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Trial - NCT04642326


Column Value
Trial registration number NCT04642326
Full text link
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Prof. Dr. Hikmet Selçuk

Contact
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

drselcukgedik@gmail.com

Registration date
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-11-24

Recruitment status
Last imported at : Nov. 7, 2022, noon
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

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

Inclusion age min
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

40

Inclusion age max
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Turkey

Type of patients
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

50

primary outcome
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

PCR Sampling;Radiological Imaging;Radiological Imaging;Blood Tests;Radiological Imaging;Blood Tests;Blood Tests;Blood Tests;Blood Tests;Blood Tests;Radiological Imaging;Blood Tests;Blood Tests;Blood Tests;Blood Tests;Blood Tests

Notes
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1343, "treatment_name": "Uvc therapy", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]