An innovative Phase 2 clinical trial, RAPID_REVIVE, is underway at Frankfurt University Hospital to explore new treatments for post-COVID syndrome (PCS), also known as long COVID. Funded by the German Federal Ministry of Education and Research (BMBF), the study will focus on alleviating long-term effects such as fatigue and cognitive impairment, with the first patient already enrolled.
Addressing the Unmet Need in Post-COVID Syndrome
Prof. Dr. Maria Vehreschild, who heads the study and oversees Frankfurt University Hospital’s Infectious Diseases Department, emphasized the urgent need for effective PCS treatments. The RAPID_REVIVE trial (Randomized Adaptive Assessment of Post COVID Syndrome Treatments—Reducing Inflammatory Activity in Patients with Post COVID Syndrome) is the first adaptive clinical study within the Network of University Medicine (NUM).
Established in 2020, NUM coordinates clinical COVID-19 research across German university hospitals. RAPID_REVIVE is sponsored by Goethe University Frankfurt and supported by the NAPKON Therapeutic Intervention Platform (NAPKON-TIP). The study aims to include 376 patients across eleven NAPKON locations.
Understanding Post-COVID Syndrome
The World Health Organization (WHO) reports that while most individuals recover fully from COVID-19, a significant subset experiences long-term effects, termed PCS. PCS is characterized by symptoms persisting for at least three months after the initial COVID-19 infection, lasting for at least two months, and not attributable to other diagnoses. Common symptoms include fatigue, shortness of breath, and cognitive impairments.
The RAPID_REVIVE study will monitor changes in participants' physical functions using questionnaires and tests at various time points. It will also assess general mental and physical health, fatigue, cognitive functions, mental health impairments, shortness of breath, and physical resilience. The study seeks to identify prognostic biomarkers to personalize PCS treatment strategies.
Vidofludimus Calcium: A Potential Therapeutic Agent
Participants in the RAPID_REVIVE trial will be randomized (1:1) to receive either vidofludimus calcium (IMU-838) or a placebo. After the inclusion of 150 patients, the allocation will be adjusted based on interim evaluations. Vidofludimus calcium is a novel drug candidate that activates the neuroprotective transcription factor Nurr1, a target for neurodegenerative diseases. It also inhibits dihydroorotate dehydrogenase (DHODH), blocking pyrimidine production, which is crucial for RNA synthesis in highly activated immune cells and virus-infected cells. Vidofludimus calcium may also benefit chronic inflammatory and autoimmune diseases by reducing excessive inflammation and preventing viral infection and reactivation.
Previous clinical trials have shown promising results with vidofludimus calcium in COVID-19 patients, with faster recovery and reduced long-term fatigue compared to placebo. The treatment was well-tolerated with minimal side effects, suggesting its potential in both acute COVID-19 and long-term symptom management.
Prof. Dr. Maria Vehreschild stated, "We hope the RAPID_REVIVE study will constitute a significant advance in the treatment of post-COVID syndrome... [and] provide an established structure available to NUM and external parties for future adaptive studies."
