Covid-19 patients who are getting an experimental drug called remdesivir have been recovering quickly, with most going home in days, STAT News reported Thursday after it obtained a video of a conversation about the trial, reports CNN.
The patients taking part in a clinical trial of the drug have all had severe respiratory symptoms and fever, but were able to leave the hospital after less than a week of treatment, STAT quoted the doctor leading the trial as saying.
"The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish," Dr. Kathleen Mullane, an infectious disease specialist at the University of Chicago who is leading the clinical trial, said in the video.
Mullane did not immediately respond to a request for comment from CNN.
The University of Chicago said Mullane's comments constituted partial information.
"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," it said in a statement.
"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."
There is no approved therapy for the Covid-19, which can cause severe pneumonia and acute respiratory distress syndrome in some patients. But the National Institutes of Health is organizing trials of several drugs and other treatments, among them remdesivir.
The drug, made by Gilead Sciences, was tested against Ebola with little success, but multiple studies in animals showed the drug could both prevent and treat coronaviruses related to Covid-19, including SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).
Back in February, the World Health Organization said remdesivir showed potential against Covid-19.
STAT said it obtained and viewed a copy of the video discussion Mullane had last week with colleagues about the trial.
"Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn't have to be 10 days," she was quoted as saying.
However, the trial does not include what's known as a control group, so it will be difficult to say whether the drug is truly helping patients recover better. With a control arm, some patients do not receive the drug being tested so that doctors can determine whether it's the drug that is really affecting their condition.
Trials of the drug are ongoing at dozens of other clinical centers, as well. Gilead is sponsoring tests of the drug in 2,400 patients with severe Covid-19 symptoms in 152 trial sites around the world. It's also testing the drug in 1,600 patients with moderate symptoms at 169 hospitals and clinics around the world.
Gilead said it expected results from the trial by the end of the month.
"We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir," the company said in a statement to CNN. But it said a few stories about patients are just that -- stories.
"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," Gilead said.
China has approved two COVID-19 inactivated vaccine candidates for clinical trials, according to the State Council joint prevention and control mechanism against the coronavirus Tuesday.
The two vaccine candidates are developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and Sinovac Research and Development Co., Ltd, a company based in Beijing. Clinical trials of the two vaccines have started.
More than half of a group of severely ill coronavirus patients improved after receiving an experimental antiviral drug, although there's no way to know the odds of that happening without the drug because there was no comparison group, doctors reported Friday.
The results published by the New England Journal of Medicine are the first in COVID-19 patients for remdesivir. The Gilead Sciences drug has shown promise against other coronaviruses in the past and in lab tests against the one causing the current pandemic, which now has claimed more than 100,000 lives.
No drugs are approved now for treating the disease. At least five large studies are testing remdesivir, and the company also has given it to more than 1,700 patients on a case-by-case emergency basis.
Friday's results are on 53 of those patients, ages 23 to 82, hospitalized in the United States, Europe, Canada and Japan. Thirty-four of them were sick enough to require breathing machines.
All were given the drug through an IV for 10 days or as long as they tolerated it.
After 18 days on average, 36 patients, or 68%, needed less oxygen or breathing machine support. Eight others worsened.
Seven patients died, nearly all of them over age 70. That 13% mortality rate is lower than seen in some other reports, but no true comparisons can be made without a study rigorously testing the drug in similar groups of patients, the authors noted.
A dozen patients had serious problems but it's not clear whether they were from the drug or their disease. Those included septic shock and trouble with kidneys and other organs. Four discontinued treatment because of health problems they developed.
"It looks encouraging," said Dr. Elizabeth Hohmann, an infectious disease specialist at Massachusetts General Hospital who is helping lead one of the studies testing the drug. The problems that occurred were not unexpected given the disease, she said.
Dr. Derek Angus, critical care chief at the University of Pittsburgh Medical Center who wasn't involved with the research, said the recovery rate is good but "there is no way of knowing from this series if remdesivir was helpful."
Results from more rigorous studies are expected by the end of this month.
Chinese researchers have identified a neuroimaging biomarker that can facilitate the early detection of Alzheimer's disease (AD).
AD is a chronic neurodegenerative disease characterized by progressive dementia. Neuroimaging techniques such as magnetic resonance imaging (MRI) can help diagnose AD. Accurate data-driven methods that can classify and characterize the neural features of AD would be powerful clinical tools.
Researchers from the Institute of Automation of the Chinese Academy of Sciences and other collaborators found that hippocampal radiomic features can be a promising personalized biomarker for AD.
In their search for suitable biomarkers, researchers proposed a novel hippocampal radiomic biomarker derived from structural MRI and systematically validated its reliability using neuroimaging data from over 1,900 individuals, including more than 700 located at six sites in China and around 1,200 subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI) dataset.
The study showed that hippocampal radiomic features are related to the clinical features and changes in cognition ability. Long-term follow-up data in some hospitals demonstrated that the markers could be used to track the progression of the disease in high-risk subjects.
The research was published in the journal Science Bulletin.
Liu Yong, one of the researchers, said the research represents a large, interdisciplinary and interinstitutional effort between clinicians and researchers to develop and validate an AD neuroimaging biomarker.
The methodology can be extended to the study of other mental diseases. It has important clinical implications as the biomarker is promising for the early clinical diagnosis or prognostic follow-up in AD, Liu said.
Liu's team has dedicated itself to neuroimaging studies of AD that could provide relevant information to clinical practice.
The team is now focusing on further verification work among people with high risks of AD in more clinical centers, Liu added.
Chinese researchers have determined the high-resolution crystal structure of the main protease (Mpro) from the COVID-19 virus and identified drugs that may have promise against COVID-19, according to the research published online in Nature on Thursday.
Rao Zihe and Yang Haitao at the Shanghai Institute for Advanced Immunochemical Studies of ShanghaiTech University, together with their collaborators, have been searching for drugs to combat the novel coronavirus, which has claimed over 85,000 lives and infected over 1.4 million people worldwide as of Thursday, according to data published by the World Health Organization.
The Mpro, which plays a pivotal role in mediating viral replication and transcription, is an attractive drug target for this virus.
The team identified a mechanism-based inhibitor, N3, by computer-aided drug design and subsequently determined the crystal structure of the COVID-19 virus Mpro in complex with this compound on Jan. 26, which is the first determined public-domain 3D structure from the COVID-19 virus.
After assaying over 10,000 compounds including approved drugs, drug candidates in clinical trials, and other pharmacologically active compounds as inhibitors of Mpro, several were found to inhibit Mpro, including Disulfiram, Carmofur, Ebselen, Shikonin, Tideglusib and PX-12. Ebselen and N3 both exhibited promising antiviral activity in cell-based assays.
In order to facilitate global researchers to develop antiviral drugs targeting N3 the first time, the joint team disclosed the list of candidate drugs and the structure of the COVID-19 virus Mpro to the public on Jan. 25 and Jan. 26 respectively in advance.
Rao and Yang have been engaged in the research against coronavirus for years since SARS (severe acute respiratory syndrome) broke out in 2003. They determined the crystal structure of the main protease from the SARS virus and discovered inhibitors for coronavirus.