Statistical analysis plan for the INHALE d nebulised unfractionated HEP arin for the treatment of hospitalised patients with COVID-19 (INHALE-HEP) meta-trial
Authors:
  1. Professor Frank M.P. van Haren, MD PhD FCICM1,2
  2. Associate Professor Alice Richardson, MStats PhD3
  3. Associate Professor Hwan-Jin Yoon, PhD3
  4. Professor Antonio Artigas, MD PhD4
  5. Professor John G. Laffey, MD MA, FCAI, FJFICMI5,6
  6. Dr Barry Dixon, MD PhD FCICM7
  7. Mr Roger Smith, MPH7
  8. Dr Alicia B Vilaseca8
  9. Ruben A Barbera8
  10. Dr Tarek I. Ismail9
  11. Dr Rabab S. Mahrous10
  12. Dr Mohamed Badr11
  13. Professor Gilberto DeNucci, MD BPharm PhD12,13
  14. Carlos Sverdloff, BPharm MSc12
  15. Lex M van Loon, PhD1
  16. Marta Camprubi-Rimblas, PhD4
  17. Dr David W. Cosgrave6
  18. Thomas L. Smoot, PharmD BCPS14
  19. Sabrina Staas, PharmD14
  20. Khine Sann, MD14
  21. Caitlin Sas, PharmD14
  22. Anusha Belani, MD14
  23. Christopher Hillman, CRNP14
  24. Professor Janis Shute, PhD15
  25. Dr Mary Carroll, MD16
  26. Professor Tom Wilkinson, MBBS PhD16
  27. Professor Miles Carroll, PhD17
  28. Professor Dave Singh, MD18
  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. Statistical Consulting Unit, Australian National University, Canberra, Australia
  4. Critical Center, Corporació Universitaria Sanitaria Parc Tauli, CIBER Enfermedades Respiratorias, Autonomous University of Barcelona, Sabadell, Spain
  5. 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
  6. Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland
  7. Department of Critical Care Medicine, St Vincent’s Hospital, Melbourne, Australia
  8. Service of Haematology and Haemostasis, San Camilo Clinic, Buenos Aires, Argentina
  9. Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Helwan University, Cairo, Egypt
  10. Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Alexandria University, Alexandria, Egypt
  11. Department of Critical Care Medicine, Faculty of Medicine, Helwan University, Cairo, Egypt
  12. Department of Pharmacology, Faculty of Medical Sciences, University of Campinas, Campinas, Brazil
  13. Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil
  14. Frederick Memorial Hospital, Frederick, Maryland, USA
  15. School of Pharmacy and Biomedical Science, University of Portsmouth, Portsmouth, United Kingdom
  16. Department of Respiratory Medicine, University of Southampton, Southampton, United Kingdom
  17. National Infection Service, Public Health England, Porton Down, United Kingdom
  18. Medicines Evaluation Unit, University of Manchester, Manchester, United Kingdom
  19. Sackler Institute of Pulmonary Pharmacology, King’s College London
Corresponding author: Frank van Haren,frank.vanharen@anu.edu.au
Authors’ contributions: Chief Investigator FvH drafted the manuscript with advice from senior statisticians AR and HJY. All authors contributed to revision and finalisation of the manuscript. All authors read and approved the final draft for submission.
Meta-trial Statistical Analysis Plan date and version: 3 December 2020, INHALE-HEP meta-trial SAP version 1.0. This SAP refers to Protocol date and version: 1 December 2020, INHALE-HEP meta-trial protocol version 1.0
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.