Clinical trial to evaluate the efficacy and safety of tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study

Phase 1

• Conditions: COVID-19 pneumonia; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001995-13-ES
• Lead Sponsor: Fundación SEIMC-GESIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-21
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

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

Study & Design

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