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Introduction and Objectives: Cases suggestive of immune-mediated acute hepatitis following SARS-CoV-2 vaccination have been reported. The risk of liver injury after Covid-19 vaccination is unknown. This study aimed to estimate the cumulative incidence of liver injury within 90 days after the Covid-19 vaccine, defined as the occurrence of AST and/or ALT increases at least two times the limit of normal or ALP increases at least x 2. To compare with an active comparator group (influenza vaccine). Material(s) and Method(s): Retrospective cohort study. We analyze a consecutive sample of adult patients vaccinated with Covid-19 vaccines (Sputnik, AstraZeneca/Oxford, Covishield, or Sinopharm) between January 1 and May 30, 2021, and a historical control group vaccinated with influenza between March 1 and July 30, 2019. Qualifying labs were collected as part of routine clinical care or the development of symptoms. Result(s): From a total of 29,918 subjects who received the Covid-19 vaccine in 2021 and 24,753 who received the Influenza vaccine in 2019, 130 and 148 patients, respectively, were excluded because of previously altered liver function tests or known hepatic disease. Both groups were comparable in age (73 years old (IQR 65-80), p=0.125) and gender (67% were females). In the Influenza group were more dysmetabolic and immunosuppressed patients. A total of 269 and 273 patients, respectively, presented altered liver function tests within 90 days post-vaccination. The cumulative incidence of liver injury was 4.6 per 1,000 (95% CI 3.9-5.5) for Covid-19 and 5.1 per 1,000 (95%CI 4.3-6.1) for Influenza (p=0.453). Although, two patients from the COVID group had a more severe injury, with hyperbilirubinemia, development of autoantibodies and requirement of steroids for disease control. Conclusion(s): The occurrence of events was similar in subjects vaccinated with Covid-19 compared to the control group. Acute hepatitis characteristics arising after the COVID-19 vaccine needs to be further clarified.Copyright © 2023
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The main objective was to estimate the prevalence of diabetes mellitus (DM) among patients with COVID-19, to explore associ-ated factors;and to describe clinical evolution of hospitalized patients. A cross-sectional study was conducted, which included adults confirmed with COVID-19 between 03/12/2020 and 10/15/2020, at Hospital Italiano de Buenos Aires. From 6009 people with COVID-19, 408 had previous diagnosis of DM, yielding a prevalence of 6% (95%CI 6-7), higher prevalence was associated with age (12% in ≥ 60 years and 3% in < 60 years;p = 0.01). In-hospital mortality was 6% (95%CI 6-7), being 15% in DM and 6% compared in non-diabetics (p < 0.01). Associated factors with DM were cardiovascular variables such as male sex, hypertension, smoking, chronic renal failure, heart failure, previous coronary disease;and clinical variables proxy of frailty such as: age, dementia and previous institutionalization (all with p < 0.01). Only 23% (96/408) of DM had an HbA1c measurement in the last 3 months and 76% in the last year, with an average 8.6%, and 25% in goal (HbA1c ≤ 7%). Management was mostly in-hospital (59%), with an average hospital stay of 12 days, with the following complications during hospitalization: 6% presented a hypoglycemic value (< 70 mg/dl), 42% required oxygen therapy, 19 % went to intensive care unit, 15% required invasive mechanical ventilation (mean 11 days), and 25% (95%CI 20-31) of in-hospital mortality (mean 82 years).
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The objective of this study was to reveal how the COVID-19 pandemic process affected the number of visits to an emergency department of a highly complex hospital located in the Ciudad Autonoma de Buenos Aires, to explore the characteristics and reasons for consultation. The monthly number of visits between January 2019 and December 2020 was analyzed. The data showed a strong decrease in the number of visits (176 370 in 2019 and 95 421 in 2020), with an abrupt drop after the lockdown disposal (In aprilshowed the maximum reduction: 77.1%), and the different stages are reflected in the evolution (a consequence of quarantine), yielding a global annual reduction of 45.9%. The number of patients admitted by ambulances increased (5.1% in 2019 to 10.4% in 2020;p < 0.05), and consequently, the number of patients in the more complex sector (area B 2019: 5.3%, 2020: 11.5%;p < 0.01), as well as unscheduled hospitalizations from 6.8% (95% CI 6.7-6.9) to 12.1% in 2020 (95%CI11.8-12.3), p < 0.01. The five most frequent reasons for consultation in 2020 were: fever (5.1%), odynophagia (4.7%), abdominal pain (2.6%), cough (1.8%) and headache (1.8%), probably all related to COVID-19. In conclusion, the number of emergency department visits decreased by half compared to the previous year.
