It took longer than desired: Researchers led by Charité professor Carmen Scheibenbogen wanted to start their first long-Covid study as early as summer 2022. The goal: to find effective drugs and therapies against the long-term effects and their most severe form ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) as quickly as possible. But high regulatory requirements for clinical studies would have slowed down the project. It's about documents, contracts, data protection. Nothing to do with research in the narrower sense.
While the development of corona vaccines was exceptionally fast and Covid-19 drugs were found quickly, a breakthrough in long-Covid drugs is pending. Researchers complain about the massive effort. It takes more than a year from the idea for a clinical study to the start, according to Berlin's university hospital. Researchers get the desperation of those affected, some of whom have not recovered for three years.
Long Covid is understood to mean complaints that persist beyond the acute phase of the disease of four weeks or then reappear. Post Covid describes the clinical picture more than twelve weeks after the corona infection. The symptoms are very inconsistent. The patient guideline deals with shortness of breath and coughing, tiredness, sleep disorders, exhaustion, but also with worries and sadness.
It is characteristic of ME/CFS that the condition deteriorates significantly after little exertion. According to the Charité, the main symptoms include severe exhaustion, concentration and sleep disorders, physical symptoms such as sore throat, muscle pain and headaches and a course lasting at least six months.
Long Covid researchers are also frustrated in other places behind closed doors. In a study on which the hopes of some of those affected are based, funding has been approved and test subjects are available, but approval is missing.
But it's not just that. Long Covid is complex. The symptoms are probably caused by different processes in the body. Overreactions of the immune system can play a role, as can vascular changes, but also viruses that are still hiding in the body after Covid-19 or have been reactivated from previous infections.
ME/CFS is not new in itself: According to estimates, 250,000 people in this country were already affected before the pandemic, for example after an infection with the Epstein-Barr virus or the flu. These people are also hoping for help in the course of research on Long Covid.
Experts consider the development of a drug that will help everyone affected by long-Covid in the foreseeable future and solve the problem permanently to be quite illusory. Scheibenbogen, who heads the Charité’s immune deficiency outpatient clinic, points to examples such as multiple sclerosis and says: “We don’t have any drugs that help everyone for other complex diseases either. It is almost always only 30 to 50 percent that respond really well.”
Scheibenbogen also heads the National Clinical Study Group (NKSG) on Post Covid and ME/CFS, which will be funded by the Federal Ministry of Research in 2022 and 2023 with almost ten million euros. Several clinical studies are planned. The concepts are based in part on Disc Arch's years of ME/CFS research. She assumes that so-called autoantibodies play a role in the disease: an immune reaction that is directed against one's own body.
"We did the first study on immune adsorption as early as 2015: a process in which autoantibodies are washed out of the blood," says Scheibenbogen. With the funding from the pandemic, the researcher now has the option of a follow-up study in patients suffering from ME/CFS after Covid-19. This has now started. A larger one is to follow in the coming months.
But she immediately restricts: “This is not a procedure for all those affected. It is extremely time-consuming and stressful for patients.” The advantage is that you can quickly understand who this approach is effective for. The plan: in the next step, test drugs against autoantibodies.
A review article in the journal "Clinical Microbiology and Infection" from January identified around 60 drugs that are currently being tested in long-Covid studies - such as anti-inflammatory drugs and immunosuppressants that are already approved for other diseases.
At the NKSG, studies on medicines that address blood circulation and inflammation are about to start or should start in the summer at the latest. "This year we will have results on immune adsorption and blood flow," says Scheibenbogen. Everything else depends on follow-up funding from the federal government or the pharmaceutical industry. So far, unfortunately, she has met with a lot of rejection. Companies only participate when the autoantibody hypothesis has been proven and it is known exactly which patient group is suitable.
The Association of Research-Based Drug Manufacturers assumes that there will be an increasing number of research projects "when ongoing basic medical research has found out more about the processes involved in the disease". In order to develop new drugs specifically against Long Covid, molecular-precise clarification from basic research is required for at least some of the mechanisms.
The Long Covid Germany initiative for those affected assumes that the studies now beginning in this country can only be a start. A spokesman says that sustainable and appropriate follow-up financing for the NKSG over the next few years is now necessary. This is the only way to continue their comprehensive research successfully. "Sooner or later politicians will have to spend the money anyway because the burden of disease in the population will continue to rise."
"Even in times of the supposedly mild omicron variant, we see people who get Long Covid, although they have been vaccinated or have already been infected," says Long Covid Germany. The spokesman is convinced that the problem for society will increase in the long term due to the sheer number of infections. "It's a game of time until we really feel all the health consequences of Covid-19."
One problem remains that it has not yet been possible to quantify exactly how many people in Germany are affected by Long Covid. Also the courses: unclear. "We can only look at data from abroad," says Scheibenbogen.
According to this, about ten percent of people would have long-term complaints after a corona infection, after an infection of vaccinated people it was about five percent. Existing remedies can often alleviate symptoms. “But one to two percent are likely to remain permanently ill. And these are mostly young people.”
Nevertheless, the professor sees reason for optimism: "I still assume that these diseases can be treated relatively well." If you find the right approach.