WHO ICTRP trial

Clinical Study to assess positive value of blood plasma from donors having built…

EUCTR2020-001310-38-DE · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2020-001310-38-DE
Public title Clinical Study to assess positive value of blood plasma from donors having built immunity against the new corona virus (SARS-CoV-2) transfused to patients suffering from SARS-CoV-2 infection
Scientific title A randomized, prospective, open label clinical trial on the use of convalescent plasma compared to best supportive care in patients with severe COVID-19 - Convalescent Plasma against COVID-19
Primary sponsor DRK-Bluspendedienst Baden-Württemberg - Hessen gGmbH
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Germany
Conditions Patients with SARS-CoV-2 infection and: 1. age = 18 years and = 75 years 2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 3. severe disease defined by at least one of the following: a. respiratory rate =…
Interventions Trade Name: Fresh frozen plasma (FFP) with marketing authorisation in Germany issued by PEI Product Name: For example "Gefrorenes Frischplasma / Apherese DRK Blutspendedienst" Pharmaceutical Form: Solution for infusion
Registration date Mar 31, 2020
Target size 120
Secondary IDs CAPSID2020-DRK-BSD
Registry page clinicaltrialsregister.eu

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