Clinical trial NCT04642326: Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.
Sponsor class: INDUSTRY
First posted: 2020-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Parallel, Multicenter Randomized Controlled Study Investigating
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PCR Sampling
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Blood Tests
timeFrame: up to 15 days
measure: Radiological Imaging
timeFrame: up to 15 days
measure: Radiological Imaging
timeFrame: up to 15 days
measure: Radiological Imaging
timeFrame: up to 15 days
measure: Radiological Imaging
timeFrame: up to 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi
state: Kayapınar
Study officials:
References:
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