Information for site staff

update alerts

1 december 2023

Substantial amendment 33 has been approved, which introduces a new dexamethasone comparison for patients with community-acquired pneumonia (CAP). This involves new versions of the protocol (V27.0) and adult PIS-ICF (V26.0). We are asking sites to implement this amendment on 8th January 2024, whether or not they plan to open the CAP comparison then. SA33 documents are available from the Regulatory documents page now, and the rest of the website will be updated with these on 8th January. Please ensure that any previous document versions are destroyed after this date.

14 november 2023

Message to RECOVERY site teams about the collaboration between REMAP-CAP and RECOVERY, from the Chief Investigators and NIHR Deputy Medical Director: 

Thank you for all your help on these trials to date. You may be aware that the REMAP-CAP and RECOVERY are both now evaluating treatments for patients admitted to hospital with influenza. Given the overlap between the trials and the treatments being tested, the chief investigators have decided that REMAP-CAP and RECOVERY will collaborate to maximise our chance of success. This collaboration involves: 

1. Co-ordination of recruitment locations, so that only one trial is active in a particular clinical area. This will avoid confusion and unnecessary duplication of procedures, allowing more efficient recruitment. It will also allow site teams to choose the trial that will work best in their setting, which could include running different trials in different clinical locations in the same hospital where this is the most practical solution (e.g. ICUs and medical wards). 
2. A combined primary analysis and publication including all patients recruited to either trial, which will maximise our chance of producing conclusive results. 

What this means for sites 

• If you are already running REMAP-CAP or RECOVERY influenza comparisons at any locations in your trust, then please continue to do so. 
• If you are in the process of setting up either trial at your site, please continue to do so.
• However, if there are clinical areas where you are not yet recruiting patients with influenza into either trial, we would like to invite you to participate in one of the trials.
• Both trials will now offer £400 per randomised participant to support trial sites with recruitment.  

Note, all hospitalised patients are now potentially eligible for REMAP-CAP influenza comparisons, not just those on ICU. If your site is currently running REMAP-CAP on ICU alone, then please consider expanding REMAP-CAP to medical wards. If this is not possible, then please consider if it would be possible to run RECOVERY on medical wards. 

What to do next if you are interested 

If you are interested in opening REMAP-CAP or RECOVERY influenza comparisons, or want to know more, then contact us at one the addresses below:

REMAP-CAP – ukremap-cap@icnarc.org  

RECOVERY – recoverytrial@ndph.ox.ac.uk 

We are aware that winter is nearly upon us, and time is running out to set up new comparisons before influenza transmission starts. If you are potentially interested in opening REMAP-CAP or RECOVERY influenza comparisons in any area in your trust, then please start local discussions now and contact us as soon as possible. We hope that by the two trials collaborating we will finally get answers about how best to manage influenza in hospital. We will hopefully also show that the UK and the NHS can lead the way in such clinical trials. Please join us. 

Best wishes, 

Anthony Gordon, Peter Horby and Martin Landray
On behalf of the REMAP-CAP and RECOVERY teams 

Paul Dark
NIHR Deputy Medical Director

31 october 2023

15 June 2023

Letter to RECOVERY Principal Investigators requesting support to complete the COVID-19 evaluations, from the Chief Investigators and NIHR Clinical Research Network leads for Respiratory Disorders and Infection.