Development of Impentri, an intravenous imatinib formulation for Covid-19 acute respiratory distress syndrome (ARDS).

Informations projet

Impentri

N° de convention de subvention: 101005142

DOI

10.3030/101005142

Projet clôturé

Date de signature de la CE 7 Août 2020

Date de début 1 Juillet 2020

Date de fin 31 Octobre 2022

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 3 985 732,00

Contribution de l’UE

€ 3 662 963,00

Coordonné par

EXVASTAT LTD
United Kingdom

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Open Research Data Pilot (2)

Data management and validation plan final

Data management and validation plan final To facilitate the obligation to make research data available within 30 days following guidelines for H2020 projects working on COVID19 available at httpseuYh49yCProtection of personal data1 The consortium must ensure that the following is addressed in the Data Management Plana detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participantsb the consortium must confirm that the specific data protection informed consent forms and information sheets in language and terms intelligible to the participants are kept on file in case this is not addressed in the informed consent procedures for human participants They must be provided to IMI JU upon request2 Details on the data which will be collected during the phone call at Day 28 within Clinical Study 1 CT p 6 must be provided

Data management and validation plan M12

Data management and validation plan M12 To facilitate the obligation to make research data available within 30 days following guidelines for H2020 projects working on COVID19 available at httpseuYh49yCProtection of personal data1 The consortium must ensure that the following is addressed in the Data Management Plana detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participantsb the consortium must confirm that the specific data protection informed consent forms and information sheets in language and terms intelligible to the participants are kept on file in case this is not addressed in the informed consent procedures for human participants They must be provided to IMI JU upon request2 Details on the data which will be collected during the phone call at Day 28 within Clinical Study 1 CT p 6 must be provided

Documents, reports (5)

Data validation and management plan

Data management and validation planDMPs should cover strategy for all data in the project and how they can be made available as from the rules 30days Protection of personal data1 The consortium must ensure that the following is addressed in the Data Management Plana detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participantsb the consortium must confirm that the specific data protection informed consent forms and information sheets in language and terms intelligible to the participants are kept on file in case this is not addressed in the informed consent procedures for human participants They must be provided to IMI JU upon request2 Details on the data which will be collected during the phone call at Day 28 within Clinical Study 1 CT p 6 must be provided

'IV imatinib in severe Covid-19' study peer reviewed publication

IV imatinib in severe Covid19 study peer reviewed publication submitted for review

'Oral imatinib in severe Covid-19' study peer reviewed publication

Peer reviewed publication reporting findings from the oral Phase II clinical study

Presentation of 'IV imatinib in severe Covid-19' study result at ERS, ESICM and ATS congresses

Preparation of an abstract for presentation of IV imatinib in severe Covid19 study result at an international conference eg ATS

Pathophysiology report & manuscript

report and manuscript for publication describing pathophysiology findings from the oral phase II clinical study

Other (1)

Presentation of 'Oral imatinib in severe Covid-19' study results at the ERS, ESICM and ATS congresses

Public presentations of findings from the oral Phase II clinical study

Publications

Conference proceedings (3)

Oral Imatinib Reduces Mortality in Hospitalized COVID-19 Patients Through Endothelial Barrier Protection and Immunomodulation

Auteurs: J. De Brabander 1, E. Duijvelaar 4, J.R. Schippers 4, P.J. Smeele 4, J. Duitman 3, J. Aman 4, H.J. Bogaard 4, T. van der Poll 1, L.D.J. Bos 2, CounterCOVID Study Group
Publié dans: American Thoracic Society International Conference Abstracts, 2022
Éditeur: American Thoracic Society
DOI: 10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a5049

90-Day Clinical Outcome of Hospitalized Covid-19 Patients Treated with Imatinib

Auteurs: J. Schippers, E. Duijvelaar, P. Smeele, M. De Raaf, S. Blok, A. Vanhove, F. De Man, H. J. Bogaard, J. Aman
Publié dans: American Thoracic Society International Conference Abstracts, 2022
Éditeur: American Thoracic Society
DOI: 10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a5048

Late Breaking Abstract - A randomised, double-blind, placebo controlled, clinical trial evaluating imatinib in patients with severe COVID-19

