RECOVERYRS Respiratory Support Respiratory Strategies in COVID19 CPAP

RECOVERY-RS Respiratory Support : Respiratory Strategies in COVID-19; CPAP, High-flow, and standard care Site teleconference 24 Nov & 2 Dec 2020

Agenda Site and recruitment update Key messages from previous site TC Trial intervention crossover guidance Site experiences

Site and recruitment update RECOVERY-RS Site and Recruitment Graph 500 457 • 450 • 400 350 300 Highest ever recruiting week last week = 49 patients recruited November is highest ever recruiting month = 181 patients recruited Date Recruitment April-20 31 May-20 71 June-20 26 Jul-20 14 50 Aug-20 11 0 Sep-20 35 Oct-20 114 Nov-20 182 Total 457 250 200 150 49 100 1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334 Calender week Sites Actual Sites cumulative Recruitment actual Recruitment cumulative

Site and recruitment update • • Sites which have recruited Sites that have not yet recruited No. 1 2 No. of relevant sites in each region 9 10 No. of sites open 5 4 Total pts recruited in region 22 28 16 13 9 16 5 4 8 2 8 1 7 97 41 140 6 2% 21% 9% 31% 1% % of Total Recruitment 3 4 5 6 7 CRN North East North West Coast Yorkshire and Humber Greater Manchester East Midlands West of England 8 9 Thames Valley & South Midlands Eastern 5 12 0 7 0 13 0% 3% Kent, Surrey and Sussex Wessex South West Peninsula North Thames South London 19 9 7 6 8 5 2 3 2 7 2 25 5 15 10 8 TBC 19 1 4 3 2 6 1 11 19 10 6 0 0% 5% 1% 3% 2% 2% 4% 2% 1% 0% 74 457 10 11 12 13 14 15 N/A N/A North West London Wales Northern Ireland Scotland Jersey TOTAL 5% 6%

Key messages from previous TC 1. 2. 3. 4. 5. 6. 7. 8. 9. Recruitment will continue to all 3 arms for now. The next interim analysis will take place at 430 patients Uncertainty regarding the benefits and harms of CPAP & HFNO remains. Consider altering clinical pathways to capture patients earlier on If patient receiving intervention for short period prior to randomisation, they might be considered for randomisation. Encourage collaboration between respiratory (pre ICU ward based trial), ICU and wider teams Embed RECOVERY-RS in to local clinical pathways and SOPs. Create dedicated ward area to deliver CPAP and HFNO with trained nurses to avoid escalation to ICU. Recruitment to RECOVERY-RS as an Urgent Public Health trial is still of upmost importance. Trainee engagement to help facilitate TRIC & RAFT meeting RECOVERY-RS is one of the largest noninvasive respiratory trials in the world.

Trial intervention crossover guidance Following scenarios are exempt from crossover of trial intervention and going forward should not be reported on the e-CRF: • • Up to 6 hours of continuous use of crossover intervention Breaks for eating and drinking Bridge to intubation to stabilise the patient Palliative care purposes Data collected up until this point may be queried in the new year with sites to reflect this guidance. To note, expert consensus is to not use CPAP or HFNO for a second episode of non-invasive support. Should go straight to intubation.

Site experiences • PI at Royal Victoria Infirmary, Newcastle: Dr Ben Messer • Clinical investigator at Sunderland Royal Hospital: Dr Tony Rostron