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Clinical Trials/EUCTR2020-001995-13-ES
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

Sponsor
Fundación SEIMC-GESIDA

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