Tocilizumab in Coronavirus-19 Positive Patients
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|ClinicalTrials.gov Identifier: NCT04423042|
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : July 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19 COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 Coronavirus Inflammation||Biological: Tocilizumab||Phase 3|
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-CoV2/COVID-19 a pandemic. Individuals infected with SARS-CoV2 have a varied clinical presentation, ranging from asymptomatic or mild respiratory symptoms to severe involvement of the lower respiratory tract, with patients requiring mechanical ventilation. A particular point of interest is how the overall severity and clinical outcomes of COVID-19 patients may be associated with the excessive production of pro-inflammatory cytokines, or hyperinflammation, leading to acute respiratory distress syndrome. This state of hyperinflammation may be associated with increased mortality in COVID-19 patients. Tocilizumab, an Interleukin-6 antagonist, may help treat COVID-19 associated hyperinflammation.
This is a nested interventional 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%. TCZ treatment may reduce mortality.
Primary objective: To establish that tocilizumab, in addition to standard of care, reduces the 30-day mortality from hyperinflammation in COVID-19 disease significantly compared to no anti-interleukin therapy plus standard of care.
Secondary objectives: To evaluate the addition of tocilizumab therapy to standard of care on a number of secondary outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||July 30, 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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.
Tocilizumab binds to both soluble and membrane-bound interleukin-6 receptors and has been shown to inhibit interleukin 6-mediated signalling.
Other Name: Actemra
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.
- All-cause mortality [ Time Frame: Assessed at 30 days post treatment ]Mortality status of participants
- Ordinal Scale for evaluating subject clinical status at days 3, 8, 15, 30, 60 post treatment. [ Time Frame: Assessed at days 3, 8, 15, 30, 60 post treatment ]Uninfected, ambulatory, hospitalized: mild disease, hospitalized: severe disease, death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423042
|Contact: Jacinda R Larson, PhDemail@example.com|
|Contact: Namneet Sandhu, MPHfirstname.lastname@example.org|
|Principal Investigator:||Susanne Benseler, MD PhD||University of Calgary|