Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
NCT ID: NCT06113757
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-09-01
2024-04-15
Brief Summary
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The aim of this study is to evaluate the safety and efficacy of the Biolyse device. for minimizing the use of drugs in COVID-19 patients and treating drug-related organ damage during treatment We hope that by conducting this study, we will obtain sufficient data to obtain approval (CE certification) for routine use and marketing of this medical device in patients. Once this happens, we will be able to ensure that this device is accessible/usable for patients suffering from similar diseases, especially COVID-19, regardless of any studies.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dr.Biolyse
When you join the Dr. Biolyse® Therapy Group, you will be given electrical signal therapy with the Dr. Biolyse® device. Before the application, the area where the electrodes will be cleaned with appropriate solutions. In addition, 500-1000 ml of isotonic serum will be supplemented according to your weight, just before the first electrical signal application during the day. The treatment protocol to be applied to DBTG patients consists of device therapy and daily fluid support therapy. No medication or different device applications are performed.
Signal Therapy provided by Dr.Biolyse device
Before the application, the area where the electrodes will be cleaned with appropriate solutions. In addition, 500-1000 ml of isotonic serum will be supplemented according to your weight, just before the first electrical signal application during the day. Electrical signal will be applied to the lung and upper leg area for 90 minutes in the morning, noon, and evening on the first 3 days, 60 minutes in the morning and evening on the 4th and 5th days, to the lung and upper leg area. During your first hospitalization, blood will be drawn from you daily for 5 days and evaluated in terms of various biochemical parameters and detailed molecular analyzes.
Liquid Support Treatment
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.
Kontrol
In the CG patients, who constitute the Comparison Group, the same non-drug fluid support therapy applied in device therapy will be repeated (isotonic, isolated 500 ml). As both groups of patients will receive fluid support therapy, the impact of the device on the disease will be observed with monitored parameters.
Liquid Support Treatment
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.
Interventions
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Signal Therapy provided by Dr.Biolyse device
Before the application, the area where the electrodes will be cleaned with appropriate solutions. In addition, 500-1000 ml of isotonic serum will be supplemented according to your weight, just before the first electrical signal application during the day. Electrical signal will be applied to the lung and upper leg area for 90 minutes in the morning, noon, and evening on the first 3 days, 60 minutes in the morning and evening on the 4th and 5th days, to the lung and upper leg area. During your first hospitalization, blood will be drawn from you daily for 5 days and evaluated in terms of various biochemical parameters and detailed molecular analyzes.
Liquid Support Treatment
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with mild moderate complicated or uncomplicated COVID 19 pneumonias
* Those who accept to be followed up and treated as an inpatient
* Those who have at least one laboratory and clinical finding that can be evaluated during follow-up
Exclusion Criteria
* Pregnant or breastfeeding women
* Epilepsy, Arrhythmia, Dementia, heart failure, severe lung disease, patients with active malignancy and those with pacemaker
* "Vulnerable Population" patients defined in ICU
18 Years
65 Years
ALL
No
Sponsors
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AVB Biotechnology
INDUSTRY
Responsible Party
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Principal Investigators
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Serkan Chairman of the Board
Role: PRINCIPAL_INVESTIGATOR
AVB Biotech A.S.
Locations
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Bezmialem Vakif University Dragos Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Ustunova S, Haciosmanoglu E, Bulut H, Elibol B, Kilic A, Hekimoglu R, Tunc S, Atmaca R, Kaygusuz I, Tunc S, Tunc GB, Meral I. A low direct electrical signal attenuates oxidative stress and inflammation in septic rats. PLoS One. 2021 Sep 9;16(9):e0257177. doi: 10.1371/journal.pone.0257177. eCollection 2021.
Related Links
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A low direct electrical signal attenuates oxidative stress and inflammation in septic rats
Other Identifiers
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ASA02-005
Identifier Type: -
Identifier Source: org_study_id
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