NCT06113757

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AVB Biotechnology · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-05-16
• Completion: 2024-04-15
• First posted: 2023-11-02
• Last updated: 2024-07-05

Locations

1 site across 1 country: Turkey (Türkiye)