Covid19NCT04642326
Study Investigating the Effects of UVC Beam and Laser Beam Therapy According to Standard Therapy in Patients With Covid-19 Diagnosis
A study testing Test Group: experimental - UVC Therapy applied in people with Covid19, run by RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş. at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Test Group: experimental - UVC Therapy applied
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2020to 4 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi
Diyarbakır, Kayapınar, 21010
About this study
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 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Test Group: experimental - UVC Therapy applied
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Group: experimental - UVC Therapy appliedDevice
Also called of Turkish Beam-Selective UV Device Model Number: 1007-001
in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy)
| Study group | Role | What they receive |
|---|---|---|
| Test Group: experimental - UVC Therapy applied | Experimental | Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy Receives: Device: Test Group: experimental - UVC Therapy applied |
| Control Group | No intervention | Control: Antiviral + Antimalarial + Antibiotic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR Sampling
viral load measurement due to covid 19,
Measured: up to 15 days
Blood Tests
Change from reference range in blood urea (mg/dL)
Measured: up to 15 days
Blood Tests
Change from reference range in blood Creatinine (mg/dL)
Measured: up to 15 days
Blood Tests
Change from reference range in blood AST,ALT (U/L)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood count (sodium, potassium mol/L)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood count (total bilirubin mg/dL)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood CRP (mg/L)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood creatine kinase (IU/L)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood LDH (U/L)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood APTT (sec)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood D-Dimer (ng/ml)
Measured: up to 15 days
Blood Tests
Change from reference range in Complete blood Ferritin (ug/L)
Measured: up to 15 days
Radiological Imaging
Radiological findings: Consolidation, ground glass appearance and reticulo-nodular opacity appearance in lung CT.
Measured: up to 15 days
Radiological Imaging
Radiological findings: reticulo-nodular opacity appearance in lung CT.
Measured: up to 15 days
Radiological Imaging
Radiological findings: ground glass appearance in lung CT.
Measured: up to 15 days
Radiological Imaging
Radiological findings: Consolidation in lung CT.
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start26 Jun 2020
- Primary completion1 Jul 2020
- Study completion4 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Parallel, Multicenter Randomized Controlled Study Investigating
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hikmet Selçuk Gedik, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642326
- Sponsor's protocol ID
- MD2020/001
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: During or when the study ends, the data will be shared for scientific publication.
Publications
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.
PubMed 24138193Cheng 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.
PubMed 17934078Yin 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.
PubMed 24060701Mohr 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.
PubMed 19682340Galasso 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.
PubMed 30696822Eickmann 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.
PubMed 31930543Dai 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.
PubMed 21208209Cypel 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.
PubMed 31606437Bak 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.
PubMed 21208210Ultroviolet,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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04642326
- Acronym / sponsor ID
- MD2020/001
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 4 May 2021 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Parallel, Multicenter Randomized Controlled Study Investigating
| Arm | Type | Receives |
|---|---|---|
| Test Group: experimental - UVC Therapy applied | Experimental | Device: Test Group: experimental - UVC Therapy appliedTest: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy |
| Control Group | No intervention | –Control: Antiviral + Antimalarial + Antibiotic Treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Group: experimental - UVC Therapy appliedAlso: of Turkish Beam-Selective UV Device Model Number: 1007-001in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy) | Device | Test Group: experimental - UVC Therapy applied |
Primary outcome
PCR Sampling
Time frame: up to 15 days
viral load measurement due to covid 19,
Blood Tests
Time frame: up to 15 days
Change from reference range in blood urea (mg/dL)
Blood Tests
Time frame: up to 15 days
Change from reference range in blood Creatinine (mg/dL)
Blood Tests
Time frame: up to 15 days
Change from reference range in blood AST,ALT (U/L)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood count (sodium, potassium mol/L)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood count (total bilirubin mg/dL)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood CRP (mg/L)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood creatine kinase (IU/L)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood LDH (U/L)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood APTT (sec)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood D-Dimer (ng/ml)
Blood Tests
Time frame: up to 15 days
Change from reference range in Complete blood Ferritin (ug/L)
Radiological Imaging
Time frame: up to 15 days
Radiological findings: Consolidation, ground glass appearance and reticulo-nodular opacity appearance in lung CT.
Radiological Imaging
Time frame: up to 15 days
Radiological findings: reticulo-nodular opacity appearance in lung CT.
Radiological Imaging
Time frame: up to 15 days
Radiological findings: ground glass appearance in lung CT.
Radiological Imaging
Time frame: up to 15 days
Radiological findings: Consolidation in lung CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 24138193Kim 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.
- Background: PubMed 17934078Cheng 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 publication: PubMed 24060701Yin 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 publication: PubMed 19682340Mohr 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 publication: PubMed 30696822Galasso 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 publication: PubMed 31930543Eickmann 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 publication: PubMed 21208209Dai 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 publication: PubMed 31606437Cypel 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 publication: PubMed 21208210Bak 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 publicationUltroviolet,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 publicationPathogen inactivation method using ultraviolet C light. Journal of Transfusion Medicine, 12(3), 83-87.
- Individual participant dataSharing planned: Undecided. During or when the study ends, the data will be shared for scientific publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Group: experimental - UVC Therapy applied in people with Covid19, run by RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR Sampling (time frame: up to 15 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642326, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.