It is a glimmer of hope. A new drug is being used in the United States, which could lead to faster recovery in Covid 19 patients. So far there is only one large study. But time is short in the face of the devastating corona virus pandemic.
Washington (dpa) - The USA allow the limited use of the active ingredient remdesivir in Covid-19 patients in hospitals. The exemption was given in light of the coronavirus pandemic "at the speed of light", says the head of the Food and Drug Administration, Stephen Hahn.
President Donald Trump described the move as "very promising". A clinical study had previously shown that the drug originally developed for Ebola in Covid patients can shorten the time to recovery by several days.
The head of the biotech company Gilead, Daniel O'Day, said the company would donate 1.5 million doses of remdesivir to the US authorities, which should be enough for more than 100,000 treatments. Patients with Covid-19 lung disease could now be given the drug for five or ten days, depending on the severity of the condition, Gilead said. The US government will take over the distribution of the drug to ensure that it arrives where it is most needed, it said. By December, they wanted to produce enough remdesivir for one million treatments.
Remdesivir has never been approved as a drug anywhere in the world. The United States exemption does not correspond to a formal approval, which is a much more complex process. Even issuing a limited exemption after just a promising clinical trial is unusual. So far, however, there has been no vaccination against the novel coronavirus and no reliable approved drug therapy.
On Wednesday, the U.S. National Institute for Infectious Diseases (NIAID) said remdesivir had significantly shortened treatment time in a clinical trial. Director Anthony Fauci spoke of a "significant positive effect in reducing the time to recovery".
The study with more than 1000 participants was carried out with control groups, the data collection was accompanied by independent experts. According to Fauci, patients with the coronavirus-related lung disease Covid-19 recovered after an average of 11 days, whereas the patients in the control group did not recover until after 15 days. The results still had to be checked and published independently, Fauci said. In addition, the drug only resulted in a slightly lower mortality rate.
According to many experts, the results of the US study seem to be sufficiently reliable. Sufficient patients had been examined; under therapy with remdesivir, they were released from the hospital earlier, said Clemens Wendtner from Munich Clinic Schwabing this week. "This means that essential endpoints of the study have been reached, so that in my opinion there should be little doubt that the substance will be approved quickly."
However, a Chinese study also presented this week in the specialist magazine "The Lancet" came 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.
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: most of their patients were treated with remdesivir only late in the course of the disease.
Remdesivir had previously shown some efficacy against the novel Sars-CoV-2 coronavirus. In animal experiments, it worked against other coronavirus infections such as Sars and Mers.
According to Johns Hopkins University, there are already around 1.1 million known infections with the new corona virus in the USA; At least 64,000 people have died.