MADRID-COVID”

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002310-41-ES
• Lead Sponsor: IIS FUNDACION JIMENEZ DIAZ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- =18 years and <80 years
- Admission to ICU =72hr at the time of inclusion
- Hospital admission =5 days at the time of inclusion
- Invasive mechanical ventilation =72hr
- COVID-19 + (diagnosis by PCR in nasal lavage / bronchoalveolar lavage))
- Invasive management (Orotracheal intubation and invasive monitoring)
- Heart rate =80 bpm
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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)<br>2. Inflammatory markers in blood (neutrophil activation and NETs production)<br>3. Incidence of hemodynamic deterioration;Timepoint(s) of evaluation of this end point: Three days

Secondary Outcome Measures

Name	Time	Method
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