Status:
COMPLETED
Clinical Trial to Evaluate the Effectiveness and Safety of Tocilizumab for Treating Patients With COVID-19 Pneumonia
Lead Sponsor:
Fundacion SEIMC-GESIDA
Collaborating Sponsors:
Roche Pharma AG
Dynamic Science S.L.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Cytokine storm syndrome (CSS) is caused by the excessive release of cytokines during an exaggerated immune response. CSS can be triggered by infections or therapeutic interventions, being more severe ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT04445272
Start Date
May 22 2020
End Date
December 23 2020
Last Update
June 2 2021
Active Locations (42)
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1
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
3
Hospital Sant Joan de Déu de Manresa
Manresa, Barcelona, Spain
4
Hospital de Mataró
Mataró, Barcelona, Spain