The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Design : multicenter randomized openlabel, phase II trial.
Number of patients to include : 500 (250 with plasma, 250 without plasma).
The principal objective is to assess the efficacy of the treatment to reduce day-28 mortality
in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Hypothesis: Passive immunization with plasma collected from patients having contracted
COVID-19 and developed specific antibodies may alleviate symptoms and viral load of
SARS-CoV-2 and reduce mortality.
The patients will receive currently accepted standard of care for both COVID-19 and usual
organ dysfunctions observed in such cases. half the patients will be administered either
Convalescent plasma, depending on the randomization process. All patients will be followed-up
for one year after inclusion. The study will be considered either positive or negative, based
on the principal objective. This means that the product convalescent plasme will be
considered effective if mortality at day 28 is lower is patients treated with convalescent
plasma than without it. The follow-up will allow to assess a series of secondary objectives,
addressing the evolution of organ failures, viral infection, inflammatory response and
long-term physical of psychological impact of COVID-19. Interim analyses will be performed
every 100 patients included in order to stop the trial if an exceptionally good or bad result
is observed, to prevent using or not using the product appropriately in further patients.
These analyses will be supervised by an independent committee.
The choice to include only those patients under mechanical ventilation for severe respiratory
failure makes this study different from other trials testing convalescent plasma, as most
trial include less severe patients.
Biological: Convalescent Plasma
2 units of convalescent plasma
Other: Standard of Care
Gold Standards
Inclusion Criteria:
- age at least 18 years
- hospitalization in an intensive care unit participating to the study
- medical diagnosis with SARS-CoV-2 pneumonia as defined by both:
- extended interstitial pneumonia on CT scan or a 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
- prior Clinical Frailty Scale < 6.
- written consent of the patient, or - if impossible - of a relative acting as the legal
representative, or - if impossible - of a physician from a non-participating
department of the same hospital acting as an impartial witness .
Exclusion Criteria:
- Pregnancy
- Prior episode of transfusion-related side effect
- Medical decision to limit therapy
- Current participation in another trial testing a COVID-19 therapy
Clinique Saint Pierre Ottignies
Ottignies, Brabant Wallon, Belgium
Centre Hospitalier Wallonie Picarde
Tournai, Hainaut, Belgium
OLVZ Aalst
Aalst, Belgium
UZ Antwerpen
Antwerp, Belgium
Imelda ZH Bonheiden
Bonheiden, Belgium
CHU Saint Pierre
Brussels, Belgium
Erasme
Brussels, Belgium
UZ Brussel
Brussel, Belgium
CHU Charleroi Marie Curie
Charleroi, Belgium
AZ Sint Blasius
Dendermonde, Belgium
UZ Gent
Gent, Belgium
AZ Groeningen Kortrijck
Kortrijk, Belgium
CHR Citadelle
Liège, Belgium
CHU Liège
Liège, Belgium
UC Louvain
Louvain, Belgium
AZ Delta
Roeselare, Belgium
CHU UCL Namur-Godinne
Yvoir, Belgium