COVID-19. COVID-19, virus identified
Conditions
Interventions
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 unde
Sponsors
Hilton Pharma Pvt. Ltd.
National Institute Of Blood Disease and Bone Marrow Transplantation
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion 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). 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Pakistan
Contacts
Public ContactDr. Arshi Naz
National Institute Of Blood Disease and Bone Marrow Transplantation
Outcome results
None listed