Tocilizumab vs CRRT in Management of Cytokine Release Syndrome (CRS) in COVID-19
TACOS
A Retrospective Study of Evaluating Safety and Efficacy of Tocilizumab Compared to Continuous Renal Replacement Therapy in Controlling CRS Triggered by COVID-19
1 other identifier
observational
120
1 country
1
Brief Summary
Some patients infected with the COVID-19 can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. Tocilizumab was first approved by the U.S. FDA in 2010 for rheumatoid arthritis and might now be used to treat serious COVID-19 patients with lung damage, according to China's National Health Commission updated its treatment guidelines in 7th version.Continuous Renal Replacement Therapy (CRRT) was recommended by China's National Health Commission treatment guidelines in 1st-7th version to control sever COVID-19 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
February 20, 2020
CompletedFirst Submitted
Initial submission to the registry
March 8, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2020
CompletedMarch 17, 2020
March 1, 2020
3 months
March 8, 2020
March 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14
This is a composite outcome measure. Criteria for fever normalization: Temperature \< 36.6 °C armpit, \< 37.2 °C oral sustained for at least 72 hours and criteria for oxygen normalization: peripheral capillary oxygen saturation (Sp02) \> 94% sustained for at least 72 hours.
First dose date up to 14 days
Secondary Outcomes (8)
Duration of hospitalization
Up to 28 days
Proportion of Participants With Normalization of Fever Through Day 14
First dose date up to 14 days
Change from baseline in white blood cell and differential count
Day 1 through Day 28
Time to first negative in 2019 novel Corona virus RT-PCR test
Up to 28 days
All-cause mortality
up to 12 weeks
- +3 more secondary outcomes
Study Arms (3)
Tocilizumab
Subjects received 8 mg/kg (body weight) Tocilizumab once in 100 ml 0.9% saline solution and administered intravenously within no less than 60 minutes. Tocilizumab was administered according to the local label.
Continuous Renal Replacement Therapy
Femoral vein catheterization was performed to complete continuous renal replacement therapy for consecutive 3 times or more.
Standard care
Standard of care therapy per local written policies or guidelines.
Interventions
Standard of care therapy per local written policies or guidelines and includes balancing of electrolytes and acid-base, the provision of enteral or parenteral nutrients support, antibiotics therapy, oxygen therapy and noninvasive ventilation.
Catheter insertion site is femoral vein.
Eligibility Criteria
Laboratory (RT-PCR) confirmed infection with 2019-nCoV. Lung involvement confirmed with chest imaging Hospitalized with a SaO2/SPO2≤93% on room air or Pa02/Fi02 ratio \<300mmHg and ≤14 days since illness onset.
You may qualify if:
- Agrees to the collection of oropharyngeal or anal swabs and venous blood per protocol.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- Has laboratory-confirmed novel coronavirus infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in oropharyngeal or anal specimen within 72 hours prior to hospitalization.
- Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- Clinical assessment (evidence of rales/crackles on physical examination) AND SpO2 ≤93% on room air, OR
- Requiring mechanical ventilation and/or supplemental oxygen, OR
- Sustained fever in the past 24 hours and unresponsive to NSAID or steroid
- Serum IL-6 ≥3 times the upper limit of normal
You may not qualify if:
- Alanine transaminase/aspartate transaminase (ALT/AST) \> 5 times the upper limit of normal.
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) \< 30 ml /min/1.73 m\^2)
- Hemoglobin\<80 g/L
- Leukocytes\<2.0×10\^9
- Platelets\<50×10\^9
- Pregnancy or breast feeding.
- Anticipated transfer to another hospital which is not a study site within 72 hours.
- Expected life span does not exceed 7 days.
- Allergy to any study medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
- Hubei Xinhua Hospitalcollaborator
- Wuhan No.1 Hospitalcollaborator
- Wuhan Central Hospitalcollaborator
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
SHAOXIAN HU, M.D
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
March 8, 2020
First Posted
March 13, 2020
Study Start
February 20, 2020
Primary Completion
May 30, 2020
Study Completion
June 20, 2020
Last Updated
March 17, 2020
Record last verified: 2020-03