Doubts have been tested about the promise of COVID-19 drug remediation that & # 39; t & # 39; fantastic results & # 39; has shown, after & # 39; t found another study that it had no benefit.

Remdesivir was reported by US officials to & # 39; clearly & # 39; to have evidence that it can help people recover from COVID-19, which shortens recovery time.

Dr. Anthony Fauci, the best expert on & # 39; infectious disease & # 39; e America, said unpublished results from an international study of 1,000 people showed that the drug could block & # 39; the virus & # 39 ;.

The results gained traction overnight, and shares for Gilead Sciences – the pharmaceutical that makes remdesivir – shot down amid hopes that it would become a cure.

Other scientists were excited about the & # 39; encouraging & # 39; and & # 39; fantastic & # 39; result. Remdesivir is expected to be tracked soon for licensing in the US, possibly as early as today.

But a separate trial conducted in China produced disappointing results. It was a randomized controlled placebo trial, seen as the gold standard of scientific evidence, the same as that reported by US officials.

The drug did not significantly benefit hospital patients because it did not accelerate recovery or reduce deaths, compared to a dummy drug.

The study was published in the prestigious medical journal Lancet and involved 237 people. It was stopped early because the researchers had difficulty recruiting people when the outbreak in Wuhan was curtailed.

Scientists believe that the strong contrast in findings can come down to when remdesivir is given. It is thought to be more effective in the & # 39; early stages of & # 39; a disease COVID-19.

Doubts are cast over the experimental remedivir Ebola drug that & # 39; fantastic results & # 39; had, in a major trial, not found another study that had no benefit

After an international study of 1,000 people, which has not yet been published, said Dr. Anthony Fauci, the best expert on & # 39; infectious disease of & # 39; America said it proved & # 39; a drug could block the virus & # 39;

After an international study of 1,000 people, which has not yet been published, said Dr. Anthony Fauci, the best expert on & # 39; infectious disease of & # 39; America said it proved & # 39; a drug could block the virus & # 39;

A randomized controlled trial of remdesivir performed in China and published in The Lancet yielded disappointing results. The drug did not significantly benefit hospital patients, because it did not accelerate recovery or reduce deaths compared to a dummy drug.

A randomized controlled trial of remdesivir performed in China and published in The Lancet yielded disappointing results. The drug did not significantly benefit hospital patients because it did not accelerate recovery or reduce death compared to a dummy drug.

Remdesivir was thrown into the spotlight in January when the WHO listed it as & # 39; the most promising candidate & # 39; for a COVID-19 therapy.

Trials have shown that the medication can fight SARS and MERS, cousins ​​of the new coronavirus, in the lab and on animals.

The new smaller study in the Chinese city, where the coronavirus was first found back in December, was conducted across 10 hospitals.

WHAT ARE THREE STUDIES OF REMDESIVIR?

1. The Covid-19 Custom Treatment Trial

How many people?

1,063, including 46 from the UK, more than 70 hospitals worldwide.

What did the process do?

The placebo-controlled study compared outcomes for hospitalized patients.

What did it find?

Patients receiving remdesivir had a recovery time that was almost a third (31 per cent) faster than those who did not receive a placebo.

Preliminary results also suggested a survival benefit, with a lower mortality rate of 8 per cent for the group receiving the drug, compared to 11.6 percent for the placebo group. But this is not considered a significant difference.

Is it published?

Now. You can find the preliminary findings on the National Institute of Allergy and Infectious Diseases (NIAD) website.

2. Phase 3 SIMPLE Trial of Gilead Sciences

How many people?

397 patients in the hospital

What did the process do?

The study compared a five-day course of medicine with a 10-day course of treatment. It looked at rates of patients recovering to the point that they no longer needed oxygen support and medical care or were sent home from the hospital.

It was not a placebo-controlled study.

What did it find?

The pharmaceutical company reported that almost two-thirds of patients, as well as 129 out of 200 patients, returned on day 14 after a five-day course of treatment.

The longer treatment time did not appear to provide any additional benefit, the company said.

Is it published?

Now. Gilead plans to publish the full data in a peer-reviewed journal in the coming weeks. A summary of & # 39; s findings were published on his website.

3. The Chinese study, led by Professor Bin Cao, of China-Japan Friendship Hospital and Capital Medical University in China.

How many people?

237 hospital COVID-19 patients at ten hospitals in Hubei, China.

The study was intended to recruit 400, but the trial was stopped because there were not enough patients because of the epidemic that was curtailed in Wuhan.

What did the process do?

It was a randomized, double-blind, placebo-controlled trial – the gold standard – comparing recovery tasks in patients who did not receive remdesivir as a dummy drug.

