A Phase 2/3 interventional study of Anakinra and Standard of Care in Covid19, Pneumonia and Cytokine Release Syndrome, sponsored by Hamad Medical Corporation. Completed at 1 site in Qatar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Hamad Medical Corporation · Phase 2/3, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 80 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hamad Medical Corporation is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anakinra + Standard of Care
Drug: Anakinra
Standard of Care Alone
Other: Standard of Care
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
Also known as: Kineret®
Patients will receive the Standard of Care therapy as per the local treatment protocol
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
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Hamad Medical Corporation