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1.
Drug Safety ; 45(10):1307-1308, 2022.
Article in English | EMBASE | ID: covidwho-2085697

ABSTRACT

Introduction: Molnupiravir and nirmatrelvir/ritonavir are two new oral antivirals approved for the treatment of COVID-19 infections in adult, non-hospitalized patients at high risk for disease progression. Since their release, they have proven to be an effective strategy to prevent hospitalizations. Although clinical trials granted their efficacy and safety, real-life data on the possible effect of these drugs are lacking [1,2]. Objective(s): To evaluate the real-life safety of oral antivirals for COVID-19 by retrospectively assessing the number and type of adverse drug reactions (ADRs) detected in clinical practice. Method(s): We conducted a retrospective study of patients referred to the outpatient clinic for the early treatment of COVID-19 at the Infectious Diseases Unit of the University Hospital of Padua. Patients' clinical data and ADRs were collected. Each ADR was recorded in the National Pharmacovigilance Network. Data were anonymized and subsequently analyzed through R software. Qualitative variables were expressed as absolute numbers and percentages and compared using the Chi-square test. Quantitative variables were expressed as mean or median and compared by T-test or Mann- Whitney test whenever it was more appropriate. Result(s): 109 consecutive patients with a median age of 73 years were included. 49 were male and 15 were unvaccinated for COVID-19. 74 (67.9%, Group1) patients received nirmatrelvir/ritonavir and 35 (32.1%,) molnupiravir (Group2). Median age was significantly higher for group2. Regarding ADRs analysis, a total of 49 (44.9%) patients reported at least one adverse event, of which 7 belonged to Group 2 and 42 to Group 1 (p<0.01). No statistically significant difference between the two groups was found regarding serious ADRs and ADRs leading to discontinuation of therapy. The most frequent ADR in the nirmatrelvir/ritonavir group was dysgeusia (37.8% of patients in this group) whereas in the molnupiravir group it was nausea (11.4%). For further information see Table 1. Conclusion(s): The evidence emerging from our study suggests a higher frequency of ADRs compared to RCTs, especially in patients treated with nirmatrelvir/ritonavir. In these patients, we observed several cases of dysgeusia, much more than reported in the literature (37.8% vs 5.6%) [2]. Molnupinavir was associated with fewer side effects than nirmatrelvir/ritonavir even if administered to an older population. These findings suggest that molnupinavir may be considered a safe early treatment option in elderly people. Further analysis on larger cohorts, also taking into account possible confounding factors, need to be performed in order to better assess the real-life safety profile of these drugs. (Table Presented).

2.
Clinical Nephrology ; 95(3):151-155, 2021.
Article in English | GIM | ID: covidwho-2072982

ABSTRACT

Background: The recent SARS-CoV-2 outbreak represents a global health emergency, and dialysis patients are a high-risk population. Patients with end-stage renal disease (ESRD) in hemodialysis facilities require specific protocols to be planned and promptly executed for the management of suspected/confirmed cases of COVID-19 with respect to prevention, protection, screening, and isolation. Materials and methods: In order to prevent the spread of SARS-CoV-2 in our Hemodialysis Unit. we adopted individual protection measures accompanied by measures to minimize contacts among hemodialysis patients with suspicious symptoms as well as other patients and medical staff. We provided our patients detailed instructions to be followed in the event of their having symptoms compatible with SARS-CoV-2 infection or having contacts with SARS-CoV-2-positive subjects. Ultimately, four possible scenarios and care paths were developed and implemented in collaboration with the Infectious Diseases and Emergency Units at the Padua University Hospital.

3.
European Journal of Hospital Pharmacy. Science and Practice ; 29(Suppl 1):A176, 2022.
Article in English | ProQuest Central | ID: covidwho-1874615

