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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
magnetostimulation
standard therapy
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, magnetostimulation, interleukin, treatment

Eligibility Criteria

39 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation and Physical Medicine, Medical University of LodzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with COVID - 19, who we were treated with magnetic stimulation.

Patients with COVID - 19, who we were treated without magnetic stimulation.

Arm Description

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.

The control group included patients receiving a comprehensive treatment without magnetic stimulation. The patients were in a moderately severe condition.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2021
Last Updated
January 16, 2023
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT05163613
Brief Title
Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients
Official Title
Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients: Preliminary Reports.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia
Keywords
COVID-19, magnetostimulation, interleukin, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with COVID - 19, who we were treated with magnetic stimulation.
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with COVID - 19, who we were treated without magnetic stimulation.
Arm Type
Experimental
Arm Description
The control group included patients receiving a comprehensive treatment without magnetic stimulation. The patients were in a moderately severe condition.
Intervention Type
Other
Intervention Name(s)
magnetostimulation
Other Intervention Name(s)
low frequency magnetic field, magnetostimultaion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the level of proinflammatory factors (IL - 6)
Description
decrease in the level of proinflammatory factors (IL - 6)
Time Frame
14 days
Title
the level of leukocytes (WBC)
Description
restoration of homeostasis in the body with regards to the range of WBC
Time Frame
14 days
Title
the level of monocytes (MONO)
Description
restoration of homeostasis in the body with regards to the range of MONO
Time Frame
14 days
Title
the level of platelets (PLT),
Description
restoration of homeostasis in the body with regards to the range of PLT
Time Frame
14 days
Title
the level of CRP (c reactive protein)
Description
restoration of homeostasis in the body with regards to the range of CRP
Time Frame
14 days
Title
the level of d-dimers.
Description
restoration of homeostasis in the body with regards to the range of d-dimers
Time Frame
14 days
Title
arterial blood pressure,
Description
normalization of the arterial blood pressure,
Time Frame
14 days
Title
the number of breaths/min
Description
normalization of the number of breaths/min
Time Frame
14 days
Title
saturation
Description
normalization of saturation
Time Frame
14 days
Title
temperature
Description
normalization of temperature
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Jankowska, doctor
Phone
532519534
Ext
+48
Email
agnieszka.jankowska@umed.lodz.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Woldańska-Okońska, profesor
Phone
601377610
Ext
+48
Email
marta.woldanska-okonska@umed.lodz.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Woldańska-Okońska, profesor
Organizational Affiliation
Department of Rehabilitation and Physical Medicine, Medical University of Lodz
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Agnieszka Jankowska, doctor
Organizational Affiliation
Department of Rehabilitation and Physical Medicine, Medical University of Lodz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Irzmański, profesor
Organizational Affiliation
Department of Internal Medicine and Cardiac Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarzyna Glibov, doctor
Organizational Affiliation
Department of Internal Medicine and Cardiac Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation and Physical Medicine, Medical University of Lodz
City
Łódź
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Jankowska, Doctor
Phone
532519534
Ext
+48
Email
agnieszka.jankowska@umed.lodz.pl
First Name & Middle Initial & Last Name & Degree
Marta Woldańska-Okońska, Profesor
Phone
601377610
Ext
+48
Email
marta.woldanska-okonska@umed.lodz.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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