Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease: Prospective, Controlled Medical Device Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serious Adverse Reaction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Liquid Support Treatment (Other)
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.
干预措施: Liquid Support Treatment (Other)
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.
干预措施: Signal Therapy provided by Dr.Biolyse device (Device)
结局指标
主要结局
Serious Adverse Reaction
时间窗: 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.
次要结局
未报告次要终点