Clinical trials are essential for the development of new therapies. This year, the International Clinical Trials Day on May 20 is dedicated to the corona pandemic on Cologne’s medical campus. To stop this life-threatening disease, experts around the world are conducting research on an unprecedented scale on diagnostics, therapies, and prevention. According to the ‘clinicaltrials.gov’ list, 1,518 studies on COVID-19 are currently underway. In Germany, eighteen drug trials are registered, and ten trials are currently being carried out or in planning on the University of Cologne’s medical campus.
Professors Gerd Fätkenheuer (Infectiology) and Florian Klein (Virology) are among the researchers at Cologne University Hospital and the Faculty of Medicine who are driving the development of corona therapies in clinical trials. ‘We are pursuing different approaches in the fight against this novel disease,’ said Gerd Fätkenheuer. ‘We are testing the use of new viral inhibitors. Our close cooperation with Professor Klein also gives us the opportunity to clinically investigate new immunotherapeutic approaches. Even if the need for a COVID-19 therapy is currently extremely high, no therapy will be employed that hasn’t been thoroughly tested.’
One of the most promising drugs already in use – originally developed to threat Ebola – is ‘Remdesivir’. Clinical trials – in Cologne and elsewhere – are currently testing whether this drug is suitable to treat COVID-19. Gerd Fätkenheuer is the leader of the German section of an international consortium researching Remdesivir: ‘The study, which was pushed ahead at record speed due to the corona pandemic, has now been largely completed,’ he said. ‘Remdesivir is the first substance whose efficacy has been proven in a controlled clinical trial. It shortens the course of the disease in afflicted patients. Within a few weeks, Remdesivir will be available for use in treating COVID-19.’ The trial also showed that, all in all, the drug is very well tolerated.
Another research group led by Florian Klein is working to identify and employ antibodies that neutralize SARS-CoV-2. This research is being supported by the German Centre for Infection Research (DZIF). Patients who have already recovered from COVID-19 carry these important neutralizing antibodies in their blood. ‘Our goal is to use specific antibodies from the blood of recovered patients to develop a clinically effective drug,’ Klein explained. In the past, Klein already isolated highly potent antibodies of other viruses, such as Ebola and HIV. Once the trials are complete, a potent antibody candidate will be available for clinical testing.
Approximately 600 clinical trials are carried out at Cologne University Hospital every year on a wide range of different issues and indications. ‘Patients in Cologne benefit directly from participating in one of our clinical trials,’ Professor Esther von Stebut-Borschitz, Dean of Science at the UoC’s Faculty of Medicine, emphasized. ‘A large proportion of all seriously ill COVID-19 patients in the region have the opportunity to be included in ongoing studies and thus gain access to drugs and treatment methods that have not yet been approved. Participation in a clinical trial is subject to strict safety precautions and medical supervision. We are happy to be able to contribute our proven expertise in the worldwide search for a therapy.’
International Clinical Trials Day goes back to the first ever recorded therapeutic experiment: In the search for an effective treatment of scurvy, the Scottish navy doctor James Lind administered various ‘trial substances’ to sailors on 20 May 1747. Comparing his results, he found that administering vitamin C in the form of lemons proved to be the best therapy. Lind’s scurvy study is considered to be the beginning of clinical research.
Professor Dr. Gerd Fätkenheuer
Director of Clinical Infectiology, Cologne University Hospital
Professor Dr. Florian Klein
Director of the Institute of Virology, Cologne University Hospital
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