TELECOVID

1200 patients diagnosed with COVID-19 in Munich are monitored using a non-invasive sensor placed into the external ear canal. The sensor enables continuous measurement of body temperature, oxygen saturation (SpO2), respiratory and heart frequencies as well as the calculation of an autonomic Polyscore.
The transfer device calculates the current risk and automatically transmits the data to the server. If pre-set limits are exceeded, an alarm is automatically triggered at the study centre. Trained specialists (medical students/study nurses) check the plausibility of the current measurement (quality of the PPG raw signal, trends in the last hours). If the alarm triggering measurement is plausible, a physician is contacted who carries out the risk assessment according to an algorithm based on recent experience in China.
The data is transmitted via an encrypted Bluetooth channel to a Raspberry Pi. All data are automatically transmitted to a web server. The primary endpoint is total mortality within two months. Approximately 8% of COVID-19 patients in the over-60 age group are expected to die. To demonstrate a 33% reduction in mortality, the inclusion of 1200 participants in Munich is required (power 80%, α 5%). The control group in another German major city, e.g. Berlin, must be at least as large. The primary endpoint will be compared between groups using a Mantel-Haenszel Test with stratification for sex and age categories.