Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)

Sponsor
Hospital Universitario Ramon y Cajal
Study ID
NCT04435717
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

Key Dates

Start date
May 4, 2020
Status verified
Aug 2021
Primary completion
Nov 4, 2020
Completion
Feb 10, 2021

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TCZ 8 mg / kg one dose
    TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
  • Experimental: TCZ 8 mg / kg in two
    TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
  • No Intervention: standard care treatment
    Usual / standard care treatment

Primary Outcome Measure

Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3. [ Time Frame: Day1 and Day3. ]

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