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NCT05220579

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

Completed NA Last updated 2 February 2022
What this trial tests

NA trial testing Exposure to "TOR" device in Coronavirus Infection COVID-19 in 236 participants. Completed in 12 August 2021.

Timeline
29 December 2020
Primary endpoint
12 August 2021
12 August 2021

Quick facts

Lead sponsorConcern GRANIT
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment236
Start date29 December 2020
Primary completion12 August 2021
Estimated completion12 August 2021
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

Concern GRANIT

Who can join

18 and older, any sex, with Coronavirus Infection COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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