Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation (NCT04558476) | Clinical Trial Compass
CompletedPhase 2
Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation
Belgium475 participantsStarted 2020-09-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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