NCT04321421

Hyperimmune Plasma for Critical Patients With COVID-19

Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
OTHER	hyperimmune plasma	administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5

Timeline

• Start date: 2020-03-17
• Primary completion: 2020-04-28
• Completion: 2020-05-07
• First posted: 2020-03-25
• Last updated: 2020-05-28

Locations

2 sites across 1 country: Italy