With NAPKON-TIP (National Pandemic Cohort Network - Therapeutic Intervention Platform), an infrastructure for adaptive clinical platform studies is to be established in Germany. Using the recruitment network established in NAPKON (National Pandemic Cohort Network) and the NUKLEUS (NUM Clinical Epidemiology and Study Platform) infrastructure, successful concepts from already internationally successful study platforms are to be integrated and adapted to the legal national context (regulatory, data protection) in the Network of University Medicine (NUM). Adaptive studies make it possible to react quickly to new findings and adapt the study design accordingly. The studies conducted within the platform can test a wide variety of therapies, e.g. drugs, medical devices and digital health applications.
RAPID_REVIVE (Randomised adaptive assessment of post COVID syndrome treatments_Reducing Inflammatory Activity in Patients with post COVID Syndrome) is being conducted as part of NAPKON-TIP andis an adaptive study of a treatment for post-COVID syndrome. The phase II clinical drug trial (AMG trial) received regulatory approval at the end of May. In addition to the sub-protocol, which describes the specific treatment, a master protocol was created. This makes it possible to add further sub-protocols in the future and to investigate other possible treatment approaches for post-COVID syndrome. A total of eleven NAPKON sites have been recruited for RAPID_REVIVE. This is expected to start in July 2024.