COV201004: Eine multizentrische randomisierte Studie zur Beurteilung der Wirksamkeit der konvaleszenten Plasmatherapie bei Patienten mit invasivem COVID-19 und akutem Lungenversagen, die mit mechanischer Beatmung behandelt wurden: die CONFIDENT-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description

A multicentre randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation:  the CONFIDENT trial.

Participants (P)

aged at least 18 years

hospitalized in an intensive care unit participating to the study

diagnosed with SARS-CoV-2 pneumonia as defined by both:

extended interstitial pneumonia on CT scan or chest X-ray, consistent with viral pneumonia, within 10 days prior to inclusion

positive result of SARS-CoV-2 PCR test, or any emerging and validated diagnostic laboratory test for COVID-19 within 15 days prior to inclusion

under mechanical ventilation administered through an endotracheal tube, for less than 5 days

Clinical frailty scale < 6

Intervention (I)

Convalescent plasma

Control (C)

Standard of Care (SOC)

Outcome (O)

The principal objective of the Plasma-COVID-MV trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma associated, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation. 

Trial Design

Randomized (1:1) open label trial

Sample Size


Trial duration

 22 months - 34 months


€ 2.07 million


Open to recruitment


Trial team


CHU Liège

Chief Investigator

Prof. Benoit Misset


Number of participating sites


External Partners

UCL St Luc, Croix Rouge and Rode Kruis


Referenzen NCT04558476

Eudra CT number: 2020-003102-31