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Corona drug Remdesivir: EU is considering conditional market approval in the coming days

2020-05-18T11:58:58.487Z

Coronavirus: A drug used to treat Covid 19 patients has been successful. The USA seems to be inspired. In Germany too, doctors and researchers are hoping for positive reports.  



Coronavirus: A drug used to treat Covid 19 patients has been successful. The USA seems to be inspired. In Germany too, doctors and researchers are hoping for positive reports.  

  • Because the development of new drugs and vaccines can take years, the coronavirus * research * relies on what is already known.
  • Reliable results from the USA on the antiviral active ingredient remdesivir are now promising .
  • A hundred-year-old vaccine * against tuberculosis is also becoming more interesting. 

Corona drug Remdesivir: EU wants to clear the way for use by Covid-19 patients

Update of May 18, 1:15 p.m .: The European Medicines Agency (EMA) is considering a conditional marketing authorization for the antiviral drug Remdesivir for the treatment of coronavirus patients in Europe. " It could be that conditional market approval can be granted in the coming days, " said EMA head Guido Rasi on Monday at a hearing in the European Parliament. This would depend on whether the experts classified the study data on the drug available to date as "robust enough".

The US Food and Drug Administration (FDA) issued an emergency approval in early May for the drug's use against the novel coronavirus-induced lung disease Covid-19. Previously, according to preliminary results, a clinical study showed that remdesivir shortened the recovery time of corona patients.

Remdesivir is manufactured by the US pharmaceutical company Gilead. It was originally developed for the treatment of Ebola, penetrates viruses and thus prevents them from multiplying.

Remdisivir - Corona drug already in use in Munich

Update from May 15, 9:15 a.m .: It is only a matter of form that the drug agency gives the green light for the use of the drug Remdesivir. The chief doctor of infectious diseases Professor Dr. Clemens Wendtner in the Munich Clinic Schwabing was optimistic in a tz * conversation.

Corona drug Remdesivir - RKI boss Wieler makes an assessment

Update from April 30, 3:50 p.m .: While US expert and immunologist Anthony Fauci has high hopes for the Ebola drug remdesivir in the fight against coronavirus , a Chinese study presented in the specialist journal The Lancet , on the other hand, concludes that the condition of the corona -Patients not significantly improved by Remdesivir . However, it should be noted that this study was stopped early due to a lack of patients.

In Germany at the regular press conference of the Robert Koch Institute (RKI) this Thursday, RKI director Lothar Wieler also spoke about the effectiveness of Remdesivir. "The numbers that are available to us make a positive impression, " said Wieler. However, according to the current state of knowledge, there is not enough data to make a statement. 

Coronavirus drug: Remdesivir may help

April 30 update : Researchers around the world are looking for a drug to treat Covid-19 patients . Various clinical studies are already underway. An active ingredient that was developed against the Ebola virus appears to be promising: Remdesivir .

The US expert and immunologist Anthony Fauci has assessed the first results of a clinical study in the USA as very positive. The results would still have to be checked and published independently, but the indications of a significantly shorter duration of illness are promising, said the adviser to US President Donald Trump.

Remdesivir has shown "a significant positive impact in reducing time to recovery, " said Fauci, chief of the United States National Institute for Infectious Diseases (NIAID).

The international clinical trial involving more than 1,000 Covid-19 patients compared remdesivir to placebo. The active ingredient remdesivir shortened the duration of treatment for patients, according to Fauci. With Remdesivir, patients recovered on average after 11 days, without after 15 days. The rate of aspiration was also somewhat lower. So far, however, the result has not been statistically significant.

Remdesivir: "Hope, but not a breakthrough" - says the expert

In the ARD Morgenmagazin (Moma), Prof. Christoph Spinner , infectiologist at the Klinikum Rechts der Isar Munich, commented on the results of the US study. In Germany, the Munich clinic is involved in a study on remdesivir in addition to the others (see below ). 

"Mortality has dropped from 11.6 to 8 percent," says Prof. Christoph Spinner. While this is not statistically significant, it is strong evidence that remdesivir could be a drug against Covid-19. In his opinion, the data presented must be scientifically checked further. A faster recovery from 15 to eleven days still means that patients would be sick for a long time - just eleven days.

