NCT05163613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

December 17, 2021

Last Update Submit

January 16, 2023

Conditions

COVID-19COVID-19 Respiratory InfectionCOVID-19 Pneumonia

Keywords

COVID-19magnetostimulationinterleukintreatment

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (2)

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

EXPERIMENTAL

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: magnetostimulationOther: standard therapy

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

EXPERIMENTAL

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

Other: standard therapy

Interventions

magnetostimulationOTHER

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.

Also known as: low frequency magnetic field, magnetostimultaion
Patients with COVID - 19, who we were treated with magnetic stimulation.
standard therapyOTHER

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.

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

Eligibility Criteria

Age39 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation and Physical Medicine, Medical University of Lodz

Lodz, Poland

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Marta Woldańska-Okońska, profesor

    Department of Rehabilitation and Physical Medicine, Medical University of Lodz

    STUDY DIRECTOR

  • Agnieszka Jankowska, doctor

    Department of Rehabilitation and Physical Medicine, Medical University of Lodz

    PRINCIPAL INVESTIGATOR

  • Robert Irzmański, profesor

    Department of Internal Medicine and Cardiac Rehabilitation

    PRINCIPAL INVESTIGATOR

  • Katarzyna Glibov, doctor

    Department of Internal Medicine and Cardiac Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Jankowska, doctor

CONTACT

532519534agnieszka.jankowska@umed.lodz.pl

Marta Woldańska-Okońska, profesor

CONTACT

601377610marta.woldanska-okonska@umed.lodz.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2021

First Posted

December 20, 2021

Study Start

January 1, 2020

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)