“A promising investigational drug.”
Those words are being written quite a bit during these days as politicians, scientists, and the general public explore avenues for combating the COVID-19 pandemic.
Those same words were used in a press release from Saint Joseph Hospital in Humbolt County in announcing their participation in a new clinical trial of a drug developed by California-based Gilead Sciences.
Clinical Trials of Anti-Viral Drug Remdesivir
St Joseph Hospital in Eureka said in a news release that it is participating in two national clinical trials of the anti-viral drug remdesivir for the treatment of moderate and severe COVID-19. The experimental drug has shown promise in some recent emergency uses and patient trials.
“This is an important opportunity for future patients who present with COVID–19 at St. Joseph Hospital and meet certain criteria, to have access to remdesivir, a promising investigational drug,” said Dr. Roberta Luskin-Hawk, St. Joseph’s chief executive.
The hospital was chosen due to an established relationship with the principal investigator of the trial and was proactive in seeking accelerated approval for the trials in Humboldt.
Interest has been so great in remdesivir that the U.S. National Institutes of Health is expanding its study, which has nearly reached its initial goal of 440 patients. The NIH study is the most rigorous test. It compares remdesivir to placebo infusions, with neither patients nor doctors aware of who is getting which treatment until the end of the study.
How Remdesivir Works
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 current studies could lead to regulatory approval.
Online medical news site Stat News describes remdesivir this way: “The drug is designed to interfere with the process the virus, called SARS-CoV-2, uses to make copies of itself. The resulting copies of the virus lack their full RNA genome, so they can’t go on to replicate themselves or infect other cells.”
‘Compassionate Use’ Allowed Under Emergency Regulations
In addition to patient trials, the U.S. Food and Drug Administration has authorized the use of remdesivir for treatment in a limited number of “compassionate use” cases.
“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,” Gilead chief executive Dan O’Day wrote in a open letter on the company’s website.
O’Day said the company has an inventory of 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 U.S., Asia, Europe and elsewhere.
A Remdesivir Recap With Mention of a ‘Red Flag’
“Stat News” recently reported on the trials and what might come next.
“Sometime this month, Chinese scientists will share results from two trials in that country, one looking at patients with severe Covid-19, and one with patients with mild and moderate infections,” the website reported.
“There is already one red flag. The investigators running the severe COVID-19 study in China have already taken an interim look at the data, but they did not stop the study early,” Stat News noted. “This suggests remdesivir isn’t working as well as hoped, and dampens optimism for an overall positive outcome.
“It’s also possible the trial will produce mixed results.”