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Trial - EUCTR2021-001665-20-HU


Column Value
Trial registration number EUCTR2021-001665-20-HU
Full text link
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001665-20/HU

First author
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Semmelweis University - Department of Oralbiology

Contact
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

zsembery.akos@dent.semmelweis-univ.hu

Registration date
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2021-03-26

Recruitment status
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

- antigen or PCR test verified COVID-19 pneumonia - age: 18-64 yrs - informed consent - CT-verified bilateral GGO > 50% (CORADS 6) - invasive ventillation within 48hrs - PaO2/FiO2 <200 (at PEEP > 5 H2O cm) - serum prokalcitonin < 0.5 ng/ml - serum ferritin > 500 ng/ml - 20 < BMI <45 - antigén teszttel vagy PCR-el igazolt COVID pneumonia - életkor: 18-64 év - a beteg vagy közeli hozzátartozója informált beleegyezését adta a vizsgálatba - CT-vel igazolt bilaterális GGO > 50% (CORADS 6) - bevonástól számított 48 órán belül intubált gépi lélegeztetett beteg - PaO2/FiO2 <200 (PEEP > 5 H2O cm mellett). - serum prokalcitonin szint < 0.5 ng/ml - serum ferritin > 500 ng/ml - 20 < BMI <45

Exclusion criteria
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

- hypernatremia - metabolic alkalosis - relevant concomitant disease (excluding well-controlled hypertension) - renal failure: se creatinin > 200 µM (on adequate volume tehrapy) - liver failure (se bilirubin > 34 µM) - hematologic disease - chronic immune and/or hemopoetic disease - bacterial infection (evaluated as serum prokalcitonin szint > 0.5 ng/ml, purulent sputum, unilateral pulmonary consolidation) - hypernatrémia - metabolikus alkalózis - releváns kísérőbetegség (kivétel jól beállított magasvérnyomás betegség) - veseelégtelenség: egyensúlyi se creatinin > 200 µM (adekvát volumenterápia ellenére) - májelégtelenség (se bilirubin > 34 µM) - ismert vérképzőszervi betegség - bármilyen immun/vérképzőszervrendszert érintő krónikus megbetegedés - bakteriális fertőzés valószínűsége (serum prokalcitonin szint > 0.5 ng/ml, purulens köpet, féloldali pulmonális konszolidáció)

Number of arms
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Semmelweis University Department of Oralbiology

Inclusion age min
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

64

Countries
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Hungary

Type of patients
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Severe/critical disease at enrollment

Severity scale
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

7: Severe/critical disease at enrollment

Total sample size
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

200

primary outcome
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

- the change in PaO2/FiO2 (Horowitz index) - the number of Ventillator Free Days (VFD) in an interval of 28 days - az oxigenizációs index változása (Az artériás oxigéntenzió PaO2 és a belégzett oxigénfrakció (FiO2) hányadosának naptári nap során mért legrosszabb értéke) - Ventillator Free Days (VFD) (időintervallum: 28 nap) (endotrachealis intubáció / tracheostoma nélkül töltött idő)

Notes
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Declared number of arm (3.0) differs from found arms (2.0)

Phase
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : April 22, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "nebulized 4.2% sodium bicarbonate", "treatment_id": 1213, "treatment_name": "Sodium bicarbonate", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]