Other Outcomes
Safety outcomes and process of care assessments are described in our methodology article published in this journal. [REFERENCE BJCP] We will also collect information regarding protocol adherence and deviations from the protocol. Individual studies in the meta-trial may have various other additional outcomes, which are listed in the individual study protocols.
Data Collection
Data will be collected by trained staff at each site under the supervision of the site principal investigator using a case report form and data dictionary. Data will be collected at baseline, from day 0-14 (blood tests, SpO2/FiO2 ratio, modified ordinal scale); on day 28 and day 60 (invasive mechanical ventilation status, vital status, discharge status). The detailed list of collected data items and the schedule for data collection are provided in the individual study protocols.
Sample Size
To demonstrate a clinically important reduction in the primary outcome, a sample size of 712 is required, assuming a decrease in the proportion of patients receiving intubation from 12% to 6%, with power 80% and a two-sided significance level of 0.05.