Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04361552
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Best Practice — OTHER
    Receive standard of care
  • Tocilizumab — BIOLOGICAL
    Given IV

Study Details

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

Key Dates

Start date
Apr 7, 2020
Status verified
Jun 2020
Primary completion
Jun 2, 2020
Completion
Jun 2, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (tocilizumab, standard of care)
    Patients receive tocilizumab IV every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
  • Active Comparator: Arm II (standard of care)
    Patients receive standard of care.

Primary Outcome Measure

7-day length of invasive mechanical ventilation (MV) [ Time Frame: Up to 7 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

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