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

Autor: Michel Moutschen, Veerle Compernolle, Daniel Desmecht, David Grimaldi, Mutien-Marie Garigliany, Geert Meyfroidt, Tome Najdovski, Pierre-François Laterre, André Gothot, Anne-Françoise Donneau, Benoit Misset, Eric Hoste
Přispěvatelé: UCL - SSS/IREC/MEDA - Pôle de médecine aiguë, UCL - (SLuc) Service de soins intensifs
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Time Factors
Convalescent plasma
medicine.medical_treatment
Respiratory System
Respiratory failure
Antibodies
Viral
Severe Acute Respiratory Syndrome
01 natural sciences
law.invention
Study Protocol
0302 clinical medicine
Mechanical ventilation
Randomized controlled trial
Belgium
law
Medicine and Health Sciences
Data monitoring committee
Multicenter Studies as Topic
030212 general & internal medicine
Randomized Controlled Trials as Topic
education.field_of_study
Mortality rate
Intensive Care Units
Treatment Outcome
Pneumologie
Life Sciences & Biomedicine
Pulmonary and Respiratory Medicine
Adult
medicine.medical_specialty
Population
Randomized
03 medical and health sciences
Clinical Trials
Phase II as Topic
Intensive care
medicine
Humans
0101 mathematics
education
lcsh:RC705-779
Science & Technology
Intention-to-treat analysis
business.industry
010102 general mathematics
Immunization
Passive
COVID-19
lcsh:Diseases of the respiratory system
Respiration
Artificial
Emergency medicine
business
Zdroj: BMC Pulmonary Medicine
BMC Pulmonary Medicine, Vol 20, Iss 1, Pp 1-9 (2020)
BMC pulmonary medicine, Vol. 20, no.1, p. 317 [1-9] (2020)
BMC pulmonary medicine, 20 (1
BMC PULMONARY MEDICINE
ISSN: 1471-2466
Popis: Background: The COVID-19 pandemic reached Europe in early 2020. Convalescent plasma is used without a consistent evidence of efficacy. Our hypothesis is that passive immunization with plasma collected from patients having contracted COVID-19 and developed specific neutralizing antibodies may alleviate symptoms and reduce mortality in patients treated with mechanical ventilation for severe respiratory failure during the evolution of SARS-CoV-2 pneumonia. Methods: We plan to include 500 adult patients, hospitalized in 16 Belgian intensive care units between September 2020 and 2022, diagnosed with SARS-CoV-2 pneumonia, under mechanical ventilation for less than 5 days and a clinical frailty scale less than 6. The study treatment will be compared to standard of care and allocated by randomization in a 1 to 1 ratio without blinding. The main endpoint will be mortality at day 28. We will perform an intention to treat analysis. The number of patients to include is based on an expected mortality rate at day 28 of 40 percent and an expected relative reduction with study intervention of 30 percent with α risk of 5 percent and β risk of 20 percent. Discussion: This study will assess the efficacy of plasma in the population of mechanically ventilated patients. A stratification on the delay from mechanical ventilation and inclusion will allow to approach the optimal time use. Selecting convalescent plasmas with a high titer of neutralizing antibodies against SARS-CoV-2 will allow a homogeneous study treatment. The inclusion in the study is based on the consent of the patient or his/her legal representative, and the approval of the Investigational Review Board of the University hospital of Liège, Belgium. A data safety monitoring board (DSMB) has been implemented. Interim analyses have been planned at 100, 2002, 300 and 400 inclusions in order to decide whether the trail should be discontinued prematurely for ethical issues. We plan to publish our results in a peer-reviewed journal and to present them at national and international conferences. Funding and registration: The trial is funded by the Belgian Health Care Knowledge Center KCE
SCOPUS: ar.j
info:eu-repo/semantics/published
Databáze: OpenAIRE
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