key: cord-0833190-7ttjk6bw authors: Pontali, Emanuele; Volpi, Stefano; Antonucci, Giancarlo; Castellaneta, Marco; Buzzi, Davide; Tricerri, Francesca; Angelelli, Alessia; Caorsi, Roberta; Feasi, Marcello; Calautti, Francesca; Castagnola, Elio; Rollandi, Gian Andrea; Ravelli, Angelo; Cassola, Giovanni; Gattorno, Marco title: Safety and efficacy of early high-dose IV anakinra in severe COVID-19 lung disease date: 2020-05-11 journal: J Allergy Clin Immunol DOI: 10.1016/j.jaci.2020.05.002 sha: 0a789f33c09c431e21a5647178d0439fdb8689aa doc_id: 833190 cord_uid: 7ttjk6bw Cytokine release syndrome plays a crucial pathogenic role in COVID-19 pneumonia. This pilot study provides the first evidence of the safety of anti-IL-1 treatment with highdose IV anakinra in 5 patients, who experienced a positive outcome. On admission, all patients displayed a recent onset of dyspnea, associated with fever, systemic 62 inflammation, rapidly worsening respiratory distress, and marked lung abnormalities on chest 63 computed tomography (CT) ( Table 1 , Fig.1A-C) . Soon after admission, all patients received, after 64 providing informed consent, treatment with high dose IV anakinra added to the current standard 65 of care (Table 1 ). The starting dose was 100 mg every 8 hours (300 mg/daily) for 24-48 hours, 66 followed by tapering, according to clinical response. Methylprednisolone was also administered in 67 pt 4 ( Table 1 ). The off-label use of Anakinra was approved by the internal review board of the 68 Galliera Hospital. Clinical course and risk factors for mortality of adult 104 inpatients with COVID-19 in Wuhan, China: a retrospective cohort study Inflammatory Response Cells During Acute Respiratory 107 Distress Syndrome in Patients With Coronavirus Disease COVID-19: consider 110 cytokine storm syndromes and immunesuppression On the alert for cytokine 113 storm: Immunopathology in COVID-19. Arthritis Rheumatol Pharmacologic Treatments for Coronavirus 115 Disease 2019 (COVID-19): A Review Characteristics of and Important Lessons From the Coronavirus Disease Treating Pediatric Secondary Hemophagocytic Lymphohistiocytosis. Arthritis Rheumatol Marco Castellaneta 1 , MD; Ente Ospedaliero Ospedale Galliera 134 Ente Ospedaliero Ospedale Galliera 140 Author Contributions: Drs Pontali, Volpi, Cassola and Gattorno had full access to all of the data in 150 the study and take responsibility for the integrity of the data and the accuracy of the data analysis Concept and design: Gattorno 1 1 Cumulative dose (mg) 600 1400 900 1000 800Other therapies administered HCQ