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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001995-13-ES

Enrollment

500

Registered

2020-05-21

Start date

2020-05-15

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 pneumonia MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Roactemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia. Improvement of respiratory function based on: - Time to intubation (if not previously intubated) and duration of intubation. - Time of non-invasive mechanical ventilation. - Time of oxygen therapy. Mortality rate;Secondary Objective: - To describe oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) - To evaluate radiological evolution - To describe the duration of hospitalization and/or ICU stay - To evaluate the requirement of additional organ support, including kidney dialysis, molecular adsorbent recirculating system (MARS), extracorporeal membrane oxygenation (ECMO), or other - To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers - To describe safety of IV tocilizumab in patients with COVID-19 pneumonia - To identify prognosis factors of IV tocilizumab effectiveness related to inflammatory markers and clinical/radiological features. - To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity, as appropriate. - To compare the effectiveness and safety outcomes based on the different doses of IV tocilizumab used in the participating centres. - To identify patient profile suitable to be benefited with tocilizumab;Primary end point(s): - Respiratory function, defined as: Start date of intubation (in patients not previously initiated). Date of extubation. Start date of NIMV and date of independence from NIMV (duration of NIMV). Start date of oxygen therapy and date of independence from oxygen therapy (duration of oxygen therapy). - Mortality rate.;Timepoint(s) of evaluation of this end point: End points will be evaluated on a ongoing basis during the clinical trial	—

Measure

Time frame

Main Objective: To evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia. Improvement of respiratory function based on: - Time to intubation (if not previously intubated) and duration of intubation. - Time of non-invasive mechanical ventilation. - Time of oxygen therapy. Mortality rate;Secondary Objective: - To describe oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) - To evaluate radiological evolution - To describe the duration of hospitalization and/or ICU stay - To evaluate the requirement of additional organ support, including kidney dialysis, molecular adsorbent recirculating system (MARS), extracorporeal membrane oxygenation (ECMO), or other - To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers - To describe safety of IV tocilizumab in patients with COVID-19 pneumonia - To identify prognosis factors of IV tocilizumab effectiveness related to inflammatory markers and clinical/radiological features. - To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity, as appropriate. - To compare the effectiveness and safety outcomes based on the different doses of IV tocilizumab used in the participating centres. - To identify patient profile suitable to be benefited with tocilizumab;Primary end point(s): - Respiratory function, defined as: Start date of intubation (in patients not previously initiated). Date of extubation. Start date of NIMV and date of independence from NIMV (duration of NIMV). Start date of oxygen therapy and date of independence from oxygen therapy (duration of oxygen therapy). - Mortality rate.;Timepoint(s) of evaluation of this end point: End points will be evaluated on a ongoing basis during the clinical trial

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Secondary

Measure	Time frame
Secondary end point(s): - Levels of oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) at 1 day after the first dose and every 3 days during the hospitalization. - Results from the chest x-ray/computed tomography (CT) scan, including extension of lung affection (unilobar or multilobar, unilateral or bilateral, diffuse) and type (opacities, interstitial infiltrates, pneumothorax, pleural effusion) obtained (when available) throughout the study. - Days of hospitalization in survivors and/or days at ICU throughout the study. - Need of additional organ support, including kidney dialysis, MARS, ECMO, or other throughout the study. - Levels of IL-6, CRP, procalcitonin (PCT), D-dimer and ferritin (when available) throughout the study. - Adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), vital signs, physical examinations, and concomitant medication use over time. - Association between the abovementioned clinical and radiological features and IV tocilizumab effectiveness. - Time to RT-PCR virus negativity, as appropriate. - Respiratory function and adverse events using different doses of tocilizumab in the participating centres. - Categorization of the different parameters of effectiveness and its relation with different factors related to the study treatment, disease status and demographic and clinical factors;Timepoint(s) of evaluation of this end point: End points will be evaluated on a ongoing basis during the clinical trial	—

Measure

Time frame

Secondary end point(s): - Levels of oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) at 1 day after the first dose and every 3 days during the hospitalization. - Results from the chest x-ray/computed tomography (CT) scan, including extension of lung affection (unilobar or multilobar, unilateral or bilateral, diffuse) and type (opacities, interstitial infiltrates, pneumothorax, pleural effusion) obtained (when available) throughout the study. - Days of hospitalization in survivors and/or days at ICU throughout the study. - Need of additional organ support, including kidney dialysis, MARS, ECMO, or other throughout the study. - Levels of IL-6, CRP, procalcitonin (PCT), D-dimer and ferritin (when available) throughout the study. - Adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), vital signs, physical examinations, and concomitant medication use over time. - Association between the abovementioned clinical and radiological features and IV tocilizumab effectiveness. - Time to RT-PCR virus negativity, as appropriate. - Respiratory function and adverse events using different doses of tocilizumab in the participating centres. - Categorization of the different parameters of effectiveness and its relation with different factors related to the study treatment, disease status and demographic and clinical factors;Timepoint(s) of evaluation of this end point: End points will be evaluated on a ongoing basis during the clinical trial

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Countries

Spain

Contacts

Public ContactRaúl Montalbán Casado

Dynamic Science S.L.

raul.m@dynasolutions.com003491 456 11 05

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026