Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia
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
1 other identifier
interventional
495
1 country
42
Brief Summary
At present, no treatment has been approved for COVID-19. However, in light of the increased interest on using the anti-cytokine therapy targeting IL-6 tocilizumab in COVID-19 infected patients due to its potential benefit, the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) have initiated the controlled distribution of the drug. Tocilizumab is indeed proposed as a potential treatment for severe COVID-19 in Spain. Based on the positive results of tocilizumab in the treatment of COVID-19 patients and the experience of tocilizumab in inducing rapid reversal of CSS in other pathologies several clinical trials and observational studies are being conducted to assess the effectiveness and safety of tocilizumab in COVID-19 patients. Further studies with a large sample size are required to confirm the effectiveness of tocilizumab in patients with COVID-19 pneumonia. The need for the management of severe COVID-19 disease is imperative, and every effort should be made to collect relevant clinical outcomes. The aim of the present study is to evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia who are currently hospitalized or admitted to ICU by describing improvement of respiratory function and mortality rate. This large real-world cohort therefore provides a unique opportunity to study this potential medicine during the current emergency situation, and support the findings from other ongoing clinical trials and observational studies, such as the Roche-sponsored Phase III study that is planned to start early April.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started May 2020
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2020
CompletedFirst Submitted
Initial submission to the registry
June 13, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2020
CompletedJune 2, 2021
June 1, 2020
7 months
June 13, 2020
May 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To calulate the time of intubation
Calculate the mean time of intubation
through study completion, and average of 1 month
To calculate the time with oxygen therapy
Calculate the mean time with oxygen therapy
through study completion, and average of 1 month
To calculate the time with Non-invasive mechanical ventilation
Calculate the mean time with Non-invasive mechanical ventilation
through study completion, and average of 1 month
To evaluate mortality rate
Number of patients deaths of the total of patients included
through study completion, and average of 1 month
Secondary Outcomes (27)
To calculate respiratory function parameters
through study completion, and average of 1 month
To calculate respiratory function parameters
through study completion, and average of 1 month
To calculate respiratory function parameters
through study completion, and average of 1 month
To evaluate radiological lung extension
through study completion, and average of 1 month
To evaluate radiological evolution
through study completion, and average of 1 month
- +22 more secondary outcomes
Study Arms (1)
Tocilizumab
EXPERIMENTALPatients will receive IV tocilizumab as per clinical practice and at the discretion of treating investigator, following the posology indicated in the SmPC, or the recommendations proposed by the Spanish Ministry of Health: The recommended posology by the SmPC is 8 mg per kg in patients weighing greater than or equal to 30 kg or 12 mg per kg in patients weighing less than 30 kg. If no clinical improvement in the signs and symptoms up to 3 additional doses of tocilizumab may be administered. The interval between consecutive doses should be at least 8 hours. The recommendations of the Spanish Ministry of Health: Patients more than 80 kg: first dose 600 mg; second dose 600 mg. Patients less than 80 kg: first dose 600 mg; second dose 400 mg. A third dose might be considered 16 to 24 hours after if: fever persists or a worsening of the laboratory parameters Given the exceptionality of the situation modification of doses according to the physician experience will be allowed.
Interventions
Eligibility Criteria
You may qualify if:
- Provide oral informed consent to participate in this study.
- At least 18 years of age.
- Diagnosed with COVID-19 pneumonia by RT-PCR.
- Hospitalized or admitted to ICU
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- Roche Pharma AGcollaborator
- Dynamic Science S.L.collaborator
Study Sites (42)
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Sant Joan de Déu de Manresa
Manresa, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Universitario de Galdakao
Galdakao, Bizkaia, Spain
Hospital Universitario Marqués Valdecilla
Santander, Cantabria, Spain
Hospital Público General del Tomelloso
Tomelloso, Ciudad Real, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Clínic i Provincial Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Dr. Josep Trueta
Girona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Universitario Salamanca
Salamanca, Spain
Hospital Universitario Virgen de la Macarena
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Virgen de la Salud
Toledo, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Universitari i Poliectenic La Fe
Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Related Publications (1)
Maude SL, Barrett D, Teachey DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014 Mar-Apr;20(2):119-22. doi: 10.1097/PPO.0000000000000035.
PMID: 24667956BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Antonio Pérez Molina
Hospital Universitario Ramón y Cajal
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2020
First Posted
June 24, 2020
Study Start
May 22, 2020
Primary Completion
December 23, 2020
Study Completion
December 23, 2020
Last Updated
June 2, 2021
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share