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

Phase 1

• Conditions: severe COVID-19 pneumonia requires invasive ventillatory support; MedDRA version: 23.1Level: LLTClassification code 10084564Term: SARS-CoV-2 pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001665-20-HU
• Lead Sponsor: Semmelweis University Department of Oralbiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-26
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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 <200 (at PEEP > 5 H2O cm)
- serum prokalcitonin < 0.5 ng/ml
- serum ferritin > 500 ng/ml
- 20 < BMI <45
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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) <br>- the number of Ventillator Free Days (VFD) in an interval of 28 days<br>;Timepoint(s) of evaluation of this end point: the change in PaO2/FiO2 (Horowitz index): at day 7<br>the number of Ventillator Free Days (VFD): at day 28<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): change in PaO2/FiO2 <br>change in sequential organ failure score (SOFA score) <br>length of invasive ventillation (in an interval of 28 days)<br>length of ICU stay (LOS) (in an interval of 28 days)<br>length of inotropic/vasopressor support (in an interval of 28 days)<br>lenght of hospital stay (LOS) (in an interval of 28 days)<br>mortality (in an interval of 28 days)<br>ICU mortality (in an interval of 28 days)<br>the effect on inflammatory response measured as changes in CRP and IL-6<br>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: <br>change in PaO2/FiO2 <br>change in sequential organ failure score (SOFA score) <br>changes in CRP and IL-6<br><br>at day 28: <br>length of invasive ventillation <br>length of ICU stay (LOS) <br>length of inotropic/vasopressor support <br>lenght of hospital stay (LOS) <br>mortality <br>ICU mortality <br>frequency of serious adverse events<br>