Auteurs: Jurjan Aman, Erik Duijvelaar, Liza Botros, Azar Kianzad, Job Schippers, Patrick Smeele, Sara Azhang, Imke Bartelink, Pierre Bet, Wim Boersma, Karin Boomars, Peter Bonta, Lieuwe Bos, Job Van Bragt, Gert-Jan Braunstahl, Lucas Celant, Katrien Eger, Miranda Geelhoed, Yurika Van Glabbeek, Hans GrotjohanShow lessLaura Hagens, Chris Happe, Leo Heunks, Michel Van Den Heuvel, Wouter Hoefsloot, Rianne Hoek,
Publié dans: European Respiratory Journal, 2021
Éditeur: European Respiratory Society
DOI: 10.1183/13993003.congress-2021.oa4119

Peer reviewed articles (5)

Imatinib in patients with severe COVID-19: a randomised, double-blind, placebo-controlled, clinical trial

Auteurs: Jurjan Aman, Erik Duijvelaar, Liza Botros, Azar Kianzad, Job R Schippers, Patrick J Smeele, Sara Azhang, Imke H Bartelink, Ahmed A Bayoumy, Pierre M Bet, Wim Boersma, Peter I Bonta, Karin A T Boomars, Lieuwe D J Bos, Job J M H van Bragt, Gert-Jan Braunstahl, Lucas R Celant, Katrien A B Eger, J J Miranda Geelhoed, Yurika L E van Glabbeek, Hans P Grotjohan, Laura A Hagens, Chris M Happe, Boaz D Haze
Publié dans: The Lancet Respiratory Medicine, Numéro 9/9, 2021, Page(s) 957-968, ISSN 2213-2600
Éditeur: Elsevier Limited
DOI: 10.1016/s2213-2600(21)00237-x

Long-term clinical outcomes of COVID-19 patients treated with imatinib

Auteurs: Erik Duijvelaar; Job R Schippers; Patrick J Smeele; Michiel Alexander de Raaf; Arthur L E M Vanhove; Siebe G Blok; CounterCOVID Collaborative Group; Jos W R Twisk; Anton Vonk Noordegraaf; Frances S de Man; Harm Jan Bogaard; Jurjan Aman
Publié dans: The Lancet Respiratory Medicine, Numéro 22132600, 2022, ISSN 2213-2600
Éditeur: Elsevier Limited
DOI: 10.1016/s2213-2600(22)00052-2

The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19

Auteurs: Leila Atmowihardjo, Job R. Schippers, Imke H. Bartelink, Pierre M. Bet, Nienke van Rein, Keith Purdy, David Cavalla, Valérie Comberiati, Andrew McElroy, Sue D. Snape, Harm Jan Bogaard, Leo Heunks, Nicole Juffermans, Marcus Schultz, Pieter R. Tuinman, Lieuwe D. J. Bos & Jurjan Aman
Publié dans: Trials, 2022, ISSN 1745-6215
Éditeur: BioMed Central
DOI: 10.1186/s13063-022-06055-9

Immunomodulation and endothelial barrier protection mediate the association between oral imatinib and mortality in hospitalised COVID-19 patients

Auteurs: Justin de Brabander, Erik Duijvelaar, Job R. Schippers, Patrick J. Smeele, Hessel Peters-Sengers, Jan Willem Duitman, Jurjan Aman, Harm J. Bogaard, Tom van der Poll, Lieuwe D.J. Bos on behalf of the CounterCOVID study group
Publié dans: European Respiratory Journal, Numéro 13993003, 2022, ISSN 1399-3003
Éditeur: European Respiratory Society
DOI: 10.1183/13993003.00780-2022

Elevated acute phase proteins affect pharmacokinetics in COVID‐19 trials: Lessons from the CounterCOVID ‐ imatinib study

Auteurs: Imke H. Bartelink, Pierre M. Bet, Nicolas Widmer, Monia Guidi, Erik Duijvelaar, Bram Grob, Richard Honeywell, Amanda Evelo, Ivo P. E. Tielbeek, Sue D. Snape, Henrike Hamer, Laurent A. Decosterd, Harm Jan Bogaard, Jurjan Aman, Eleonora L. Swart
Publié dans: CPT: Pharmacometrics & Systems Pharmacology, Numéro 5 October 2021, 2021, ISSN 2163-8306
Éditeur: Nature Publishing Group
DOI: 10.1002/psp4.12718