Experimental Use of COVID-19 Convalescent Plasma for the Purpose Of Passive Immunization in Current COVID-19 Pandemic

Hilton Pharma Pvt. Ltd.0 个研究点目标入组 357 人开始时间: 待定最近更新: 2020年11月9日

试验速览

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•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

•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.

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