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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04642326
• Other study ID #: MD2020/001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: November 2020
• Source: RD Global Arastirma Gelistirme Saglik Ilaç Insaat Yatirimlari A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 4, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Turkey	Diyarbakir SBÜ Gazi Yasargil Egitim Ve Arastirma Hastanesi	Diyarbakir	Kayapinar

Sponsors (1)

Lead Sponsor	Collaborator
RD Global Arastirma Gelistirme Saglik Ilaç Insaat Yatirimlari A.S.

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Bak J, Jørgensen 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: 10.111 — View Citation

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. Review. — View Citation

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, W — View Citation

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.1751-1097.2011.00 — View Citation

Eickmann M, Gravemann U, Handke W, Tolksdorf F, Reichenberg S, Müller TH, Seltsam A. Inactivation of three emerging viruses - severe acute respiratory syndrome coronavirus, Crimean-Congo haemorrhagic fever virus and Nipah virus - in platelet concentrates — View Citation

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 — View Citation

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. — View Citation

Mohr H, Steil L, Gravemann U, Thiele T, Hammer E, Greinacher A, Müller TH, Völker 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.1537-2995.2009.02 — View Citation

Pathogen inactivation method using ultraviolet C light. Journal of Transfusion Medicine, 12(3), 83-87.

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

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.201 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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