Efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia

Prospective, randomized, controlled, double-blinded study on the efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001665-20-HU

Enrollment

200

Registered

2021-03-26

Start date

2021-04-20

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe COVID-19 pneumonia requires invasive ventillatory support MedDRA version: 23.1 Level: LLT Classification code 10084564 Term: SARS-CoV-2 pneumonia System Organ Class: 100000004862

Interventions

Trade Name: Natrium-hydrogen-carbonicum Pharmamagist 42 mg/ml oldatos injekció Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Inhalation solution Route of adm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 5 H2O cm) - serum prokalcitonin 500 ng/ml - 20 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the oxygenization of ventillated patients with COVID-19 pneumonia;Secondary Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the clinical and inflammatory status of ventillated patients with COVID-19 pneumonia To assess the safety of nebulized 4.2% sodium bicarbonate in ventillated patients with COVID-19 pneumonia;Primary end point(s): - the change in PaO2/FiO2 (Horowitz index) - the number of Ventillator Free Days (VFD) in an interval of 28 days ;Timepoint(s) of evaluation of this end point: the change in PaO2/FiO2 (Horowitz index): at day 7 the number of Ventillator Free Days (VFD): at day 28	—

Measure

Time frame

Main Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the oxygenization of ventillated patients with COVID-19 pneumonia;Secondary Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the clinical and inflammatory status of ventillated patients with COVID-19 pneumonia To assess the safety of nebulized 4.2% sodium bicarbonate in ventillated patients with COVID-19 pneumonia;Primary end point(s): - the change in PaO2/FiO2 (Horowitz index) - the number of Ventillator Free Days (VFD) in an interval of 28 days ;Timepoint(s) of evaluation of this end point: the change in PaO2/FiO2 (Horowitz index): at day 7 the number of Ventillator Free Days (VFD): at day 28

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Secondary

Measure	Time frame
Secondary end point(s): change in PaO2/FiO2 change in sequential organ failure score (SOFA score) length of invasive ventillation (in an interval of 28 days) length of ICU stay (LOS) (in an interval of 28 days) length of inotropic/vasopressor support (in an interval of 28 days) lenght of hospital stay (LOS) (in an interval of 28 days) mortality (in an interval of 28 days) ICU mortality (in an interval of 28 days) the effect on inflammatory response measured as changes in CRP and IL-6 safety parameters as the frequency of serious adverse events;Timepoint(s) of evaluation of this end point: at days 0, 1, 3, 7, 14, 28: change in PaO2/FiO2 change in sequential organ failure score (SOFA score) changes in CRP and IL-6 at day 28: length of invasive ventillation length of ICU stay (LOS) length of inotropic/vasopressor support lenght of hospital stay (LOS) mortality ICU mortality frequency of serious adverse events	—

Measure

Time frame

Secondary end point(s): change in PaO2/FiO2 change in sequential organ failure score (SOFA score) length of invasive ventillation (in an interval of 28 days) length of ICU stay (LOS) (in an interval of 28 days) length of inotropic/vasopressor support (in an interval of 28 days) lenght of hospital stay (LOS) (in an interval of 28 days) mortality (in an interval of 28 days) ICU mortality (in an interval of 28 days) the effect on inflammatory response measured as changes in CRP and IL-6 safety parameters as the frequency of serious adverse events;Timepoint(s) of evaluation of this end point: at days 0, 1, 3, 7, 14, 28: change in PaO2/FiO2 change in sequential organ failure score (SOFA score) changes in CRP and IL-6 at day 28: length of invasive ventillation length of ICU stay (LOS) length of inotropic/vasopressor support lenght of hospital stay (LOS) mortality ICU mortality frequency of serious adverse events

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Countries

Hungary

Contacts

Public ContactDepartment of Oralbiology

Semmelweis University

zsembery.akos@dent.semmelweis-univ.hu

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026