Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Device: Test Group: experimental - UVC Therapy applied


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Parallel, Multicenter Randomized Controlled Study Investigating
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group: experimental - UVC Therapy applied<br>Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy | Device: Test Group: experimental - UVC Therapy applied<br>* in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy)<br>* Other names: of Turkish Beam-Selective UV Device Model Number: 1007-001;|
| No Intervention: Control Group<br>Control: Antiviral + Antimalarial + Antibiotic Treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR Sampling | viral load measurement due to covid 19, | up to 15 days | 
| Blood Tests | Change from reference range in blood urea (mg/dL) | up to 15 days | 
| Blood Tests | Change from reference range in blood Creatinine (mg/dL) | up to 15 days | 
| Blood Tests | Change from reference range in blood AST,ALT (U/L) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood count (sodium, potassium mol/L) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood count (total bilirubin mg/dL) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood CRP (mg/L) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood creatine kinase (IU/L) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood LDH (U/L) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood APTT (sec) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood D-Dimer (ng/ml) | up to 15 days | 
| Blood Tests | Change from reference range in Complete blood Ferritin (ug/L) | up to 15 days | 
| Radiological Imaging | Radiological findings: Consolidation, ground glass appearance and reticulo-nodular opacity appearance in lung CT. | up to 15 days | 
| Radiological Imaging | Radiological findings: reticulo-nodular opacity appearance in lung CT. | up to 15 days | 
| Radiological Imaging | Radiological findings: ground glass appearance in lung CT. | up to 15 days | 
| Radiological Imaging | Radiological findings: Consolidation in lung CT. | up to 15 days |