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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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
Patients will receive the Standard of Care therapy as per the local treatment protocol
Hamad Medical Corporation
Doha, Qatar
Treatment Success at day 14
Defined as WHO Clinical Progression score of ≤3 \[Ambulatory mild disease: symptomatic; assistance needed\].
Time frame: Day 14
Change in WHO Clinical Progression Score
Change in WHO Clinical Progression Score between day 1 and day 7 \[WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)\]
Time frame: Day 7
Time to ICU admission
Time to ICU admission up to 28 days
Time frame: Day 28
Incidence of Adverse Events
Incidence of adverse events up to 28 days
Time frame: Day 28
Length of hospital stay
Length of hospital stay up to 28 days
Time frame: Day 28
All-cause Mortality
All-cause mortality rate at hospital discharge or at 28 days, whichever is first
Time frame: Day 28
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