What is the guidance if a patient’s clinical condition changes between consent and randomisation while they are waiting for their subphenotyping result?

Aim to randomise as soon as possible after consent. For minor changes in condition (e.g. a change in P/F ratio), the recommendation is generally to proceed with randomisation. If there is a significant change (e.g. extubated), consider not randomising the patient. The team should use clinical judgement and consider whether the trial treatment would still be appropriate. If unsure, please contact the trial team via pantheruk@imperial.ac.uk.