120
Participants
Start Date
April 1, 2022
Primary Completion Date
January 18, 2024
Study Completion Date
June 17, 2024
Current standard of care and COVID-19 convalescent and vaccinated plasma
ABO compatible convalescent plasma infused intravenously on study day 1 (as soon as possible after randomisation) and the second on day 1 or day 2. Plasma obtained by apheresis from donors who have recovered from COVID-19 infection (at least 14 days after recovery) and have been vaccinated (at least 3 weeks after first dose of vaccine). A combination of both a SARS-CoV-infection and a SARS-CoV-2 vaccination of the donor is required - irrespective of the sequence of infection and vaccination. As far as the availability of CCP units allows, the two plasma units should have been donated by two different convalescents.
Current standard of care
"Standard of care therapy may include anti-SARS-CoV-2 specific medication such as, but not limited to:~* Casirivimab~* Casirivimab / Imdevimab (REGN-COV2 or Ronapreve)~* Imdevimab~* Sotrovimab (Xevudy)~* Tixagevimab / Cilgavimab (Evusheld)~* Molnupiravir (MK-4482)~* Nirmatrevlir / Ritonavir (Paxlovid)~* Remdesivir~Centres should ensure that medications used as standard of care are used similarly for patients in both treatment arms."
Charité Medizinische Klinik IV, Berlin
Universitätsklinikum Brandenburg, Brandenburg
CHU Besançon, Besançon
Universitätsklinikum Frankfurt, Frankfurt am Main
Klinikum Stuttgart, Stuttgart
Diakonie-Klinikum Stuttgart, Stuttgart
Uniklinikum Tübingen, Tübingen
Stauferklinikum Schwäbisch Gmünd, Mutlangen
Institut für Klinische Transfusionsmedizin (IKT), Ulm
Uniklinikum Ulm, Ulm
Elblandkliniken Riesa, Riesa
Klinikum Chemnitz gGmbH, Chemnitz
Erasmus Medical Center, Rotterdam
NHS Blood and Transplant, Oxford
Collaborators (1)
NHS Blood and Transplant
OTHER_GOV
Erasmus Medical Center
OTHER
Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
OTHER