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Information for site staff

Every COVID-19 patient in the UK may be invited to participate in the RECOVERY Trial. Randomisation includes the following arms: usual care alone; high-dose vs standard corticosteroids; baricitinib and dimethyl fumarate. The trial is designed to have the least possible impact on NHS staff. You will find Frequently Asked Questions on the site set-up page.

See Update Alerts on this page for update details.  

UK

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update alerts

16 august 2021

We have now received MHRA, REC and HRA approval for Substantial Amendment 19. The approval letters and copies of amended documents can be downloaded from the regulatory documents page. Please note:

  • The approved protocol is V17.1. This will be available on this website once the amendment has been implemented. The additional blood/urine ketone monitoring is only required for participants with diabetes (as described in appendix 2).
  • The PIS/ICFs for adults and children have been updated and will be available on this website once the amendment has been implemented.
  • The training has been updated. If you have completed the previous version, we will send you a summary of the changes so you do not need to repeat it.

We will implement this amendment on Friday 20 August.

10 august 2021

We have submitted a Substantial Amendment (number 19) to MHRA, REC and HRA. This amendment provides additional safety monitoring for participants in the empagliflozin comparison. Please ensure your R&D departments are aware. This amendment does not have implications for pharmacy. The .training will be updated once we receive approval and a summary of the changes will be provided to staff who have completed the current version.

Please note this amendment will change the PIS/ICF as well so, once approved, the new version will be available in the usual locations on the website. The documents submitted to the REC can be downloaded from the regulatory documents page.


STUDY PROTOCOL

The RECOVERY Trial protocol is available for use by investigators everywhere to design their own randomised trials that could help identify effective treatments for COVID-19.

Study protocol