Information for site staff in the UK

update alerts

13 december 2024

We face an immediate shortage of our current baloxavir supply and so we have had to change supply arrangements, which have just received approval as SA36. Please note:

• Oseltamivir will now be supplied from NHS stock (like dexamethasone), and there will be no trial-specific oseltamivir supply. This has been reflected in the updated SoECAT, and we hope this will make the comparison simpler for sites.
• The new baloxavir supply will be labelled like a typical clinical trial IMP and will be provided in packs of 2 x 20mg tablets rather than 1x40mg tablet. However, there is no difference in how baloxavir is used in the trial, and SA36 does not alter the protocol, trial procedures, consent forms, or reference safety information.
• Documents and approvals for SA36 are on the regulatory documents page
• Ordering baloxavir will now involve emailing the Oxford trial team directly, who will dispatch orders via the Roche clinical trial distribution system. Instructions for ordering, including a template email, are in the updated pharmacy manual below.

We will activate the new ordering system the week commencing 16 December, and deliver an initial shipment of the new baloxavir supply to all sites without the need for a request. Any existing baloxavir or oseltamivir at sites can still be used for trial patients, but orders via the old supply system will no longer be processed.

27 september 2024

Dear Colleagues,  

ASPECT and RECOVERY are large-scale, open-label, randomised trials testing treatments for patients admitted to hospital with community-acquired pneumonia (CAP). ASPECT is assessing whether aspirin reduces the risk of major cardiovascular events, and RECOVERY is assessing whether dexamethasone improves 28-day survival.  

We would like to encourage sites taking part in ASPECT or RECOVERY to consider also participating in the other trial if local capacity allows, to help us answer these important questions.  

Screening for eligible patients can be done in parallel for the two trials. Some patients will be eligible for only one trial (usually due to concomitant medications), but many patients will be eligible for both. For these patients, local research teams can decide to either (i) recruit to one trial alone, with the preferred trial depending on local priorities and/or patient preference, or (ii) recruit to both trials simultaneously, with consent obtained separately for each trial and with two separate treatment allocations.  

Coordination plan for the two trials 

If you are interested in opening ASPECT or the RECOVERY CAP comparison at your site, or want to know more, then contact us at one of the addresses below:  

ASPECT 

RECOVERY (for more information on the RECOVERY CAP comparison, including its rationale, see the CAP dexamethasone intervention sheet) 

We hope that by maximising the opportunity for participation in these trials we can produce clear answers about how to manage patients hospitalised with CAP.  

Best wishes, 

Nick Maskell, David Arnold, Peter Horby and Martin Landray 

On behalf of the ASPECT and RECOVERY teams.