ABSTRACT

Background and importanceSince June 2020, the European Medicines Agency granted conditional approval to the antiviral drug Veklury (remdesivir) as a treatment for COVID-19 pneumonia. Many studies have shown conflicting results regarding its efficacy. Data from observational studies should be encouraged in order to provide valuable information about its real-life effectiveness.Aim and objectivesThe aim of the study was to describe the effectiveness of remdesivir in terms of mortality rate and duration of hospitalisation in a cohort of patients admitted to an Italian University Hospital during the COVID-19 pandemic.Material and methodsWe carried out a retrospective observational study at a 1600-bed University hospital in Northern Italy. Our cohort included all patients who received remdesivir between September 2020 and April 2021, corresponding to the second and third pandemic waves in Italy. As a primary endpoint, we measured the mortality rate at any time after initiation of therapy. Secondary endpoints included 30-day mortality and duration of hospitalisation. As a post hoc analysis, we compared patients requiring high-flow oxygen supplementation (HFO) after starting remdesivir and patients who did not require HFO (eg, NHFO group). High-quality data were extracted from the medical records and from the Veklury AIFA (Agenzia Italiana del Farmaco) monitoring register. Statistical analyses were carried out with R (R Core Team 2021).ResultsThe study sample included 528 patients, mainly men (68.4%) with a median age of 66.7 years. The overall mortality rate was 5.1%, while the 30-day mortality rate was 4.2%. In the post hoc analysis, 291 patients (55.1%) fell in the NHFO group. HFO therapy confirmed a stronger association with mortality (11.0% HFO vs 0.3% NHFO, p<0.001). The NHFO group performed better in all the considered endpoints: rate of discharge to home, mortality, intensive care unit admission/transfer, and length of hospital stay.Conclusion and relevanceIn our study, the mortality rate was similar to that reported in clinical studies. Since no reports of adverse drug reactions were notified, these data support remdesivir as a possible therapeutic option, given the positive benefit–risk profile. As expected, patients who required high-flow oxygen were at increased risk of negative outcomes. This seems to suggest that potential early use of remdesivir could optimise its clinical efficacy.References and/or acknowledgementsConflict of interestNo conflict of interest

7.
PLoS ONE ; 16(2), 2021.
Article in English | CAB Abstracts | ID: covidwho-1410670

ABSTRACT

Background: The aim of this secondary analysis of the TESEO cohort is to identify, early in the course of treatment with tocilizumab, factors associated with the risk of progressing to mechanical ventilation and death and develop a risk score to estimate the risk of this outcome according to patients' profile.

9.
Open Forum Infectious Diseases ; 7(SUPPL 1):S167, 2020.
Article in English | EMBASE | ID: covidwho-1185705

ABSTRACT

Background: Remdesivir (RDV), a RNA polymerase inhibitor with potent in vitro activity against SARS-CoV-2, is the only treatment with demonstrated efficacy in shortening the duration of COVID-19. Here we report regional differences in clinical outcomes of severe COVID-19 patients treated with RDV, as part of an open-label, randomized phase-3 trial establishing RDV treatment duration. Methods: Hospitalized patients with oxygen saturation ≤94%, a positive SARS-CoV-2 PCR in the past 4 days and radiographic evidence of pneumonia were randomized 1:1 to receive 5d or 10d of intravenous RDV. We compared d14 clinical outcomes of patients from different geographical areas, as measured by mortality rates, change in clinical status from baseline (BL) on a 7-point ordinal scale and change in O2 requirements from BL. Based on previous analyses in compassionate use data showing region as an important predictor of outcome, Italy was examined separately from other regions. Results: 397 patients were treated with RDV, of which 229 (58%) were in the US, 77 (19%) Italy, 61 (15% in Spain), 12 (3%) Republic of Korea, 9 (2%) Singapore, 4 (1%) Germany, 4 (1%) Hong Kong and 1 (< 1%) Taiwan. BL clinical status was worse in Italy compared to other regions (72% vs 17% requiring high-flow oxygen delivery or higher), and Italian patients were more likely to be male than patients from other regions (69% vs 63%). Overall results showed 5d RDV was as effective as 10d. Mortality at d14 was higher in Italy (18%) compared to all other countries except Italy (7%). Similarly, clinical improvement at d14, measured as ≥2-point increase in the ordinal scale, was lower in Italian patients (39%) compared to all other countries combined (64%). (Fig.1). Conclusion: Overall, our results demonstrate significant geographical differences in the clinical course of severe COVID-19 patients treated with RDV. We observed worse outcomes, such as increased mortality and lower rate of clinical improvement, in patients from Italy compared to other regions. (Table Presented).

10.
Pathog Glob Health ; 115(7-8): 483-486, 2021.
Article in English | MEDLINE | ID: covidwho-1137914

ABSTRACT

A variety of dermatological lesions have been described in COVID-19, although the prevalence and pathogenic relationship remain unclear particularly for chilblain-like lesions. Dermatological examination was performed in a prospective cohort of consecutive patients seen at the service for SARS-CoV-2 infection. Out of 417 patients with confirmed SARS-CoV-2 infection [median age 29.5 years (range 15-65); 62.5% males], dermatological lesions were detected in 7 (1.7%). Three patients had acral lesions; their age (range) was 15-29 years; all had a negative nasopharyngeal swab and developed IgG and/or IgM-specific antibodies; all presented none or mild symptoms. A fourth patient remained negative at repeated testing; mother, father and sister had a documented mild COVID-19. Non-acral lesions were observed in four older patients, with severe COVID-19. Chilblain-like lesions may be the sole manifestation of SARS-CoV-2 infection; their presence in asymptomatic school children and adolescents should be considered a potential signal of familial or community spread of the virus.


