Development of approaches and metrics to assess the impact and improve the outcome of patients with frailties in the Covid-19 era

Principal Investigator: CILIBERTO GENNARO

The outbreak of the coronavirus 2 disease 2019 (COVID-19) is hard challenging the health care systems worldwide. In this context, the impact of the COVID-19 pandemic on frail patients is growing rapidly and the need to allocate major health care resources to the COVID-19 emergency has been reported to impact negatively on patients’ adherence to treatments and/or follow up programs. In patients with severe chronic diseases, such as cancer, autoimmune diseases and immune-deficiencies, this may translate into outcome worsening. We present here CO.M.E.TA, a network project involving six Italian institutions whose goals are:

• to measure and compare the impact of the pandemic on the access of cancer and immunocompromised patients to therapies in three Italian regions;
• to assess how reorganizational measures put in place in these different institutions have impacted on specific metrics of performance;
• to establish a COVID-19 Biobank of biological samples from SARS-Cov-2 infected patients to be used to study immunological alterations in patients with fragilities.

Regarding the first two AIMs of the project the results of the analyses show that in all the centers participating in the study, all the parameters analyzed (first visit, follow-up visit, surgeries, admissions) have almost entirely recovered in 2021 the drop that was evident in 2020, returning to values comparable to those of 2019.

Within the AIM3 the activity was focused on the implementation of a biobank of biological samples from patients with different degrees of COVID disease and/or with other concomitant diseases (immunological and tumors). The purpose of this collection lies in the possibility of analyzing in frail patients other factors related to COVID-19 disease severity, which made frail patients more prone to complications and a longer course of hospitalization, often with an inauspicious outcome. Since the start of the project, 137 patients has been enrolled. For all enrolled patients, serum, plasma and circulating lymphocyte cells (PBMC) were collected. All patients were stratified according to disease severity, classified according to their co-morbidities, and all clinical, laboratory and molecular-genetic data on each patient were recorded on the eCRF. Among the conditions associated with frailty we noted age, origin from nursing homes, the presence of associated diseases (co-morbidities) such as diabetes, hypertension, obesity, autoimmune diseases and cancer.

We are in debt with the Godda Sakkai Institute that support the project with 600.000 euros.