On May 1, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the antiviral drug remdesivir, which is still under study, to treat patients with suspected or confirmed new coronary pneumonia, including adults and children.
The FDA said that while little information is known about the safety and efficacy of using Redciewe to treat new coronary pneumonia, the drug has been shown in a clinical trial to shorten the recovery time of some patients.
Redciewe was once considered the most promising drug to fight the new coronavirus, developed by California-based Gilead Sciences. Redciewe has shown some hope in the treatment of SARS and Middle East Respiratory Syndrome (MERS), both of which are caused by coronaviruses.
On April 29th the U.S. and Chinese research teams simultaneously published the results of three clinical trials of Ridseywe, which were different and sparked heated debate. Chinese researchers believe that Redsiewe therapy and standard therapy have no statistically significant clinical benefits, while The U.S. researchers believe that Redciewe has a significant positive effect in shortening the recovery time.
In response, Professor John Norrie, professor of medical statistics and experimental methods at the University of Edinburgh’s School of Medicine and Veterinary Medicine, told Newsbeat (www.thepaper.cn) that the conclusions of the Sino-American team’s trial were not contradictory.
“Although their results differ in performance, one is inconclusive and the other is showing potential benefits, so this is not contradictory.” “
Three clinical trials in Redseyway
Although the U.S. has accelerated the approval and use of Redsey, the results of recent clinical trials of Redciewe are not yet clear that it is a “magic drug” for the treatment of new coronary pneumonia.
On April 29, the website of The Lancet, an internationally renowned medical journal, published the results of a clinical trial of the new coronary pneumonia antiviral drug Redciwe, conducted by a Chinese team. The results showed that no statistically significant clinical benefits were observed in the combination of Redcywe and standard therapies.
The Chinese team’s study was the first randomized, double-blind, placebo-controlled clinical trial to assess the effectiveness of intravenous radsivir in adult hospital for coavid-19. The trial was conducted at 10 hospitals in Wuhan, Hubei Province. However, the study was terminated without reaching a predetermined sample size.
Professor Cao Bin, of Sino-Japanese Friendship Hospital and Capital Medical University, who led the study, said: “This trial found that although Ridsiewe was safe and tolerant, there were no significant benefits compared to placebos. “
Professor John Norrie, who was not involved in the study, commented in a review published in The Lancet: “This study was well designed to be a double-blind, placebo-controlled, multicenter randomized trial, and was well-performed, had high programcompliance, and rarely missed visits. “
On the same day, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced that positive data had been produced in a study of Redciewe’s treatment of the new coronavirus pneumonia, which had reached its main destination.
On April 29, The Director of the National Institute of Allergy and Infectious Diseases (NIAID) said That Redsiewe had shown efficacy in a randomized double-blind control trial of NIAID that could moderate the speed of recovery for people infected with the new coronavirus.
The trial recruited 1,063 patients with new coronary pneumonia from several countries around the world. Preliminary results showed that the median recovery time in the Redsiewe treatment group was 11 days, compared with 15 days in the placebo-controlled group, and the rhaidsiwet group recovered 31% faster than the placebo-controlled group. At the same time, the mortality rate in the Redcywe treatment group was 8.0%, which was not statistically significant compared to the 11.6% mortality rate in the placebo-controlled group (p s 0.059).
“Speeding up recovery time by 30 percent doesn’t sound as attractive as a 100 percent cure. “But this is very important evidence because it has been shown that Redciewe can block the new coronavirus. “
The U.S. National Institute of Allergy and Infectious Diseases is one of 27 research institutes and centers under the National Institutes of Health (NIH), which is part of the U.S. Department of Health and Human Services.
On the same day, Gilead also announced the results of a Phase III clinical trial of Open Label, which showed similar clinical improvements in patients receiving a five-day treatment of Redsiewe compared to those who received a 10-day redsiewe treatment.
“These data are encouraging because they show similar clinical improvements in patients receiving a shorter five-day treatment regimen and patients receiving a 10-day course of treatment,” said Aruna Subramanian, M.D., chief clinical professor of immunofunctional host infectious diseases at Stanford University School of Medicine and one of the lead researchers in the trial. These results help to provide a clearer understanding of how to optimize their treatment. “
The good news is that the key to getting the FDA to grant Redsey’s emergency use authorization is key. At present, the United States has confirmed more than a million cases of new coronary pneumonia, the need for therapeutic drugs is clearly the most urgent.
British expert: The conclusion of the Sino-US experiment is not contradictory, more research is needed
Why do the results of clinical trials by the U.S. and Chinese research teams point to different conclusions? How should the above-mentioned differences in test results be viewed at a time when Redsey wee has been granted an emergency use mandate?
