Tocilizumab in Coronavirus-19 Positive Patients
A Nested Interventional Cohort Study to Assess the Efficacy and Safety of Adjunctive Humanized Monoclonal Interleukin-6 Receptor Blocker Tocilizumab (TCZ) Therapy to Standard of Care for the Reduction of Hyperinflammation Related Mortality in SARS-Cov2 Positive Patients
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2020
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 22, 2020
July 1, 2020
10 months
June 5, 2020
July 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause mortality
Mortality status of participants
Assessed at 30 days post treatment
Secondary Outcomes (1)
Ordinal Scale for evaluating subject clinical status at days 3, 8, 15, 30, 60 post treatment.
Assessed at days 3, 8, 15, 30, 60 post treatment
Study Arms (2)
Tocilizumab Arm
EXPERIMENTALTocilizumab 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 Arm
NO INTERVENTIONNo 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.
Interventions
Tocilizumab binds to both soluble and membrane-bound interleukin-6 receptors and has been shown to inhibit interleukin 6-mediated signalling.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- All genders
- Hospitalization for suspected or confirmed SARS-CoV2 infection. COVID-19 diagnosis defined as positive on reverse-transcriptase polymerase chain reaction, with provincial laboratory confirmation.
- Signs of hyperinflammation (cytokine release syndrome) defined by the presence of any of the following:
- i. Elevated C-reactive protein (≥70 mg/dl and/or rising since last 24h not due to bacterial infection), ii. Ferritin (\>700 mcg/L and/or rising since last 24h),
- Anti-interleukin treatment indication as per hyperinflammation team
- Informed consent for participation in the study
You may not qualify if:
- Goal of Care C (palliative care)
- Known hypersensitivity to TCZ or its components
- Current systemic immunosuppressive therapy; anti-interleukin 1 or anti-interleukin 6 treatment
- Known active bacterial or fungal infections or other clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment
- Current or history of bowel perforation or diverticulitis
- Suspicion of active or latent tuberculosis
- Pregnant or breastfeeding patient
- Patients with known prior liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Xu X, Han M, Li T, Sun W, Wang D, Fu B, Zhou Y, Zheng X, Yang Y, Li X, Zhang X, Pan A, Wei H. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A. 2020 May 19;117(20):10970-10975. doi: 10.1073/pnas.2005615117. Epub 2020 Apr 29.
PMID: 32350134BACKGROUNDAlzghari SK, Acuna VS. Supportive Treatment with Tocilizumab for COVID-19: A Systematic Review. J Clin Virol. 2020 Jun;127:104380. doi: 10.1016/j.jcv.2020.104380. Epub 2020 Apr 21. No abstract available.
PMID: 32353761BACKGROUNDZhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents. 2020 May;55(5):105954. doi: 10.1016/j.ijantimicag.2020.105954. Epub 2020 Mar 29.
PMID: 32234467BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Benseler, MD PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
July 30, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
Results will be rapidly published.