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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 will initially be to one of five arms: usual care; usual care plus lopinavir-ritonavir; usual care plus low-dose dexamethasone; usual care plus hydroxychloroquine; usual care plus azithromycin, a commonly used antibiotic; usual care plus convalescent plasma (collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus). There is a second randomisation for participants who deteriorate between tocilizumab and control. 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 Alert on this page for update details.  

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update alert

20 May 2020

We have now received approval for Substantial Amendment 5 from REC, MHRA and HRA. These approval letters are available on the Site Set-Up page. As noted in the HRA categorisation e-mail, this is a Category A amendment and sites have 3 days to review it from today. We will therefore implement this on Saturday 23rd May. The main changes are:

  1. To include convalescent plasma in the trial. We will contact those sites selected for the first wave of convalescent plasma separately with further information.
  2. To amend the inclusion criteria for the second randomisation for children
  3. To allow use of Kaletra liquid (for children) and for Kaletra to be dissolved in water so it can be given via a nasogastric tube to adults. Further information on these will be put in the updated pharmacy FAQs shortly.

We will be contacting the sites selected for the convalescent plasma arm shortly. Please ensure that all sites use the latest version (V5.0) of the PIS/ICF from next week, irrespective of whether selected for the convalescent plasma arm or not. These will be available to download from the website (along with V6.0 of the protocol) from Saturday. Please ensure all paper copies of previous versions are destroyed.

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