Milestone for adaptive clinical trials in Germany

On 9 February 2026, Prof. Dr Maria Vehreschild (Head of the Infectious Diseases Unit at Academic Medical Centre Frankfurt) presented initial results and experiences from RAPID-REVIVE to around 60 participants as part of the NUM Insights event series.

The phase 2 study, funded by the BMFTR as part of the Network of University Medicine (NUM), investigated innovative drug therapy approaches for Post-COVID syndrome (PCS).

What makes RAPID-Revive special:
The study was conducted in a multicentre, randomised, placebo-controlled and double-blinded manner - and is also adaptive. This means that treatment arms can be flexibly adapted on the basis of planned interim analyses. This makes RAPID-Revive the first adaptive platform study for post-COVID in Germany. The organisational and regulatory requirements for preparation and initiation were correspondingly high. The team led by Prof Vehreschild and Prof Oliver A. Cornely successfully mastered these challenges.

In the first REVIVE sub-protocol, 150 post-COVID patients were included at eleven academic medical centres. Apps and wearables were used to record physical functions, cognitive performance and psychological stress, among other things. Following a planned interim evaluation, the study was concluded by the Data Safety Monitoring Board. The experience gained during the set-up process will pave the way for future sub-protocols: the new ELAPSE sub-protocol will be based on the existing master protocol and continue to utilise the established processes.

RAPID-Revive impressively demonstrates how innovative study designs can sustainably strengthen clinical research in Germany.

Further dates in the NUM Insights event series