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

NCT05220579 | Completed DMC

• 1 other identifier: SamaraTOR1
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronavirus Infection; COVID-19; electromagnetic therapy; SARS-CoV-2

Outcome Measures

Primary Outcomes (5)

• PCR

  Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR.

  Day 5

• PCR

  Dynamics of changes in the number of banded neutrophils.Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR.

  Day 14

• Banded neutrophils

  Dynamics of changes in the number of banded neutrophils.

  Day 7

• Banded neutrophils

  Dynamics of changes in the number of banded neutrophils.

  Day 14

• Banded neutrophils

  Dynamics of changes in the number of banded neutrophils.

  Day 28

Secondary Outcomes (22)

• Blood oxygen saturation

  Day 2

• Blood oxygen saturation

  Day 3

• Blood oxygen saturation

  Day 4

• Blood oxygen saturation

  Day 5

• Respiratory rate

  Day 2

Study Arms (3)

Exposure to "TOR" device

EXPERIMENTAL

Patients undergo standard therapy + exposure to the "TOR" device Modes of patients' treatment with the "TOR" device: The exposure is carried out for at least 5 (five) days in a row for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break). Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)".

Device: Exposure to "TOR" device

Control

NO INTERVENTION

Patients received standard therapy Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)".

Placebo (exposure to switched off "TOR" device)

PLACEBO COMPARATOR

Patients undergo standard therapy + a switched off "TOR" device was installed in the wards Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)".

Device: Exposure to switched off "TOR" device

Interventions

Exposure to "TOR" device 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.

Exposure to "TOR" device

Exposure to switched off "TOR" device 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.

Placebo (exposure to switched off "TOR" device)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 and over, diagnosed with coronavirus infection COVID-19 after specific testing. When the course of the disease progressed to a severe degree, patients were excluded from the study;
• Signed consent to participate in the trial;
• Patients hospitalized with COVID-19 disease. Positive result of a PCR test (biomaterial - a swab from the nasopharynx and / or oropharynx) for infection with the SARS-CoV-2 virus within 72 hours on the day of screening.
• Patients with characteristic computed tomographic signs of the "ground-glass opacity" (one or two-sided spread) in combination with local foci of consolidation or without them;
• Oxygen therapy is not required, or oxygen therapy is required using a face mask or nasal cannulas;
• The duration of the disease from the first symptoms to the day of screening is not more than 7 days;
• The ability to understand the requirements for research participants, to give written consent to participate in the research (including the use and transfer of information about the health of patients, relevant to the research) and to follow the procedures specified in the research protocol.

You may not qualify if:

• The patient's desire to discontinue participation in the study (withdrawal of informed consent).
• The decision of the investigating physician that the patient should be excluded for the benefit of the patient him/herself;
• The patient refuses to cooperate with the investigator or is not disciplined;
• Death of the patient;
• Progressing of the disease to a severe degree.

Sponsors & Collaborators

• Concern GRANIT: lead
• Samara State Medical University: collaborator

Study Sites (1)

Concern GRANIT

Moscow, 119019, Russia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oleg V Fatenkov, Ph.D, M.D.

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The "TOR" device was provided by the sponsor to the investigators with screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized placebo controlled double-blind trial

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 2, 2022
• Study Start: December 29, 2020
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: February 2, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Until December 31, 2022
• Access Criteria: Upon request to the administrator's email address gryaznov.v@granit-concern.ru

Locations

RU (1)