Monoclonal Antibodies Anti-Covid-19: Analysis Of Efficacy And Safety Data In The Early Months Of Use

Introduction. In addition to the vaccination, other options for treating COVID-19 have been made available;such options include the monoclonal antibody (MAbs) combinations Casirivimab/Imdevimab and Bamlanivamab/Etesevimab, which have shown to reduce the chances of hospitalisation in patients at risk of severe forms of disease. The aim of this work is to define data on the use of monoclonal therapy at the hospital where our U.O.C. Pharmacy is located and also to provide a first analysis on the efficacy and safety of the treatments. Methods and materials. The period under consideration runs from March 20th to August 15th 2021. Clinical data were extracted from AIFA web records and processed using Microsoft Excel. For patients whose treatment was closed, it has been calculated: follow-up period, degree of healing, rates of negativization, average overall negativization time and for subgroups of patients identified according to specific clinical parameters. Finally, a total percentage by type of adverse reaction was established. Results. 91 treatments with one of the two MAbs combinations have been activated. The average age of patients was between 59 and 72 years. The most common symptom was fever (83,52% of patients), while the most frequently encountered risk factor was Cardio-cerebrovascular disease (59,34%). Patient files have been closed for 86 patients, 84 of which recovered and 2 deceased. Negativization rates at 7, 14, 21, 28 and 35 days were 2.60%, 27.27%, 44.16%, 74.03% and 77.92% respectively. The average time of negativization was 22.33 days;in patients treated within 3 days of onset symptom, the average time was of 18,09 days, while in those treated after 3 days it was 26.00. Only 9.09% of patients involved in the treatment experienced one or more adverse reactions to the infusion. Conclusions. The results of this work show that correctly used anti-Covid-19 MAbs are an important therapeutic resource against the new infectious agent. As observed during the experimental phase, monoclonal antibodies prove their beneficial effect when used in the early stages of infection.

Peculiar clinical presentation of COVID-19 and predictors of mortality in the elderly: A multicentre retrospective cohort study.

BACKGROUND: The spectrum of COVID-19 clinical manifestations is not yet known. In the elderly, mortality and extrapulmonary involvement appears more frequent than expected. METHODS: A multicentre-retrospective-case-series study of COVID-19 patients, aged ≥65 years, hospitalised between March 1 and June 15, 2020. Patients were classified at admission into 3 groups based on their Clinical Frailty Scale (CFS) score: 1-3 (group A), 4-6 (group B) and 7-9 (group C). RESULTS: Of the 206 patients in the study, 60 (29%) were assigned to group A, 60 (29%) to B and 86 (42%) to C. Significantly more frequent in group C than in B or A were: mental confusion (respectively 65%, 33%, 7%; P < 0.001), kidney failure (39%, 22%, 20%; P = 0.019), dehydration syndrome (55%, 27%, 13%; P < 0.001), electrolyte imbalance (54%, 32%, 25%; P = 0.001), and diabetic decompensation (22%, 12%, 7%; P = 0.026). Crude mortality was 27%. By multivariate logistic regression model independent predictors of death were male sex (adjusted odds ratio (aOR) = 2.87,95%CI = 1.15-7.18), CFS 7-9 (aOR = 9.97,95%CI = 1.82-52.99), dehydration at admission (aOR = 4.27,95%CI = 1.72-10.57) and non-invasive/invasive ventilation (aOR = 4.88,95%CI = 1.94-12.26). CONCLUSIONS: Elderly patients with a high CFS showed frequent extrapulmonary signs at admission, even in the absence of lung involvement. These findings, along with a high CFS, predicted a significant risk of mortality.

Tocilizumab and corticosteroids for covid-19 treatment in elderly patients

Background. The mortality rate for coronavirus disease-19 (COVID-19) increases with age. Some anti-inflammatory drugs such as tocilizumab or steroids have been proposed for the treatment of severe disease;however, few data are available in the elderly. Methods. A retrospective case-series of patients hospitalized between March 1st and June 15th, 2020 with confirmed COVID-19 by RT-PCR testing on throat/nasopharyngeal swabs and age ≥ 65 years was analysed. Patients were retrospectively divided into three groups according to the chosen treatment [standard of care (SOC), tocilizumab or corticosteroids] and patient characteristics and occurrence of adverse events were compared among groups. Results. Overall, 206 patients were included, 148 treated with standard of care, 42 with steroids and 16 with tocilizumab. Patients treated with steroids or Tocilizumab presented more frequently with fever (p =.003), dyspnea (p <.001), bilateral opacities/infiltrates at chest X-ray (p =.026) or CT-scan (p =.020), and more frequently required non-invasive/invasive ventilation (p <.001). Crude mortality was 27%, without differences among groups (p =.074). No specific adverse events were observed during/after the administration of steroids or tocilizumab;however, a trend towards an increased risk of secondary infections was described compared to SOC (p =.097). At multivariate logistic regression, only tocilizumab administration was an independent predictor of secondary infections (aOR = 6.72, 95% CI = 1.43-31.39, p =.015). Conclusions. Tocilizumab and corticosteroid could have a possible role for severe form of pneumonia in course of COVID-19 also in elderly patients, even if great attention to the monitoring of infectious complications should be paid in this special population.