Tocilizumab for Treatment of Severe COVID-19 Patients: Preliminary Results from SMAtteo COvid19 REgistry (SMACORE)

DOI record: { "DOI": "10.3390/microorganisms8050695", "ISSN": [ "2076-2607" ], "URL": "http://dx.doi.org/10.3390/microorganisms8050695", "abstract": "<jats:p>Objective: This study aimed to assess the role of Tocilizumab therapy (TCZ) in terms of ICU admission and mortality rate of critically ill patients with severe COVID-19 pneumonia. Design: Patients with COVID-19 pneumonia were prospectively enrolled in SMAtteo COvid19 REgistry (SMACORE). A retrospective analysis of patients treated with TCZ matched using propensity score to patients treated with Standard Of Care (SOC) was conducted. Setting: The study was conducted at IRCCS Policlinico San Matteo Hospital, Pavia, Italy, from March 14, 2020 to March 27, 2020. Participants: Patients with a confirmed diagnosis of COVID-19 hospitalized in our institution at the time of TCZ availability. Interventions: TCZ was administered to 21 patients. The first administration was 8 mg/kg (up to a maximum 800 mg per dose) of Tocilizumab intravenously, repeated after 12 h if no side effects were reported after the first dose. Main Outcomes and Measures: ICU admission and 7-day mortality rate. Secondary outcomes included clinical and laboratory data. Results: There were 112 patients evaluated (82 were male and 30 were female, with a median age of 63.55 years). Using propensity scores, the 21 patients who received TCZ were matched to 21 patients who received SOC (a combination of hydroxychloroquine, azithromycin and prophylactic dose of low weight heparin). No adverse event was detected following TCZ administration. This study found that treatment with TCZ did not significantly affect ICU admission (OR 0.11; 95% CI between 0.00 and 3.38; p = 0.22) or 7-day mortality rate (OR 0.78; 95% CI between 0.06 and 9.34; p = 0.84) when compared with SOC. Analysis of laboratory measures showed significant interactions between time and treatment regarding C-Reactive Protein (CRP), alanine aminotransferase (ALT), platelets and international normalized ratio (INR) levels. Variation in lymphocytes count was observed over time, irrespective of treatment. Conclusions: TCZ administration did not reduce ICU admission or mortality rate in a cohort of 21 patients. Additional data are needed to understand the effect(s) of TCZ in treating patients diagnosed with COVID-19.</jats:p>", "alternative-id": [ "microorganisms8050695" ], "author": [ { "affiliation": [ { "name": "Division of Infectious Diseases I, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy" } ], "family": "Colaneri", "given": "Marta", "sequence": "first" }, { "affiliation": [ { "name": "Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, 27100 Pavia, Italy" } ], "family": "Bogliolo", "given": "Laura", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Diseases I, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy" } ], "family": "Valsecchi", "given": "Pietro", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Diseases I, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy" } ], "family": "Sacchi", "given": "Paolo", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Diseases I, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy" } ], "family": "Zuccaro", "given": "Valentina", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy" } ], "family": "Brandolino", "given": "Fabio", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0001-8263-3925", "affiliation": [ { "name": "Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, 27100 Pavia, Italy" }, { "name": "Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy" } ], "authenticated-orcid": false, "family": "Montecucco", "given": "Carlomaurizio", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Clinical, Surgical, Diagnostic, and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy" }, { "name": "Anesthesia and Intensive Care, Emergency Department, Fondazione IRCCS Policlinico S. Matteo, 27100 Pavia, Italy" }, { "name": "Anesthesia, Intensive Care and Pain Therapy, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy" } ], "family": "Mojoli", "given": "Francesco", "sequence": "additional" }, { "affiliation": [ { "name": "Catholic University of Milan, Department of Psychology, 20123 Milan, Italy" }, { "name": "Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, San Giuseppe Hospital, 28824 Verbania, Italy" } ], "family": "Giusti", "given": "Emanuele", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-0235-9207", "affiliation": [ { "name": "Division of Infectious Diseases I, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy" }, { "name": "Department of Clinical, Surgical, Diagnostic, and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy" } ], "authenticated-orcid": false, "family": "Bruno", "given": "Raffaele", "sequence": "additional" }, { "affiliation": [], "name": "the COVID IRCCS San Matteo Pavia Task Force", "sequence": "additional" } ], "container-title": "Microorganisms", "container-title-short": "Microorganisms", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2020, 5, 11 ] ], "date-time": "2020-05-11T14:01:18Z", "timestamp": 1589205678000 }, "deposited": { "date-parts": [ [ 2024, 6, 27 ] ], "date-time": "2024-06-27T21:46:00Z", "timestamp": 1719524760000 }, "indexed": { "date-parts": [ [ 2025, 5, 4 ] ], "date-time": "2025-05-04T06:26:34Z", "timestamp": 1746339994576, "version": "3.37.3" }, "is-referenced-by-count": 172, "issue": "5", "issued": { "date-parts": [ [ 2020, 5, 9 ] ] }, "journal-issue": { "issue": "5", "published-online": { "date-parts": [ [ 2020, 5 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2020, 5, 9 ] ], "date-time": "2020-05-09T00:00:00Z", "timestamp": 1588982400000 } } ], "link": [ { "URL": "https://www.mdpi.com/2076-2607/8/5/695/pdf", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "1968", "original-title": [], "page": "695", "prefix": "10.3390", "published": { "date-parts": [ [ 2020, 5, 9 ] ] }, "published-online": { "date-parts": [ [ 2020, 5, 9 ] ] }, "publisher": "MDPI AG", "reference": [ { "article-title": "The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak—An update on the status", "author": "Guo", "first-page": "1", "journal-title": "Mil. 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