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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; REGN-COV2 monoclonal antibodies; 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

21 april 2021

We have now received REC, MHRA and HRA approvals for substantial amendment 17. This change will be implemented on 26 April 2021, when the participant information sheet and protocol on this website will be updated. Please destroy any paper copies of older versions of the PIS/ICF you may have. In the UK this amendment does not require any other changes.

14 April 2021

  • We have submitted a substantial amendment to the protocol to MHRA and HRA. This removes colchicine and aspirin from the trial protocol. It also adds two new IMPs, but these will only be used outside the UK initially.
  • An update on SUSARs reported during quarter 1, 2021 in RECOVERY (and in other trials of REGN-COV2) is also available.
  • The investigators' brochure for REGN-COV2 has been updated. The changes do not change the risk/benefit analysis so did not require MHRA or HRA approval. The updated investigators' brochure is included in non-substantial amendment 3 on 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