CONFIDENT: 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 (COV201004)

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)

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

500

Trial duration

Budget

€ 2.07 million

Sponsor

CHU Liège

Chief Investigator

Prof. Benoit Misset

Number of participating sites

External Partners

UCL St Luc, Croix Rouge and Rode Kruis