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.