Source: Hanson Clinical Research
Author: Dr. Wang Yuge
The novel coronavirus (SARS-CoV-2) continues to spread rapidly around the world, and although vaccine development is accelerating, it may still take the end of the year for results to be achieved and for the general public to be vaccinated in 2021.
In the face of 400,000 new infections and 3-6,000 deaths of COVID-19 every day, in addition to active prevention, doctors and scientists are still looking at potential therapeutic drugs.
For viral infections, the ideal treatment option is early administration of antiviral + monoclonal antibodies.
Remdesivir (Remdesivir) has been given great expectations because of its anti-coronavirus characteristics, and has become the original "hope of the people". But as more findings are released, people are increasingly disillusioned with remdesivir. The results just released by the World Health Organization show that remdesivir in the WHO-organized study is ineffective.
On October 15, 2020, the World Health Organization (WHO) uploaded the results of a very critical SOLARID clinical trial (NCT04315948) in medRxiv, which immediately attracted worldwide attention and a large number of media reports.
The clinical trial is currently the world's largest clinical trial to evaluate treatments for COVID-19, recruiting a total of 11,266 HOSPITALIZED PATIENTS FOR COVID-19 in 405 hospitals in 30 countries. Of these, 2,750 people used remdesivir, 954 used hydroxychloroquine, 1,411 used the HIV protease inhibitor lopinavir, 651 people used interferon + lopinavir, 1,412 people used interferon alone, and 4,088 people were the standard treatment control.
< h1 class="pgc-h-arrow-right" > the main findings
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A total of 1,253 people died in the study. The study divided the corresponding controls according to each trial drug. There were 303 deaths in the remdesivir group, with a case fatality rate of 11%, compared with 11.2% in the corresponding control group (p=0.5).
Hydroxychloroquine was 11% in the group and 9.2% for the corresponding control. Lopinavir was 10.6% and the corresponding control group was 10.6%. Interferon was 11.9%, compared with 10.5% for the corresponding control group.
Source: Figure 2
None of the four trial drugs, including remdesivir, reduced the case fatality rate for COVID-19; moreover, none of these trial drugs reduced mechanical ventilation (intubation) rates or length of hospital stay.
The article is currently being submitted to the New England Journal of Medicine (NEJM), the top journal of medicine.
Despite disappointing results, medical scientists generally praised the study for helping to clarify currently vague therapeutics.
WHO Chief Scientist Sumya Swaminathan said:
"We want to have an effective drug. But the first thing to know is whether the drug is effective, rather than continuing to use it without knowing it. ”
Jeremy Farrar, director of the Wellcome Trust, said: "The RECOVERY and SOLIDARITY trials have given the standard of clinical treatment, providing clear answers for the clinic,"
This is where the clinical value of these trials lies.
Prior to the publication of these results by WHO, the RECOVERY study at the University of Oxford in the United Kingdom had confirmed that hydroxychloroquine and the HIV drug ritonavir/lopinavir were ineffective in treating COVID-19. Because the UK findings were so scientific and rigorous, it was decided to remove the two drugs from the treatment recommendations before WHO published its results.
But hopes remain on remdesivir and interferon-β, which was initially used in combination with ritonavir/lopinavir and tested as a stand-alone drug after the publication of the results at RECOVERY in Oxford.
But the RESULTS of the WHO trial puncture the last bit of expectation.
Remdesivir, in particular, in the U.S. study, the recovery time in the remdesivir treatment group was shorter than in the control group, although there was no difference in case fatality rate between the two groups.
As a result, remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration (FDA) in May to treat patients with severe COVID-19 and later expanded to all hospitalized patients.
Just before who released the results on 8 October, the European Commission ordered 500,000 courses of medicines worth US$1 billion from Gilead Sciences, which produces remdesivir, because of the second wave of COVID-19 in Europe.
One detail is particularly noteworthy: According to WHO, who told Gilead on September 28 of the results of the SOLARID trial. This means that Gilead knew about the invalid outcome before the $1 billion Deal for Europe was struck; it is not known whether Gilead had disclosed the information to the EU at the time.
Moreover, after who announced its results, Gilead, which produces remdesivir, immediately issued a statement arguing that this multicentre open-label clinical trial does not have strict admission criteria, but seeks to maximize the use of drugs for patients to test, so the design lacks rigor.
What a similar plot.
In April of this year, WHO "accidentally leaked" a draft article on Lancet, a Sino-Japanese Friendship Hospital with no benefit in remdesivir treatment for COVID-19, on its website. At that time, Gilead also immediately refuted the irregularities of these studies.
Some of Gilead's small actions that it considers "more scientific" are more confusing and even scornful.
Expanding the sample size does allow for statistical differences. But how effective is this statistical difference, clinically?
In fact, as an antiviral drug, the sooner it is used, the better the effect.
When a person with COVID-19 develops symptoms, it has been 3-5 days since infection. In the current WHO study, remdesivir is used for the treatment of hospitalized patients; even if remdesivir can really suppress the new crown virus, how effective is it at the hospitalization stage?
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