Vincenzo Scaglione1, Salvatore Rotundo1, Nadia Marascio2, Carmela De Marco3, Rosaria Lionello1, Claudia Veneziano3, Lavinia Berardelli1, Angela Quirino2, Vincenzo Olivadese1, Francesca Serapide1, Bruno Tassone1, Helen Linda Morrone1, Chiara Davoli1, Valentina La Gamba1, Andrea Bruni4, Bruno Mario Cesana5, Giovanni Matera2, Alessandro Russo1, Francesco Saverio Costanzo6, Giuseppe Viglietto3, Enrico Maria Trecarichi1, Carlo Torti7. 1. Chair of Infectious and Tropical Diseases, Department of Medical and Surgical Sciences, "Magna Græcia" University, Viale Europa, Loc. Germaneto, 88100, Catanzaro, Italy. 2. Chair of Clinical Microbiology, Department of Health Sciences, "Magna Græcia" University, Catanzaro, Italy. 3. Department of Experimental and Clinical Medicine, "Magna Græcia" University, Catanzaro, Italy. 4. Chair of Intensive Care, Department of Medical and Surgical Sciences, "Magna Græcia" University, Catanzaro, Italy. 5. Unit of Medical Statistics, Biometrics and Bioinformatics "Giulio A. Maccacaro", Department of Clinical Sciences and Community Health, Faculty of Medicine and Surgery, University of Milan, Milan, Italy. 6. Department of Experimental and Clinical Medicine, Interdepartmental Center of Services (CIS), Molecular Genomics and Pathology, "Magna Græcia" University, Catanzaro, Italy. 7. Chair of Infectious and Tropical Diseases, Department of Medical and Surgical Sciences, "Magna Græcia" University, Viale Europa, Loc. Germaneto, 88100, Catanzaro, Italy. torti@unicz.it.
Abstract
BACKGROUND: Monoclonal antibodies (mAbs) and antivirals have been approved for early therapy of coronavirus disease (COVID-19), however, in the real-life setting, there are difficulties to prescribe these therapies within few days from symptom onset as recommended, and effectiveness of combined use of these drugs have been hypothesised in most-at-risk patients (such as those immunocompromised) but data supporting this strategy are limited. METHODS: We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalisation rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits achieved through a strategic proximity territorial centre are provided. We also report a case series with an in-depth evaluation of SARS-CoV-2 genome in relationship with treatment strategy and clinical evolution of patients. RESULTS: Two hundred eighty-eight patients were analysed; 94/288 (32.6%) patients were treated with mAb monotherapy, 171/288 (59.4%) patients were treated with antivirals, and 23/288 (8%) patients received both mAbs and one antiviral drug. Haematological malignancies were more frequent in patients treated with combination therapy than in the other groups (p = 0.0003). There was a substantial increase in the number of treated patients since the opening of the centre dedicated to early therapies for COVID-19. The provided disease-management and treatment appeared to be effective since 98.6% patients recovered without hospital admission. Moreover, combination therapy with mAbs and antivirals seemed successful because all patients admitted to the hospital for COVID-19 did not receive such therapies, while none of the most-at-risk patients treated with combination therapy were hospitalized or reported adverse events. CONCLUSIONS: A low rate of COVID-19 progression requiring hospital admission was observed in patients included in this study. The dedicated COVID-19 proximity territorial service appeared to strengthen the regional sanitary system, avoiding the overwhelming of other services. Importantly, our results also support early combination therapy: it is possible that this strategy reduces the emergence of escape mutants of SARS-CoV-2, thereby increasing efficacy of early treatment, especially in immunocompromised individuals.
BACKGROUND: Monoclonal antibodies (mAbs) and antivirals have been approved for early therapy of coronavirus disease (COVID-19), however, in the real-life setting, there are difficulties to prescribe these therapies within few days from symptom onset as recommended, and effectiveness of combined use of these drugs have been hypothesised in most-at-risk patients (such as those immunocompromised) but data supporting this strategy are limited. METHODS: We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalisation rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits achieved through a strategic proximity territorial centre are provided. We also report a case series with an in-depth evaluation of SARS-CoV-2 genome in relationship with treatment strategy and clinical evolution of patients. RESULTS: Two hundred eighty-eight patients were analysed; 94/288 (32.6%) patients were treated with mAb monotherapy, 171/288 (59.4%) patients were treated with antivirals, and 23/288 (8%) patients received both mAbs and one antiviral drug. Haematological malignancies were more frequent in patients treated with combination therapy than in the other groups (p = 0.0003). There was a substantial increase in the number of treated patients since the opening of the centre dedicated to early therapies for COVID-19. The provided disease-management and treatment appeared to be effective since 98.6% patients recovered without hospital admission. Moreover, combination therapy with mAbs and antivirals seemed successful because all patients admitted to the hospital for COVID-19 did not receive such therapies, while none of the most-at-risk patients treated with combination therapy were hospitalized or reported adverse events. CONCLUSIONS: A low rate of COVID-19 progression requiring hospital admission was observed in patients included in this study. The dedicated COVID-19 proximity territorial service appeared to strengthen the regional sanitary system, avoiding the overwhelming of other services. Importantly, our results also support early combination therapy: it is possible that this strategy reduces the emergence of escape mutants of SARS-CoV-2, thereby increasing efficacy of early treatment, especially in immunocompromised individuals.
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