Clinical trial NCT05163613: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
COVID-19 Respiratory Infection
COVID-19 Pneumonia
Keywords: COVID-19
magnetostimulation
interleukin
treatment
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 120
Sex: ALL
Minimum age (years): 39
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the level of proinflammatory factors (IL - 6)
timeFrame: 14 days
measure: the level of leukocytes (WBC)
timeFrame: 14 days
measure: the level of monocytes (MONO)
timeFrame: 14 days
measure: the level of platelets (PLT),
timeFrame: 14 days
measure: the level of CRP (c reactive protein)
timeFrame: 14 days
measure: the level of d-dimers.
timeFrame: 14 days
measure: arterial blood pressure,
timeFrame: 14 days
measure: the number of breaths/min
timeFrame: 14 days
measure: saturation
timeFrame: 14 days
measure: temperature
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Department of Rehabilitation and Physical Medicine, Medical University of Lodz
Study officials:
affiliation: Department of Rehabilitation and Physical Medicine, Medical University of Lodz
name: Marta Woldańska-Okońska, profesor
role: STUDY_DIRECTOR
affiliation: Department of Rehabilitation and Physical Medicine, Medical University of Lodz
name: Agnieszka Jankowska, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine and Cardiac Rehabilitation
name: Robert Irzmański, profesor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine and Cardiac Rehabilitation
name: Katarzyna Glibov, doctor
role: PRINCIPAL_INVESTIGATOR
References: