By James Rogers | Fox News
The experimental COVID-19 treatment remdesivir is showing promise in a Chicago clinical trial, according to the health news site STAT.
STAT reported that patients in the trial experienced rapid recoveries from fever and respiratory symptoms. Nearly all patients were discharged in less than a week, it said.
The news sent shares of remdesivir developer Gilead Sciences surging more than 14 percent in after-hours trading.
EXPERIMENTAL CORONAVIRUS DRUG REMDESIVIR IS SHOWING EARLY PROMISE, RESEARCH SAYS
Some 125 people with COVID-19 — 113 with severe symptoms — were recruited by the University of Chicago Medicine into the two Gilead Phase 3 clinical trials, according to STAT. The news site obtained a recorded video discussion of the trial results.
In the video, Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies, said that most of the patients had already been discharged and only two had perished, according to STAT.
“Partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation,” said a spokeswoman for University of Chicago Medicine, in a statement emailed to Fox News.”In this case, information from an internal forum for research colleagues concerning work in progress was released without authorization. Drawing any conclusions at this point is premature and scientifically unsound.”
A Gilead spokeswoman told Fox News that the totality of data need to be analyzed in order to draw any conclusions from the trial. “Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19,” she said, in an emailed statement. “We expect the data from our Phase 3 study in patients with severe COVID-19 infection to be available at the end of this month, and additional data from other studies to become available in May.”
“We are grateful for all of the efforts of investigators and patients participating in our studies and look forward to sharing the results from the complete dataset,” the spokeswoman added.
We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir. The totality of the data need to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19. We expect the data from our Phase 3 study in patients with severe COVID-19 infection to be available at the end of this month, and additional data from other studies to become available in May. We are grateful for all of the efforts of investigators and patients participating in our studies and look forward to sharing the results from the complete dataset.
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The report comes less than a week after a small research study revealed that remdesivir is showing early promise in the battle against the coronavirus outbreak.
The study, which was published in the New England Journal of Medicine, was supported by Gilead Sciences.
Remdesivir is still awaiting regulatory approval as a coronavirus treatment.
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The antiviral was previously used to treat Ebola patients and has been garnering massive attention as the world scrambles to contain the coronavirus pandemic. Experts, however, have warned that people should not take drugs unless prescribed by a doctor.
Remdesivir is one of a number of drugs in the spotlight as the U.S. tries to contain the pandemic. In a press conference last month, President Trump and Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn described several approaches under testing, such as chloroquine, a drug long used to treat malaria, and remdesivir.
In an open letter published last week, Gilead CEO Daniel O’Day explained that seven clinical trials have been set up to determine whether remdesivir is a safe and effective treatment for COVID-19. “China initiated the first two studies in early February for patients with severe and moderate symptoms of the disease,” he wrote. “Since then, an additional five trials have been initiated around the world.”
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“Two Phase 3 studies are being run by Gilead in areas with a high prevalence of COVID-19 in the United States, Asia and Europe,” O’Day added. “One of these is for patients with severe disease and the other studies remdesivir in patients with more moderate symptoms.”
The U.S National Institute of Allergy and Infectious Disease (NIAID) and the World Health Organization (WHO) are also running global trials, respectively.
“We expect that we will have preliminary data from the study of remdesivir in severe patients at the end of April and will work quickly to interpret and share the findings,” O’Day said in the letter. “The publication of data from the China remdesivir trials rests with the Chinese investigators, but we have been informed that the study in patients with severe symptoms was stopped due to stalled enrollment. We look forward to reviewing the published data when available.”
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In May, Gilead expects to get initial data from the NIAID trial, which is placebo-controlled, as well as its own study of patients with moderate symptoms of COVID-19.
Last month, Gilead announced changes to its treatment program. The company implemented the “expanded access” program in an effort to enable hospitals and physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time. The prior “compassionate use” program is now designated for children and pregnant women.
In another open letter sent out last month, O’Day said that Gilead is ramping up remdesivir production, a process that requires specialized chemistry and multiple chain reactions.
