Information for site staff

update alerts

29 november 2021

The planned implementation of protocol V19.1 will not go ahead as planned today.

In the light of the emergence of the Omicron variant, the Department of Health and Social Care have asked that we do not implement it today. We will keep the situation under review and will provide a further update in the next 2-3 weeks. Further details were sent to sites today. Therefore protocol V18.1 (and associated PIS/ICFs) remain in place for now. We look forward to meeting many of you at the collaborators’ meetings today and tomorrow.

19 november 2021

Thank you very much for your help with the RECOVERY Trial to date.

We have now received approval from HRA, REC and MHRA for substantial amendment 21. The submitted documents, amended documents after REC review and approvals are available on the regulatory documents page.

This amendment includes the following changes:

1. Addition of influenza to the protocol, including three IMPs (low-dose corticosteroids, oseltamivir, baloxavir)
2. Change to eligibility criteria to require all patients to have confirmed infection (either SARS-CoV-2, influenza or both)
3. Removal of early phase assessment of dimethyl fumarate (now that recruitment is complete).

What we need you to do:

• Please inform your R&D department about the amendment and request that they review it as soon as possible. The HRA have stated that trusts/health boards have 7 days to review this amendment.

• Please inform your pharmacy team that an updated manual is now available. If your site has not already provided your Alliance account number (which will be used to provide oseltamivir and baloxavir) please do so. Dexamethasone will be provided from the DHSC stockpile (as for the comparison in COVID-19) and further details will be available soon.

• Training materials will be available from Monday 22nd. Please ensure that anyone your PI wishes to recruit people for this comparison has completed the influenza treatments training and anyone your PI wishes to obtain consent has completed the new consent training (if they have not already done so).

• Please attend the collaborator meetings at 4pm on either 29th or 30th November when this will be discussed in detail and any questions can be answered. Links to these will be sent to you shortly.

This amendment will ‘go live’ on Monday 29th November. [See update alert 29 November postponing this.] Before sites are activated we will need confirmation of training from the PI as well as the necessary pharmacy details. We will then provide the details required to order the drug in our activation e-mail.