CORONAVIRUS PANDEMIC UPDATE: HYDROXYCHLOROQUINE SHOWS NO BENEFIT IN HOSPITALIZED COVID-19 PATIENTS – UK CLINICAL TRIAL
OXFORD, UK - FRIDAY, JUNE 5, 2020: The RECOVERY trial is a randomized clinical trial conducted by researchers at the University of Oxford, UK, to test a range of potential drugs for COVID-19, including hydroxycholoroquine in hospitalized COVID-19 patients.
This study aims to compare several different treatments that may be useful for patients with COVID-19. These treatments have been recommended for testing by the expert panel that advises the Chief Medical Officer in England. Although these treatments show promise, their effectiveness in helping patients recover than the usual standard of care at your hospital (which all patients will receive) is unknown.
The treatments, which may be given in addition to the usual care at the hospital, include: Lopinavir-Ritonavir (commonly used to treat HIV); corticosteroids used to reduce inflammation; hydroxychloroquine; or azithromycin. For patients whose condition is more severe, tocilizumab (a treatment for rheumatoid arthritis) is also an option.
Since March 2020 when the clinical opened, over 11,000 patients has been enrolled from 175 NHS hospitals in the UK. Throughout this time, the independent Data Monitoring Committee has reviewed the emerging data about every two weeks to determine if there is evidence that would be strong enough to affect national and global treatment of COVID-19.
On Thursday 4 June, in response to a request from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the independent Data Monitoring Committee conducted a further review of the data. Last night, the Committee recommended the chief investigators review the unblinded data on the hydroxychloroquine arm of the trial.
Based on this review, it has been concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalized with COVID-19. The RECOVERY study team has therefore decided to stop enrolling participants to the hydroxychloroquine arm of the trial with immediate effect. The preliminary results are being release as they have important implications for patient care and public health.
A total of 1542 patients were randomized to hydroxychloroquine and compared with 3132 patients randomized to usual care alone. There was no significant difference in the primary endpoint of 28-day mortality (25.7% hydroxychloroquine vs. 23.5% usual care; hazard ratio 1.11 [95% confidence interval 0.98-1.26]; p=0.10). There was also no evidence of beneficial effects on hospital stay duration or other outcomes.
These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalized with COVID-19. Full results will be made available as soon as possible.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the trial, said: ‘Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs.’
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Deputy Chief Investigator, said, ‘There has been huge speculation and uncertainty about the role of hydroxychloroquine as a treatment for COVID-19, but an absence of reliable information from large randomized trials. Today’s preliminary results from the RECOVERY trial are quite clear – hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease. This result should change medical practice worldwide and demonstrates the importance of large, randomized trials to inform decisions about both the efficacy and the safety of treatments.’
Full details of the study protocol and related materials are available at www.recoverytrial.net