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

Marta Colaneri,Carlomaurizio Montecucco,Pietro Valsecchi,Paolo Sacchi,Raffaele Bruno,Laura Bogliolo,Fabio Brandolino,Valentina Zuccaro,Emanuele Giusti,Francesco Mojoli,The Covid Irccs San Matteo Pavia Task Force

doi:10.3390/microorganisms8050695

Abstract

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.

Highlights

At the end of December 2019, a novel coronavirus, referred to as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), was first reported in China as the cause of COVID-19 [1,2]
We report a retrospective analysis of two groups of the SMAtteo COvid19 REgistry (SMACORE) cohort: patients who were administered TCZ and patients who were treated according to Standard Of Care (SOC)
Our analyses indicate that treatment with TCZ did not significantly affect ICU admission and 7-day mortality rate when compared with SOC

Summary

Introduction

At the end of December 2019, a novel coronavirus, referred to as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), was first reported in China as the cause of COVID-19 [1,2]. Since it has quickly spread worldwide, becoming a pandemic [3,4]. Pneumonia appears to be the most frequent serious manifestation of infection and approximately 6–10% of patients develop Acute Respiratory Distress Syndrome (ARDS), requiring continuous positive airway pressure therapy or mechanical ventilation [5,6]. Several drugs that have been highly promising in vitro have failed in clinical studies [10]

Methods

Discussion

Conclusion