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

November 20, 2020 updated by: Hikmet Selçuk Gedik, RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kayapınar
      • Diyarbakır, Kayapınar, Turkey, 21010
        • Diyarbakır SBÜ Gazi Yaşargil Eğitim Ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group: experimental - UVC Therapy applied
Test: Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy
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)
Other Names:
  • of Turkish Beam-Selective UV Device Model Number: 1007-001
No Intervention: Control Group
Control: Antiviral + Antimalarial + Antibiotic Treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RD Global Araştirma Geliştirme Sağlik Ilaç Inşaat Yatirimlari A.Ş.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Anticipated)

May 4, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD2020/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

During or when the study ends, the data will be shared for scientific publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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