Prospective, Parallel, Multicenter Randomized Controlled Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PCR Sampling
研究概览
简要总结
Clinical research study that evaluates the effect of Turkish Beam-Selective UV developed by RD GLOBAL ARAŞTIRMA GELİŞTİRME SAĞLIK İLAÇ İNŞAAT YATIRIMLARI A.Ş. use into Intravascular, Intrapulmonary, Intratracial, Intrarespiratory area. Bacteria, Fungal and Virus-based pathogens systematically to collect and evaluate specific clinical performance and safety data.
This Clinical Research aims to investigate the effectiveness of the treatment group and control group mortality rates, intensive care hospitalization times, monitoring the virus load by PCR, and the treatment effectiveness of UVC application.
This Clinical Research covers determining the treatment effectiveness and reliability of UVC application to patient groups, the details of which are determined in the protocol.
详细描述
DESIGN
Prospective, parallel, multicentre, randomized controlled study Ages between 40 and 75 years of age and positive symptoms such as fever, malaise, cough, and shortness of breath, or positive atypical pneumonia in CT findings or COVID-19 (SARS-CoV-2) test In the intensive care unit, which is accepted as COVID 19 infection and has been treated, patients will be treated with UVC radiation and laser beam treatment according to IKU principles in addition to Antimalarial therapy + Antiviral therapy + Anitibiotic therapy. Standard treatment consisting of Antimalarial therapy + Antiviral therapy + Antibiotic therapy will be applied to the control group. The dosage of the standard treatment consisting of antimalarial therapy + Antiviral therapy + Anitibiotic therapy, the number of days of treatment, and its active ingredient are indicated in the table.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Respiratory rate ≥ 30
- •Dyspnea and breathing difficulties findings
- •Cases with oxygen saturation below 90% despite nasal oxygen support of 5 liters / minute and above
- •Cases with partial oxygen pressure below 70 mmHg despite nasal oxygen support of 5 liters / minute and above
- •PaO2 / FiO2 <300 Lactate> 4 mmol / L Bilateral infiltrations or multi-lobar involvement on chest x-ray or tomography
- •Hypotension (systolic blood pressure <90 mmHg,> 40 mmHg drop from usual SKB, mean arterial pressure <65 mmHg)
- •Skin perfusion disorder Organ dysfunction such as kidney function test, liver function test disorder, thrombocytopenia, confusion Presence of immunosuppressive disease- Presence of uncontrolled comorbidity with more than one feature
- •Troponin height, arrhythmia
- •COVID 19 Test positivity
排除标准
- •Under 40 years old
- •Pregnant women and those with suspected pregnancy
- •Those with a history of anaphylaxis
- •Those with known DNA repair deficiencies:
- •Those diagnosed with mental disorder,
- •puerperant women and lactating women
结局指标
主要结局
PCR Sampling
时间窗: up to 15 days
viral load measurement due to covid 19,
Radiological Imaging
时间窗: up to 15 days
Radiological findings: Consolidation, ground glass appearance and reticulo-nodular opacity appearance in lung CT.
Blood Tests
时间窗: up to 15 days
Change from reference range in blood urea (mg/dL)
次要结局
未报告次要终点
研究者
Hikmet Selçuk Gedik
Cardiovascular Surgeon
Gazi University