Secondary outcomes
Secondary outcomes will be analysed with the same analyses as described
for the primary outcome.
Subgroup analyses
We plan to undertake subgroup analyses of the following variables:
severity of COVID-19 (according to the PaO2/FiO2 ratio and the modified
ordinal scale), duration of intervention, time from admission to start
of intervention, time from development of symptoms to start of
intervention, administration of other therapies, age and sex of the
patients.
Safety outcomes and adverse events
Adverse events are categorised as “not related”, “unlikely”,
“possibly”, “probably” or “definitely related” to treatment, as
determined by site investigators. Events will be tabulated by treatment
group and reported as frequency counts (n) and proportions (%).
Future analyses
Individual studies contributing to the meta-trial may be analysed and
published separately as per the original protocols of these studies. We
will consider conducting hypothesis-generating exploratory analyses
other than those pre-specified above to further evaluate the impact of
nebulised heparin on outcomes in this dataset. Any such analyses
conducted after knowing the main results of the INHALE-HEP meta-trial
will be cautiously interpreted and clearly indicated in any subsequent
publications.