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

NCT04558476 | Completed Phase 2 DMC

• 1 other identifier: 2020-003102-31
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Keywords

Covid 19; Convalescent plasmatherapy; SARS Cov-2 pneumonia

Outcome Measures

Primary Outcomes (1)

• Vital status

  dead or alive

  at day 28

Secondary Outcomes (18)

• day 90 mortality

  at day 90

• number of ventilator-free days at day 28

  at day 28

• number of renal replacement therapy free days at day 28

  at day 28

• number of vasopressors free-days at day 28

  at day 28

• use of ECMO before day 28

  till day 28

Study Arms (2)

Convalescent Plasma

EXPERIMENTAL

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

Biological: Convalescent Plasma

Standard of care

OTHER

Standard of care according the last gold standards

Other: Standard of Care

Interventions

Convalescent Plasma BIOLOGICAL

2 units of convalescent plasma

Convalescent Plasma

Standard of Care OTHER

Gold Standards

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 .

You may not qualify if:

• Pregnancy
• Prior episode of transfusion-related side effect
• Medical decision to limit therapy
• Current participation in another trial testing a COVID-19 therapy

Sponsors & Collaborators

• University of Liege: lead
• KCE Belgian Healthcare Knowledge Centre: collaborator

Study Sites (17)

Clinique Saint Pierre Ottignies

Ottignies, Brabant Wallon, 1340, Belgium

Location

Centre Hospitalier Wallonie Picarde

Tournai, Hainaut, 7500, Belgium

Location

OLVZ Aalst

Aalst, 9300, Belgium

Location

UZ Antwerpen

Antwerp, 2650, Belgium

Location

Imelda ZH Bonheiden

Bonheiden, 2820, Belgium

Location

CHU Saint Pierre

Brussels, 1000, Belgium

Location

Erasme

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

CHU Charleroi Marie Curie

Charleroi, 6042, Belgium

Location

AZ Sint Blasius

Dendermonde, 9200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Groeningen Kortrijck

Kortrijk, 8500, Belgium

Location

UC Louvain

Leuven, 1200, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

CHU Liège

Liège, 4000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

CHU UCL Namur-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (3)

• 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.

  PMID: 39432177 DERIVED

• 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.

  PMID: 37889107 DERIVED

• 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.

  PMID: 33287790 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Respiratory Insufficiency; Severe Acute Respiratory Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 22, 2020
• Study Start: September 11, 2020
• Primary Completion: April 9, 2022
• Study Completion: March 9, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

BE (17)