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The COVID-19 pandemic has changed routine care practice for older persons, especially in those with frailty living in long term care (LTC) facilities. Due to the high mortality rates of Nursing home (NH) residents during the first wave of the COVID-19 pandemic, priority for COVID-19 vaccinations was given to this vulnerable population. However, the safety and efficacy of such vaccines in older frail elders remains questionable due to the fact that initial randomized clinical trials (RCTs) for such vaccines did not include this population. This type of discrimination in patient participation in RCTs continues and has been recognized in the literature. Nevertheless, in the context of a worldwide emergency, COVID-19 vaccination in older persons living in LTC facilities may provide a solid basis to protect against negative outcomes, such as COVID-19 infection and death. In this report, we present the protocol of the GeroCovid Vax study, an Italian study that began in February 2021 which is aimed at investigating the safety and efficacy of the anti-SARS-CoV-2 vaccinations in older persons living in LTCs. This protocol specially aims to continuously and closely monitor events related to- and following- the anti-SARS-CoV-2 vaccination in elderly living in LTC facilities. In this report, we will provide information related to the study protocol and describe baseline characteristics of the sample.

OBJECTIVE Type 2 diabetes may affect the humoral immune response after vaccination, but data concerning coronavirus disease 19 (COVID-19) vaccines are scarce. We evaluated the impact of diabetes on antibody response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in older residents of long-term care facilities (LTCFs) and tested for differences according to antidiabetic treatment. RESEARCH DESIGN AND METHODS For this analysis, 555 older residents of LTCFs participating in the GeroCovid Vax study were included. SARS-CoV-2 trimeric S immunoglobulin G (anti-S IgG) concentrations using chemiluminescent assays were tested before the first dose and after 2 and 6 months. The impact of diabetes on anti-S IgG levels was evaluated using linear mixed models, which included the interaction between time and presence of diabetes. A second model also considered diabetes treatment: no insulin therapy (including dietary only or use of oral antidiabetic agents) and insulin therapy (alone or in combination with oral antidiabetic agents). RESULTS The mean age of the sample was 82.1 years, 68.1% were women, and 25.2% had diabetes. In linear mixed models, presence of diabetes was associated with lower anti-S IgG levels at 2 (β = −0.20; 95% CI −0.34, −0.06) and 6 months (β = −0.22; 95% CI −0.37, −0.07) after the first vaccine dose. Compared with those without diabetes, residents with diabetes not using insulin had lower IgG levels at 2- and 6-month assessments (β = −0.24; 95% CI −0.43, −0.05 and β = −0.30; 95% CI −0.50, −0.10, respectively), whereas no differences were observed for those using insulin. CONCLUSIONS Older residents of LTCFs with diabetes tended to have weaker antibody response to COVID-19 vaccination. Insulin treatment might buffer this effect and establish humoral immunity similar to that in individuals without diabetes.

Nursing home (NH) residents suffered the greatest impact of the COVID-19 pandemic. Limited data are available on vaccine-induced immunity and on the protection ensured by a prior infection in this population.The present study aims to monitor antibody levels and their persistence over a 6-month period in NH residents according to the history of prior SARS-CoV-2 infection.We measured anti-trimeric Spike IgG antibody levels in a sample of 395 residents from 25 NHs in 6 Italian Regions at study enrolment (prior to the first dose of vaccine, T0) and then after 2 (T1) and 6 months (T2) following the first vaccine dose. All participants received mRNA vaccines (BNT162b2 or mRNA-1273). Analyses were performed using log-transformed values of antibody concentrations and geometric means (GM) were calculated.Superior humoral immunity was induced in NH residents with previous SARS-CoV-2 infection. (T0: GM 186.6 vs. 6.1 BAU/ml, p 0.001; T1: GM 5264.1 vs. 944.4 BAU/ml, p 0.001; T2: GM 1473.6 vs. 128.7 BAU/ml, p 0.001). Residents with prior SARS-CoV-2 infection receiving two vaccine doses presented significantly higher antibody concentration at T1 and T2. A longer interval between previous infection and vaccination was associated with a better antibody response over time.In a frail sample of NH residents, prior SARS-CoV-2 infection was associated with a higher humoral response to vaccination. Number of vaccine doses and the interval between infection and vaccination are relevant parameters in determining humoral immunity.These findings provide important information to plan future immunization policies and disease prevention strategies in a highly vulnerable population.

Italy was one of the first western countries to embrace the first wave of COVID-19 and undergo detrimental outcomes in older adults in different clinical settings, especially in those with comorbidity and frailty. In addition, older nursing home (NH) residents had significantly higher mortality rates most likely due to the increased susceptibility of infection due to combined physical vulnerability and risks linked to the NH living environment itself. Different reports throughout Italy have rapidly highlighted selected outcomes related to COVID-19 in older patients being treated in acute and long-term care (LTC) settings. However, the majority of these studies are single center studies. Thus, it remains fundamental to collect large data from prospective based-population studies in order to identify preventive and therapeutic COVID-19 risk/protective factors correlated with COVID-19 health status outcomes. In this commentary paper, we will discuss different Italian reports according to clinical settings and highlight the importance of GeroCovid Observational and GeroCovid Vax, two large population based prospective studies in Italy.

OBJECTIVES The aim of this study was to evaluate in a group of patients with psychosis the effect of the dopamine agonist rotigotine on neuroleptic-induced extrapyramidal symptoms (EPSs), a set of movement disorders such as pseudoparkinsonism, dyskinesias, akinesia, and akathisia that occur as result of taking drugs that block dopamine receptors. METHODS Twenty patients with psychosis with EPSs were clinically evaluated before and after the administration of rotigotine. The drug was started at a dosage of 2 mg daily and gradually increased until the best clinical benefit was achieved (mean ± SD, dosage, 3.2 ± 1.8 mg; range, 2-8 mg). The neurological status was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) total and UPDRS section III, the Simpson-Angus Scale, and the Barnes Akathisia Rating Scale. The Positive and Negative Syndrome Scale and the Hamilton Depression Rating Scale were used to appraise possible modifications of the psychiatric conditions. RESULTS Compared with baseline, there was a significant improvement in the UPDRS total, the UPDRS section III, the Simpson-Angus Scale (P < 0.0001), and the Barnes Akathisia Rating Scale (P < 0.05), without changes in the Positive and Negative Syndrome Scale and the Hamilton Depression Rating Scale (P < 0.05). All patients tolerated rotigotine well, except 1 who dropped out of the trial because of the recurrence of his psychotic symptoms. CONCLUSIONS The results of this observational study suggest that low doses of rotigotine are well tolerated in patients with psychosis and are effective in neuroleptic-induced EPSs.