Conclusion
This investigator-initiated international prospective meta-trial of
randomised controlled trials and early phase studies will investigate
the efficacy and safety of nebulised UFH, on relevant outcomes in
hospitalised COVID-19 patients. Our pre-specified statistical analysis
plan was prepared before completion of patient recruitment and data
collection of the INHALE-HEP meta-trial. The plan provides a detailed
description of the principles and methods for analysing and reporting
the trial results and is in keeping with best research practice.