Overview

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