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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

23 July 2021

NHS England and the Department of Health have confirmed that in England empagliflozin can be provided from 'business as usual' stocks and reimbursed through Blueteq. All sites have been registered with Blueteq, but please contact the team if you have questions. The reimbursement arrangements are yet to be finalised in the devolved nations so we will provide further information when this is available. We will therefore implement this amendment from Wednesday 28 July.

Sites will be activated for it when we receive confirmation of training by the PI (who must ensure that other staff involved in consent or eligibility discussions also completes the training). Please note that the latest protocol is V16.1 and the latest PIS/ICF is 14.0. These will be provided on this website when the amendment is implemented.

13 july 2021

We have now received HRA, MHRA and REC approval for Substantial Amendment 18. The REC requested a minor amendment to the protocol (now V16.1) and this and the approval letters are available on the regulatory documents page.

Training for the new arm (empagliflozin) is available on the 'other oral therapies' page of the training section. Please could PIs complete this and ensure that other members of their teams involved in obtaining consent or assessing eligibility also complete this (and the associated confirmation form).

We are still making arrangements for drug supply and finalising the revised pharmacy manual. We have therefore not set an implementation date yet, and will be in touch again when we are in a position to do so. In the meantime, we would be grateful if your R&D departments could process this amendment.

7 july 2021

We have submitted a substantial amendment to the MHRA, HRA and REC. The main purpose of this is to add empagliflozin to the trial protocol. Please ensure your R&D department are aware of this amendment. We will be in contact about implementing this (including drug supply) in due course.

6 July 2021

We have uploaded RECOVERY trial SUSAR reports for Q2, 2021. Also provided is a linelist of SUSARs reported in other trials of REGEN-COV. These are for information only and no action is required.

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