UK set to start world’s biggest drug trial for COVID-19


LONDON, APR 17 (DNA) – The world’s largest trial of drugs to treat COVID-19 is set to take place in the UK, for which over 5,000 patients in 165 NHS hospitals have been recruited at a record speed, The Guardian reported Friday.

Around 10% of COVID-19 patients in the UK are also participating in the trial.

“This is by far the largest trial in the world,” said Peter Horby, professor of infectious diseases and global health at the Oxford University, who is leading it. “We’re guessing sometime in June we may get the results.”

The professor has previously led Ebola drug trials in West Africa and the Democratic Republic of Congo.

Called the Recovery trial, it might be the first to provide conclusive data. Both hydroxychloroquine and azithromycin are being tested separately as part of the trial, and if there is any effect in patients given those drugs alone, compared with those given no drugs, they can be combined later.

For now, Horby said, the stories on social media about patients who have recovered after taking hydroxychloroquine prove nothing. He says there is no real scientific evidence to support it yet.

“There is in-vitro evidence that it is inhibitory against the virus [in the lab]. But I haven’t seen any sound clinical data,” Horby said.

“We’re seeing a large number of publications. It’s hard to keep up with them. Most of them are very disappointing. There was a paper that said it was a breakthrough – chloroquine works. But there was zero data in it.”

The hype causes problems for serious researchers, according to the professor. “There is pushback from clinicians saying we should just use this because it clearly works and shouldn’t use that because it clearly doesn’t work,” he said. “They are both wrong because neither of them know.”

Also in the trial now are a combination of two antiretroviral drugs used in HIV treatment, lopinavir-ritonavir and low-dose dexamethasone, a type of steroid used to reduce inflammation.

Horby says the next drug to be included is tocilizumab, an interleukin 6 antagonist, one of the immunomodulator drugs used in rheumatoid arthritis. It can treat cytokine storm—something that happens when the immune system goes into overdrive resulting in death, as in COVID-19.

Convalescent plasma therapy is also being considered. The researchers want to trial remdesivir, an antiviral, but have not been able to obtain the stocks they need as it is being tested in China and the US.

Repurposed drugs are the first priority because they already have a proven safety record. But as experimental drugs come along, Recovery will include those. Patients are randomly allocated one of the drugs (or a placebo). There are already 500 to 900 patients on each of the drugs being tested and 2,000 in the control groups.

Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Population Health, who leads the trial with Horby, says it’s extraordinary and may change the research landscape once the pandemic ends.

“One of the things it tells you is what can happen when everybody is incentivised to make stuff happen as opposed to dither, delay or feelings that they will get into trouble if they say no,” said Prof Landray, who has worked for 20 years on cardiovascular drug trials at Oxford.

The second extraordinary thing is that the clinical care of patients and the scientific rigour involved in trialling the drugs are hand in hand in a way that doesn’t normally happen, where the research might be going on in one corner of the hospital.

Professor Horby says it’s unlikely they will come up with a quick cure. “We haven’t got anything like a magic bullet,” he said. “I think we have to temper people’s expectations about these drugs.”

He is more optimistic about monoclonal antibodies, which worked in Ebola. “Very surprisingly, the monoclonal antibodies that were trialled in eastern DRC did work,” Horby said. “Those are the ones we will be waiting for with a bit of bated breath.”=DNA