Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease

COVID-19 Clinical Trial

— DoBiC-19  

Official title:

Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease: Prospective, Controlled Medical Device Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113757
• Other study ID #: ASA02-005
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: October 2023
• Source: AVB Biotechnology
• Contact: Rabia Scientific Research Coordinator
• Phone: +9005551035606
• Email: ratmaca[@]avbbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dr. Biolyse® is a device with artificial intelligence that works in sync with the immune system and can be integrated like an element of this system. It is designed to develop chemical immunity within the body against infections. It gives electrical signals to the body without causing any pain and suffering to the patient. The electric current it applies is of a type that is not used in homes, and it is the frequency feature of direct current.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 15, 2024
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women between the ages of 18-65

• 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:

• Patients with severe course or COVID 19 pneumonia requiring intensive care follow-up

• 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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Virus Diseases

Intervention

Device:
• 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.

Other:
• Liquid Support Treatment
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Dragos Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
AVB Biotechnology

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Reaction	The fundamental principle of this study is to prioritize the preservation of the volunteer's health. Therefore, in the event of multiple serious adverse effects that pose a threat to the life of the volunteers during device applications and cannot be prevented, or if the device applications fail to achieve the targeted effectiveness within the framework of the examined parameters, the research will be terminated.	5 days, during hospital stay

External Links

•   A low direct electrical signal attenuates oxidative stress and inflammation in septic rats