Clinical trial NCT06113757: Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Virus Diseases
COVID-19
Keywords: electrification
signal therapy
dr.biolyse
Lead sponsor: AVB Biotechnology
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The clinical study is designed on a comparative control basis, comparing treatment interventions applied to patients. As there are no medical devices with antiviral effects, the comparison is structured to evaluate the progression and effects of the disease. It is specifically designed to compare the change between the group receiving only liquid serum support and supportive treatment and the group receiving Dr. Biolyse® treatment, with the aim of demonstrating the development and impact of the disease.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Reaction
timeFrame: 5 days, during hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Dragos Hospital
Study officials:
affiliation: AVB Biotech A.S.
name: Serkan Chairman of the Board
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.