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The antibody combination of casirivimab and imdevimab will be administered intravenously
Photo: Vicki Smith / Getty Images
According to study data, the administration of an antibody combination of casirivimab and imdevimab can reduce the risk of symptomatic corona infections by around 81 percent.
The Swiss pharmaceutical company Roche announced on Monday in Basel.
In patients with symptomatic infection, the symptoms resolved on average within one week, compared with three weeks in the placebo group.
Unexpected serious side effects did not occur.
Monoclonal antibodies are currently one of the few drugs that specifically fight the coronavirus.
Health Minister Jens Spahn (CDU) announced in January that he had secured 200,000 doses of the funds in Germany, although they have not yet been approved.
The European Medicines Agency Ema is currently examining Roche's preparation.
In the USA, the drug had received an emergency approval.
Former President Donald Trump was treated with him, among others.
Antibodies must be given early
In the meantime, several pharmaceutical companies have developed drugs with monoclonal antibodies that are supposed to help Covid-19 sufferers.
The approach is always similar: researchers use a natural antibody as a model, for example from someone who has recovered from corona, decode it in the laboratory and then reproduce it in large quantities.
"The drugs are nothing more than neutralizing antibodies, like those developed by the immune system in the event of an infection, only that they were artificially produced," said Clemens Wendtner, chief physician of infectious diseases at Munich Clinic Schwabing.
According to Roche, 1,500 people who lived with a corona infected person but had not yet tested positive themselves took part in the current phase III study.
Some of them received the antibody cocktail, others a placebo.
The main results:
Accordingly, only eleven subjects who had been treated with the antibodies as a precaution later showed symptoms of Covid-19.
This corresponds to a share of 1.5 percent.
In the placebo group, on the other hand, a good 59 subjects showed symptoms, which corresponds to a proportion of 7.8 percent.
This difference results in a reduced risk of a good 81 percent.
Whether the drug completely prevents infections has not been investigated.
So far, however, the results are based
solely on the manufacturer's information
.
The results would be presented to the regulatory authorities as soon as possible, it said.
Roche developed the antibody cocktail together with its partner Regeneron.
Therapy in general practitioners difficult
According to the current state of knowledge, however, the drugs only help if they are used very early - ideally after contact with an infected person or within the first few days after a positive test.
The aim is to support the immune system in fighting the virus and thereby prevent a serious course of the disease.
"If the patient has formed their own antibodies after 10 or 14 days, the drugs are no longer effective," says Wendtner.
In addition, antibodies against inflammation or other consequences of the infection cannot do anything.
"You can compare it to a burning bale of straw," says Wendtner.
“If he smokes something, it still makes sense to pour a bucket of water on it.
As soon as it burns brightly, it's too late for that. "
This was also shown during the current analysis.
In another study arm, 204 people who had recently tested positive for the virus were already given the drug or a placebo.
The administration of the drug was therefore only able to reduce the risk of symptoms by 31 percent.
Experts therefore demand that therapy should start early and not only in the hospital when Covid-19 patients are already seriously ill.
However, that could be a problem.
Because the drug has to be administered intravenously.
According to Wendtner, the fact that infected people come to a family doctor's practice for this therapy is difficult to reconcile with the Infection Protection Act.
4000 euros per patient?
And: The means are expensive, the production is complex.
According to Spahn, the federal government paid 400 million euros for 200,000 doses of the antibody drugs, which corresponds to an average of 2,000 euros per dose.
As a rule, two treatments are required per person.
It is not yet known how much the drug will cost should it be approved.
“The drugs could be another building block in fighting the pandemic.
But we don't expect the ultimate savior, ”says Marylyn Addo, head of the Infectious Diseases Section at the University Medical Center Hamburg-Eppendorf (UKE).
As with any medical treatment, there is also a risk of side effects with monoclonal antibodies.
For example, according to the American FDA, the antibodies from Regeneron can trigger an anaphylactic shock, i.e. a severe allergic reaction.
Fever, chills and itching or reddening of the puncture site are also possible.
AstraZeneca drug flops
Apart from the current study, further investigations are being carried out to find out whether patients who have already been admitted to the hospital need to be transferred to the intensive care unit less often if they have been treated with artificial antibodies.
The results are still pending.
Research is currently being carried out on countless drugs against the coronavirus around the world.
Recently, a diabetes drug from the pharmaceutical company AstraZeneca has not proven to be helpful in the treatment of corona patients.
The drug Farxiga flopped in a Phase III clinical trial for the treatment of Covid-19 in hospitalized patients who are at risk of serious complications.
The results of the study of 1,250 participants were not statistically significant, AstraZeneca announced.
koe / irb / dpa