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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 |
|
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"}] |