" There is hope, but in my opinion there is still no breakthrough, " says Prof. Spinner. On the positive side, remdesivir is relatively well tolerated and the side effects are minor. 

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Prof. Christoph Spinner

© fkn

Coronavirus: drug seems to work - but then a Chinese study causes a stir

April 24 update: A drug against the lung disease Covid-19 would have cleared the first hurdle in the coronavirus pandemic . At least the disease could then be effectively combated instead of just treating the symptoms as before. There is currently particular hope for the US product Remdesivir , which is currently being investigated in studies worldwide. In the short term, reports from China caused a stir, according to which the product was unsuccessful. 

Coronavirus: drug seems to work - but Chinese study causes a stir

Manufacturers and doctors, on the other hand, warn against hasty conclusions in both directions. The drug has brought initial success to patients at Munich Clinic Schwabing , said Clemens Wendtner, chief physician of the clinic for infectiology involved in the study.

According to conservative estimates, half of the patients treated with it benefited, said Wendtner, who did not give a number. It appears that seriously ill people could be taken off the ventilation machines earlier. Doctors in the United States also reported first encouraging experiences. According to media reports, 125 Corona patients were treated with the drug in Chicago . According to reports, the manufacturer wants to publish an interim analysis of 400 patients with severe course shortly.

On Thursday, a publication surprisingly caused a stir, according to which a Chinese study with remdesivir is said to have given disappointing results. The antiviral drug has proven to be a flop, according to reports in a document published on the World Health Organization (WHO) website - which was, however, removed after a short time.

Coronavirus: A drug seems to work - but the Chinese study is causing a stir

The US manufacturing company Gilead Sciences rejected the reports, which promptly hit the company's share price. The stock turned significantly into the red. The company said there was no permission to publish the results. The study was terminated prematurely due to low participation, so no statistically meaningful conclusions could be drawn. "In this respect, the results of the study are not conclusive, although trends in the data suggest a potential benefit for remdesivir, particularly in patients who are treated early in the disease," said Gilead Sciences. Results from worldwide studies with seriously and moderately ill patients are expected in late May.

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Hopes rest on the US pharmaceutical company Gilead

© AFP / OLIVIER DOULIERY

In Germany , in addition to the Schwabinger Clinic , the studies also include the Munich Klinikum Rechts der Isar at the Technical University of Munich , the Hamburg University Hospital Eppendorf and the University Hospital Düsseldorf . It was still too early for a final evaluation, said Wendtner, who had treated the first Corona cases nationwide in January. Around 7,600 patients are expected to participate in the studies worldwide. "We haven't even recruited half of it."

Regarding the controversial Chinese study , Wendtner said that just under half of the 453 seriously ill patients targeted were treated with the drug. This does not allow a reliable statement. In addition, it was not defined what was considered a severe Covid 19 disease. The ultimately unreliable Chinese interim results should not jeopardize the continuation of the ongoing studies.

Coronavirus: drug seems to work - but Chinese study causes a stir

Wendtner said that it was necessary to “wait in peace” to see what they would achieve. At the end of May, data should be available "which will then allow a final statement regarding Remdesivir ". At the moment, however, the following applies: "There is still no drug that has been proven to work with Covid-19." It is all the more important to take the risks seriously and to adhere to protective measures.

Other already existing drugs , including an anti-malarials and an HIV drug would have any success brought: The chloroquine was used against malaria, the US president Donald Trump hailed as a miracle cure for Covid-19, no success has brought. One study even suggested that the drug, which, depending on the dosage, could have serious side effects, drove the death rate in Covid 19 patients. According to another study, another HIV drug that he initially hoped would remain without effect, said Wendtner.

Coronavirus: A drug seems to work - even a 100-year-old vaccine gives hope

Update of April 18, 10:50 p.m .: A Viennese infectiologist has warned of premature euphoria when looking for a drug against the coronavirus with a view to Remdesivir. The most important thing about the topic is also available on our brand new Facebook page Corona News. Become a fan now.

