The UK medicines agency reportedly approved the resumption of a global trial to find whether hydroxychloroquine can prevent COVID-19. The decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) comes weeks after the RECOVERY trial concluded that the anti-malaria drug has ‘no beneficial effect’ in patients hospitalised with the deadly virus. According to an international media report, the trial will restart under the COPCOV trial, which will determine whether a daily prophylactic dose of HCQ can protect people from catching the coronavirus infection.
Hydroxychloroquine has been a controversial drug. While US President Donald Trump has been a strong supporter and even called the drug a ‘game-changer’, several studies suggested that the patients receiving HCQ were more likely to die and experience dangerous irregular heartbeats. The chief investigators of the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial also decided to stop enrolling participants to the hydroxychloroquine arm as they believe that the drug has no mortality benefit.
Last week, the World Health Organisation also announced that they will be stopping HCQ arm of the Solidarity Trial. The UN organisation clarified that the 'decision applies only to the conduct of the Solidarity trial and does not apply to the use or evaluation of hydroxychloroquine in pre or post-exposure prophylaxis in patients exposed to COVID-19’. As the data procured from the trial suggested that HCQ does not result in the reduction of mortality of hospitalised COVID-19 patents, WHO stopped the randomised tests of HCQ on patients.
The USA Food and Drug Administration (FDA) also withdrew the emergency use authorisation of HCQ after concluding that they may not be effective to cure the virus infections. FDA said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
Even with several European countries, including France, Italy and Belgium, paused the large trial of HCQ, the MHRA is set to resume the global trial of the drug. The WHO chief had also said that the drugs hydroxychloroquine and chloroquine were generally safe for treating patients of autoimmune diseases or malaria. However, a ‘final decision’ is yet to make whether the drug harms or benefits COVID-19 patients.