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

NCT ID: NCT04558476

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2023-03-09

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Convalescent Plasma

2 units of plasma ( 400-500ml) from 2 different donnors duration of treatment =2 h

Group Type: EXPERIMENTAL

Convalescent Plasma

Intervention Type: BIOLOGICAL

2 units of convalescent plasma

Standard of care

Standard of care according the last gold standards

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Gold Standards

Interventions

Convalescent Plasma

2 units of convalescent plasma

Intervention Type: BIOLOGICAL

Standard of Care

Gold Standards

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCE Belgian Healthcare Knowledge Centre

UNKNOWN

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Misset Benoit

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Brussels, , Belgium

CHU Charleroi Marie Curie

Charleroi, , Belgium

AZ Sint Blasius

Dendermonde, , Belgium

UZ Gent

Ghent, , Belgium

AZ Groeningen Kortrijck

Kortrijk, , Belgium

UC Louvain

Leuven, , Belgium

CHR Citadelle

Liège, , Belgium

CHU Liège

Liège, , Belgium

AZ Delta

Roeselare, , Belgium

CHU UCL Namur-Godinne

Yvoir, , Belgium

Countries

Belgium

References

Misset B, Diep AN, Bertrand A, Piagnerelli M, Hoste E, Michaux I, De Waele E, Dumoulin A, Jorens PG, van der Hauwaert E, Vallot F, Swinnen W, De Schryver N, de Mey N, Layios N, Mesland JB, Robinet S, Cavalier E, Donneau AF, Moutschen M, Laterre PF. Immunological sub-phenotypes and response to convalescent plasma in COVID-19 induced ARDS: a secondary analysis of the CONFIDENT trial. Ann Intensive Care. 2024 Oct 21;14(1):160. doi: 10.1186/s13613-024-01392-1.

Reference Type: DERIVED

PMID: 39432177 (View on PubMed)

Misset B, Piagnerelli M, Hoste E, Dardenne N, Grimaldi D, Michaux I, De Waele E, Dumoulin A, Jorens PG, van der Hauwaert E, Vallot F, Lamote S, Swinnen W, De Schryver N, Fraipont V, de Mey N, Dauby N, Layios N, Mesland JB, Meyfroidt G, Moutschen M, Compernolle V, Gothot A, Desmecht D, Taveira da Silva Pereira MI, Garigliany M, Najdovski T, Bertrand A, Donneau AF, Laterre PF. Convalescent Plasma for Covid-19-Induced ARDS in Mechanically Ventilated Patients. N Engl J Med. 2023 Oct 26;389(17):1590-1600. doi: 10.1056/NEJMoa2209502. Epub 2023 Oct 25.

Reference Type: DERIVED

PMID: 37889107 (View on PubMed)

Misset B, Hoste E, Donneau AF, Grimaldi D, Meyfroidt G, Moutschen M, Compernolle V, Gothot A, Desmecht D, Garigliany M, Najdovski T, Laterre PF. 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 protocol. BMC Pulm Med. 2020 Dec 7;20(1):317. doi: 10.1186/s12890-020-01361-x.

Reference Type: DERIVED

PMID: 33287790 (View on PubMed)

Other Identifiers

2020-003102-31

Identifier Type: -

Identifier Source: org_study_id