Status:
COMPLETED
Early Treatment of Cytokine Storm Syndrome in Covid-19
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Cytokine Storm
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infe...
Detailed Description
The first aim of this project is to determine whether rapidly assayed early clinical laboratory markers of CSS (eCSS: leucopenia, lymphopenia, and elevated ferritin, d-dimer, LDH, CRP, and AST/ALT) in...
Eligibility Criteria
Inclusion
- 18 years old or older
- Molecular (pcRNA) diagnosis of SARS-CoV-2 infection
- Chest imaging studies consistent with Covid-19 pneumonia
- Hyperferritinemia (\>700 ng/ml)
- History of fever \>38 degrees C
- Any three of the following:
- Elevated d-dimer (\> 500 ng/ml)
- thrombocytopenia (\< 130,000/mm3)
- leucopenia (WBC \<3500/mm3) or lymphopenia (\<1000/mm3)
- elevated AST or ALT (\> 2X ULN)
- elevated LDH (\> 2X ULN)
- CRP \> 100 mg/L
Exclusion
- Participation in other investigational treatment protocols for Covid-19 infection
- Culture confirmed active bacterial infection requiring antibiotic therapy
- On mechanical ventilation
- Previous known hypersensitivity reaction to anakinra
- Previous known hypersensitivity reaction to E Coli derived proteins
- Pregnant or breast-feeding females
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04362111
Start Date
August 1 2020
End Date
June 1 2023
Last Update
August 24 2023
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294