaking. It should be frozen within 8 hours after collection, stored at -18C or colder and have an expiration date one year from the date of collection. Not to exceed IV infusion rate of 1 mL/kg/min, emergency IND (eIND) approved by FDA. provided by Blood bank of the hospital mentioned in the IRB. Fever. Timepoint: registration day and week 4. Method of measurement: thermometer will be used for physical examination to check fever. Resolution of infection. Timepoint: 28 days. Method of measurement: Two non-reactive Nucleic Acid Tests (NAT) for SARS-CoV-2 performed at an interval of at least 24 hours on nasopharyngeal swabs. Lung infiltrates. Timepoint: registration day and week 4. Method of measurement: X-ray will be used. Arterial blood oxygen saturation. Timepoint: registration day and week 4. Method of measurement: Lab test (blood from artery will used). Respiratory rate. Timepoint: registration day and week 4. Method of measurement: physical examination was conducted to measure the breath rate by counting chest or abdomen rises number over a minute. National Institute Of Blood Disease and Bone Marrow Transplantation Hilton Pharma Pvt. Ltd. National Institute Of Blood Disease and Bone Marrow Transplantation Approved 2020-04-04 National Bioethics Committee (NBC) Pakistan Pakistan Health Research Council, Shahrah-e-Jamhuriat, Off Constitution Avenue, Sector G-5/2, Islamabad Karachi Sindh Pakistan