US doctors race against time to develop coronavirus cure
Many top researchers are skipping peer-review journals and clinical protocols to speed up COVID-19 drugs and therapies.
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The experimental COVID-19 treatment remdesivir is showing early promise in the battle against the coronavirus outbreak, according to a small research study.
The study, which was published in the New England Journal of Medicine, was supported by remdesivir developer Gilead Sciences.
“These are patients who received treatment through the compassionate use program for remdesivir, which is for critically ill patients who are unable to take part in a clinical trial,” said Gilead CEO Daniel O’Day in an open letter released Friday. “The results, which cover 53 of the first patients to have been treated in the program, show that the majority demonstrated clinical improvement after taking remedesivir.”
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However, O’Day acknowledged the small scale of the research, which was not the result of a clinical trial.
“We recognize the limitations of these compassionate use data from a purely investigational perspective, while knowing they are of the greatest significance for the patients whose symptoms improved,” he said, in the letter. “These early data from 53 patients have not been generated in a clinical trial and cover only a small portion of the critically ill patients who have been treated with remdesivir.”
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.
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Remdesivir is still awaiting regulatory approval as a coronavirus treatment.
“Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan,” explains an abstract of the study in the New England Journal of Medicine. “In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%).”
The research is based on data from patients who received remdesivir during the period from Jan. 25, 2020, through March 7, 2020, and have clinical data for at least one subsequent day, according to the abstract.
“At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation,” the abstract explains. “During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.”
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Remdesivir is one of a number of drugs in the spotlight as the U.S. scrambles to contain the pandemic. In a press conference last month, President Trump and FDA Commissioner Dr. Stephen Hahn described several approaches under testing, such as chloroquine, a drug long used to treat malaria, and remdesivir.
In his letter, 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.”
“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.”
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The U.S National Institute of Allergy and Infectious Disease and the World Health Organization are also running global trials.
“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.”
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.
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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 week, O’Day said that Gilead is ramping up remdesivir production, a process that requires specialized chemistry and multiple chain reactions.
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As of Saturday morning, at least 1.72 million coronavirus cases have been diagnosed worldwide, at least 501,680 of which are in the U.S. The disease has accounted for at least 104,800 deaths around the world, including more than 18,000 people in the U.S.
Follow James Rogers on Twitter @jamesjrogers
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