Tocilizumab in Coronavirus-19 Positive Patients
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| ClinicalTrials.gov Identifier: NCT04423042 |
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Recruitment Status : Unknown
Verified July 2020 by University of Calgary.
Recruitment status was: Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : July 22, 2020
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| 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 |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Biological: Tocilizumab
Tocilizumab binds to both soluble and membrane-bound interleukin-6 receptors and has been shown to inhibit interleukin 6-mediated signalling.
Other Name: Actemra |
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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.
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- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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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 Criteria:
- 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
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, PhD | 4039555537 | jacinda.larson@albertahealthservices.ca | |
| Contact: Namneet Sandhu, MPH | namneet.sandhu@ucalgary.ca |
| Principal Investigator: | Susanne Benseler, MD PhD | University of Calgary |
Publications:
| Responsible Party: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT04423042 |
| Other Study ID Numbers: |
REB20-0713 |
| First Posted: | June 9, 2020 Key Record Dates |
| Last Update Posted: | July 22, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Results will be rapidly published. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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COVID-19 Coronavirus Infections Severe Acute Respiratory Syndrome Inflammation Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia |
Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pathologic Processes |