A Randomized Blind Placebo-controlled 3rd Phase Study of the Safety and Efficacy of the Device "Device for Non-invasive Electromagnetic Therapy "TOR" in 236 Patients Diagnosed With Moderate Coronavirus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- PCR
研究概览
简要总结
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.
详细描述
This is a research work with the participation of patients to study the effect of low-power electromagnetic radiation with a selected spectrum on infected cells and the SARS-CoV-2 virus itself.
In the course of work with wave emitters Research center of JSC "Concern GRANIT" conducted research in the field of the body's response to various wave frequencies and their combinations. In February 2020, the Concern's specialists, based on open information, created a computer model of the SARS-CoV-2 virus (COVID-19).
After creating the simulation, work was carried out to isolate the spectrum of the wave emanating from the COVID-19 virus colony and infected cells.
The resulting spectrum was modified for the purpose of noise pollution, and as a result the virus should lose activity and the standard line of behavior, which in turn should lead to a pause in its spread and enable the human immune system to cope with the infection on its own.
Based on these assumptions, the prepared wave spectrum was recorded into the "TOR" device emitter, acting with an electromagnetic field with an intensity not exceeding that of a household microwave oven.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
PCR
时间窗: Day 14
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.
Banded neutrophils
时间窗: Day 28
Dynamics of changes in the number of banded neutrophils.
次要结局
- Respiratory rate(Day 5)
- Blood oxygen saturation(Day 5)
- NEWS-2 (National Early Warning Score) scale(Day 28)
- Ordinal Scale for Clinical Improvement(Day 28)