Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. In laboratory tests, the following levels were assessed in the patients: interleukin 6 (IL -6), leukocytes (WBC), monocytes (MONO), platelets (PLT), CRP and d-dimers. The patients' blood was taken twice: on admission to the department and after a series of treatments with magnetostimulation. Approximately 6 ml of blood was collected at one time (3 tubes). Medical records of the patients and scientific reports collected from the University Library and medical databases, e.g. PubMed, were analyzed and discussed.

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

Conditions
-----------------
COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Other: magnetostimulation
* Other: standard therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection Exclusion Criteria: patients with absolute contraindications to magnetic field application patients with limited verbal - logical contact were excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 39 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with COVID - 19, who we were treated with magnetic stimulation.<br>The study group included patients hospitalized due to PCR-confirmed SARS-Cov-2 infection, who were treated with magnetic stimulation in addition to a standard therapy. Standard therapy used in all patients consisted of the use of pharmacological agents necessary to treat the viral infection (antiviral drugs, antibiotics, dexamethasone) and the inclusion of proper care, education, occupational therapy, self-service learning, breathing exercises and motor mobilization. | Other: magnetostimulation<br>* 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.<br>* Other names: magnetostimultaion;Other: standard therapy<br>* Standard therapy used in all patients consisted of the use of pharmacological agents necessary to treat the viral infection (antiviral drugs, antibiotics, dexamethasone) and the inclusion of proper care, education, occupational therapy, self-service learning, breathing exercises and motor mobilization.<br>|
| Experimental: Patients with COVID - 19, who we were treated without magnetic stimulation.<br>The control group included patients receiving a comprehensive treatment without magnetic stimulation. The patients were in a moderately severe condition. | Other: standard therapy<br>* Standard therapy used in all patients consisted of the use of pharmacological agents necessary to treat the viral infection (antiviral drugs, antibiotics, dexamethasone) and the inclusion of proper care, education, occupational therapy, self-service learning, breathing exercises and motor mobilization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the level of proinflammatory factors (IL - 6) | decrease in the level of proinflammatory factors (IL - 6) | 14 days | 
| the level of leukocytes (WBC) | restoration of homeostasis in the body with regards to the range of WBC | 14 days | 
| the level of monocytes (MONO) | restoration of homeostasis in the body with regards to the range of MONO | 14 days | 
| the level of platelets (PLT), | restoration of homeostasis in the body with regards to the range of PLT | 14 days | 
| the level of CRP (c reactive protein) | restoration of homeostasis in the body with regards to the range of CRP | 14 days | 
| the level of d-dimers. | restoration of homeostasis in the body with regards to the range of d-dimers | 14 days | 
| arterial blood pressure, | normalization of the arterial blood pressure, | 14 days | 
| the number of breaths/min | normalization of the number of breaths/min | 14 days | 
| saturation | normalization of saturation | 14 days | 
| temperature | normalization of temperature | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, magnetostimulation, interleukin, treatment