Information for site staff

update alerts

24 may 2023

Closure of molnupiravir and Paxlovid comparisons

After reviewing current and projected recruitment in RECOVERY, the Trial Steering Committee has decided to close the molnupiravir and Paxlovid comparisons, effective from tomorrow. The RECOVERY collaboration has successfully enrolled over 1,000 participants into these two comparisons, but based on current recruitment rates it is unlikely that continuing them will materially improve the accuracy of the final results. Closing these comparisons will also allow collaborators to focus on completing recruitment to the two COVID-19 comparisons that remain open (sotrovimab and higher dose corticosteroids). The Steering Committee is blinded to the results of ongoing comparisons, so this decision does not reflect any evidence of benefit or hazard of any trial treatments. 

The study IT system has been modified to prevent enrolment into the molnupiravir and Paxlovid comparison from 18.00 this evening. Participants who have been randomised recently should complete their course of treatment and follow-up data should be collected as usual. Analyses will be conducted when follow-up is complete, and results will be shared with collaborators as soon as these are available.

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 has 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) has 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 has, 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.