ABSTRACT
Background: During COVID pandemic, many cancer patients (pts) refused to come to hospital, suspending therapies, with ominous consequences. Based on positive (+) results of DOMONCOVID, our homecare project for COVID+ cancer pts, we created a new model of assistance, ONCOHOME, delivering cancer care at home to immune-compromised pts. We aim to provide data on feasibility, efficacy and costs of this innovative model. Material and Methods: ONCOHOME is a multicenter project involving 3 Cancer Center (CC) of the North of Italy: National Cancer Institute, San Raffaele in Milan and Cremona CC. We created an organizational homecare model based on a medical and nursing team with a car equipped for home visits and a secretariat managing patient calls, with a dedicated phone number. The team administers cancer care at home and provides pts with the same assistance usually delivered in hospital. Patientreported outcome (PRO) assessment is performed. Results: From August 3rd 2020 to May 5th 2021, 79 cancer pts were assisted at home by Cremona team, receiving oral (62 pts), subcutaneous (10pts) or intravenous therapy (7 pts). All types of cancer were included. 77% of pts had a metastatic disease, 88% had a PS ECOG 0-1. Median duration of assistance was 126 days [range 2-270 days]. Most of the pts received oral chemotherapy (41pts). TKIs (25 pts), hormonal therapy (12 pts), supportive care with denosumab and zolendronic acid (5 pts ) and immunotherapy (1 patient, pt) were successfully administered at home, too. 13 pts required hospitalization due to clinical complications. In this group, only 2 pts were admitted to hospital due to severe toxicity;in particular, 1 pt treated with trifluridin/ tipiracil developed febrile neutropenia and 1 pt treated with gefitinib reported Grade 3 diarrhea. Both pts were discharged and continued to be assisted at home. Conclusions: ONCOHOME showed that inpatient or outpatient cancer drug administration could be successfully replaced by home administration, for appropriate therapies and selected pts. This model is feasible at an affordable cost. The project is ongoing, planning to accrue other 100 pts for each center. ONCOHOME will be implemented with electronic devices for PRO evaluation, certified telemedicine service and non-invasive wearable smart tissue monitoring physiological parameters devices.
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Background: Cancer patients (pts) have higher risk of serious COVID-19 symptoms, morbidity and mortality than general population. SARS-CoV-2 vaccine trials excluded patients with metastatic cancer or undergoing immunosuppressive therapies;therefore, the effectiveness of vaccines are unknown in this population. Hence, there is an urgent need to understand the correlation between cancer type, its treatment and vaccine efficacy. Material and Methods: This is a prospective study conducted by the Oncology Unit of Cremona Hospital, enrolling pts from Oncology, Hematology, Radiotherapy and Palliative Care divisions. The trial aims to evaluate effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], incidence of symptomatic COVID-19 infection, antibodies (Abs) response in a consecutive population of 300 cancer pts, undergoing antiblastic therapies, starting from March 2021. Primary endpoint: Number of symptomatic pts affected by COVID-19, diagnosed 7-60 days after the 2nddose of vaccines. Secondary endpoints: Abs variation at different timepoints;duration of abs;correlation between effectiveness of vaccines and antiblastic treatments. Statistical Analysis: The primary objective will be tested by non-inferiority one-single proportion test, compared with the value of 95% observed in the vaccine registration trials. The hypothesis of vaccine inferiority in the trial population is rejected if a rate of protection conferred by the vaccine is observed in 89% of the sample size. Results: 356 patients received mRNA anti-COVID-19 vaccines. None of them reported symptomatic COVID-19 infection after vaccination. Whereas almost all patients (95.6%) with solid tumors developed an antibody response, only 77% of patients with hematological malignancy demonstrated anti-COVID-19 antibody production after vaccination. The different antiblastic treatments didn't have a significant impact on the antibody response. In particular, patients treated with immunotherapies and with chemotherapy developed antibodies against COVID-19 in 98% and 92% of cases, respectively. Conclusions: Vaccination against COVID-19 demonstrated to be effective and to prevent symptomatic COVID- 19 infection in patients with solid and hematological tumors during antiblastic treatment. The depth of antibody response resulted different between patients with solid and hematological malignancies. Different antiblastic therapies didn't significantly impact on the development of the antibody response.
