Concept and design
A meta-trial employs prospective pooling of individual patient data from
ongoing individual clinical trials and early phase studies.[21] The
term “meta-trial” refers to a prospective pooled analysis planned to
streamline data collection from multiple individual trials, allowing for
faster accumulation of data for major clinical endpoints during the
pandemic.[24] The meta-trial concept enables researchers to combine
the agility of smaller national trials into a much larger international
project in a short period of time.[24, 25] Meta-trial interim
analysis enables to detect a positive or negative response to the
scientific question as soon as an adequate sample size is reached across
several countries, thus potentially speeding up the research process
dramatically.[24, 26, 27] Adherence to methodological standards of
individual trials represents a guarantee of a high level of overall
final quality. Furthermore, by estimating the treatment effect across
the various trials upfront, the meta-trial may provide stronger evidence
in favour of external validity and replicability of the individual
trials. Our meta-trial is designed as a collaborative prospective
individual patient data analysis of on-going 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.