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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra Group | Active Comparator | Anakinra + Standard of Care |
|
| Standard of Care Group | Other | Standard of Care Alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Drug | 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 |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36778864 | Derived | Elmekaty EZI, Maklad A, Abouelhassan R, Munir W, Ibrahim MIM, Nair A, Alibrahim R, Iqbal F, Al Bishawi A, Abdelmajid A, Aboukamar M, Hadi HA, Khattab MA, Al Soub H, Al Maslamani M. Evaluation of anakinra in the management of patients with COVID-19 infection: A randomized clinical trial. Front Microbiol. 2023 Jan 26;14:1098703. doi: 10.3389/fmicb.2023.1098703. eCollection 2023. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D000080424 | Cytokine Release Syndrome |
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Standard of Care | Other | Patients will receive the Standard of Care therapy as per the local treatment protocol |
|
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 |
| D030341 |
| Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |