NCT04558476

Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation

A Multicenter 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Covid19
• Mechanical Ventilation Complication
• Corona Virus Infection
• Respiratory Failure
• SARS (Severe Acute Respiratory Syndrome)

Interventions

Type	Name	Description
BIOLOGICAL	Convalescent Plasma	2 units of convalescent plasma
OTHER	Standard of Care	Gold Standards

Timeline

• Start date: 2020-09-11
• Primary completion: 2022-04-09
• Completion: 2023-03-09
• First posted: 2020-09-22
• Last updated: 2024-10-29

Locations

17 sites across 1 country: Belgium