Table.

Anakinra trials in COVID-19

	Population	Intervention	Control	Outcome (primary)	Targeted recruitment (receiving anakinra)	Completion date	Country
NCT04364009 2020-001734-36	Confirmed SARS-CoV-2; patients with respiratory symptoms and requirement of oxygen therapy; CRP >50 mg/L	Intravenous: 200 mg twice a day on days 1–3; 100 mg twice a day on days 4–10	SOC	Treatment success by day 14 (patient alive and not requiring IMV or EMCO)	240 (120)	September, 2020	France
NCT04357366 2020-001466-11	Confirmed SARS-CoV-2; x-ray or CT confirmation of lower respiratory tract infection; plasma soluble urokinase plaminogen activator receptor ≥6 ng/mL	Subcutaneous: 100 mg once a day on days 1–10 and antibiotic (trimethoprim–sulfamethoxazole)	None	Patients not developing serious respiratory failure by day 14	100 (100)	April, 2022	Greece
NCT04324021 2020-001167-93	Confirmed SARS-CoV-2; presence of respiratory distress (PaO2/FiO2 <300 mm Hg, or respiratory rate ≥30 breaths per min, or peripheral oxygen saturation <93%); hyperinflammation (lymphocyte counts <1000 cells per μL and two of the following: ferritin >500 ng/mL, LDH >300 U/L, and D-dimer >1000 ng/mL)	Intravenous: 100 mg every 4 h on days 1–15 (comparator group: emapalumab [anti-IFNγ mAb])	SOC	Treatment success by day 15 (proportion of patients not requiring IMV or EMCO)	54 (18)	September, 2020	Italy
NCT04339712 2020-001-039-29	Confirmed SARS-CoV-2; organ dysfunction defined as presence of total SOFA score ≥2 or involvement of lower respiratory tract; macrophage activation syndrome	Intravenous: 200 mg three times a day on days 1–7	SOC	Change of SOFA score; improvement of lung involvement measurements; increased PaO2/FiO2 ratio (all by day 8)	40 (20)	April, 2022	Greece
NCT04362111 NA	Confirmed SARS-CoV-2; hyperferritinaemia >700 ng/mL; fever >38°C; any two of the following: increased D-dimers >500 ng/mL or thrombocytopenia <130 000 mm3, leukopenia (white blood cell count <3500 mm3) or lymphopenia (<1000 mm3), elevated AST or ALT >2 times upper limit of normal, elevated LDH >2 times upper limit of normal	Subcutaneous: 100 mg every 4 h on days 1–5	Placebo	No increase in oxygen requirement and no increase in respiratory support measures	20 (10)	December, 2020	USA
NCT04330638 2020-001-500-41	Confirmed COVID-19 diagnosis; PaO2/FiO2 <350 mm Hg (on room air) or PaO2/FiO2 <280 mm Hg (supplemental oxygen) and requiring high flow or IMV; cytokine release syndrome defined as the following: ferritin >1000 μg/L and rising over last 24 h, or ferritin >2000 μg/L in high flow or IMV patients, or lymphopenia (<800 cells per μL), and two of the following: ferritin >700 μL, increased LDH >300 IU/L, D-dimers >1000 ng/mL, CRP >70 mg/mL; chest x-ray or CT with bilateral infiltrates	Subcutaneous: 100 mg once a day on days 1–28 (comparator groups:with or without siltuximab; with or without tocilizumab)	SOC	2 point improvement on six category ordinal scale or discharge from hospital	342 (171)	December, 2020	Belgium
NCT04341584 2020-001-246-18	Patients in CORIMUNO-19 cohort; CRP >25 mg/L; patients in either group 1: requiring >3 L/min oxygen, WHO progression scale 5, no NIV or high flow; or group 2: respiratory failure and IMV or NIV or high flow, WHO progression scale ≥6, do-not-resuscitate order	Intravenous: 200 mg twice a day on days 1–3; 100 mg twice a day on day 4; 100 mg once a day on day 5	SOC	Survival without need of ventilator use at day 14; WHO progression scale ≤5 by day 4; cumulative incidence of successful tracheal extubation or withdrawal of NIV or high flow at day 14; decrease of at least 1 point in WHO progression scale at day 4	240 (120)	December, 2020	France
NCT02735707 2015-002340-14 (REMAP-CAP)	Suspected or confirmed COVID-19; admission to ICU with symptoms, signs, or both that are consistent with lower respiratory tract infection, and radiological evidence of new onset consolidation; up to 48 h after ICU admission, receiving organ support with one or more of the following: NIV, IMV, vasopressor and ionotropes alone or in combination	Intravenous: 300 mg bolus; 100 mg every 4 h	SOC	All-cause mortality (day 90); days alive and outside of ICU (day 21)	7100 (unspecified)	December, 2023	Global
NCT04366232 2020-001963-10	Confirmed SARS-CoV-2; hypoxic pneumonia (including arterial oxygen saturation <90 mm Hg); CRP >150 mg/L; acute respiratory distress syndrome (including IMV with PaO2/FiO2 <300 mm Hg)	Intravenous: 300 mg once a day on day 1–5 (then dose tapering)with or without ruxolitinib	SOC	At least three parameters met (including CRP, ferritin, or both) from: CRP decrease >50%, ferritinaemia decrease >1/3, serum creatine decrease >1/3, AST or ALT decrease >50%, eosinophils >50 mm3, lymphocytes >1000 mm3	50 (25)	August, 2020	France
NA 2020-001636-95	Suspected or confirmed COVID-19; receiving organ support with one or more of the following: NIV, IMV, vasopressor and inotropes alone or in combination	Subcutaneous: 100 mg twice a day; or intravenous: 100 mg every 4 h	NA	Plasma IL-1 receptor antagonist and IL-6 on days 1–7	30 (30)	September, 2020	UK

SARS-CoV-2=severe acute respiratory syndrome coronavirus 2. CRP=C-reactive protein. SOC=standard of care. IMV=invasive mechanical ventilation. EMCO=extracorporeal membrane oxygenation. NA=not applicable. LDH=lactose dehydrogenase. SOFA=sequential organ failure assessment. AST=aspartate aminotransferase. ALT=alanine aminotransferase. NIV=non-invasive ventilation. ICU=intensive care unit. IL=interleukin.