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:
- Professor Frank M.P. van Haren, MD PhD FCICM1,2
- Dr Alicia B Vilaseca3
- Ruben A Barbera3
- Dr Tarek I. Ismail4
- Dr Rabab S. Mahrous5
- Dr Mohamed Badr6
- Professor Gilberto DeNucci, MD BPharm PhD7,8
- Carlos Sverdloff, BPharm MSc7
- Lex M van Loon, PhD1
- Associate Professor Alice Richardson, MStats PhD9
- Associate Professor Hwan-Jin Yoon, PhD9
- Professor Antonio Artigas, MD PhD10
- Marta Camprubi-Rimblas, PhD10
- Professor John G. Laffey, MD MA, FCAI, FJFICMI11,12
- Dr David W. Cosgrave11
- Thomas L. Smoot, PharmD BCPS13
- Sabrina Staas, PharmD13
- Khine Sann, MD13
- Caitlin Sas, PharmD13
- Anusha Belani, MD13
- Christopher Hillman, CRNP13
- Professor Janis Shute, PhD14
- Dr Mary Carroll, MD15
- Professor Tom Wilkinson, MBBS PhD15
- Professor Miles Carroll, PhD16
- Professor Dave Singh, MD17
- Mr Roger Smith, MPH18
- Dr Barry Dixon, MD PhD FCICM18
- Professor Clive Page OBE PhD19
Authors’ Affiliations
- Australian National University, College of Health and Medicine,
Canberra, Australia
- University of Canberra, Faculty of Health, Canberra, Australia
- Service of Haematology and Haemostasis, San Camilo Clinic, Buenos
Aires, Argentina
- Department of Anaesthesia and Surgical Intensive Care, Faculty of
Medicine, Helwan University, Cairo, Egypt
- Department of Anaesthesia and Surgical Intensive Care, Faculty of
Medicine, Alexandria University, Alexandria, Egypt
- Department of Critical Care Medicine, Faculty of Medicine, Helwan
University, Cairo, Egypt
- Department of Pharmacology, Faculty of Medical Sciences, University of
Campinas, Campinas, Brazil
- Department of Pharmacology, Institute of Biomedical Sciences,
University of São Paulo, Brazil
- Statistical Consulting Unit, Australian National University, Canberra,
Australia
- Critical Center, Corporació Universitaria Sanitaria Parc Tauli, CIBER
Enfermedades Respiratorias, Autonomous University of Barcelona,
Sabadell, Spain
- 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
- Department of Anaesthesia, University Hospital Galway, Saolta Hospital
Group, Ireland
- Frederick Memorial Hospital, Frederick, Maryland, USA
- School of Pharmacy and Biomedical Science, University of Portsmouth,
Portsmouth, United Kingdom
- Department of Respiratory Medicine, University of Southampton,
Southampton, United Kingdom
- National Infection Service, Public Health England, Porton Down, United
Kingdom
- Medicines Evaluation Unit, University of Manchester, Manchester,
United Kingdom
- Department of Critical Care Medicine, St Vincent’s Hospital,
Melbourne, Australia
- 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.