IRCT20200414047072N1
Recruiting
未知
Experimental Use of COVID-19 Convalescent Plasma for the Purpose Of Passive Immunization in Current COVID-19 Pandemic
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hilton Pharma Pvt. Ltd.
- Enrollment
- 357
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
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.
Outcomes
Primary Outcomes
Not specified
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