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Background: Cancer patients (pts) have higher risk of serious COVID-19 symptoms, morbidity and mortality than general population. SARS-CoV-2 vaccine trials excluded patients with metastatic cancer or undergoing immunosuppressive therapies;therefore, the effectiveness of vaccines are unknown in this population. Hence, there is an urgent need to understand the correlation between cancer type, its treatment and vaccine efficacy. Trial design: Methods: This is a prospective study conducted by the Oncology Unit of Cremona (Cr) Hospital, enrolling pts from Oncology, Hematology, Radiotherapy (RT) and Palliative Care divisions. The trial aims to evaluate effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], incidence of symptomatic COVID-19 infection, antibodies (Abs) response and onset of adverse events (AEs) in a consecutive population of 300 cancer pts, undergoing antiblastic therapies, starting from March 2021. A vaccination point was set up by Cr Hospital, dedicated to cancer pts treated with chemotherapy (CT), TKIs, RT, hormones. Only pts in follow-up or treated with adjuvant hormone are excluded. CT was suspended at least 5 days before and 3 days after vaccination;targeted therapy, immunotherapy and RT are not interrupted. Primary endpoint: Number of symptomatic pts affected by COVID-19, diagnosed 7-60 days after the 2nddose of vaccines. The infection is defined according to the FDA criteria combined with a positive nasopharyngeal swab. Secondary endpoints: Abs variation at different timepoints compared to baseline;vaccine-related adverse events;duration of abs, up to 12 months after 2nd dose;correlation between effectiveness of vaccines and antiblastic treatments, tumor burden, PS ECOG. Statistical analysis: The primary objective will be tested by non-inferiority one-single proportion test, compared with the value of 95% observed in the vaccine registration trials. The hypothesis of vaccine inferiority in the trial population is rejected if a rate of protection conferred by the vaccine is observed in 89% of the sample size. Results Preliminary results will be available in July 2021. Clinical trial identification: NCT04878796. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: During COVID pandemic, many cancer patients (pts) refused to come to hospital, suspending therapies, with ominous consequences. Based on positive (+) results of DOMONCOVID, our homecare project for COVID+ cancer pts, we created a new model of assistance, ONCOHOME, delivering cancer care at home to immune-compromised pts. We aim to provide data on feasibility, efficacy and costs of this innovative model. Methods: ONCOHOME is a multicenter project involving 3 Cancer Center (CC) of the North of Italy: National Cancer Institute, San Raffaele in Milan and Cremona CC. We created an organizational homecare model based on a medical and nursing team with a car equipped for home visits and a secretariat managing patient calls, with a dedicated phone number. The team administers cancer care at home and provides pts with the same assistance usually delivered in hospital. Patient-reported outcome (PRO) assessment is performed. Results: From August 3rd 2020 to May 5th 2021, 79 cancer pts were assisted at home by Cremona team, receiving oral (62 pts), subcutaneous (10pts) or intravenous therapy (7 pts). All types of cancer were included. 77% of pts had a metastatic disease, 88% had a PS ECOG 0-1. Median duration of assistance was 126 days [range 2-270 days]. Most of the pts received oral chemotherapy (41pts). TKIs (25 pts), hormonal therapy (12 pts), supportive care with denosumab and zolendronic acid (5 pts ) and immunotherapy (1 patient, pt) were successfully administered at home, too. 13 pts required hospitalization due to clinical complications. In this group, only 2 pts were admitted to hospital due to severe toxicity;in particular, 1 pt treated with trifluridin/tipiracil developed febrile neutropenia and 1 pt treated with gefitinib reported Grade 3 diarrhea. Both pts were discharged and continued to be assisted at home. Conclusions: ONCOHOME showed that inpatient or outpatient cancer drug administration could be successfully replaced by home administration, for appropriate therapies and selected pts. This model is feasible at an affordable cost. The project is ongoing, planning to accrue other 100 pts for each center. ONCOHOME will be implemented with electronic devices for PRO evaluation, certified telemedicine service and non-invasive wearable smart tissue monitoring physiological parameters devices. