Oxford Covid-19 trial of Trump-backed hydroxychloroquine is CONTINUING - despite WHO chiefs suspending a global study on the anti-malaria drug after results showed it may raise the risk of death

  • Recovery trial of 10,000 NHS Covid patients will go ahead despite safety worries
  • But separate Oxford-Brighton COPCOV trial has been temporarily suspended
  • UK's drugs watchdog urged the research to be pulled to protect Brit volunteers 
  • Comes on back of Lancet paper which linked pills with higher mortality rates
  • WHO suspended its global study, the Solidarity Trial, on Monday amid concerns
A major British coronavirus trial of the anti-malaria drug hydroxychloroquine is going ahead despite fears it might raise the risk of death, it emerged today.
Oxford University researchers were given the green light by the UK drugs watchdog to continue giving the tablets to NHS patients with COVID-19.
Concerns about the Donald Trump-backed medicine were raised in a scientific paper published in The Lancet last Friday. 
It linked the anti-malaria medicine with higher mortality and heart arrhythmias in severely ill coronavirus patients.
The finding prompted the World Health Organization (WHO) to pull the plug on its own global study of hydroxychloroquine, known as the Solidarity Trial, on Monday. 
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) 'did not see any safety concerns' with the Recovery Trial, which is investigating the effect of five promising treatments on Covid patients with moderate to severe illness, including hydroxychloroquine.
More than 10,500 Covid NHS patients are taking part in the Randomised Evaluation of COV-id19 thERapY (RECOVERY) trial at hundreds of hospitals around the UK. 
Last Friday, The Lancet study looked at more than 96,000 people hospitalised with COVID-19 and found patients treated with hydroxychloroquine had a higher risk of death and heart rhythm problems than those who were not given the medicines.
However, the antimalarial was only given to patients who had fallen severely unwell with Covid and were already at a high risk of falling victim to the illness.
The Recovery Trial has been deemed safe because the drug is being randomly allocated to patients with varying degrees of illness and compared against a control group. 
On Monday, the World Health Organization (WHO) announced it was suspending the hydroxychloroquine arm of its trial over safety concerns (file image)
On Monday, the World Health Organization (WHO) announced it was suspending the hydroxychloroquine arm of its trial over safety concerns (file image)
On Sunday, President Donald Trump said he had finished taking his two-week prescription of the anti-malaria medication, which he'd used as a prophylactic to stave off the virus
On Sunday, President Donald Trump said he had finished taking his two-week prescription of the anti-malaria medication, which he'd used as a prophylactic to stave off the virus
WHO Director General Dr Tedros Adhanom Ghebreyesus (pictured) said the decision came after a study on Friday revealed higher mortality rates among COVID-19 patients who took the drug
WHO Director General Dr Tedros Adhanom Ghebreyesus (pictured) said the decision came after a study on Friday revealed higher mortality rates among COVID-19 patients who took the drug
One of Recovery's chief investigators, Peter Horby, professor of emerging infectious diseases and global health at Oxford, said: 'Since Recovery (trial) patients are randomised, our data are much less vulnerable to the biases that plague studies that use routine health care data.
'An independent committee has looked at our data and did not see any safety concerns.
'We discussed our findings with (the) Medicines and Healthcare products Regulatory Authority (MHRA), who have agreed with our interpretation that the data provide reassurance that continued enrolment into the hydroxychloroquine arm is safe and that we should press ahead with getting a reliable answer on hydroxychloroquine through the Recovery trial.'
However, the MHRA has temporarily suspended recruitment for the COPCOV trial, a separate Oxford study being carried out alongside Brighton University. 
COPCOV is an international study investigating whether the malaria tablets can prevent coronavirus infection in the first place.
Hydroxychloroquine will be given to more than 40,000 frontline healthcare workers from Europe, Africa, Asia and South America.  
The Oxford researchers believe their research is safe because it does not involve patients already ill with coronavirus. They remain confident their study will go ahead.
But the University said it had temporarily paused enrollment around the globe and would wait on the MHRA's decision. 
Commenting on the announcement, Professor Trudie Lang, director of The Global Health Network, Nuffield Department of Medicine, University of Oxford, said: 'The WHO temporarily halting the use of chloroquine in Covid-19 clinical trials highlights why we need to run carefully-designed clinical trials during outbreaks.
'This enables us to learn as quickly as possible about whether potential therapies can tackle the virus and are safe.
'Properly designed and managed clinical trials are the only way we can see whether drugs might also cause harm. They are designed to assess the safety of the drug relative to the ability to bring any benefit.
'We have long known that chloroquine can cause harmful cardiac-related side effects from the use of chloroquine in the treatment of malaria.
'Recent trials carried out in China of a lower chloroquine dose didn't show efficacy in relation to Covid-19. A higher chloroquine dose could bring increased risk of harmful side effects.'
She added that using chloroquine 'off licence' or outside a trial does not help answer questions about its safety and can also present a risk to the patient.  
Dr Stephen Griffin, associate professor in the School of Medicine, University of Leeds, said: 'The WHO has taken the wise precaution of halting arms of their wide-ranging therapeutics trial relating to chloroquine (CQ) and hydroxychloroquine (HCQ).
'This is largely based upon a study published last week that retrospectively analysed thousands of patients receiving these drugs as part of their Covid-19 treatment, either alone or in combination with antibiotics.
'The study could find no evidence for a beneficial effect in patients taking these drugs.
'However, worryingly, patients appeared to be at heightened risk of cardiac complications, especially when taking CQ or HCQ alongside macrolide antibiotics.' 
 President Trump was among the first to wax lyrical about the possible benefits of hydroxychloroquine for coronavirus patients in March.
Then last week he revealed he'd been taking the malaria drug for a week-and-a-half to stave off the virus.  
In an interview with Full Measure with Sharyl Attkisson that aired on Sunday, Trump announced he'd finished taking his prescription. 
'Finished, just finished,' the commander-in-chief said. 'And by the way, I'm still here. To the best of my knowledge, here I am.'
Trump suggested he began taking the drug after two White House workers tested positive for the virus.
'I believe in it enough that I took a program because I had two people in the White House that tested positive,' he said. 'I figured maybe it's a good thing to take a program.'  

Hydroxychloroquine: What you should know about the drug 

Hydroxychloroquine was approved in the 1940s as a way to treat malaria. It is also prescribed for patients with arthritis and lupus. 
Trump has hailed the 'game-changing' drug and said: 'This would be a gift from heaven, this would be a gift from God if it works.'  
Physicians, however, have urged that the medication shouldn't be used without more testing. 
The US Food and Drug Administration (FDA) has also warned doctors against prescribing the drug to treat coronavirus outside of hospitals following reports of serious side effects, including irregular heart rhythms and death among patients.  
Preliminary results from a recent study done on coronavirus patients at US veterans hospitals showed no benefit, casting more doubt on the drug's efficacy during the pandemic.
The Centers for Disease Control and Prevention (CDC) has removed guidance from its website informing doctors on how to prescribe hydroxychloroquine. 
Initially, the CDC webpage had read: 'Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some US clinicians have reported anecdotally.'
It now says: 'There are no drugs or other therapeutics approved by the US FDA to prevent or treat COVID-19.

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