EUCTR2021-001665-20-HU
Active, not recruiting
Phase 1
Prospective, randomized, controlled, double-blinded study on the efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia
Semmelweis University Department of Oralbiology0 sites200 target enrollmentMarch 26, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- severe COVID-19 pneumonia requires invasive ventillatory support
- Sponsor
- Semmelweis University Department of Oralbiology
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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
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)
Outcomes
Primary Outcomes
Not specified
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