Results of ongoing studies are expected in May or June, and then it will be seen "whether it promises what we hope for," said Christoph Wenisch, head of the infection department at the Kaiser-Franz-Josef Hospital in the Austrian capital.

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Cure for Corona? The Ebola drug Remdesivir.

© dpa / Ulrich Perrey

Remdesivir  is usually used to treat Ebola patients.

Corona drug: experiments with remdesivir

Update of April 18, 11:43 am: A small-scale experiment with monkeys is hoping that the remdesivir treatment will help against the coronavirus-induced lung disease Covid-19.

 The animals' state of health had improved significantly twelve hours after treatment, and this trend would have continued over the entire one-week study period .

The scientists infected two groups of six rhesus monkeys each  with the pathogen Sars-Cov-2. One of the two groups was given the active ingredient remdesivir twelve hours later, shortly before the virus concentration in the lungs peaked.

While only one of the animals in the treatment group suffered from slight breathing difficulties despite the remdesivir therapy , the health status of the control group deteriorated rapidly. Here all six monkeys struggled with severe breathing difficulties .

Coronavirus: "Remdesivir" appears to be working - even a 100-year-old vaccine gives hope

First report from April 17th:

Chicago / Brazil / Munich - It has long been known that remdesivir, an active ingredient that has been tested in the fight against Ebola, may also be effective against SARS-CoV-2 and cure the disease Covid-19. A Munich infectiologist is also working on this and other active substances in collaboration with other researchers worldwide. A Munich risk patient * was even cured of a coronavirus infection with the drug. 

However, according to the US health magazine Stat, there are increasing signs that remdesivir could really become the first approved active ingredient. The US pharmaceutical company Gilead - one of the largest pharmaceutical companies worldwide - is currently conducting a study in collaboration with several hospitals. Official results are not yet available - but first results are seeping out of Chicago that give hope. 133 patients were treated with remdesivir, including 125 in critical condition. Most of the symptoms * such as fever and breathing problems decreased after a few days and could be released. "Only" three patients died.

Coronavirus drug: Sad news from Brazil

How narrow the line on which researchers and doctors are walking can be seen, for example, in Brazil : Here, too, people hopefully opted for a new drug - but with a completely different result. Of 81 patients treated with the malaria drug chloroquine, 11 died, the study in Manau was canceled, as Deutsche Welle reports - dismayed that people from risk groups * were apparently treated here with an overdosed drug cocktail of chloroquine and antibiotics.

The use of ventilators in the treatment of Covid19 - for a long time the number of ventilators was considered the measure of all things in the fight against the new coronavirus - has become quite controversial.

Mai Nguyen-Kim spoke about the difficulty of communicating science well in a YouTube video - and showed that a well-known virologist in particular is struggling.

Coronavirus vaccine: can a hundred-year-old drug help?

Tuberculosis vaccine could activate the immune system and thus alleviate the course of a Covid 19 disease. The VPM1002 vaccine developed at @mpiib_berlin is now also being tested for effectiveness in corona infections.https: //t.co/quclQkePJC

- Max Planck Institute for Infection Biology (@mpiib_berlin) March 20, 2020

A vaccine of all things that could never convince against another disease is now gaining the interest of researchers - a study with a thousand volunteers has started in Hanover . Doctors as well as nursing and emergency services personnel were vaccinated here with the vaccine Bacillus-Calmette-Guérin (BCG) - it should help against tuberculosis a hundred years ago and is now being used with improved genetic engineering. An immunity to SARS-CoV-2 is not expected from this drug, but that it strengthens people's immune defenses against the virus. 

Or will there possibly be no vaccine against Sars-CoV-2? And how dangerous is Covid-19 anyway? A US study now comes to a surprising result.

In Germany, a 101-year-old towered out of a senior citizen's home because she wanted to congratulate her daughter on her birthday - she did this with the help of the police.

Different countries, different customs: Meanwhile, a strictly religious Hindu in India wanted to stop the corona pandemic with a bizarre ritual of faith.

* tz.de is part of the nationwide Ippen-Digital editors network

List of rubric lists: © dpa / Ulrich Perrey

Source: merkur

All news articles on 2020-05-18

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