Lessons learned and implications of early therapies for coronavirus disease in a territorial service center in the Calabria region

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 hypothesized in most-at-risk patients (such as those immonocompromised) but there are no data supporting this strategy.Methods: We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalization rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits obtained through a strategic proximity territorial center 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 analyzed; 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. Hematological 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 center 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. By contrast, emergence and accumulation of possible relevant mutations in the SARS-CoV-2 genome were observed in cases not treated with early combination therapy.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 significantly strengthened the regional sanitary system, providing a strong benefit in terms of prescriptions and quality of care and avoiding the overwhelming of other services. Importantly, our results also support early combination therapy in immunocompromised patients to avoid clinical worsening, onset of mutations, and resistance to anti-SARS-CoV-2 agents.