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.