Coronavirus patients from around the world are pleading to join studies of an experimental US antiviral drug that could help fight off the potentially deadly disease.
Interest has been so great that the US National Institutes of Health (NIH) is expanding its study of remdesvir, which has nearly reached its initial goal of 440 patients.
The drug’s maker, California-based Gilead Sciences, says it is quickly ramping up its own studies as well.
Originally developed as a treatment for Ebola, the medication has been shown to fight against coronaviruses such as severe acute respiratory syndrome (SARS), which is a cousin of the new virus.
More recently, it was found to help relieve symptoms in the first American coronavirus patient while he was hospitalized.
It comes on the heels of news that Gilead said it plans to distribute 1.5 million doses, for free which could mean hundreds of thousands of treatment courses.
Hundreds of coronavirus patients are hoping to join clinical trials of remdesivir, developed by California-based Gilead Sciences. Pictured: A vial of remdesivir is visually inspected at a Gilead manufacturing site in the US, March 2020
Remdesivir was originally conceived as a drug to fight Ebola and works by blocking a protein that helps coronaviruses make copies of themselves. Pictured: EMTs bring a patient into Wyckoff Hospital in Brooklyn, New York, April 6
Gilead has given remdesivir to more than 1,700 patients on a case-by-case emergency basis. Pictured: EMTs bring a patient into Wyckoff Hospital in Brooklyn, New York, April 6
Dr Jag Singh, a heart specialist at Massachusetts General, became a patient at his own hospital because of the virus.
His alarm grew as he saw an X-ray of his pneumonia-choked lungs and colleagues asked his wishes about life support while wheeling him into the intensive care unit
Then was offered a chance to help test remdesivir and ‘it did not even cross my mind once to say: “No”,’ said Singh.
Dr Libby Hohmann placed Singh and nearly 30 others in the NIH study at Mass General and said it was a no-brainer.
‘I would enroll my family in a heartbeat,’ she said, adding that having no approved medicines for COVID-19 now is ‘kind of terrifying.’
For most people, the new coronavirus causes mild or moderate symptoms, which can include fever and cough but sometimes pneumonia requiring hospitalization. The risk of death is greater for older adults and people with other health problems.
Remdesivir, which is given through an IV, is designed to interfere with an enzyme that reproduces viral genetic material.
In animal tests against SARS and Middle East Respiratory Syndrome (MERS), diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness.
It’s farther along in testing than many other potential therapies and the current studies could lead to regulatory approval.
Gilead has given remdesivir to more than 1,700 patients on a case-by-case emergency basis, but more people ultimately will be helped if the company does the needed studies to prove safety and effectiveness, chief executive Dan O’Day wrote in a recent letter to the public.
‘Many people have reached out to Gilead to advocate for access to remdesivir on behalf of friends and loved ones. I can only imagine how it must feel to be in that situation,’ he wrote. ‘We are taking the ethical, responsible approach.’
Gilead said it has 1.5 million doses, which could mean more than 140,000 treatment courses, that it plans to distribute for free. Pictured: EMTs bring a patient into Wyckoff Hospital in Brooklyn, New York, April 6
The company hopes to make more than a million treatment courses available by the end of the year. Pictured: Medical workers move the body of a deceased patient from a refrigerated overflow morgue outside the Wyckoff Heights Medical Center in Brooklyn, New York, April 4
In another letter on Saturday, O’Day said the company has 1.5 million doses, which could mean more than 140,000 treatment courses, depending on how long treatment needs to last.
The company is providing the drug for free for now and has set a goal of making 500,000 treatment courses by October and more than a million by the end of the year.
Gilead supplied remdesivir for two studies in China expected to give results by the end of the month.
It also launched two studies for hospitalized patients in the US, Asia, Europe and elsewhere.
One in severely ill patients tests five versus 10 days of treatment. Another in moderately sick patients compares those two options to standard care alone.
‘There’s so much anxiety about the disease that the patients are quite interested’ and no one offered the chance has refused, said Dr Arun Sanyal, the study leader at Virginia Commonwealth University in Richmond.
The first patient he enrolled was a previously healthy middle-aged man who had an out-of-state visitor a few days before his symptoms began. What started as mild illness escalated to profound shortness of breath requiring supplemental oxygen.
At University Hospitals Cleveland Medical Center, Dr Grace McComsey has enrolled roughly half a dozen patients.
‘We’re seeing more and more younger people, like 30, really sick,’ she said.
The NIH study is the most rigorous test. It compares remdesivir to placebo infusions, and neither patients nor doctors know who is getting what until the end of the study. Besides the US, it’s open in Japan, Korea and Singapore.
In Chicago, an 89-year-old man was Northwestern Memorial Hospital’s first participant and ‘the family was very excited’ to have him included, said infectious diseases chief Dr Babafemi Taiwo.
At the University of California, Irvine, Dr Alpesh Amin has enrolled several patients. All are getting standard care even if they wind up getting a placebo rather than remdesivir, Amin said.
The Boston cardiologist, Singh, said he was willing to take that chance to advance science even if he personally winds up not benefiting. He’s now recovering at home after spending a week in the hospital.
‘The word “placebo” freaks some people out,’ Hohmann said. However, rigorous testing is needed to avoid giving false hope or using something unsafe.
Still, she says it’s tough to face patients with no proven therapy.
‘The worst thing is seeing some really young people who are really, really sick,’ such as a 49-year-old man with three young children on life support, Hohmann said.
‘That’s pretty awful.’
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