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

NCT04642326 | Unknown

• 1 other identifier: MD2020/001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

Test Group: experimental - UVC Therapy applied

EXPERIMENTAL

Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy

Device: Test Group: experimental - UVC Therapy applied

Control Group

NO INTERVENTION

Control: Antiviral + Antimalarial + Antibiotic Treatment

Interventions

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)

Also known as: of Turkish Beam-Selective UV Device Model Number: 1007-001

Test Group: experimental - UVC Therapy applied

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.: lead

Study Sites (1)

Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi

Diyarbakır, Kayapınar, 21010, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 24138193 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.

  PMID: 17934078 BACKGROUND

• 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.

  PMID: 24060701 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.

  PMID: 19682340 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.

  PMID: 30696822 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.

  PMID: 31930543 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.

  PMID: 21208209 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.

  PMID: 31606437 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.

  PMID: 21208210 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.

  RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgeon

Model Details: Prospective, Parallel, Multicenter Randomized Controlled Study Investigating

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 24, 2020
• Study Start: June 26, 2020
• Primary Completion: July 1, 2020
• Study Completion: May 4, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

TU (1)