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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163613
• Other study ID #: RNN/339/20/KE
• Secondary ID: RNN/339/20/KE
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2023
• Source: Medical University of Lodz
• Contact: Agnieszka Jankowska, doctor
• Phone: 532519534
• Email: agnieszka.jankowska[@]umed.lodz.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 39 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Respiratory Tract Infections

Intervention

Other:
• magnetostimulation
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.
• 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.

Locations

Country	Name	City	State
Poland	Department of Rehabilitation and Physical Medicine, Medical University of Lodz	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

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