Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04479358
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab 40mg
  • Tocilizumab — DRUG
    Tocilizumab 120mg
  • Standard of Care — OTHER
    Tocilizumab-Free Standard of Care
  • Standard of Care — OTHER
    Tocilizumab 400mg or 8mg/kg

Study Details

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled trial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg). Randomization was stratified on remdesivir and corticosteroid at enrollment. The primary outcome was the time to recovery. The key secondary outcome was 28-day mortality.

Key Dates

Start date
Sep 10, 2020
Status verified
May 2026
Primary completion
Mar 1, 2024
Completion
Feb 10, 2025

Study Design

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

Arms

  • Active Comparator: Sub-study A, Tocilizumab-Free Standard of Care
    Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab.
  • Experimental: Sub-study A, Tocilizumab 40mg
    Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg.
  • Experimental: Sub-study A, Tocilizumab 120mg
    Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg.
  • Active Comparator: Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care
    Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg).
  • Experimental: Sub-study B, Tocilizumab 40mg
    Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg.
  • Experimental: Sub-study B, Tocilizumab 120mg
    Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg.

Primary Outcome Measure

Time to Recovery [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago MedicineChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of Chicago Medicine· Chicago, IL

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