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

Summary (French or Dutch)

This trial compares two treatments, one conventional, and the other involving the administration of plasma from convalescent patients who have recovered from their Coronavirus infection. Plasma from convalescent patients contains antibodies to the virus responsible for the disease that is hoped to block the virus. It is therefore hoped that transfusion of plasma from patients who have contracted COVID-19 and have developed antibodies specific to this virus may reduce the symptoms, viral load and mortality of ventilated patients suffering from respiratory distress due to COVID-19.

Trial Description
Title

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

500

Trial duration

 22 months - 34 months

Budget

€ 2.07 million

Status

Open to recruitment

 

Trial team

Sponsor

CHU Liège

Chief Investigator

Prof. Benoit Misset

 

Number of participating sites

16

External Partners

UCL St Luc, Croix Rouge and Rode Kruis

 

Documents
Protocol  
Report

 

Publication

 

References

Clinicaltrials.gov: NCT04558476

Eudra CT number: 2020-003102-31

Webpage: