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.
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 to the pathogen by overproducing immune cells and their signaling molecules
in a dangerous phenomenon called cytokine release storm.It has been recently speculated that
IL-6 as a main culprit in that immune over activation among COVID-19 patients, hence the
Tocilizumab clinical trial was initiated. In 2017, the FDA also approved Tocilizumab to treat
cytokine release syndrome (CRS), a form of cytokine storm caused by CAR-T treatment. The
investigator's hypothesis was that Tocilizumab would be associated with better clinical
outcomes, such as decreased systemic inflammation, improved survival rate, better hemodynamic
and improved of respiratory distress.Systemic inflammatory response syndrome was one of the
main indications for treatment with CRRT. So it is clinically significant to compare the
efficacy and safety of Tocilizumab and CRRT in management of CRS triggered by COVID-19.
Drug: Tocilizumab
Administered as an intravenous infusion.
Other Name: Actemra
Other: Standard of care
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.
Procedure: Continuous renal replacement therapy
Catheter insertion site is femoral vein.
Inclusion Criteria:
1. Agrees to the collection of oropharyngeal or anal swabs and venous blood per protocol.
2. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
3. 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.
4. Illness of any duration, and at least one of the following:
1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
2. Clinical assessment (evidence of rales/crackles on physical examination) AND SpO2
≤93% on room air, OR
3. Requiring mechanical ventilation and/or supplemental oxygen, OR
4. Sustained fever in the past 24 hours and unresponsive to NSAID or steroid
5. Serum IL-6 ≥3 times the upper limit of normal
Exclusion Criteria:
1. Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of
normal.
2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular
filtration rate (eGFR) < 30 ml /min/1.73 m^2)
3. Hemoglobin<80 g/L
4. Leukocytes<2.0×10^9
5. Platelets<50×10^9
6. Pregnancy or breast feeding.
7. Anticipated transfer to another hospital which is not a study site within 72 hours.
8. Expected life span does not exceed 7 days.
9. Allergy to any study medication.
Tongji Hospital
Wuhan, Hubei, China
Investigator: AIHUA DU, M.D
Contact: +86 2783662886
Investigator:
YIKAI YU, M.D
+1 (484) 995-5917
yuyikai@163.com
WEI TU, M.D
+86 15671678920
SHAOXIAN HU, M.D, Study Director
Tongji Hospital