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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group: experimental - UVC Therapy applied | Experimental | Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy |
|
| Control Group | No Intervention | Control: Antiviral + Antimalarial + Antibiotic Treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Group: experimental - UVC Therapy applied | Device | in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi | Diyarbakır | Kayapınar | 21010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24138193 | Background | Kim S, Kim J, Lim W, Jeon S, Kim O, Koh JT, Kim CS, Choi H, Kim O. In vitro bactericidal effects of 625, 525, and 425 nm wavelength (red, green, and blue) light-emitting diode irradiation. Photomed Laser Surg. 2013 Nov;31(11):554-62. doi: 10.1089/pho.2012.3343. Epub 2013 Oct 19. | |
| 17934078 | Background | Cheng VC, Lau SK, Woo PC, Yuen KY. Severe acute respiratory syndrome coronavirus as an agent of emerging and reemerging infection. Clin Microbiol Rev. 2007 Oct;20(4):660-94. doi: 10.1128/CMR.00023-07. |
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During or when the study ends, the data will be shared for scientific publication.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2020 |
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Prospective, Parallel, Multicenter Randomized Controlled Study Investigating
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|
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 |
| 24060701 | Result | Yin R, Dai T, Avci P, Jorge AE, de Melo WC, Vecchio D, Huang YY, Gupta A, Hamblin MR. Light based anti-infectives: ultraviolet C irradiation, photodynamic therapy, blue light, and beyond. Curr Opin Pharmacol. 2013 Oct;13(5):731-62. doi: 10.1016/j.coph.2013.08.009. Epub 2013 Sep 20. |
| 19682340 | Result | Mohr H, Steil L, Gravemann U, Thiele T, Hammer E, Greinacher A, Muller TH, Volker U. A novel approach to pathogen reduction in platelet concentrates using short-wave ultraviolet light. Transfusion. 2009 Dec;49(12):2612-24. doi: 10.1111/j.1537-2995.2009.02334.x. Epub 2009 Aug 4. |
| 30696822 | Result | Galasso M, Feld JJ, Watanabe Y, Pipkin M, Summers C, Ali A, Qaqish R, Chen M, Ribeiro RVP, Ramadan K, Pires L, Bagnato VS, Kurachi C, Cherepanov V, Moonen G, Gazzalle A, Waddell TK, Liu M, Keshavjee S, Wilson BC, Humar A, Cypel M. Inactivating hepatitis C virus in donor lungs using light therapies during normothermic ex vivo lung perfusion. Nat Commun. 2019 Jan 29;10(1):481. doi: 10.1038/s41467-018-08261-z. |
| 31930543 | Result | Eickmann M, Gravemann U, Handke W, Tolksdorf F, Reichenberg S, Muller TH, Seltsam A. Inactivation of three emerging viruses - severe acute respiratory syndrome coronavirus, Crimean-Congo haemorrhagic fever virus and Nipah virus - in platelet concentrates by ultraviolet C light and in plasma by methylene blue plus visible light. Vox Sang. 2020 Apr;115(3):146-151. doi: 10.1111/vox.12888. Epub 2020 Jan 12. |
| 21208209 | Result | Dai T, Kharkwal GB, Zhao J, St Denis TG, Wu Q, Xia Y, Huang L, Sharma SK, d'Enfert C, Hamblin MR. Ultraviolet-C light for treatment of Candida albicans burn infection in mice. Photochem Photobiol. 2011 Mar-Apr;87(2):342-9. doi: 10.1111/j.1751-1097.2011.00886.x. Epub 2011 Feb 10. |
| 31606437 | Result | Cypel M, Feld JJ, Galasso M, Pinto Ribeiro RV, Marks N, Kuczynski M, Kumar D, Bahinskaya I, Bagnato VS, Kurachi C, Slutsky AS, Yeung JC, Donahoe L, de Perrot M, Yasufuku K, Pierre A, Binnie M, Chaparro C, Martinu T, Chen M, Tikkanen J, Chow CW, Sidhu A, Waddell TK, Keshavjee S, Singer LG, Humar A. Prevention of viral transmission during lung transplantation with hepatitis C-viraemic donors: an open-label, single-centre, pilot trial. Lancet Respir Med. 2020 Feb;8(2):192-201. doi: 10.1016/S2213-2600(19)30268-1. Epub 2019 Oct 9. |
| 21208210 | Result | Bak J, Jorgensen TM, Helfmann J, Gravemann U, Vorontsova I. Potential in vivo UVC disinfection of catheter lumens: estimation of the doses received by the blood flow outside the catheter tip hole. Photochem Photobiol. 2011 Mar-Apr;87(2):350-6. doi: 10.1111/j.1751-1097.2011.00887.x. Epub 2011 Jan 31. |
| Result | Ultroviolet,C lrrodiation for Prevention of Centrol Venous Cotheter-reloted · lnfections: An in Vitro Study,Tianhong Dai 1,2, George P. Tegos 1,2§, Tyler G. St. Denis l ,3, Don Anderson4,. Ed SinofskyS ond Michael R. Homblin* l ,2,6, Received 11 Moy 201 O, accepted 8 September 201 o; DOi: l 0.1111/ j.1751-1097.2010.00819 .x |
| Result | Pathogen inactivation method using ultraviolet C light. Journal of Transfusion Medicine, 12(3), 83-87. |
| Nov 20, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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