London, June 5: A major UK trial testing a range of drugs for their potential in treating the coronavirus concluded on Friday that the antimalarial drug hydroxychloroquine has “no beneficial effect” in patients hospitalised with COVID-19.
The Chief Investigators of the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, being run by the University of Oxford, said they have stopped the hydroxychloroquine trial with immediate effect as a result of the findings.
“We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19,” Professors Peter Horby and Martin Landray said in a joint statement.
“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,” they said.
As part of their trial, a total of 1,542 patients were randomised to hydroxychloroquine and compared with 3,132 patients randomised to usual care alone. There was no significant difference in the primary endpoint of 28-day mortality and 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,” the researchers said.
Hydroxychloroquine and chloroquine, used as antimalarial drugs, have been in the headlines as US President Donald Trump repeatedly endorsed their benefits to fight coronavirus.
The Oxford University trial was launched in March into a range of potential drugs to fight the deadly virus, including hydroxychloroquine, and proceeded at what scientists have said was “unprecedented speed”, enrolling over 11,000 patients from 175 National Health Service (NHS) hospitals in the UK.
An independent Data Monitoring Committee has been reviewing the emerging data and recommended the chief investigators review the unblinded data on the hydroxychloroquine arm of the trial this week.
Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine at the University of Oxford and Chief Investigator for the RECOVERY 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.”
His colleague, Landray, who is Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Deputy Chief Investigator, added: 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.” (PTI)