Status:
UNKNOWN
Tocilizumab in Coronavirus-19 Positive Patients
Lead Sponsor:
University of Calgary
Conditions:
Covid19
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 mo...
Detailed Description
The novel coronavirus, SARS-Cov2/COVID-19, emerged in late 2019 in Wuhan, China. Quickly, SARS-CoV2 spread to all corners of the globe. In March 2020, The World Health Organization (WHO) declared SARS...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04423042
Start Date
July 30 2020
End Date
June 1 2021
Last Update
July 22 2020
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