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

July 4, 2024 updated by: AVB Biotechnology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University Dragos Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Names:
  • Quantum Signal Therapy Technology
Other: Liquid Support Treatment
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.
Experimental: 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.
Other: Liquid Support Treatment
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Reaction
Time Frame: 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.
5 days, during hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVB Biotechnology

Investigators

  • Principal Investigator: Serkan Chairman of the Board, AVB Biotech A.S.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASA02-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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