Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020
Covid-19
About this trial
This is an interventional other trial for Covid-19
Eligibility Criteria
Inclusion Criteria:
FOR DONORS:
- Volunteer enrolment (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: 18-55years
- Body weight cut off: >50 kg for men and > 45kg for women
FOR RECIPIENTS:
- Volunteer enrolment (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. CriticalCOVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction
Exclusion Criteria:
- 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.
Sites / Locations
- National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD)Recruiting
Arms of the Study
Arm 1
Experimental
Single Arm
Intervention: Convalescent plasma (Frozen Solution for infusion) obtained from COVID-19 recovered patients. The dosage depends upon the clinical situation and underlying disorder. Children: 15 ml/kg over 4-6 hours once in patients under 35 kg body weight. Adults: maximum 450 - 500 ml over 4-6 hours once in all adults patients.