Following the previous news reported in Total Health on a new clinical trial to test the effects of potential drug treatments for patients admitted to hospital with COVID-19, the results are already coming in. Oxford University report that there is, "no clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19".
The new study convincingly rules out any meaningful benefit from hydroxychloroquine. The study echoes the results from The University of Minnesota study reported in the New England Journal of Medicine and subsequently covered in the media featuring the author of the study Dr. David Boulware. Dr Boulware says that the president's physician sent him an email on May 9, seeking his opinion about taking the drug preventatively, and asking about the results of the study and the dose the study subjects were taking.
Boulware says he advised Trump's physician that there was no published research showing hydroxychloroquine worked preventatively and shared that the people in his study who took hydroxychloroquine had higher rates of side effects, mostly gastrointestinal problems such as nausea and vomiting. CNN reported Dr Boulware saying, "I knew they were probably going to ignore what I said because the White House had been talking about hydroxychloroquine for weeks and weeks and weeks."
In the continued fight against 'fake news' and for an evidence base, it is useful therefore to see the results of the latest study on the efficacy of a drug being otherwise so widely lauded.
No beneficial effect of hydroxychloroquine
In a new statement from the Chief Investigators of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial on hydroxychloroquine, Professor Peter Horby and Professor Martin Landray said, "In March this year, RECOVERY was established as a randomised clinical trial to test a range of potential drugs for COVID-19, including hydroxycholoroquine.
"The trial has proceeded at unprecedented speed, enrolling over 11,000 patients 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.
‘We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19. We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY trial with immediate effect. We are now releasing the preliminary results as they have important implications for patient care and public health.
‘A total of 1542 patients were randomised to hydroxychloroquine and compared with 3132 patients randomised 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 hospitalised 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, ‘Hydroxychloroquine and chloroquine have received a lot of attention and have been used very widely to treat COVID patients despite the absence of any good evidence. The RECOVERY trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with COVID-19. 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.’
Prof Martin Landray 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 randomised trials. Today’s preliminary results from the RECOVERY trial are quite clear – hydroxychloroquine does not reduce the risk of death among hospitalised patients with this new disease. This result should change medical practice worldwide and demonstrates the importance of large, randomised 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
A range of potential treatments have been suggested for COVID-19, but it has been unclear whether any of them will turn out to be more effective in improving survival than the usual standard of hospital care which all patients will receive.
Other drugs that are being tested
The RECOVERY Trial is a large, randomised controlled trial of possible treatments for patients admitted to hospital with COVID-19. Over 11,000 patients have been randomised to the following treatment arms, or no additional treatment:
- Lopinavir-Ritonavir (commonly used to treat HIV)
- Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation)
- Hydroxychloroquine (related to an anti-malarial drug)
- Azithromycin (a commonly used antibiotic)
- Tocilizumab (an anti-inflammatory treatment given by injection)
- Convalescent plasma (collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus).
Involving thousands of doctors and healthcare professionals
The RECOVERY trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 175 NHS Trusts across the whole of the UK, supported by staff at the NIHR Clinical Research Network, Public Health England, Department of Health & Social Care, and the NHS in England, Scotland, Wales and Northern Ireland.