The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.
Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately. Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
Catherine Klersy
Pavia, PV, Italy
Ospedale Asst Carlo Poma Mantova
Mantova, Italy
death
death from any cause
Time frame: within 7 days
time to extubation
days since intubation
Time frame: within 7 days
length of intensive care unit stay
days from entry to exit from ICU
Time frame: within 7 days
time to CPAP weaning
days since CPAP initiation
Time frame: within 7 days
viral load
naso-pharyngeal swab, sputum and BAL
Time frame: at days 1, 3 and 7
immune response
neutralizing title
Time frame: at days 1, 3 and 7
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