Back to resultsStudy Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Test Group: experimental - UVC Therapy applied
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
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
Sites / Locations
- Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test Group: experimental - UVC Therapy applied
Control Group
Arm Description
Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy
Control: Antiviral + Antimalarial + Antibiotic Treatment
Outcomes
Primary Outcome Measures
PCR Sampling
viral load measurement due to covid 19,
Blood Tests
Change from reference range in blood urea (mg/dL)
Blood Tests
Change from reference range in blood Creatinine (mg/dL)
Blood Tests
Change from reference range in blood AST,ALT (U/L)
Blood Tests
Change from reference range in Complete blood count (sodium, potassium mol/L)
Blood Tests
Change from reference range in Complete blood count (total bilirubin mg/dL)
Blood Tests
Change from reference range in Complete blood CRP (mg/L)
Blood Tests
Change from reference range in Complete blood creatine kinase (IU/L)
Blood Tests
Change from reference range in Complete blood LDH (U/L)
Blood Tests
Change from reference range in Complete blood APTT (sec)
Blood Tests
Change from reference range in Complete blood D-Dimer (ng/ml)
Blood Tests
Change from reference range in Complete blood Ferritin (ug/L)
Radiological Imaging
Radiological findings: Consolidation, ground glass appearance and reticulo-nodular opacity appearance in lung CT.
Radiological Imaging
Radiological findings: reticulo-nodular opacity appearance in lung CT.
Radiological Imaging
Radiological findings: ground glass appearance in lung CT.
Radiological Imaging
Radiological findings: Consolidation in lung CT.
Secondary Outcome Measures
Full Information
NCT ID
NCT04642326
First Posted
November 16, 2020
Last Updated
November 20, 2020
Sponsor
RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.
1. Study Identification
Unique Protocol Identification Number
NCT04642326
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
May 4, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Parallel, Multicenter Randomized Controlled Study Investigating
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group: experimental - UVC Therapy applied
Arm Type
Experimental
Arm Description
Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control: Antiviral + Antimalarial + Antibiotic Treatment
Intervention Type
Device
Intervention Name(s)
Test Group: experimental - UVC Therapy applied
Other Intervention Name(s)
of Turkish Beam-Selective UV Device Model Number: 1007-001
Intervention Description
in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy)
Primary Outcome Measure Information:
Title
PCR Sampling
Description
viral load measurement due to covid 19,
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in blood urea (mg/dL)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in blood Creatinine (mg/dL)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in blood AST,ALT (U/L)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood count (sodium, potassium mol/L)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood count (total bilirubin mg/dL)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood CRP (mg/L)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood creatine kinase (IU/L)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood LDH (U/L)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood APTT (sec)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood D-Dimer (ng/ml)
Time Frame
up to 15 days
Title
Blood Tests
Description
Change from reference range in Complete blood Ferritin (ug/L)
Time Frame
up to 15 days
Title
Radiological Imaging
Description
Radiological findings: Consolidation, ground glass appearance and reticulo-nodular opacity appearance in lung CT.
Time Frame
up to 15 days
Title
Radiological Imaging
Description
Radiological findings: reticulo-nodular opacity appearance in lung CT.
Time Frame
up to 15 days
Title
Radiological Imaging
Description
Radiological findings: ground glass appearance in lung CT.
Time Frame
up to 15 days
Title
Radiological Imaging
Description
Radiological findings: Consolidation in lung CT.
Time Frame
up to 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi
City
Diyarbakır
State/Province
Kayapınar
ZIP/Postal Code
21010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
During or when the study ends, the data will be shared for scientific publication.
Citations:
PubMed Identifier
24138193
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.
Results Reference
background
PubMed Identifier
17934078
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. doi: 10.1128/CMR.00023-07.
Results Reference
background
PubMed Identifier
24060701
Citation
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.
Results Reference
result
PubMed Identifier
19682340
Citation
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.
Results Reference
result
PubMed Identifier
30696822
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 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.
Results Reference
result
PubMed Identifier
31930543
Citation
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.
Results Reference
result
PubMed Identifier
21208209
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.1751-1097.2011.00886.x. Epub 2011 Feb 10.
Results Reference
result
PubMed Identifier
31606437
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, 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.
Results Reference
result
PubMed Identifier
21208210
Citation
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.
Results Reference
result
Citation
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
Results Reference
result
Citation
Pathogen inactivation method using ultraviolet C light. Journal of Transfusion Medicine, 12(3), 83-87.
Results Reference
result
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Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis
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