St. Joe’s patient enters clinical trial
Hospital's CEO calls drug 'most hopeful' for coronavirus treatment
The first Humboldt County patient is involved in clinical trials for remdesivir, an antiviral drug being tested at St. Joseph Hospital in Eureka, the hospital’s top administrator confirmed Tuesday.
“There is a patient enrolled at St. Joseph … they fell into the severe COVID category with dropping oxygen and thus were a candidate for the trial,” said Dr. Roberta Luskin-Hawk, chief executive of St. Joseph Health, Humboldt County.
Luskin-Hawk, who has a background in infectious disease and clinical research, said she was anxious to have clinical trials done locally.
“In my mind, this is the most potent, most hopeful drug we have right now,” she said. “That’s why I was anxious to get access. It reduces the viral load in patients. It really has antiviral activity against this particular virus. … Now we have to prove change in viral load means that outcomes will be better.”
There are two clinical trials being done at the hospital — one to treat severe symptoms and another to treat more moderate symptoms.
According to the Humboldt County Department of Health and Human Services, there are 50 cases of COVID-19 in Humboldt County; of those, three people are hospitalized.
Luskin-Hawk said the hospital screens prospective patients for the trial, noting there are three things that will preclude someone from participating.
“People can’t be offered the trial if they are pregnant, because of concerns about safety and pregnancy, they can’t be offered the trial if they have multiple organs failing and they can’t be offered the trial if the disease is so mild they are ready to go home,” she said.
The drug, remdesivir, which is manufactured by California-based Gilead Sciences, has shown positive results in previous trials. The trials being conducted in Eureka are phase 3, the final step before a medication can “can go to be a fully licensed drug if it looks to be safe and effective,” Luskin-Hawk said.
Coronavirus patients around the world have been rushing to join remdesivir studies that opened in hospitals in the last few weeks, the Associated Press reported this week. Luskin-Hawk said bringing the trials to Humboldt County provides access to the much-sought-after treatment.
“The only standard of care right now is just supportive: Give them oxygen, give them a ventilator, there is no specific treatment either antiviral or other that is known to make a difference,” Luskin-Hawk said. “Because this drug is not FDA-approved yet, it is difficult to get access to.”
She said that it worked well on the first patient who had a confirmed case of coronavirus in the United States, a patient who was treated in a Providence hospital north of Seattle. Providence-St. Joseph Health owns St. Joseph Hospital in Eureka and Redwood Memorial Hospital in Fortuna.
“(The trials) at least guarantees the drug for patients in Humboldt who meet the criteria who have severe COVID,” LuskinHawk said. “To me, that a huge thing. For those patients on ventilators with severe COVID who otherwise meet the safety criteria, they will either get a five-day course or a 10-day course. That’s a huge deal.”
Gilead announced last week it ramped up production of the drug.
The company did not immediately respond to a request for comment on the Eureka trials.
A statement by the company’s CEO Daniel O’Day said the company is seeking to provide as broad of access as possible to the drug.
“We know from the heartbreaking letters we receive, the images we see in the news and the alltoo-bleak statistics that the urgency to find broad, effective solutions becomes more intense each day,” he wrote. “In the ways we believe it is appropriate for Gilead to play a role today — primarily through clinical trials, as well as expanded access and compassionate use — we are doing everything it takes to meet our significant responsibility with remdesivir.”
The company’s rampedup efforts expect to be able to provide treatment to 140,000 patients.
“Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses,” O’Day said.
There are currently around 390,000 cases of COVID-19 in the United States and more than 12,000 deaths, according to data tracked by Johns Hopkins University.
Remdesivir is given through an IV. It’s designed to interfere with an enzyme that reproduces viral genetic material.
In animal tests against SARS and 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.
Contact reporter Ruth Schneider at 707-441-0520.