Study concept and design
The meta-trial employs prospective pooling of individual patient data from ongoing individual clinical trials and early phase studies.[19] The term “meta-trial” refers to a prospective meta-analysis planned to streamline data collection from multiple individual trials, allowing for faster accumulation of data for major clinical endpoints during the pandemic.[21] This meta-trial is designed as a collaborative prospective individual patient data meta-analysis of investigator-initiated, randomised studies of inhaled nebulised UFH in addition to standard care compared to standard care alone in hospitalised patients with confirmed COVID-19. The primary outcome of the meta-analysis is intubation (or death, for patients who died before intubation) after randomisation, assessed in a time-to-event analysis. Primary outcomes for individual studies may be different clinical or biochemical endpoints and are listed in the individual trial protocols.