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

Deliverables

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

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

Publications

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

Author(s): 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
Published in: American Thoracic Society International Conference Abstracts, 2022
Publisher: 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

Author(s): J. Schippers, E. Duijvelaar, P. Smeele, M. De Raaf, S. Blok, A. Vanhove, F. De Man, H. J. Bogaard, J. Aman
Published in: American Thoracic Society International Conference Abstracts, 2022
Publisher: 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

Author(s): 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,
Published in: European Respiratory Journal, 2021
Publisher: European Respiratory Society
DOI: 10.1183/13993003.congress-2021.oa4119

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

Author(s): 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
Published in: The Lancet Respiratory Medicine, Issue 9/9, 2021, Page(s) 957-968, ISSN 2213-2600
Publisher: Elsevier Limited
DOI: 10.1016/s2213-2600(21)00237-x

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

Author(s): 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
Published in: The Lancet Respiratory Medicine, Issue 22132600, 2022, ISSN 2213-2600
Publisher: 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

Author(s): 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
Published in: Trials, Issue 17456215, 2022, ISSN 1745-6215
Publisher: 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

Author(s): 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
Published in: European Respiratory Journal, Issue 13993003, 2022, ISSN 1399-3003
Publisher: 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

Author(s): 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
Published in: CPT: Pharmacometrics & Systems Pharmacology, Issue 5 October 2021, 2021, ISSN 2163-8306
Publisher: Nature Publishing Group
DOI: 10.1002/psp4.12718

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