Cerebrovascular AccidentPhase 3NCT04361552
Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
A Phase 3 study testing Best Practice and Tocilizumab in people with Cerebrovascular Accident and Chronic Obstructive Pulmonary Disease, run by Emory University at 1 site in United States.
Trial summary
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Chronic Obstructive Pulmonary Disease, Chronic Renal Failure
- What is being tested?
- Best Practice and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2020to 2 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved)
- Should be hospitalized and exhibit at least one of the following predictors of mortality
- Age >= 65 years
- Current smoker (smoked >= 100 cigarettes in life and actively smoking)
- Chronic obstructive pulmonary disease (COPD)
- Diabetes
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- Hypertension
- Coronary artery disease
- Cerebrovascular accident (CVA)
- Chronic renal disease (creatinine of >= 2 mg/dl)
- Cancer
- Patients that have C-reactive protein (CRP) >= 10 mg/L
- D-dimer >= 0.5 mg/L
- Procalcitonin >= 0.5 mg/L
- Lactate dehydrogenase (LDH) >= upper limit of normal (ULN)
- Patients or authorized family member willing to sign informed consent to participate in this study
Who cannot join
- Pregnant or lactating women
- Hypersensitivity to tocilizumab
- Patients or authorized family member unwilling to sign informed consent to participate in this study
- Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2.
SECONDARY OBJECTIVES:
- To decrease the rates of intensive care unit (ICU) transfer. II. To decrease the rate of invasive mechanical ventilation (MV). III. To decrease the length of ICU stay. IV. To decrease the rate of tracheostomy. V. Safety and efficacy of tociluzumab. VI. Biomarker assessment for response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive tocilizumab intravenously (IV) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
ARM II: Patients receive standard of care.
- Conditions
- Cerebrovascular Accident, Chronic Obstructive Pulmonary Disease, Chronic Renal Failure, Coronary Artery Disease, Diabetes Mellitus, Malignant Neoplasm
- Being tested
- Best Practice, Tocilizumab
- Medical subject headings
- Stroke, Pulmonary Disease, Chronic Obstructive, Kidney Failure, Chronic, Coronary Artery Disease, Diabetes Mellitus, Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
TocilizumabBiological
Also called Actemra, Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer, MRA, R-1569
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (tocilizumab, standard of care) | Experimental | Patients receive tocilizumab IV every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care. Receives: Other: Best Practice; Biological: Tocilizumab |
| Arm II (standard of care) | Active comparator | Patients receive standard of care. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day length of invasive mechanical ventilation (MV)
The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
Measured: Up to 7 days
30-day mortality rate
Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measured: Up to 30-day after randomization
Secondary outcomes (5)
Rate of intensive care (ICU) transfer
The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measured: Up to 2 years
Rate of invasive mechanical ventilation
The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measured: Up to 2 years
Rate of tracheostomy
The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measured: Up to 2 years
Length of ICU stay
Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test
Measured: Up to 2 years
Length of hospital stay
Measured: Up 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start7 Apr 2020
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Why it stopped: Study abandoned due to drug billing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ajay Nooka, Emory University
- Investigators
- Ajay K Nooka, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361552
- Sponsor's protocol ID
- STUDY00000419
- Other IDs
- NCI-2020-02314, WINSHIP4998-20, P30CA138292
- Status last verified
- Jun 2020
- First submitted
- 7 Apr 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
- ClinicalTrials.gov ID
- NCT04361552
- Acronym / sponsor ID
- STUDY00000419
- Conditions
- Cerebrovascular Accident, Chronic Obstructive Pulmonary Disease, Chronic Renal Failure, Coronary Artery Disease, Diabetes Mellitus, Malignant Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study abandoned due to drug billing issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
Detailed description
PRIMARY OBJECTIVE:
- To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2.
SECONDARY OBJECTIVES:
- To decrease the rates of intensive care unit (ICU) transfer. II. To decrease the rate of invasive mechanical ventilation (MV). III. To decrease the length of ICU stay. IV. To decrease the rate of tracheostomy. V. Safety and efficacy of tociluzumab. VI. Biomarker assessment for response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive tocilizumab intravenously (IV) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
ARM II: Patients receive standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (tocilizumab, standard of care) | Experimental | Other: Best Practice, Biological: TocilizumabPatients receive tocilizumab IV every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care. |
| Arm II (standard of care) | Active comparator | Other: Best PracticePatients receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved)
- Should be hospitalized and exhibit at least one of the following predictors of mortality
- Patients or authorized family member willing to sign informed consent to participate in this study
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Hypersensitivity to tocilizumab
- Patients or authorized family member unwilling to sign informed consent to participate in this study
- Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm I (tocilizumab, standard of care), Arm II (standard of care) |
| TocilizumabAlso: Actemra, Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer, MRA, R-1569Given IV | Biological | Arm I (tocilizumab, standard of care) |
Primary outcome
7-day length of invasive mechanical ventilation (MV)
Time frame: Up to 7 days
The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
30-day mortality rate
Time frame: Up to 30-day after randomization
Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
5 secondary outcomes
Rate of intensive care (ICU) transfer
Time frame: Up to 2 years
Rate of invasive mechanical ventilation
Time frame: Up to 2 years
Rate of tracheostomy
Time frame: Up to 2 years
Length of ICU stay
Time frame: Up to 2 years
Length of hospital stay
Time frame: Up 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No. Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay K Nooka principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Best Practice and Tocilizumab in people with Cerebrovascular Accident and Chronic Obstructive Pulmonary Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day length of invasive mechanical ventilation (MV) (time frame: Up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.