Status:
TERMINATED
Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19
Lead Sponsor:
Hospital Sao Domingos
Conditions:
Cytokine Release Syndrome
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study compare the efficacy and safety of tocilizumab versus methylprednisolone in the cytokine release syndrome of patients with COVID-19
Detailed Description
In December 2019, several patients were diagnosed with pneumonia of undefined etiology in Wuhan, China. A few days later, a virus was identified as the etiologic agent. It was a new beta coronavirus t...
Eligibility Criteria
Inclusion
- Men and non-pregnant women over 18 years old COVID diagnosis confirmed by real time polymerase chain reaction (RT-PCR) Pao2 / FIO2 \<200 Laboratory: high sensitivity C reactive protein\> 5 mg / L; lactic dehydrogenase (LDH ) \> 245 U / l; Ferritin\> 300; D-dimer\> 1500; Interleukin-6\> 7.0 pg / ml.
Exclusion
- Known sensitivity/Allergy to tocilizumab
- Active tuberculosis
- Pregnancy
- Individuals, in the opinion of the investigators where progression to death is imminent and inevitable in the next 24 hours
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04377503
Start Date
May 1 2020
End Date
November 30 2020
Last Update
March 29 2022
Active Locations (1)
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1
Hospital Sao Domingos
São Luís, Maranhão, Brazil, 65060-000