It remains one of the most dramatically successful outcomes in the battle against COVID-19. A cheap treatment for inflammation was found to save lives of seriously ill patients, while a trio of much-touted therapies were shown to have no effect.
It is now estimated that the discovery of the effectiveness of the drug dexamethasone has saved about 650,000 lives worldwide, said Martin Landray, a founder of the Recovery program — the world’s largest randomized COVID-19 drugs trial — which revealed the medicine’s anti-COVID-19 properties last summer.
“In the UK alone, dexamethasone has already prevented more than 12,000 deaths,” he said.
The breakthrough demonstrates the power of large-scale randomized trials in pinpointing effective medicines and is to be followed in the next few weeks with results from another handful of promising treatments being studied as part of the program.
These medicines, which could be crucial in the fight to contain COVID-19 next year, are: convalescent plasma, taken from recovering COVID-19 patients; monoclonal antibodies made by Regeneron, which were used to treat US President Donald Trump; two anti-inflammatory drugs, tocilizumab and colchicine; and aspirin.
All are undergoing trials carried out by thousands of doctors and nurses on tens of thousands of patients in hospitals across the UK. The first results are expected next month or in early February.
Recovery was set up by Landray and Peter Horby at the start of the COVID-19 pandemic. The two Oxford scientists realized that doctors would soon be looking for treatments once cases started pouring into hospitals, but would need a clinical trial to find which were effective.
It took them nine days from drafting their first protocol to the enrolling of their first patient, a process that normally takes nine months. One in 10 patients hospitalized with COVID-19 have since entered the trial.
Such numbers have been crucial to success, Landray added.
Comparing 100 people who receive a drug with 100 who do not can produce highly variable results.
However, by randomizing thousands of patients to get contrasting treatments, robust answers are produced.
“You find out which actually work,” Landray said. “In addition, we can discover which patients will benefit most. Will it be the old or the young or the immuno-compromised? You can only find that out if you have a trial with thousands of people in it.”
So far, Recovery — short for Randomised Evaluation of COVID-19 Therapy — has pronounced on four medicines: azithromycin, an antibiotic; the drug combination lopinavir-ritonavir; hydroxychloroquine, a treatment for malaria and rheumatic diseases; and dexamethasone.
Only the last saved lives or aided recovery.
A hit rate of only one in four might seem poor value. However, the extraordinary numbers of lives saved thanks to dexamethasone demonstrates the value of the program, the world’s largest randomized COVID-19 drug trial.
It also ensured time and money have not been wasted on medicines that were found not to help patients.
That would become an increasingly important issue, Landray said.
“When we started Recovery we looked at cheap, widely available but promising drugs, and found one of them — dexamethasone — worked, but the medicines we’re looking at now will cost hundreds of pounds per treatment, so we need to be really sure they work before we deploy them on wide scale,” Landray said.
Having thousands of individuals with COVID-19 complications is a grim reality in the UK at present, but that high number at least makes it possible to run large-scale trials.
However there is a limit to what doctors and nurses can be expected to do, Lanray said.
“We designed this study to be as simple to implement as possible so as not to overwhelm busy frontline [British National Health Service] staff,” Lanray said. “The support from them and patients has been remarkable. Our results have improved COVID care for millions. The answers we get early next year, whatever they are, will do so again.”
Convalescent blood plasma is taken from those recovering from COVID-19 and has antibodies that might help others fight infections. It is widely used in the US, although scientists do not yet know if it works or who would benefit most from it.
The Recovery program should have answers in a few weeks.
Monoclonal antibodies are artificial antibodies made by US biotech company Regeneron and were used to treat Trump. It is not yet clear at which stage of illness they should be administered.
Although costly, tocilizumab is an anti-inflammatory arthritis drug thought to hold considerable promise, but its exact benefits are unknown.
Colchicine is another promising anti-inflammatory drug, often used to treat gout.
Aspirin is a blood-thinning agent that could help reduce blood clots in the lungs — a worrying complication in some COVID-19 cases.
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