Anakinra in the Management of COVID-19 Infection

• Status: Recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes.

Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion criteria:

• Hospitalized adult (age ≥ 18yrs)

• Confirmed COVID-19 diagnosis

• Presence of respiratory distress in addition to signs of cytokine release syndrome

• Radiological evidence of pneumonia

• Signed informed consent

Exclusion Criteria:

• Known allergic reactions to the study medication or any component of the product.

• Active bacterial, viral, TB, fungal infectious diseases

• Received immunosuppressant or immunomodulatory in the past 30 days

• Neutrophil count < 500 cells/microliter

• Platelets < 50,000/microliter

• Pregnant or breastfeeding females