John Norrie, professor of medical statistics and experimental methods at the University of Edinburgh’s School of Medicine and Veterinary Medicine, told reporters that he did not believe the Chinese and Us testconclusions were contradictory because the Chinese study was non-conclusive, did not conclude that Ridsywe was beneficial, nor could it be said that Redsey was unhelpful. Clinical trials in China were terminated early, with 237 patients in the U.S. with larger studies and statistically significant and clinical value in the main results of the patient’s recovery time.
“So while their results are different in terms of performance, one is inconclusive and the other is showing potential benefits, so it’s not contradictory.” “
Professor John Norrie’s comments also note that clinical trials in China are well designed, but that the trialended early, resulting in “ineffective” research and no statistically significant data, so it is impossible to draw firm conclusions. John Norrie told reporters that the lack of sample size meant the study’s results were “under-supported”.
Gilead also made the “non-conclusive” claim before the results of the Chinese team’s clinical trials were officially published.
On April 24th the Financial Times reported that gilead’s development of the potentially effective anti-crown drug, Redsiewe, had failed in its first randomized clinical trial to treat the new coronavirus, disappointing scientists and investors who had given it high hopes, according to a draft document unexpectedly released by the World Health Organization.
At the time, Gilead responded that the article contained an inappropriate description of the study, which was terminated early because of the low number of admissions, and that its data were not sufficient to support a statistically significant conclusion. On its own, the findings are non-conclusive. Although the trends in the data suggest the potential benefits of Redcievir, especially in patients undergoing early treatment.
Dr Jennifer Ron, a cytobiologist at University College London’s Department of Medicine, said in an April 30 commentary on the results of the Redsey weiser trial, published in the Guardian, that while science was preferred to be “black and white”, clinical trials were rarely deterministic and that new treatments might fail in a key trial, but were eventually on the market because different test parameters were different: the number of patients involved might be different and different doses might be taken. and set different endpoints and metrics for success. In addition, the extent of the patient’s condition at the time of treatment is also an important factor, which is particularly critical for antiviral drugs that typically show greater effectiveness in the early stages of the disease.
However, in response to questions about the differences in the conclusions of clinical trials in China and china, Professor Cao Bin, head of clinical trials in Redsey, china, points out that the evaluation criteria are different. “These are two different studies, and the evaluation criteria are different, ” he said in response to the reporter. “The U.S. NIH started out with the same standards as we did, and it was later changed. Cao Bin said.
As for the impact of lower numbers on the trial, Professor Cao Bin said in an interview with Caixin that if the drug is effective, the effect should not be difficult to show. “237 patients should not be as few, if Redciewe is really a god drug, the control group is a placebo, if the difference between the two, no matter how compared, can be seen.” “
As for the positive findings of the NIAID trial, John Norrie told reporters that we need to pay more attention to the agency’s publishing of peer-reviewed test results data in professional journals such as the New England Journal of Medicine, such as the Lancet, including complete and finally validated data sets for efficacy, safety, viral load, death, subgroup analysis, and more. This would be good news if the final data confirmed the valid conclusions of Theridsiwe.
According to the New York Times, some scientists are also uneasy about the way the findings are disclosed, which are not published without peer review or publication. Dr. Steve Vinson, a cardiologist at the Craven Clinic who has conducted dozens of clinical trials, asks, “Where’s the data?” He said scientists needed to look at data on the side effects of the drug to further assess its benefits, “which is too important to be handled in such a hasty manner.” “
Some scientists are confident about Fauci’s assessment, said Michele Barry, a global health expert at Stanford University, “It is very rare to refer to a drug as a ‘standard of treatment’ before peer review and publication, and before research shows the benefits of reducing mortality.” “
John Norrie said that based on the available information, if Redciewe has some effect, it is understandable that people will want to use it, so morally, it may be difficult to do a randomized placebo-controlled trial against Redciewe.
“However, there is much more to know about the duration of treatment and how early it is used for treatment, and more data are needed, such as which category of people may be less effective, but useful for the other, which requires investigation, confirmation and denial in well-designed studies.” Professor John Norrie told reporters.
“We can say now that it is not clear who will benefit from Redciewe, and whether it can help patients who would otherwise recover more quickly,” said Dr. Elena K Schneider-Futschik, of the Department of Pharmacology and Therapeutics at the University of Melbourne, according to the Guardian. Is Redsiewe more beneficial to younger patients than older patients? At what stage of the infection is interventional treatment working best? It is hoped that global clinical research will answer these questions. “