COVID-19 PneumoniaDoBiC-19NCT06113757
Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
A study testing Signal Therapy provided by Dr.Biolyse device and Liquid Support Treatment in people with COVID-19 Pneumonia and Virus Diseases, run by AVB Biotechnology at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Pneumonia, Virus Diseases, COVID-19
- What is being tested?
- Signal Therapy provided by Dr.Biolyse device and Liquid Support Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Dragos Hospital
Istanbul
About this study
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
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
- Being tested
- Signal Therapy provided by Dr.Biolyse device, Liquid Support Treatment
- Keywords
- electrification, signal therapy, dr.biolyse
- Medical subject headings
- Virus Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal Therapy provided by Dr.Biolyse deviceDevice
Also called Quantum Signal Therapy Technology
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.
Liquid Support TreatmentOther
The control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Dr.Biolyse | Experimental | 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. Receives: Device: Signal Therapy provided by Dr.Biolyse device; Other: Liquid Support Treatment |
| Kontrol | Experimental | 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. Receives: Other: Liquid Support Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days, during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Sep 2022
- Primary completion16 May 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVB Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serkan Chairman of the Board, Principal investigator, AVB Biotech A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113757
- Sponsor's protocol ID
- ASA02-005
- Acronym
- DoBiC-19
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34499695
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06113757
- Acronym / sponsor ID
- DoBiC-19 / ASA02-005
- Conditions
- COVID-19 Pneumonia, Virus Diseases, COVID-19
- Keywords
- electrification, signal therapy, dr.biolyse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AVB BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dr.Biolyse | Experimental | Device: Signal Therapy provided by Dr.Biolyse device, Other: Liquid Support TreatmentWhen 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. |
| Kontrol | Experimental | Other: Liquid Support TreatmentIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signal Therapy provided by Dr.Biolyse deviceAlso: Quantum Signal Therapy TechnologyBefore 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. | Device | Dr.Biolyse |
| Liquid Support TreatmentThe control group will only receive fluid therapy and will be monitored with the same blood parameters throughout the hospitalization. | Other | Dr.Biolyse, Kontrol |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 34499695Ustunova 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.
- A low direct electrical signal attenuates oxidative stress and inflammation in septic ratsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Chairman of the Board principal investigator
AVB Biotech A.S.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signal Therapy provided by Dr.Biolyse device and Liquid Support Treatment in people with COVID-19 Pneumonia and Virus Diseases, run by AVB Biotechnology at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Reaction (time frame: 5 days, during hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.