Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19

PHASE3TerminatedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

January 18, 2024

Study Completion Date

June 17, 2024

Conditions
COVID-19
Interventions
BIOLOGICAL

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.

OTHER

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."

Trial Locations (14)

10117

Charité Medizinische Klinik IV, Berlin

14770

Universitätsklinikum Brandenburg, Brandenburg

25000

CHU Besançon, Besançon

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

70174

Klinikum Stuttgart, Stuttgart

70176

Diakonie-Klinikum Stuttgart, Stuttgart

72076

Uniklinikum Tübingen, Tübingen

73527

Stauferklinikum Schwäbisch Gmünd, Mutlangen

89081

Institut für Klinische Transfusionsmedizin (IKT), Ulm

Uniklinikum Ulm, Ulm

01589

Elblandkliniken Riesa, Riesa

09116

Klinikum Chemnitz gGmbH, Chemnitz

3000CA

Erasmus Medical Center, Rotterdam

Unknown

NHS Blood and Transplant, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NHS Blood and Transplant

OTHER_GOV

collaborator

Erasmus Medical Center

OTHER

lead

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

OTHER