The trial is unique as it will be set up pre-pandemic. Once set-up is complete and all the required approvals have been obtained, the trial will be placed into ‘hibernation’.
After the initial set-up, there will be 3 distinct phases to the trial.
During hibernation, regular review (at least annually) of trial procedures and sites will ensure that the trial is maintained in a state in which it can be readily activated to start recruitment in the event of a pandemic.
When the National Institute for Health Research (NIHR) decide to activate the trial, a pre-activation phase of four to six weeks will begin immediately. This will include final review of trial procedures, trial drug production and distribution, production and distribution of trial materials and a check of site readiness prior to beginning recruitment.
During activation, patients will be recruited into the trial. Recruitment Is planned to be completed within the first pandemic wave, typically of six weeks duration. This phase also includes data collection and follow-up.
During the hibernation phase, regular review (at least annually) of trial procedures and sites will ensure that the trial is maintained in a state in which it can be rapidly activated to start recruitment in the event of a pandemic. If the NIHR activate the trial it will move to a pre-activation phase of 4-6 weeks. This final phase of trial set-up will include production and distribution of the trial drug and trial materials, finalisation of trial procedures, and a check of site readiness prior to beginning recruitment.
Investigational Medicinal Product (IMP)
- Check availability of IMP and placebo
- Check expiry dates of current stocks
- Check no changes to packaging
- Check site staff information
- Check all documentation at site is current
- Check access to online systems
- Provide refresher training