Tocilizumab vs CRRT in Management of Cytokine Release Syndrome (CRS) in COVID-19

Sponsor
Tongji Hospital
Study ID
NCT04306705
Status
Unknown

Conditions

  • Covid-19
  • Cytokine Release Syndrome
  • Cytokine Storm
  • SARS
  • Tocilizumab

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Administered as an intravenous infusion.
  • Standard of care — OTHER
    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.
  • Continuous renal replacement therapy — PROCEDURE
    Catheter insertion site is femoral vein.

Study Details

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.

Key Dates

Start date
Feb 20, 2020
Status verified
Mar 2020
Primary completion
May 30, 2020
Completion
Jun 20, 2020

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Continuous Renal Replacement Therapy
    Femoral vein catheterization was performed to complete continuous renal replacement therapy for consecutive 3 times or more.
  • Arm: Standard care
    Standard of care therapy per local written policies or guidelines.

Primary Outcome Measure

Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14 [ Time Frame: First dose date up to 14 days ]

Central Contacts

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