Source: Recovery Trial
Professor Peter Horby, Professor Martin Landray
RECOVERY trial Co-chairs
Nuffield Department of Public Health
Oxford
24th May 2020
Dear Peter and Martin
RECOVERY trial DMC Chairman’s report
In the light of the response by MHRA to my letter, I arranged an urgent re- review by the full committee of the safety and efficacy data that were available by 12.22hrs on the 23rd May, for the 10,680 patients randomised.
The Committee reviewed the external evidence from the non-randomised observational study (Mehra et al. Lancet May 22nd 2020) and the evidence from the RECOVERY trial on the effects of
hydroxychloroquine on mortality among patients admitted to hospital with COVID-19.
We saw no cogent reason to suspend recruitment for safety reasons. In particular, we noted that the hazard ratio for 28-day mortality (our primary outcome) in the current RECOVERY data differs significantly (at 2p=0.01) to the HR of 1.335 from the non-randomised assessment reported by Mehra et al.
Professor Peter Sandercock
The Committee therefore recommends the trial continue recruitment without interruption until the next scheduled meeting of the full Committee on 28th May.
Yours sincerely,
Professor Peter Sandercock, MA, DM, FRCPE, FESO, FWSO
Emeritus Professor of Medical Neurology, Centre for Clinical Brain Sciences
Chairman RECOVERY trial DMC
Cc DMC members, RECOVERY trial office, MHRA
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