The main objective of this pilot trial is to evaluate the effect of metoprolol on biological correlates of benefit of this therapy (inflammatory markers in blood and bronchoalveolar mini-lavage, mini-BAL). In addition, it will study cardiopulmonary hemodynamics to assess the impact of metoprolol administration in the context of respiratory distress in COVID-19
Conditions
Interventions
Trade Name: Beloken 1 mg/ml solución inyectable:
1 ml de solución para inyección contiene 1 mg de metoprolol tartrato
Product Name: metoprolol IV
Product Code: ?C07AB02
Pharmaceutical Form: Injection
Sponsors
IIS FUNDACION JIMENEZ DIAZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Known allergy or hypersensitivity to metoprolol tartrate or other beta-blockers - Cardiac index (CI) =2.5 L / m / m2 - Pulmonary capillary pressure (PCP) =15 mmHg - Invasive systolic blood pressure (SBP) <110 mmHg - Need for dobutamine due to pump failure in the previous 48 hours - LVEF <50% - RV systolic dysfunction in visual estimation - Significant valve disease (moderate-severe). - Patients with previous moderate or severe COPD / ASMA - Previous treatment with beta-blockers - Associated pulmonary thromboembolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this pilot trial is to evaluate the effect of metoprolol on biological correlates of benefit of this therapy (inflammatory markers in blood and bronchoalveolar mini-lavage, mini-BAL). In addition, it will study cardiopulmonary hemodynamics to assess the impact of metoprolol administration in the context of respiratory distress in COVID-19;Secondary Objective: The study will be considered to meet the safety objective as long as no patient out of the 10 randomized to metoprolol i.v. develop cardiogenic shock, defined as IC =2.2 L / m / m2 + invasive systolic pressure <90 mmHg maintained in two measurements separated by 5 minutes;Primary end point(s): 1. Inflammatory markers in BAL (neutrophil activation and NETs production) 2. Inflammatory markers in blood (neutrophil activation and NETs production) 3. Incidence of hemodynamic deterioration;Timepoint(s) of evaluation of this end point: Three days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical evolution (days of mechanical ventilation, days of admission, mortality);Timepoint(s) of evaluation of this end point: index hospitalization period | — |
Countries
Spain
Contacts
Public ContactNOEMI ESCALERA
ISS FJD
Outcome results
None listed