Four drugs for corona were found to be ineffective, including the...

The World Health Organization released over the weekend the disappointing results of the Solidarity trial, in which it examined the effectiveness of drugs already on the market for Corona treatment. According to the interim report, none of the drugs have significantly benefited hospitalized patients.

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This is a large and ambitious experiment that began as early as March, when the corona plague was just beginning. It is designed to quickly and objectively test four drugs whose mechanisms have given rise to assess that they can be effective against corona. However, a separate mechanism and real activity in humans separately, so it was decided to conduct the experiment, in about 12 thousand patients. Conducting the experiment for the four drugs simultaneously created a synergy that cheapened and accelerated the experiment, compared to conducting four large experiments simultaneously.

In the experiment, four drugs were tested against a control group – Gilead’s Remedial Siberia; Hydroxychloroquine; A combination of two drugs originally developed for AIDS, lupinavir and ritonavir; And interferon, a drug that is considered helpful in controlling the activity of the immune system. In none of the drug treatment groups was a dramatically lower mortality rate achieved than in other groups.

The drug received was also found to be ineffective | Photo: reuters
The purpose of the drug is to shorten the time of hospitalization | Photo: Nati Shochat, Flash 90

For some drugs it is a big surprise, and for some – less. Both hydroxychloroquine and the combination of AIDS drugs have been found to be ineffective in hospitalized corona patients during the period from March to the present.

The biggest surprise is Ramadsibir. This drug from the Gilead company, has already been approved for marketing on an emergency route in May (and is sold under the trade name Veklury). The approval was given after a study conducted by the American National Institute of Infectious and Allergic Diseases (NIAID) in 1,000 patients found that the drug reduced the number of days until recovery in hospitalized patients by 4 days, and that patients on the 15th day were better than control patients. In this experiment, a trend of reducing mortality was found in the treatment population, but this was not a significant trend (i.e. it can be said that the experiment failed to prove mortality reduction). Emergency clearance is given to the product, because it seemed to have some activity, and it is better than nothing at the stage of the plague where we are. The WHO’s current trial also found no significant difference in mortality rates, and failed to replicate Giliad’s findings regarding a significant shortening during hospitalization.

Remedial is one of the drugs that US President Donald Trump received for treating his disease. Because it is the drug approved for marketing and the least experimental of those he has received, it has been estimated that it is the one that has had a positive effect on him. And yet it cannot be ruled out.

Giliad’s supply contracts in Europe will be re-examined

Did Gilead come for an emergency permit, and what happens now? The emergency clearance is likely to be maintained, as Giliad did show a shortening of hospitalization time, but the EU medical regulator has already announced that it will re-examine drug supply contracts in Europe, once the EU receives the full results of the World Health Organization study. The union announced just last week a $ 1 billion deal to buy the drug from Gilead.

Giliad responded directly to the health organization’s publications, saying that “the results of this trial do not seem to match the more comprehensive evidence we have from several controlled trials published in scientific journals. “Especially in light of the limitations in the trial design. The health organization used the trial to bring drugs to places where no other clinical trials had been conducted. However, in accordance with the law that requires it, Giliad stressed in her press release that the product is not approved for use in the regular route, but only in an emergency route.

Doctors treating corona patients have enlisted to tell the American network “NBC” that they are actually impressed by the daily treatment of the disease. They argued that the experiment conducted by the WHO may not differentiate enough between very critically ill patients, and inpatients but in a milder condition, who are the main beneficiaries of the product according to you doctors. Dr. Andre Klil of the NIH, the National Institutes of Health in the U.S., joined Giliad on the grounds that the experiment lacked a control group, blindness (patients do not know what drug they were receiving) and a confirmation test that it was indeed corona. Other scientists supported the experiment.

Giliad is in the midst of another trial, in which Ramsesibir is being tested in a thousand other patients, in combination with the drug interferon and as a single treatment. However, the results of this experiment are only expected in 2023. Interim results may come before then. Meanwhile, various factors continue to experiment with the famous product. An experiment published a few weeks ago in the leading journal “The” Lancet failed to replicate Gilead’s results in reducing hospitalization days – but the sample was small.

In the age of big data we are in, it is quite surprising that more information has not yet been published about the efficacy of drugs used in the real world. Comprehensive tools available today make it possible to generate such information, even if it is not as powerful as a double-blind controlled experiment. Such information is likely to become more available as the use of the drug becomes more common, and now when questions are asked about the product that have not been asked before.

Even before the current trial, it was clear that Ramadan Siberia was not the drug that would dramatically change the course of Corona’s disease. It does not provide a benefit that is equivalent to that of antibiotics for bacteria, or of Gilead’s own drug for the bacterial disease hepatitis C, which completely cures the disease. The race for secondary disease or vaccination continues.

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