About: Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study

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About: Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study
Creator	Campochiaro, Corrado Cavalli, Giulio De Luca, Giacomo Della-Torre, Emanuel Ripa, Marco Canetti, Diana Castiglioni, Barbara Oltolini, Chiara Boffini, Alessandro Chiara, Tassan Ciceri, Giovanni Dagna, Din, Nicola Farina, Annalisa Landoni, Alberto Lucca, Sabina Martinenghi, Raffaella Rovere-Querini, Giuseppe Ruggeri, Patrizia Scarpellini, Lorenzo Scotti, Moreno Tomelleri, Nicola Tresoldi, Fabio Zangrillo, Paolo
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: Mortality of patients with coronavirus disease 2019 (COVID-19), acute respiratory distress syndrome (ARDS), and systemic inflammation is high. In areas of pandemic outbreak, the number of patients can exceed maximum capacity of intensive care units (ICUs), and, thus, these individuals often receive non-invasive ventilation outside of the ICU. Effective treatments for this population are needed urgently. Anakinra is a recombinant interleukin-1 receptor antagonist that might be beneficial in this patient population. METHODS: We conducted a retrospective cohort study at the San Raffaele Hospital in Milan, Italy. We included consecutive patients (aged ≥18 years) with COVID-19, moderate-to-severe ARDS, and hyperinflammation (defined as serum C-reactive protein ≥100 mg/L, ferritin ≥900 ng/mL, or both) who were managed with non-invasive ventilation outside of the ICU and who received standard treatment of 200 mg hydroxychloroquine twice a day orally and 400 mg lopinavir with 100 mg ritonavir twice a day orally. We compared survival, mechanical ventilation-free survival, changes in C-reactive protein, respiratory function, and clinical status in a cohort of patients who received additional treatment with anakinra (either 5 mg/kg twice a day intravenously [high dose] or 100 mg twice a day subcutaneously [low dose]) with a retrospective cohort of patients who did not receive anakinra (referred to as the standard treatment group). All outcomes were assessed at 21 days. This study is part of the COVID-19 Biobank study, which is registered with ClinicalTrials.gov, NCT04318366. FINDINGS: Between March 17 and March 27, 2020, 29 patients received high-dose intravenous anakinra, non-invasive ventilation, and standard treatment. Between March 10 and March 17, 2020, 16 patients received non-invasive ventilation and standard treatment only and comprised the comparison group for this study. A further seven patients received low-dose subcutaneous anakinra in addition to non-invasive ventilation and standard treatment; however, anakinra treatment was interrupted after 7 days because of a paucity of effects on serum C-reactive protein and clinical status. At 21 days, treatment with high-dose anakinra was associated with reductions in serum C-reactive protein and progressive improvements in respiratory function in 21 (72%) of 29 patients; five (17%) patients were on mechanical ventilation and three (10%) died. In the standard treatment group, eight (50%) of 16 patients showed respiratory improvement at 21 days; one (6%) patient was on mechanical ventilation and seven (44%) died. At 21 days, survival was 90% in the high-dose anakinra group and 56% in the standard treatment group (p=0·009). Mechanical ventilation-free survival was 72% in the anakinra group versus 50% in the standard treatment group (p=0·15). Bacteraemia occurred in four (14%) of 29 patients receiving high-dose anakinra and two (13%) of 16 patients receiving standard treatment. Discontinuation of anakinra was not followed by inflammatory relapses. INTERPRETATION: In this retrospective cohort study of patients with COVID-19 and ARDS managed with non-invasive ventilation outside of the ICU, treatment with high-dose anakinra was safe and associated with clinical improvement in 72% of patients. Confirmation of efficacy will require controlled trials. FUNDING: None.
has issue date	2020-05-07(xsd:dateTime)
bibo:doi	10.1016/s2665-9913(20)30127-2
bibo:pmid	32501454
has license	no-cc
sha1sum (hex)	1b78dcbceb299a9058685165ea6cddbc9d9cbdf6
schema:url	https://doi.org/10.1016/s2665-9913%2820%2930127-2
resource representing a document's title	Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study
has PubMed Central identifier	PMC7252085
has PubMed identifier	32501454
schema:publication	Lancet Rheumatol
resource representing a document's body	covid:1b78dcbceb299a9058685165ea6cddbc9d9cbdf6#body_text
is schema:about of	named entity 'COVID-19' named entity 'patients' named entity 'number' named entity 'acute respiratory distress syndrome (ARDS)' named entity 'interleukin' named entity 'ICUs' named entity 'population' named entity 'anakinra' named entity 'Interleukin-1' named entity 'ICU' named entity 'acute respiratory distress syndrome' named entity 'COVID' named entity 'coronavirus disease 2019' named entity 'ICUs' named entity 'acute respiratory distress syndrome' named entity 'Interleukin-1' named entity 'hyperinflammation' named entity 'phase 2 clinical trial' named entity 'C-reactive protein' named entity 'COVID' named entity 'standard treatment' named entity 'Anakinra' named entity 'standard treatment' named entity 'anakinra' named entity 'lopinavir' named entity 'COVID-19' named entity 'ICU' named entity 'interleukin-1' named entity 'comparison group' named entity 'intravenously' named entity 'hyperinflammation' named entity 'liver' named entity 'half-life' named entity 'clinical trials' named entity 'coronavirus disease 2019' named entity 'anakinra' named entity 'C-reactive protein' named entity 'COVID-19' named entity 'hyperinflammation' named entity 'anakinra' named entity 'ICU' named entity 'IL-1 receptor antagonist' named entity 'PEEP' named entity 'anakinra' named entity 'ordinal scale' named entity 'anakinra' named entity 'inflammatory response' named entity 'supplemental oxygen' named entity 'anti-inflammatory' named entity 'serum' named entity 'C-reactive protein' named entity 'peak levels' named entity 'pulmonary thromboembolism' named entity 'non-invasive ventilation' named entity 'SPSS' named entity 'risk factors' named entity 'comparison group' named entity 'ARDS'

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