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临床试验/NCT05163613
NCT05163613招募中不适用

Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients: Preliminary Reports.

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
the level of monocytes (MONO)

研究概览

简要总结

The purpose of this study was to evaluate the efficacy of low-frequency magnetic field in the hybrid treatment of COVID-19 patients, i.e., including magnetostimulation in the standard treatment. The authors evaluated among other things, the immunocorrective therapeutic effect of magnetostimulation, improving the defensive functions of the immune system and thus supporting the immune function by, among other things, suppressing the "cytokine storm".

After application of low-frequency magnetic field in the hybrid treatment of COVID-19 patients, the authors expected: a decrease in the level of proinflammatory factors (IL - 6), restoration of homeostasis in the body with regards to the range of parameters evaluated in laboratory tests (WBC, MONO, PLT, CRP, d-dimers) and normalization of the following parameters: arterial blood pressure, the number of breaths/min, saturation, temperature.

详细描述

Study aim:

The purpose of this study was to evaluate the efficacy of low-frequency magnetic field in the hybrid treatment of COVID-19 patients, i.e., including magnetostimulation in the standard treatment.

Material and methods:

The study was conducted on patients aged 39 to 80 years, of both sexes affected by COVID-19. The study subjects were recruited at the Covid Unit of the Military Medical Academy University Teaching Hospital - Central Veterans' Hospital in Lodz. The study group (13 patients) included patients hospitalized due to PCR (polymerase chain reaction)-confirmed SARS (severe acute respiratory syndrome) -Cov-2 infection, who were treated with magnetostimulation in addition to a standard therapy. The control group (10 patients) included patients receiving a comprehensive treatment without magnetostimulation. The patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection were qualified for the study. Patients with absolute contraindications to magnetic field application and patients with limited verbal - logical contact were excluded from the study.

In the study groups, the patients were subjected to magnetic field - magnetostimulation with the use of apparatus Viofor JPS System (mata). 14 treatments were performed, 7 times a week. Treatment parameters: 12 minutes M2P2 program, with increasing intensity from 1 to 8. The authors applied magnetic field with a frequency of 180 - 190 Hz, pulse packet frequencies between 12.5 and 29 Hz, packet groups 2.8 - 7.6 Hz, series 0.08 - 0.3 Hz, with magnetic induction B= 3.2 µT (on average) and B = 40 µT at a pulse peak.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
39 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection

排除标准

  • patients with absolute contraindications to magnetic field application
  • patients with limited verbal - logical contact were excluded from the study

结局指标

主要结局

the level of monocytes (MONO)

时间窗: 14 days

restoration of homeostasis in the body with regards to the range of MONO

the level of CRP (c reactive protein)

时间窗: 14 days

restoration of homeostasis in the body with regards to the range of CRP

saturation

时间窗: 14 days

normalization of saturation

temperature

时间窗: 14 days

normalization of temperature

the level of proinflammatory factors (IL - 6)

时间窗: 14 days

decrease in the level of proinflammatory factors (IL - 6)

the level of leukocytes (WBC)

时间窗: 14 days

restoration of homeostasis in the body with regards to the range of WBC

the level of platelets (PLT),

时间窗: 14 days

restoration of homeostasis in the body with regards to the range of PLT

arterial blood pressure,

时间窗: 14 days

normalization of the arterial blood pressure,

the level of d-dimers.

时间窗: 14 days

restoration of homeostasis in the body with regards to the range of d-dimers

the number of breaths/min

时间窗: 14 days

normalization of the number of breaths/min

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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