It's all invalid! The largest new crown clinical trial ended in disappointment, with four candidate therapies failing

As early as March 20 this year, the World Health Organization (WHO) announced the launch of a large-scale global clinical trial called SOLIDARITY (Solidarity) to test the effectiveness of a number of candidate therapies for the treatment of neo-coronary pneumonia.
about a week after the announcement, the first subjects joined the large-scale trial in Norway.
as of 2 October, 43 countries worldwide had approved the recruitment of subjects, and 30 countries were already conducting trials.
the World Health Organization's official website, the Solidarity clinical trial is a global, randomized, adaptive design clinical trial.
it consists of 1 control group and 4 trial groups.
the control group received the current standard treatment in their country, and the other four trial groups used additional drugs in addition to the standard treatment.
the trial group initially used hydroxychloroquine, the HIV drug Lopinavir/Litonave, Lopinavir/Litonave and Redsivir, and the Lopinavir/Litonave and β interferon.
However, with clinical data from a number of patients in various research units, the WHO found that redsivir and β interferon appeared to work alone, and eliminated the two drugs in a subsequent treatment group in a joint use with lopinavir/litonave.
disappointing results Recently, the WHO gave a large data analysis of the four treatment groups, and the end result may be disappointing: these four drugs are ineffective or ineffective in treating neo-coronary pneumonia.
Based on clinical trials in more than 400 hospitals and about 12,000 subjects, even with the four drugs, patient survival rates did not improve, including Redsyvir, which had previously given high hopes.
, WHO has now posted a report on the Unite clinical trial on the preprinted website medRxiv.
In fact, as early as June, the WHO stopped trials of oxycodone and lopinevir/litonave, both of which failed to improve patient survival, according to a clinical report released in the UK at the time.
a major clinical trial in the UK, Recovery, tested the new coronary pneumonia drug, and in the Lopinave/Litonave test, a total of 1596 people were tested for the hiv-combined drug to treat the new coronary pneumonia, while 3,376 others received routine treatment.
there was no significant difference in mortality between the two groups.
there was no good news for hydroxychloroquine, and Recovery recruited thousands of patients in hydroxychloroquine trials, 1,542 of whom were tested for the effects of hydroxychloroquine, and 3,123 who received routine treatment as a control.
after 28 days, the mortality rates in the hydroxychloroquine group and the control group were 25.7 per cent and 23.5 per cent, respectively, and the mortality rate from the use of hydroxychloroquine was slightly higher.
Photo Source: JOHN LOCHER/AP Former FDA Commissioner Robert Califf commented: "This study has ruled out the need for patients to use hydroxychloroquine, a drug that can only be said to be reactive."
" After the data from both studies were released, the WHO decided to discontinue follow-up clinical trials of both drugs after an evaluation, as it became clear that neither Lopinevir/Litonave and hydroxychloroquine played a role in the treatment of neocosmoxine pneumonia.
why, as soon as these two trials came out, the WHO declared that the trials could be terminated? Because Recovery's report gives the real criteria for clinical trials: large and random.
generally speaking, "randomness" is observable to everyone, but "large" is difficult to meet.
during the outbreak, many studies wanted to give other colleagues in the scientific community some enlightening clinical results.
but many of the clinical trials in the study recruited only three or four hundred people, and it's hard to get a complete result," said Ana Maria, medical officer at WHO's Department of Immunization, Vaccines and Biologics.
redsiwe hopes to be lost, and despite the fall of two treatments in June, researchers are still looking forward to Redsiway β and interferon.
the beginning of the outbreak, you may not have heard of Redsyvir, but on January 21st a news report from the CDC made the drug widely worldwide.
35-year-old man was treated by Redsiway on the 7th day of his hospitalization and showed good clinical results, the police said at the time.
January 31st, when the patient's procedure was published in the New England Journal of Medicine, Redsyvir has since ascended to the altar, which is also considered a potential drug for the treatment of new coronary pneumonia.
less than a month after the paper was published, Redsiway's large-scale clinical trial began under the leadership of the American Institute of Allergy and Infectious Diseases (NIAID).
between February 21 and April 19, 73 clinical trial centers worldwide participated in the trial, with 1,062 patients randomly grouped, 541 assigned to the trial group and 521 assigned to the control group.
results, published at the same time as NIAID, showed that patients who used Redsiway had shorter recovery times and 11 days shorter recovery times.
this is also the focus of the medium-term results: recovery time.
this result offers greater hope to the scientific community.
, the greater the hope, the greater the disappointment.
NIAID recently published Redsiway's final report, which also includes this part of the interim report.
, Redseve doesn't seem to have any other role to play than his recovery time.
"Unity" trial combined NIAID reports with the results of two other small uses of Redsywe in severely ill patients.
, led by the FDA, showed a mortality rate of about 11 percent for patients who received Redsyway, compared with 11.2 percent for the control group.
photo source: PAU BARRENA/AFP and NIAID In the trial, the mortality rate in the Redsiway group was 6.7 per cent on the 15th day, 11.9 per cent in the control group, 11.4 per cent in the Redsiway group and 15.2 per cent in the control group on the 29th day, but there was still no statistically significant difference.
that Redsyway may speed up recovery, but it doesn't significantly improve survival.
WHO wrote in its Unity trial report: "This certainly denies some of the previous claims that Redsyway could reduce some of the potential deaths."
"These results are not as bad as hydroxychloroquine, but they clearly don't meet the expectations of the beginning β," said Eric Topol, director of the Scripps Institute in the United States.
2,050 patients treated with β interferon, the mortality rate was 11.9 percent, compared with 10.5 percent in the control group.
, of course, in some previous trials, there was evidence that interferon was effective only at an early stage of infection, and that when hospitalized, it had little effect.
details may not have been taken into account in the data from the "unity" clinical trials, leaving β a lot of room for testing interferon.
still promising, but in August, the National Institutes of Health also realized that Redsiway had not shown any effect in improving survival.
they decided to use Redsiway β with lysin interferon to enhance Redsyve's effect.
the trial, Redsyvir was used with other drugs and compared with β effects of interferon.
, the project has also completed Phase III clinical trials, the initial results will be announced in the near future.
that while none of the four highly-expected drugs has fulfilled its mission of saving the lives of patients with new coronary pneumonia, that doesn't mean there are no drugs capable of it.
at least in June this year, Oxford University found that the cheap drug dexamison could reduce the death rate from neocyclytic pneumonia.
in the control group, the mortality rate was 41 percent within 28 days for severe patients who needed a ventilator and 25 percent for oxygen alone.
Dexamisson had a significant therapeutic effect on patients with severe illnesses requiring ventilators, with a mortality rate of only 28% in the experimental group and a direct reduction of 1/3 compared to the control group, which meant that one in eight patients with severe respiratory problems was able to avoid death due to dexamison.
and a news article on the Science website also point out that the WHO report does not give a gold drug for the treatment of neo-coronary pneumonia, but strengthens the criteria for conducting large randomized clinical trials, from which point of view the Unite clinical trial and the UK's Recovery clinical trial have been very successful.
they could recruit a large number of patients into clinical trials in just a few months.
, which would give the WHO the final say, allowing the scientific community to invest resources in other drug development.
"Unity" trial involves doctors and researchers from around the world, and based on this sheer amount of data, they can quickly know which drugs are effective and which are not, which is key to saving lives.
we have to have a strict criterion to determine whether a drug can be used on a patient, and in this respect, the process may be more meaningful than the results.
, it would have been unthinkable to conduct large-scale clinical trials so quickly.