Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis
NCT ID: NCT04642326
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-06-26
2021-05-04
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Group: experimental - UVC Therapy applied
Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy
Test Group: experimental - UVC Therapy applied
in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy)
Control Group
Control: Antiviral + Antimalarial + Antibiotic Treatment
No interventions assigned to this group
Interventions
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Test Group: experimental - UVC Therapy applied
in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.
INDUSTRY
Responsible Party
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Hikmet Selçuk Gedik
Cardiovascular Surgeon
Locations
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Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi
Diyarbakır, Kayapınar, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Pathogen inactivation method using ultraviolet C light. Journal of Transfusion Medicine, 12(3), 83-87.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MD2020/001
Identifier Type: -
Identifier Source: org_study_id