COVID-19NCT05163613
Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients
A study testing magnetostimulation and standard therapy in people with COVID-19 and COVID-19 Respiratory Infection, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 39 to 80 years
- Conditions the study is for
- COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia
- What is being tested?
- magnetostimulation and standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection
Who cannot join
- patients with absolute contraindications to magnetic field application
- patients with limited verbal - logical contact were excluded from the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Rehabilitation and Physical Medicine, Medical University of Lodz
Lodz
Agnieszka Jankowska, Doctor, 532519534 ext. +48, agnieszka.jankowska@umed.lodz.pl
Marta Woldańska-Okońska, Profesor, 601377610 ext. +48, marta.woldanska-okonska@umed.lodz.pl
About this study
Official title: Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients: Preliminary Reports.
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.
Read the 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.
- Conditions
- COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia
- Being tested
- magnetostimulation, standard therapy
- Keywords
- COVID-19, magnetostimulation, interleukin, treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetostimulationOther
Also called low frequency magnetic field, magnetostimultaion
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: magnetostimulation; Other: 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. Receives: Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of proinflammatory factors (IL - 6)
decrease in the level of proinflammatory factors (IL - 6)
Measured: 14 days
the level of leukocytes (WBC)
restoration of homeostasis in the body with regards to the range of WBC
Measured: 14 days
the level of monocytes (MONO)
restoration of homeostasis in the body with regards to the range of MONO
Measured: 14 days
the level of platelets (PLT),
restoration of homeostasis in the body with regards to the range of PLT
Measured: 14 days
the level of CRP (c reactive protein)
restoration of homeostasis in the body with regards to the range of CRP
Measured: 14 days
the level of d-dimers.
restoration of homeostasis in the body with regards to the range of d-dimers
Measured: 14 days
arterial blood pressure,
normalization of the arterial blood pressure,
Measured: 14 days
the number of breaths/min
normalization of the number of breaths/min
Measured: 14 days
saturation
normalization of saturation
Measured: 14 days
temperature
normalization of temperature
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Woldańska-Okońska, profesor, Study director, Department of Rehabilitation and Physical Medicine, Medical University of LodzAgnieszka Jankowska, doctor, Principal investigator, Department of Rehabilitation and Physical Medicine, Medical University of LodzRobert Irzmański, profesor, Principal investigator, Department of Internal Medicine and Cardiac RehabilitationKatarzyna Glibov, doctor, Principal investigator, Department of Internal Medicine and Cardiac Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163613
- Sponsor's protocol ID
- RNN/339/20/KE
- Other IDs
- RNN/339/20/KE
- Status last verified
- Jan 2023
- First submitted
- 17 Dec 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low-frequency Magnetic Fields in the Hybrid Treatment of COVID-19 Patients: Preliminary Reports.
- ClinicalTrials.gov ID
- NCT05163613
- Acronym / sponsor ID
- RNN/339/20/KE
- Conditions
- COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia
- Keywords
- COVID-19, magnetostimulation, interleukin, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID - 19, who we were treated with magnetic stimulation. | Experimental | Other: magnetostimulation, Other: standard therapyThe 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. |
| Patients with COVID - 19, who we were treated without magnetic stimulation. | Experimental | Other: standard therapyThe control group included patients receiving a comprehensive treatment without magnetic stimulation. The patients were in a moderately severe condition. |
Who may qualify
- Ages
- 39 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients hospitalized due to PCR-confirmed SARS - Cov - 2 infection
Key exclusion criteria (2 listed)
- patients with absolute contraindications to magnetic field application
- patients with limited verbal - logical contact were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetostimulationAlso: low frequency magnetic field, magnetostimultaionTreatment 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. | Other | Patients with COVID - 19, who we were treated with magnetic stimulation. |
| standard therapyStandard 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 | Patients with COVID - 19, who we were treated with magnetic stimulation., Patients with COVID - 19, who we were treated without magnetic stimulation. |
Primary outcome
the level of proinflammatory factors (IL - 6)
Time frame: 14 days
decrease in the level of proinflammatory factors (IL - 6)
the level of leukocytes (WBC)
Time frame: 14 days
restoration of homeostasis in the body with regards to the range of WBC
the level of monocytes (MONO)
Time frame: 14 days
restoration of homeostasis in the body with regards to the range of MONO
the level of platelets (PLT),
Time frame: 14 days
restoration of homeostasis in the body with regards to the range of PLT
the level of CRP (c reactive protein)
Time frame: 14 days
restoration of homeostasis in the body with regards to the range of CRP
the level of d-dimers.
Time frame: 14 days
restoration of homeostasis in the body with regards to the range of d-dimers
arterial blood pressure,
Time frame: 14 days
normalization of the arterial blood pressure,
the number of breaths/min
Time frame: 14 days
normalization of the number of breaths/min
saturation
Time frame: 14 days
normalization of saturation
temperature
Time frame: 14 days
normalization of temperature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Woldańska-Okońska, profesor study director
Department of Rehabilitation and Physical Medicine, Medical University of Lodz
Agnieszka Jankowska, doctor principal investigator
Department of Rehabilitation and Physical Medicine, Medical University of Lodz
Robert Irzmański, profesor principal investigator
Department of Internal Medicine and Cardiac Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetostimulation and standard therapy in people with COVID-19 and COVID-19 Respiratory Infection, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Jankowska, doctor (532519534 ext. +48, agnieszka.jankowska@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of proinflammatory factors (IL - 6) (time frame: 14 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.