Professor Chris Butler, Chief Investigator of the PRINCIPLE Trial, and Professor Richard Hobbs, Co Chief Investigator of the PRINCIPLE Trial, Nuffield Department of Primary Care Health Sciences, University of Oxford, said:
‘On 22 May 2020, The Medicines and Healthcare products Regulatory Authority (MHRA) instructed the PRINCIPLE trial of community-based treatments for COVID-19 illness to suspend recruitment into its hydroxychloroquine arm, based on the findings of an observational study of hospitalised patients in the Lancet, which has now been retracted.
‘Recruitment of participants into the hydroxychloroquine arm of the PRINCIPLE trial was suspended on that date. None of the participants in the PRINCIPLE trial have been given hydroxychloroquine since that time.
‘Since the Lancet paper was retracted, the RECOVERY trial has found that hydroxychloroquine is not an effective treatment for hospitalised patients with COVID-19.
‘While all our participants who were given hydroxychloroquine as part of the trial have now completed their short course of hydroxychloroquine, we are asking them to continue the remainder of their 28-day diaries so we can get as much information about the effect of this drug on COVID-19 illness as possible.
‘PRINCIPLE is a flexible, platform trial of interventions suitable for use in the community that may prevent hospitalisation and speed recovery from COVID-19 illness. In keeping with the generic, flexible trial design, we will continue to evaluate other treatments for COVID-19-like-illness in primary care.
‘The trial is now randomising participants to usual care and usual care plus azithromycin since suspending the hydroxychloroquine arm.
‘The safety of trial participants has always been paramount in PRINCIPLE. Those at greater risk of adverse reactions to study medicines are excluded from taking part.’