Status:
UNKNOWN
Tocilizumab vs CRRT in Management of Cytokine Release Syndrome (CRS) in COVID-19
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Hubei Xinhua Hospital
Wuhan No.1 Hospital
Conditions:
Covid-19
SARS
Eligibility:
All Genders
18-80 years
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...
Detailed Description
Tocilizumab doesn't directly kill the novel coronavirus. It's known as an inhibitor of the receptor of interleukin 6 (IL-6), a pro-inflammatory cytokine. In the disease COVID-19, the body may respond ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 20 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04306705
Start Date
February 20 2020
End Date
June 20 2020
Last Update
March 17 2020
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030