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Remdesivir is a beacon of hope in the search for agents for the treatment of Covid-19, studies on the effectiveness of the substance started early. The first results from China and the USA are now available, but these are in stark contradiction to one another.
The active ingredient remdesivir may shorten the duration of treatment in Covid 19 patients, according to a US study. The results of the study are very positive, said the immunologist and head of the United States’ National Institute for Infectious Diseases (NIAID), Anthony Fauci, on Wednesday (local time).
A Chinese study presented in the specialist magazine “The Lancet”, on the other hand, comes to the conclusion that the condition of the patients with remdesivir does not improve significantly. However, due to a lack of patients, this study was stopped early.
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According to Fauci, an adviser to US President Donald Trump, remdesivir has shown “a significant positive impact in reducing the time to recovery”. The clinical study with more than 1000 participants was carried out with control groups, and the data collection was accompanied by independent experts. However, the results would still have to be checked and published independently. In any case, the indications of a significantly shorter duration of illness are promising.
According to Fauci, patients with Covid-19 lung disease who received remdesivir in hospitals recovered after an average of 11 days, and patients in the control group only after 15 days. However, this does not solve all the problems, Fauci said during a meeting in President Trump’s office. The mortality rate was also somewhat lower, but this result has not yet been statistically significant.
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The Chinese study included 237 patients from ten hospitals in Wuhan, the site of the pandemic. 158 received remdesivir, 79 an ineffective sham drug. The researchers found no statistically significant influence on the duration of the illness or the death rate. In addition to the early termination of the study, however, they point to another weakness of the study: Most of their patients were treated with Remdesivir only quite late in the course of the disease. Starting therapy earlier may improve treatment outcomes.
British medical statistician John Norrie from the University of Edinburgh emphasizes in an accompanying commentary on the study that high-quality research on active ingredients that promise initial treatment attempts should not be foregone. “This is a particular challenge in the midst of a pandemic, the temptation to lower the threshold for convincing evidence is great.” You have to avoid using ineffective and potentially dangerous measures, because this is more of a shame than use and complicates clinical studies on really effective means .
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According to German experts, the results of the US study are sufficiently reliable. Sufficient patients had been examined; Clemens Wendtner from the Munich Clinic Schwabing said that they had previously been discharged from the hospital under therapy with Remdesivir. “This means that essential endpoints of the study have been reached, so there should be little doubt in my view that the substance will be approved quickly.”
Gerd Fätkenheuer from Cologne University Hospital, head of a clinical trial of Remdesivir (GS-5734) in patients in Germany, is also expecting approval soon due to the positive results.
Remdesivir was originally developed against the Ebola virus and has shown some efficacy against Sars-CoV-2 in laboratory tests. In cell experiments it stopped the virus from multiplying, in animal experiments it worked against other coronavirus infections such as Sars and Mers. Remdesivir has not yet been approved in any country in the world.
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The Food and Drug Administration (FDA) is currently in talks with drug maker Gilead to quickly make remdesivir available to hospital patients, Fauci said. A formal approval of the drug, however, takes much longer and requires further studies.
Trump said Wednesday night (local time) when asked whether he wanted the agency to accelerate the drug approval process, he wanted to proceed as quickly as possible. “We want very quick approvals.”
The biotech company Gilead said in a press release that they were aware of the “positive data” from the clinical trial, but the communication was with the NIAID.
Source: dpa
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