Table 4.

Studies assessing interleukin-1 inhibitor treatment in patients with COVID-19

Study/Sites	Design/Population	Inclusion Criteria	Intervention (dose, timing, duration)	Primary Endpoint	Results	Observations
CORIMUNO-ANA-1 Bureau et al.[45▪▪] France	RCT/Hospitalized patients non-ICU	Confirmed SARS-CoV-2 infection with mild-moderate, severe or critical pneumonia and CRP > 25 mg/L	IV Anakinra 200 mg BID on day 1-3, then 100 mg BID day 4 and 100 mg day 5 (n = 59) vs SOC (n = 57) Additional doses given if no improvement after day 4	Score > 5 on WHO-CPS at day 4 or composite outcome of MV or death at day 14	WHO-CPS >5 at day 4: 36% with anakinra vs 38% with SOC (ARD -2.5% [90% CrI -17.1 to 12.0]) MV or death at day 14: 47% with anakinra vs 51% with SOC (HR 0.97 [90% CrI 0.62–1.52])	Study stopped early by recommendation of DSMB.
SAVE Kyriazopoulou et al.[47] Greece	Open-label nonrandomized with parallel controls/Hospitalized patients non-ICU	Confirmed SARS-CoV-2 infection, imaging consistent with pneumonia and plasma suPAR levels > 6 ng/ml	SC anakinra 100 mg daily for 10 days (n = 130) vs SOC (n = 179)	Severe respiratory failure at day 14	22.3% with anakinra vs 59.2% with SOC (HR 0.30 [95% CI 0.20–0.46])	Parallel controls chosen by propensity-score matching. Decrease mortality.
OMA-COVID-19 Balkhair et al.[76] Oman	Prospective, open-label interventional study/Hospitalized patients	Confirmed SARS-CoV-2 infection, imaging consistent with bilateral pneumonia, and at least one of the following: RR >30/min and SpO2 < 90% on RA, SpO2 ≤ 93% on oxygen ≥ 6L/min, ARDS.	SC anakinra 100 mg BID for 3 days, then 100 mg daily for 7 days (n = 45) vs SOC (n = 24)	MV and in-hospital death	MV: 31% with anakinra vs 75% with SOC (P < 0.001) In-hospital death: 29% with anakinra vs 46% SOC (P = 0.082)	Historical controls. 60% on glucocorticoids.
CAN-COVID Press release[48] US and Europe	RCT/Hospitalized patients non-ICU	Confirmed SARS-CoV-2 infection, imaging consistent with pneumonia, SpO2 ≤ 93% on RA or PaFiO2 < 300 mmHg, and CRP ≥ 20 mg/L or ferritin ≥ 600 ug/L	Canakinumab weight-bases single dose vs SOC	Survival without MV at day 28	88% with canakinumab vs 85.7% with SOC (P = 0.29)	No difference in mortality. Interim analysis, pending final publication.

IV, intravenous; SOC, standard of care; ICU, intensive care unit; SpO2, oxygen saturation; suPAR, soluble urokinase plasminogen activator receptor; CI, confidence interval; CrI, credible interval; HR, hazard ratio; OR, odds ratio; ARD, absolute risk difference; ARDS, acute respiratory distress syndrome; WHO-CPS, World Health Organization Clinical Progression Scale; CRP, C reactive protein.