Anakinra in the Management of COVID-19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial

Conditions
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Covid19, Pneumonia, Cytokine Release Syndrome, Corona Virus Infection, Viral Infection

Intervention / Treatment
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* Drug: Anakinra
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anakinra Group<br>Anakinra + Standard of Care | Drug: Anakinra<br>* Patient will receive Anakinra 100 mg SC injection every 12 hours for 3 days, then 100 mg once daily from day 4 to day 7 plus Standard of Care<br>* Other names: Kineret®;|
| Other: Standard of Care Group<br>Standard of Care Alone | Other: Standard of Care<br>* Patients will receive the Standard of Care therapy as per the local treatment protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success at day 14 | Defined as WHO Clinical Progression score of ≤3 [Ambulatory mild disease: symptomatic; assistance needed]. | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WHO Clinical Progression Score | Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)] | Day 7 | 
| Time to ICU admission | Time to ICU admission up to 28 days | Day 28 | 
| Incidence of Adverse Events | Incidence of adverse events up to 28 days | Day 28 | 
| Length of hospital stay | Length of hospital stay up to 28 days | Day 28 | 
| All-cause Mortality | All-cause mortality rate at hospital discharge or at 28 days, whichever is first | Day 28 |