Clinical Trial of a Medical Device "Device for Non-invasive Electromagnetic Therapy "TOR" in the Treatment of COVID-19"

Summary

A clinical trial was conducted with human participation in order to assess the safety and efficacy of the medical device "TOR device for non-invasive electromagnetic therapy" when used as an adjunct in combination with standard COVID-19 treatment methods to accelerate the elimination (elimination) of the SARS-COV-2 virus from the nasopharynx in patients diagnosed with COVID-19.

Device principle of operation is based on the use of weak electromagnetic radiation, continuously induced by high-voltage pulses on the launcher of a pulsed electromagnetic field electrodes and causing noise in the SARS-CoV-2 virus.

The study included 236 patients who met all of the specified criteria: male and female patients aged ≥ 18 years with a coronavirus infection COVID-19 established diagnosis after specific testing, with a course of moderate disease, who do not require mechanical ventilation at the time of enrollment in the study. Infection with the SARS-CoV-2 virus had to be confirmed by PCR (nasopharyngeal and oropharyngeal swab). Informed consent was obtained from all patients. Results were statistically evaluated for 222 patients due to death and exclusion from the clinical study of 14 patients.

Patients of the test group were exposed to the "TOR" device for at least 5 (five) consecutive days for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break) in combination with standard therapy. Patients in the placebo group were exposed to the switched off "TOR" device in combination with standard therapy. The control group received standard therapy. Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the current version of the Temporary guidelines of the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". The study had the periods of screening (day 1, visit 0 - V0), treatment (days 2-6, visits 1-5 - V1-V5), discharge (day 7-14, visit 6 - V6), follow-up (day 26 -30, visit 7 - V7).

As a result of the clinical trial, it was established: "The device of non-invasive electromagnetic therapy "TOR" is safe when used as directed; effective as an adjuvant in combination with standard COVID-19 treatments to accelerate the elimination of the SARS-COV-2 virus from the nasopharynx.

Conditions

• Coronavirus Infection COVID-19

Interventions

DEVICE

Exposure to "TOR" device

Specific wave spectrum is directed by the "TOR" device to human tissues affected by the SARS-CoV-2 virus in order to disrupt its activity.

DEVICE

Exposure to switched off "TOR" device

The "TOR" device has screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators.

Sponsors & Collaborators

• Samara State Medical University

  collaborator OTHER

• Concern GRANIT

  lead INDUSTRY

Principal Investigators

• Oleg V Fatenkov, Ph.D, M.D. · Samara State Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-29

Primary Completion

2021-08-12

Completion

2021-08-12

Countries

• Russia

Study Locations