INHALE d nebulised unfractionated HEP arin for the treatment of hospitalised patients with COVID-19 (INHALE-HEP): Protocol for an investigator-initiated international meta-trial of randomised studies
Authors:
  1. Professor Frank M.P. van Haren, MD PhD FCICM1,2
  2. Dr Alicia B Vilaseca3
  3. Ruben A Barbera3
  4. Dr Tarek I. Ismail4
  5. Dr Rabab S. Mahrous5
  6. Dr Mohamed Badr6
  7. Professor Gilberto DeNucci, MD BPharm PhD7,8
  8. Carlos Sverdloff, BPharm MSc7
  9. Lex M van Loon, PhD1
  10. Associate Professor Alice Richardson, MStats PhD9
  11. Associate Professor Hwan-Jin Yoon, PhD9
  12. Professor Antonio Artigas, MD PhD10
  13. Marta Camprubi-Rimblas, PhD10
  14. Professor John G. Laffey, MD MA, FCAI, FJFICMI11,12
  15. Dr David W. Cosgrave11
  16. Thomas L. Smoot, PharmD BCPS13
  17. Sabrina Staas, PharmD13
  18. Khine Sann, MD13
  19. Caitlin Sas, PharmD13
  20. Anusha Belani, MD13
  21. Christopher Hillman, CRNP13
  22. Professor Janis Shute, PhD14
  23. Dr Mary Carroll, MD15
  24. Professor Tom Wilkinson, MBBS PhD15
  25. Professor Miles Carroll, PhD16
  26. Professor Dave Singh, MD17
  27. Mr Roger Smith, MPH18
  28. Dr Barry Dixon, MD PhD FCICM18
  29. Professor Clive Page OBE PhD19
Authors’ Affiliations
  1. Australian National University, College of Health and Medicine, Canberra, Australia
  2. University of Canberra, Faculty of Health, Canberra, Australia
  3. Service of Haematology and Haemostasis, San Camilo Clinic, Buenos Aires, Argentina
  4. Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Helwan University, Cairo, Egypt
  5. Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Alexandria University, Alexandria, Egypt
  6. Department of Critical Care Medicine, Faculty of Medicine, Helwan University, Cairo, Egypt
  7. Department of Pharmacology, Faculty of Medical Sciences, University of Campinas, Campinas, Brazil
  8. Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil
  9. Statistical Consulting Unit, Australian National University, Canberra, Australia
  10. Critical Center, Corporació Universitaria Sanitaria Parc Tauli, CIBER Enfermedades Respiratorias, Autonomous University of Barcelona, Sabadell, Spain
  11. Anaesthesia and Intensive Care Medicine, School of Medicine, and Regenerative Medicine Institute (REMEDI) at CÚRAM Centre for Research in Medical Devices, Biomedical Sciences Building, National University of Ireland Galway, Galway, Ireland
  12. Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland
  13. Frederick Memorial Hospital, Frederick, Maryland, USA
  14. School of Pharmacy and Biomedical Science, University of Portsmouth, Portsmouth, United Kingdom
  15. Department of Respiratory Medicine, University of Southampton, Southampton, United Kingdom
  16. National Infection Service, Public Health England, Porton Down, United Kingdom
  17. Medicines Evaluation Unit, University of Manchester, Manchester, United Kingdom
  18. Department of Critical Care Medicine, St Vincent’s Hospital, Melbourne, Australia
  19. Sackler Institute of Pulmonary Pharmacology, King’s College London
Corresponding author: Frank van Haren, frank.vanharen@anu.edu.au
Authors’ contributions: FvH drafted the manuscript. All authors contributed to revision and finalisation of the manuscript. All authors read and approved the final draft for submission.
Meta-trial Protocol date and version: 1 December 2020, INHALE-HEP meta-trial version
Sponsor meta-trial: INHALE-HEP Collaborative Research Group (CRG). Each individual investigator of every contributing trial is a member of the INHALE-HEP CRG.
Role sponsor: The INHALE-HEP CRG’s executive committee is responsible for the meta-trial’s study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Investigators from individual trials have ownership of their trial data. A collaboration and data sharing agreement between investigators facilitates and governs the collecting and meta-analysing of de-identified individual patient data from individual trials and sets out eligibility for authorship.