NCT04408209

Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection

Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.

Detailed description

Convalescent plasma will be collected by plasmapheresis from patients fully recovered from COVID-19 infection and will be administered in patients with severe COVID-19 infection. The results will be compared with an historical matched control.

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
PROCEDURE	Convalescent Plasma	Convalescent Plasma - early treatment of patients with severe COVID-19. Clinical and laboratory data of patients will be collected before initiation of the procedure, 30 minutes after the first dose, 30 minutes after the second dose and 30 minutes after the third plasma dose and then on days 1-7, 14, 21, 28, 35 from the start of treatment. In case of adverse reactions during transfusion such as acute shortness of breath, haemodynamic instability or high pre-existing and non-disease-related fever, the transfusion will be interrupted and detailed recording of the event as well as updating the Adverse Events Management Committee will be performed. In addition to the standard assessments, the titer of neutralizing anti-SARS-CoV-2 antibodies will be measured in a sample drawn prior to plasmapheresis. All donors will be tested for: 1. the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute) 2. the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)

Timeline

• Start date: 2020-04-23
• Primary completion: 2023-08-30
• Completion: 2023-12-15
• First posted: 2020-05-29
• Last updated: 2024-11-18

Locations

6 sites across 1 country: Greece