Early Treatment of Cytokine Storm Syndrome in Covid-19

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

1. 18 years old or older

2. Molecular (pcRNA) diagnosis of SARS-CoV-2 infection

3. Chest imaging studies consistent with Covid-19 pneumonia

4. Hyperferritinemia (>700 ng/ml)

5. Fever >38 degrees C

6. Any three of the following:

1. Elevated d-dimer (> 500 ng/ml)

2. thrombocytopenia (< 130,000/mm3)

3. leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)

4. elevated AST or ALT (> 2X ULN)

5. elevated LDH (> 2X ULN)

6. CRP > 100 mg/L

Exclusion Criteria:

1. Participation in other investigational treatment protocols for Covid-19 infection

2. Culture confirmed active bacterial infection requiring antibiotic therapy

3. On mechanical ventilation

4. Previous known hypersensitivity reaction to anakinra

5. Previous known hypersensitivity reaction to E Coli derived proteins

6. Pregnant or breast-feeding females