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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

9 MARCH 2023

Empagliflozin

The RECOVERY trial independent Data Monitoring Committee (DMC) held a routine meeting on Friday 3 March to review the available safety and efficacy data.

On the advice of the DMC, the Trial Steering Committee have reviewed the unblinded data for the comparison of empagliflozin + usual standard of care vs. usual standard of care alone. Based on the available information on 4263 randomised participants, the Trial Steering Committee (TSC) have concluded that there is no convincing evidence of benefit nor a realistic possibility of identifying a meaningful benefit from empagliflozin through continued recruitment. The TSC have, therefore, decided to close recruitment to this comparison. There was no evidence of any safety concerns. Follow-up of patients is ongoing and the final results will be made public as soon as possible.

The study IT system has been modified to prevent enrolment in this comparison. Participants who have been randomised recently may complete the course of treatment and follow-up data should be collected as usual.

9 january 2023

GSK/Vir have provided data to support extending the expiry date for the sotrovimab stock supplied for RECOVERY by a further 6 months. This has been reviewed and approved by MHRA, REC and HRA.

Further information is available in an updated pharmacy FAQs and an updated worksheet is also available. Please ensure your pharmacy colleagues are aware of this amendment.

20 june 2022

Thank you very much for your help with the RECOVERY Trial to date. Protocol V25.0 is to be implemented from today (20 June 2022). Please ensure all previous copies of the PIS/ICF are destroyed and only the latest version (V24.0 for adults; V14.0 for children) is used from today onwards. This must be done at all sites irrespective of which comparisons you are participating in and whether your R&D office has issued C&C formal approval yet (as HRA have stated that this amendment should be considered approved from three days after their approval).

13 June 2022

We have now received all the approvals for Substantial Amendment 28 which includes the following changes:

  1. Excluding patients on no oxygen or simple oxygen therapy only from the high-dose dexamethasone comparison (as per the urgent safety measure)
  2. Recommending that participants in the Paxlovid comparison receive an alternative glucocorticoid to dexamethasone. This is because Paxlovid increases dexamethasone blood concentrations so receiving Paxlovid and low-dose dexamethasone gives equivalent exposure to high-dose dexamethasone. Now that it is clear that patients on no or simple oxygen should not receive high-dose dexamethasone we need to ensure this does not occur. Other glucocorticoids (including prednisolone, methylprednisolone and hydrocortisone) are not affected (and have similar efficacy to dexamethasone) so the protocol recommends these are used instead. We would ask that if any participants are currently receiving Paxlovid and dexamethasone that this change is explained to them sensitively. Please ensure all staff responsible for prescribing Paxlovid are aware of this change.

Please note that Substantial Amendment 27 was withdrawn from MHRA when Substantial Amendment 28 was submitted so there is no MHRA or HRA approval for this, but all changes are included in Substantial Amendment 28.

What we need you to do:

  • This amendment will be implemented on 20 June 2022. Please ensure all previous copies of the PIS/ICF are destroyed and only the latest version is used from this date onwards. This must be done at all sites irrespective of which comparisons you are participating in.
  • Please inform your R&D department about the approval of the amendment and request that they process it as soon as possible.
  • Training materials and the intervention sheet have been updated accordingly.

Many thanks for all your help with RECOVERY.


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