An innovative study for the treatment of post-COVID syndrome (PCS) is starting under the direction of Frankfurt University Hospital's Department of Infectious Diseases. The research project, funded by the German Federal Ministry of Education and Research (BMBF), will investigate new ways of alleviating the long-term effects of COVID-19, including fatigue and cognitive impairment. The first patient has been enrolled in the study this week.
"There is still an urgent need for the treatment of post-COVID and associated symptoms," says Prof. Dr. Maria Vehreschild, who heads the study and oversees Frankfurt University Hospital's Infectious Diseases Department. "That is why we are pleased to conduct RAPID_REVIVE, the first adaptive clinical study within the Network of University Medicine." The German Network of University Medicine (NUM) was set up in 2020 as part of the country's COVID-19 pandemic crisis management to coordinate clinical COVID-19 research at German university hospitals.
RAPID_REVIVE (Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome) is a phase 2, adaptive, randomized, placebo-controlled, and double-blind clinical trial sponsored by Goethe University Frankfurt and funded by the Federal Ministry of Education and Research (BMBF) as part of NUM. The structural conditions required to commence the study were created as part of the NUM project "NAPKON Therapeutic Intervention Platform" (NAPKON-TIP). A total of 376 patients at eleven different NAPKON locations will be included in the study.
Post-COVID Syndrome
The World Health Organization (WHO) estimates that most people who have had COVID-19 recover fully. However, after overcoming the infection, a subset of those affected suffer long-term effects, known as post-COVID syndrome (PCS). PCS is defined by symptoms that remain even three months after the onset of COVID-19, that continue for at least two months thereafter and that cannot be explained by another diagnosis. While the symptoms are diverse, those affected by PCS often suffer from pronounced fatigue, shortness of breath as well as cognitive impairments.
The RAPID_REVIVE study examines changes in the physical functions of participants, which are recorded at different points in time using questionnaires and tests. Beyond that, the study also looks at general mental and physical health, fatigue, cognitive functions, the severity of mental health impairments, shortness of breath and physical resilience. The study also seeks to identify prognostic biomarkers that provide information about the individual progression of PCS, which should pave the way for the selection of a treatment strategy tailored to the individual patient.
Vidofludimus calcium: Testing a promising drug candidate
Study participants will receive either the drug vidofludimus calcium (IMU-838) or a placebo. The decision as to who receives which preparation is randomly made (blinded 1:1 randomization). Once 150 patients have been included in the study, the allocation will be adjusted in accordance with the study's interim evaluations. Vidofludimus calcium is a novel drug candidate that activates the neuroprotective transcription factor Nurr1, a novel target for neurodegenerative diseases. In addition, the drug inhibits the enzyme DHODH, thereby blocking the production of pyrimidines, which cells rely on primarily for RNA synthesis. It is particularly effective in highly activated immune cells as well as virus-infected cells, which have a high demand for pyrimidines. Administering vidofludimus calcium could also help in treating chronic inflammatory and autoimmune diseases, since the drug reduces excessive inflammation and prevents viral infection and reactivation.
Vidofludimus calcium showed promising results in an earlier clinical trial involving COVID-19 patients: Those who received the drug recovered faster and suffered less long-term fatigue compared to those who received a placebo. The treatment was well tolerated with few side effects. Vidofludimus calcium could thus not only help with the acute treatment of COVID-19, but also alleviate long-term symptoms.
"We hope the RAPID_REVIVE study will constitute a significant advance in the treatment of post-COVID syndrome. Thanks to the successful implementation within the NAPKON-TIP structures, the platform should provide an established structure available to NUM and external parties for future adaptive studies - which will enable us to react flexibly to new findings and ensure the best possible patient care," says Prof. Dr. Maria Vehreschild, adding: "We look forward to receiving the results of this groundbreaking study and evaluating its potential impact on future therapeutic approaches."
Links:
Study at German Network of University Medicine (NUM) (in German)
https://www.netzwerk-universitaetsmedizin.de/projekte/napkon-tip/studie-rapid-revive
German Network of University Medicine (NUM)
https://www.netzwerk-universitaetsmedizin.de/en/about-us/network-of-university-medicine
WHO information on post-COVID 19 condition (long COVID):
https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition
