Anakinra in the Management of COVID-19 Infection

Hamad Medical Corporation (HMC)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cytokine Release Syndrome; Corona Virus Infection; Covid19; Viral Infection; Pneumonia

Treatments: Drug: Anakinra; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04643678

MRC-05-140

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Anakinra Group

Active Comparator group

Description:

Anakinra + Standard of Care

Treatment:

Drug: Anakinra

Standard of Care Group

Other group

Description:

Standard of Care Alone

Treatment:

Other: Standard of Care