EFFICACY OF THE TOR NON-INVASIVE ELECTROMAGNETIC THERAPY DEVICE FOR THE REMOTE TREATMENT OF COVID-19 CLEARANCE: PHASE II CLINICAL TRIAL RESULTS

Background. The COVID-19 pandemic necessitated innovative approaches for effective treatment and rehabilitation of patients. This study explores the use of remote pulsed electromagnetic field (PEMF) therapy for virus elimination in the human oro- and naso-pharynx. For this purpose, a PEMP-based method was developed and implemented in the device “TOR”. Purpose. To evaluate the safety and efficacy of the medical device when used for its intended purpose, as established by the manufacturer of “Non-invasive electromagnetic therapy device “TOR” according to BEMP.941523.001TU”. Materials and Methods. This article reports on a randomized Phase II clinical trial evaluating this approach. In the trial, PEMF therapy was administered for five consecutive days, with a regime of 15-minute exposure with magnetic flux density of 1.5 µT, with peak electrode voltages 5-6.5 kV and pulse frequencies of 100-150 Hz from a distance of 5 metres from the patient to the TOR device. The therapy was combined with a standard anti-COVID treatment. A total of 236 patients were divided into three groups: control, experimental (activated “TOR” device) with standard therapy, and placebo (deactivated “TOR” device) with standard therapy. Results. On the 5th day, 87% of patients receiving PEMF therapy had a negative PCR result, compared to 43% in the control group. By day 14th, this increased to 99% for the PEMF group, compared with 85% in the control group. Conclusion. The combination of “TOR” non-invasive electromagnetic therapy device with standard COVID-19 treatment significantly accelerated patient recovery, with a high rate of PCR-negative results and no reported side effects. This trial is registered at ClinicalTrials.gov (NCT05220579). The “TOR” device was registered as a medical device in the State Register of the Federal Service for Surveillance in Healthcare of the Russian Federation (#RZN 2021/15459 dated September 23rd, 2021, register dossierNoRD36804/79643).