EUCTR2020-001995-13-ESActive, not recruitingPhase 1
A multicentre, open-label clinical trial to evaluate the effectiveness and safety of intravenous tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study
Fundación SEIMC-GESIDA0 sites500 target enrollmentStarted: May 21, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Provide oral informed consent to participate in this study.
- •- At least 18 years of age.
- •- Diagnosed with COVID-19 pneumonia by RT-PCR.
- •- Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment.
- •- Hospitalized or admitted to ICU.
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
Exclusion Criteria
- •- The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient’s safety or collected data.
- •- Known severe allergic reactions to tocilizumab or other monoclonal antibodies.
- •- Active acute and severe infections, including tuberculosis infection.
- •- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
Investigators
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