A randomized evaluation of the treatment of post-COVID syndrome
Medical recommendations are based on high-quality evidence, which is ideally generated by randomized controlled trials (RCTs). In order to collect sufficient data to assess a therapy, a new RCT is usually set up for each new therapeutic approach. This procedure is associated with long implementation times, high costs and a lack of flexibility. Adaptive platform studies are considered a practicable solution to these problems. The “National Pandemic Cohort Network – Therapeutic Intervention Platform” (NAPKON-TIP) aims to establish an infrastructure for adaptive clinical platform studies in Germany. NAPKON-TIP is part of the Network University Medicine (NUM) infrastructure.
Together with renowned university project partners, cosinuss° contributes to the first use case of the NAPKON-TIP infrastructure entitled “Randomized adaptive assessment of Post-COVID-Syndrom treatments_Reducing Inflammatory Activity in Patients with post COVID Syndrome (RAPID_REVIVE)”.
RAPID_REVIVE: Randomized adaptive assessment of Post-COVID-Syndrom treatments_Reducing Inflammatory Activity in Patients with post COVID Syndrome
People suffering from post-COVID often have to contend with impaired functioning of the autonomic nervous system. This is usually accompanied by a considerable restriction of activity. Traditional tests based on medical examinations to record these limitations and to measure the effects of therapeutic measures have generally been of limited quality to date. The use of health sensors, on the other hand, can enable optimum data quality.
Project objective
As part of this interventional study, a drug intervention is being tested in post-COVID patients. The cosinuss° in-ear sensors are used to record vital signs.
Project structure
Between 350 and 400 people will take part in the study. The required data will be collected at the participants’ homes after they have initially been familiarized with the technology and its use at the study center and given the necessary components to take home. The measured data will be transmitted to the relevant hospital and made available.
Duration
The study is expected to start in the third quarter of 2024. The project is scheduled to run for 12 months.
Vital parameter measurement with cosinuss° patient monitoring
It is very important to capture a signal with as little artifact as possible, as changes in post-COVID syndrome can be very subtle. The external auditory canal offers ideal conditions in this respect, as the sensor can be securely anchored in the auditory canal and no interference signals are generated due to the darkness. Previous studies with remotely monitored patients have already shown that the cosinuss° sensors reliably measure vital signs (e.g. TeleCovid, CO-SI-ONKO).
Outcomes
We will report on the initial results as soon as they are available.
Partners involved
- Charité – University Medicine Berlin
- Bielefeld University with Faculty of Medicine and UK OWL
- University Hospital Frankfurt
- University Medical Center Göttingen
- University Medical Center Greifswald
- University Hospital Giessen and Marburg
- Hanover Medical School
- University Hospital Cologne
- University Hospital Würzburg
- Klinikum rechts der Isar of the Technical University of Munich
- German Research Center for Environmental Health Munich
Further information
Status: April 2024