What did it find?

Those on placebo drugs had similar outcomes to those who did not receive remdesivir.

It took a shorter time for the remdesivir-treated patients to get better, 21 days compared to 23, but this is not statistically significant.

There was a one percent difference in mortality between the two groups, which again, it is unclear if this means anything important.

Is it published?

Yes, in the peer-reviewed journal The Lancet.

Chinese researchers launched two formal studies of remdesivir; one in severely ill patients, and another in people with a milder illness, after Gilead agreed to deliver remdesivir.

Those on placebo drugs had similar outcomes to those who did not receive remdesivir.

It took a shorter time for the remdesivir-treated patients to get better, 21 days compared to 23, but this is not statistically significant.

There was a one percent difference in mortality between the two groups, which means that there is no clear advantage in & # 39; e survival rates dry.

It was also noted that a greater number stopped their treatment due to unusual events while on remdesivir.

Some 66 percent experienced side effects, including constipation and anemia – but doctors still classified it as safe.

Professor Bin Cao, of China-Japan Friendship Hospital and Capital Medical University in China, who led the study, said it was not the outcome his team hoped for.

He said, & # 39; Unfortunately, our trial found that remdesivir, although safe and adequately tolerated, did not provide significant benefits over placebo. & # 39;

But the authors said that until the trial was stopped early, the true effectiveness of remdesivir remains unclear.

The data security supervisor stopped the trial because investigators were unable to recruit enough patients following the steep decline of cases in China.

Commenting on & # 39; the study, Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, said: & # 39; The figures in the trial are too small to draw strong conclusions, but are certainly not an indication of benefit to remdesivir and are somewhat more compatible with potential harm. & # 39;

Professor Saad Shakir, director of & # 39; the drug insurance research unit, at Southampton, said it & # 39; was not the end of the story for remdesivir & # 39 ;.

Indeed, the study came to light because the findings of an international remdesivir trial were also published. This study was on more people and far beyond the globe.

More than 1,000 patients were recruited from 70 hospitals around the world. It included 46 patients from the United Kingdom.

The Adaptive Covid-19 treatment test began in early April and & # 39; positive data & # 39; is public – but it is not published or subject to peer review, unlike The Lancet research.

Patients receiving remdesivir had a recovery time that was almost a third (31 per cent) faster than those who did not receive a placebo.

Specifically, the median time to recovery time was 11 days for patients treated with remdesivir, compared to 15 days for those who received placebo.

Preliminary results also suggested a survival benefit, with a lower mortality rate of 8 per cent for the group receiving the drug, compared to 11.6 percent for the placebo group. But this is not considered a significant difference.

The results were announced by the National Institute of Allergy and Infectious Diseases (NIAD) in the US, which is conducting the study.

Dr Fauci said although the results did not & # 39; knock out 100 per cent & # 39; were, it was an important proof of concept.

& # 39; The data shows that remdesivir has a clear cut, significant, positive effect in reducing & # 39; e time for recovery, & # 39; he told reporters at the White House.

& # 39; This is very optimistic, mortality counted for better words in & # 39; a sentence of minor deaths in a REM-designated group. Eight percent versus eleven percent in a placebo group.

& # 39; So bottom line. You will hear more details about this, this will be submitted in a peer reviewed journal, and will be peer reviewed. & # 39;

He added that the trial was proof & # 39; a drug can block this virus & # 39; and compare the finding with the arrival of & # 39; the first antiretrovirals that & # 39; worked against HIV in the 1980s, though at first with modest success.

After the NAID findings became public, Gilead reported preliminary data from a private study of nearly 400 patients – Phase 3 SIMPLE trial.

The study, set to compare a five-day course of & # 39; drug with a 10-day course, looked at rates of patients recovering to the point that they no longer needed oxygen support and medical care or left home. hospitals were sent.

The pharmaceutical company reported that almost two-thirds of patients, as well as 129 out of 200 patients, returned on day 14 after a five-day course of treatment.

The longer treatment time did not appear to provide any additional benefit, the company said.

It has plans to publish the full data in a peer-reviewed journal as well as a second part of the & # 39; s trial on 600 people.

But the study lacked a placebo-controlled arm, which wasn't difficult to interpret.

Documents from the World Health Organization organizers last week suggested the drug had failed to help patients in the & # 39; to restore a Gilead trial.

But Gilead defended the trial, saying it believed the leaked data was a & # 39; mischaracterization & # 39; of & # 39; results were.