Subject(s)
COVID-19 , Chilblains , Skin Diseases , Adolescent , Adult , Aged , Child , Female , Humans , Male , Middle Aged , Prospective Studies , SARS-CoV-2 , Young Adult
11.
Tumori ; 106(2 SUPPL):212, 2020.
Article in English | EMBASE | ID: covidwho-1109813

ABSTRACT

Background: COVID-19 pandemic started in Italy with clusters identified in Northern Italy. Since the beginning, the Veneto region started a proactive approach, including testing for SARS-CoV-2 part of the asymptomatic population and healthcare providers. The Veneto Oncology Network ROV licensed a dedicated PDTA to ensure proper care minimizing the risk of infection in cancer patient (pts). At the same time, a regional registry (ROVID) has been set up, to describe epidemiology and clinical course of SARS-CoV-2 infection in cancer pts. Materials and methods: All pts with cancer diagnosis and documented SARS-CoV-2 infection are eligible. The following information are recorded: age, cancer diagnosis, stage, tumor biology, comorbidities, presence of COVID- 19 symptoms, anticancer treatment at the time infection (type, aim, line of therapy, discontinuation, recovery), other medical treatments, hospitalization, treatments for SARS-CoV-2 infection, fate of the infection. Results: 144 pts from 18 centers have been enrolled. Mean age at the time infection: 69 yrs (25 to 95 yrs). The 5 most common cancer types were breast cancer (n=26), colorectal, prostate, lung cancer (n=16 each), melanoma (n=10). Distribution by stage was as follows: I 19%, II 9%, III 13%, IV 59%. Lung metastases were documented in 15% of the cases. 77% of the pts had at least one comorbidity. COVID-19 symptoms were reported in 78% of the pts. Active anticancer therapy at the time of the infection was reported for 71 pts (chemotherapy n=37, targeted therapy n=14, hormonal therapy n=13, immunotherapy n=6). Treatment was discontinued because of infection in 44 case. 101 pts were hospitalized;45 received low flow oxygen support and 26 received non-invasive mechanical ventilation, high flow nasal cannula or endotracheal intubation. The fate of infection is available for 95 cases so far: 44 infection resolution with confirmed negative swab, 16 with clinical resolution discharged with positive swab, and 35 deaths. Among cases with fatal exitus, 22 were attributable to COVID-19. Conclusions: Data collection is still ongoing, including further follow up and results of serological tests, where available. The mortality rate reported in this study is in line with other registry of cancer patients, confirming the frailty of this population. These data reinforce the need to protect cancer patients from SARS-CoV2 infection.

12.
Biochimica Clinica ; 44(SUPPL 2):S67, 2020.
Article in English | EMBASE | ID: covidwho-983996

ABSTRACT

Introduction. Saliva has been proposed as a valid alternative to naso-pharyngeal swabs for detecting viral SARS-CoV-2 RNA sequences. In addition salivary glands have been described as a potential SARSCoV-2 virus reservoir, thus supporting the search for antibodies in saliva. Furthermore, the non-invasive nature of saliva collection is conducive to self-collection, patients' compliance for repeated testing, and reduction of risk to operators, thus making saliva an eligible matrix in the SARS-CoV-2 diagnostic process. Aim. The aim of this study was to verify whether standardized and safe saliva collection is suitable for SARS-CoV-2 molecular detection and IgA class antibody measurement. Methods. A total of 49 COVID-19 patients hospitalized at the University-Hospital of Padova (Italy) and 326 subjects who underwent screening underwent naso-pharyngeal (NP) swab and saliva collection using Salivette®. Repeat blood collections were performed to evaluate hematological and coagulation parameters, biochemical markers of inflammation, and renal, liver, heart and pancreatic involvement in hospitalized patients. In all patients and subjects, saliva SARS-CoV-2 (gene E) rRT-PCR was undertaken in parallel with NP swabs. Salivary IgA and serum IgA, IgG, IgM were measured on samples from hospitalized patients. Results. NP swabs were SARSCoV-2 positive in 9/49 patients. The comparison with saliva testing was possible for 43/49 patients, 7 of whom shared positivity, and 35 negativity while in one, the saliva result, not NP-swab, was positive. Positive molecular testing results were significantly associated with disease duration (p=0.0049). All the 326 screened subjects were SARS-CoV-2 negative on both NP and saliva swabs. Among the 27 saliva samples tested for IgA, 18 were IgA positive. Salivary IgA positivity was significantly associated with pneumonia (p=0.002) and CRP values (p=0.0183), not with other clinical and molecular data, or with immunoglubulins in serum.Conclusions. The results reported in the present study demonstrate that a standardized and safe saliva collection method can be adopted to detect SARS-CoV-2 infection in alternative to NP-swabs. Preliminary data on salivary IgA also support the use of saliva in local adaptive immunity patient monitoring.

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