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

Not Applicable

Completed

• Conditions: COVID-19 Pneumonia; Virus Diseases; COVID-19
• Interventions: Other: Liquid Support Treatment; Device: Signal Therapy provided by Dr.Biolyse device

• Registration Number: NCT06113757
• Lead Sponsor: AVB Biotechnology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-05-16
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-02
• Study Completion: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kontrol	Liquid Support Treatment	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.
Dr.Biolyse	Signal Therapy provided by Dr.Biolyse device	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.
Dr.Biolyse	Liquid Support Treatment	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.

Primary Outcome Measures

Name	Time	Method
Serious Adverse Reaction	5 days, during hospital stay	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.

Trial Locations

Locations (1)

Bezmialem Vakif University Dragos Hospital; 🇹🇷 Istanbul, Turkey