A table from Gilead shows that more than half of patients were in each treatment group and were discharged from the hospital, although a total of 37 patients died

A table from Gilead shows that more than half of patients were in each treatment group and were discharged from the hospital, although a total of 37 patients died

Pictured: A five-day view of Gilead shares shows sharply increasing shares at the open on Wednesday

Pictured: A five-day view of Gilead shares shows sharply increasing shares at the open on Wednesday

Originally developed to treat Ebola, Remdesivir is one of a handful of experimental drugs that have undergone worldwide clinical trials to treat coronavirus

Originally developed to treat Ebola, Remdesivir is one of a handful of experimental drugs that have undergone worldwide clinical trials to treat coronavirus

WHAT IS REMDESIVIR AND DOES IT WORK WITH CORONAVIRUS

Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that originated in 2014 in West Africa.

Ebola, like COVID-19, is caused by a virus, and scientists are now testing remdesivir to treat coronavirus patients, but it's too soon to know if the drug works or not.

Remdesivir produced promising results earlier this year when it promised to both prevent and treat MERS – another coronavirus – in macaques.

The drug seems to stop the replication of viruses such as coronavirus and ebola.

It is not entirely clear how the drug completes this performance, but it seems to stop the genetic material of the virus, RNA, from copying itself.

This, in turn, stops the virus from proliferating in the patient's body.

NIH researchers responsible for the macaque study recommended that progress to human trials with the new coronavirus.

Scientists have listened, and human trials for remdesivir first began in Nebraska.

Most recently, researchers reporting & # 39; drug testing at the University of Chicago reported that most of & # 39; E 125 COVID-19 patients who had the drug with them were discharged from the hospital, according to Stat News.

Two patients died in the & # 39; course of & # 39; a trial.

Professor Mahesh Parmar, director of the & # 39; Clinical Trials Unit for Medical Research Council at UCL, who & # 39; t the EU part of & # 39; e Adaptive trial filed, said scientists will continue to collect further data, while early results will be monitored by regulators.

He said, & # 39; These results are indeed very promising. They show that this drug can improve the time after recovery.

& # 39; Before this drug can be made more comprehensive, a number of things have to happen: the data and results must be checked by the regulators to determine if the drug can be licensed and then they must be reviewed by the relevant health authorities in different countries .

& # 39; While this is happening, we will get more and longer-term data from this trial, and others, on whether the drug also prevents Covid-19 deaths. & # 39;

The announcement of promising provisional results from remdesivir sent the Dow up by more than 500 points, though Gilead's own shares were halted for trading, in order not to announce results of the trial.

Remdesivir, originally developed to treat Ebola, is one of a handful of experimental drugs that have undergone worldwide clinical trials to treat coronavirus.

The name is not capitalized because it is only a research agent, which means that it is not produced to a marketed drug.

Remdesivir's progress would make it the third drug approved under the EUA by the FDA after the agency approved anti-malaria drugs chloroquine and hydroxychloroquine.

After the drug is quickly spotted in FDA licensing, it is thought that its next target will be the European Medicines Agency.

Remdesivir has been one of the top contributors to existing drugs that are being tested for coronavirus treatment.

Abdel Babiker, professor of epidemiology and medical statistics at University College London, told BBC Radio 4's Today program: & # 39; These are very encouraging results from & # 39; a first large-scale randomized trial to report on any Covid-19 treatment. & # 39;

He said the group of adults with advanced coronaviruses that got Remdesivir & # 39; much faster & # 39; recovered if the group did not receive a placebo.

He added that the Chinese study & # 39; unfortunately was not likely to be large in favor of & # 39; detect a drug & # 39 ;.

Other experts said that the Chinese study may not have succeeded in finding positive results if the drug was not given at the right time.

The trial protocol required that patients should be included in the trial within 12 days of the onset of symptoms.

Dr Penny Ward, Visiting Professor of Pharmaceutical Medicine at Kings College London and the Chair of the & # 39; Education & Standards Committee of & # 39; e Department of Pharmaceutical Medicine, said viral load peaks at or within two days after the onset of symptoms.

& # 39; This trial has unfortunately begun late with treatment, and for the most part at a time when individuals will have developed neutral antibody, & # 39; she claims.

Data from the & # 39; 400 Cohort in & # 39; A Gilead study also suggests that patients too early, within 10 days of the onset of symptoms, can help to recover quickly.

Professor Evans said, & # 39; It is suggested that these drugs should be started early in & # 39; course of illness, but it seems that there are several days after infection before symptoms appear.

& # 39; If the drug only works well when given the cure after infection, it can in & # 39; e practice will be much less useful. We need appropriate randomized threads to test this hypothesis. & # 39;

Professor Philip Bath, Head of & # 39; Division of Clinical Neuroscience at & # 39; e University of Nottingham, said more information is needed before the drug is used.

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