Remdesivir anti-viral trial reports ‘rapid recoveries’ for severe hospitalised coronavirus patients

Coronavirus hopes were today raised after the anti-viral remdesivir was found to help critically-ill patients recover within a week. 

University of Chicago Medicine recruited 125 people with COVID-19 as part of global clinical trials. Of those people, 113 had severe disease. 

All the patients were treated with daily infusions of remdesivir, an experimental drug first touted to treat Ebola which has been in the making for ten years. 

Most of the patients have been discharged after their symptoms eased over a week, and only two patients have died.

The manufacturer – pharmaceutical giant Gilead Sciences – saw its shares surge by 16 per cent in after hours trading on Thursday as American stock markets rallied overnight in response to the encouraging trial results.

There are currently no approved treatments for COVID-19, the highly contagious respiratory illness caused by the novel coronavirus that has infected over two million people worldwide. 

Hopes have been pinned on remdesivir, but experts have urged cautious optimism over early findings. 

Remdesivir is only an experimental drug, and was initially hoped to help fight Ebola. But it faltered in comparison to others drugs.

It has been thrust into the limelight once more after the World Health Organization listed it as ‘the most promising candidate’ for a COVID-19 therapy in January. 

The medicine has been shown to stop other similar coronaviruses, including MERS, in tests on animals. 

And the first COVID-19 patient diagnosed in the US reportedly improved overnight after doctors gave the 35-year-old remdesivir as a last-ditch attempt to treat him. 

Scientists say remdesivir – which is also being trialled in scores of British hospitals – could have a ‘profound impact’ on the global pandemic.

The University of Chicago is one of 152 locations participating in Gilead’s phase three clinical trial involving severe COVID-19 patients, with other locations in the UK.

It’s a ‘single arm’ study meaning it does not measure the drug against a matched group of patients treated with a placebo. 

UChicago Medicine recruited 125 people with COVID-19 into Gilead’s two Phase 3 clinical trials, according to medical news website STAT. 

Of those people, 113 had severe disease. All the patients were been treated with daily infusions of remdesivir.

The antiviral medication led to ‘rapid recoveries in fever and respiratory symptoms’, with ‘nearly all patients discharged in less than a week’.

Most of them have now been discharged, despite the large majority being severly sick to start with, and two patients died.

The results were revealed by Kathleen Mullane, the infectious disease specialist overseeing the remdesivir studies for the hospital, in a video conference, of which STAT obtained a copy. 

The ‘anecdotal data … looks promising on the surface and continues to support some potential for the drug to be active in certain COVID-19 patients,’ RBC Capital Markets analyst Brian Abrahams said in a research note. 

‘Nonetheless, there are major limitations to contextualizing and interpreting this data.’

Interest in Gilead’s drug amid the ongoing coronavirus pandemic has been high.

The New England Journal of Medicine last week published an analysis showing that two-thirds of a small group of severely ill COVID-19 patients saw their condition improve after treatment with remdesivir.

The paper’s author called the findings ‘hopeful,’ but cautioned it is difficult to interpret the results since they do not include comparison to a control group.

The patient numbers were small, the details being disclosed were limited, and the follow-up time was relatively short. 

Gilead, in an emailed statement, said ‘the totality of the data need to be analyzed in order to draw any conclusions from the trial’.

UChicago Medicine, also in an email, said ‘partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions’.

The university said information from an internal forum for research colleagues concerning work in progress was released without authorization.

Gilead expects results from its Phase 3 study in patients with severe COVID-19 at the end of this month, and additional data from other studies to become available in May.

The company’s severe COVID-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. 

British patients will also be enrolled, with 15 NHS trusts in London, Liverpool, Sheffield, Glasgow and Plymouth signed up.

Another Gilead trial of patients with moderate COVID-19 symptoms has 169 study locations.  

Hilary Hutton-Squire, vice president and general manager at Gilead Sciences UK and Ireland, said Gilead started research into remdesivir more than a decade ago. 

In animal tests, remdesivir has shown to be ‘quite effective at preventing infection’ and reducing severity of illness and damage to the lungs caused by COVID-19. 

That’s according to Dr Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston, where research on remdesivir is taking place.

Dr Kuritzkes said: ‘It interferes with the enzyme that reproduces the genetic material of the virus.’

Previously researchers at the University of North Carolina, Chapel Hill, showed in test tube and animal studies that the drug can inhibit the coronaviruses that cause SARS and MERS.

And it’s been granted a spot in the World Health Organization’s large global trial, called SOLIDARITY, of four drugs. 

The US National Institute of Allergy and Infectious Disease in February began an 800-patient trial that randomly assigns patients to treatment with either remdesivir or a placebo. Those results are not expected until after Gilead’s trial reads out. 

Remdesivir has been provided to several hundred severely ill COVID-19 patients in the US, Europe and Japan under ‘compassionate use’ provisions. 

For example, a young man in Snohomish county in Washington, the first COVID-19 patient in the US, was given remdesivir when his condition worsened.

He improved the next day, according to a case report in The New England Journal of Medicine (NEJM). As of January 30, he had a mild cough. 

But the ‘compassionate use’ program is reportedly being halted due to an unmanageable number of requests, it was revealed on March 22. 

Shares of Gilead, which closed at $76.54 in regular trading, were up 16 per cent at $89.10 after hours.

Blue-chip futures indexes saw big upward spikes following a flurry of positive signals, setting the stage for a decent day of trading today.

The Dow Jones was up 2.96 per cent, the S&P was up 2.76 per cent and Nasdaq was up 1.97 per cent as of 4.30am ET. 

And Boeing, which floats shares on the Dow, helped drag up the index after it rose 8 per cent overnight after announcing intentions to resume airplane production at its Washington State plant.

But the rises made by the airline were on half that of Gilead, which benefited from a media publications dispatch from the trial laboratory.

FTSE 100 has also kicked in again, up 193 points, and the Europe-wide Stoxx 600 index gained 2.9 per cent.

London’s index of heavyweight shares was up 3.4 per cent at 5,822, just a dozen or so points below its high point of the day.  

Investor confidence was also buoyed by Donald Trump unveiling the White House’s guidance to state governors for easing restrictions and restarting the economy.

At the daily evening press briefing, the President outlined his plan ‘to preserve the health of our citizens we must also preserve the health and functioning of our economy’.

Although conceding control of when the lockdown is lifted to individual state governors, he unveiled a three-phase guideline.  

In phase one, schools and organized youth activities are to remain closed, but large venues, including sit-down dining, movie theaters, places of worship and sporting venues can reopen under social distancing protocols. 

Businesses are also encouraged to allow workers to work from home where possible. 

In phase two, telework is encouraged, but where workers return to the office, it’s suggested common areas are closed. 

In this phase, non-essential travel can also resume, bars can reopen and gyms will be allowed to operate.

In phase three, schools and youth activities can reopen, visits to senior care facilities and hospitals can resume. Worksites can also resume unrestricted staffing of worksites.