Tocilizumab in Coronavirus-19 Positive Patients

Sponsor
University of Calgary
Study ID
NCT04423042
Phase
PHASE3
Status
Unknown

Conditions

  • COVID-19
  • Coronavirus
  • Covid19
  • Inflammation
  • Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility Criteria

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

Interventions

  • Tocilizumab — BIOLOGICAL
    Tocilizumab binds to both soluble and membrane-bound interleukin-6 receptors and has been shown to inhibit interleukin 6-mediated signalling.

Study Details

This is a cohort study of COVID-19 patients with hyperinflammation. It aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death when untreated is estimated to be 50-80%.

Key Dates

Start date
Jul 30, 2020
Status verified
Jul 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab Arm
    Tocilizumab 8 mg/kg IV up to a maximum of 800 mg with possible repetition of the same dosage within 28 hours (the optional second dose after 12 hours but before 28 hours following the first dose), based on the clinical judgement of the attending physician in consultation with the COVID-inflammation team.
  • No Intervention: No Intervention Arm
    No intervention arm patients will be identified from medical records, as being COVID-19 positive patients with hyperinflammation who did not receive any interleukin antagonist treatment.

Primary Outcome Measure

All-cause mortality [ Time Frame: Assessed at 30 days post treatment ]

Central Contacts

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