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: The province of Cremona had one of the highest incidence of COVID-19 (COV-19) infection in Italy. The pandemic determined a significant shrinkage of our healthcare resources with difficulty for many patients (pts) to be assisted in the hospital, especially for the risk of being infected. Therefore, we created a homecare project for cancer pts with the aim of reducing hospitalizations, accesses to the oncology ward and emergency room. Methods: The team was composed by oncologists and nurses from the Oncology Unit of Cremona Community Hospital, supported by a secretary with a dedicated telephone number. The assistance was provided from Monday to Saturday, 9 AM-5 PM. Cancer pts were eligible if presenting confirmed diagnosis or suggestive symptoms for COV-19. A telephonic triage was performed. Cancer pts and their cohabitants were tested with at least 2 nasopharyngeal swabs (NPS). Blood test, medical examinations and vital parameters were performed. We advised screened individuals to follow the quarantine procedures, providing them with an information leaflet. We administered oral/infusional treatments, including antiviral drugs. Results: From March 23rd to April 30th 2020, 71 cancer pts were assisted at home, with a total of 191 visits. Of the 71 pts tested with NPS, 26 resulted COV-19 positive (COV-19+). 19 of COV-19+ pts had mild symptoms;7 pts with stable vital parameters and initial pneumonia were successfully treated at home with hydroxychloroquine, antivirals and NSAIDs. 7 pts with severe symptoms were promptly hospitalized. 4 of them died, 2 due to the infection, 2 to progression disease. 52 cohabitants were screened with NPS, 28 lived with a COV-19+ cancer patient;in this subgroup, 16 resulted COV-19+. 15 of them were completely asymptomatic. Conclusions: This project demonstrated the feasibility of an innovative model based on homecare assistance for COV-19+ cancer pts with mild symptoms. This strategy, limiting the number of hospital accesses for COV-19+ pts, might be useful to contain the spread of the infection. Further studies are needed to test this strategy in COV-19 negative cancer pts. Moreover, our experience indicates a high probability of identifying asymptomatic positive individuals cohabiting with COVID+ pts. NPS screening for asymptomatic subjects is not routinely performed in Italy. There is a urgent need to extend the screening to this population.
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Background: Risks associated with COVID outbreak and consequent restrictive measures taken by the Government, can cause concern and anxiety. The impact on cancer patients (pts) may be even greater. We investigated the influence of COVID pandemic on pts' perceptions, opinions and feelings during the peak of the epidemic and after the loosening of the Government restrictions. Methods: Multicenter, serial cross-sectional study conducted in 11 cancer centers located in the hardest hit Italian areas. The study is composed by 2 surveys administered to unselected adult pts receiving onsite oncologic treatments: the first during the enforcement of containment measures against COVID spread;the second upon the loosening of Government restrictions. A self-administered questionnaire composed by 11 closed questions (only 1 answer) was used. At least 1000 pts per each survey were deemed necessary. Multivariable logistic regression models will be used to identify factors associated to recorded perceptions and opinions. Main outcomes are: 1) perception of the pandemic effect on feelings 2) perception of changes in the relationship with the medical team 3) opinions on healthcare reorganization and on the information campaign. Results: The first survey was conducted between March 16th and April 30th. 1027 questionnaires were collected. Mean age was 64 years (SD 11.7), 58% were women, 49% had low educational level. 80% and 20% received i.v. and oral treatment, respectively. As for pts feelings, 45.5% indicated that their fears related to cancer had increased because hope in recovery had diminished (23%). Courage of coping with tumor was increased in 26%, unchanged in 64%;95% perceived a high availability of healthcare facilities and 97.6% declared confidence in the treating team's handling of the epidemic, while 65.3% stated that the information received from the Government and local bodies was confusing. Conclusions: Although half of the pts had more fears and concerns about the epidemic, they feel reassured, maintain trust in healthcare facilities and a good communication with doctors and nurses. Due to the epidemic's course, the second survey could not yet be performed and data will be available by June.
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Background: Risks associated with COVID outbreak and consequent restrictive measures taken by the Government can cause concern and anxiety. The impact on cancer patients (pts) may be even greater. We investigated the influence of COVID pandemic on pts’ perceptions, opinions and feelings during the peak of the epidemic and after the loosening of the Government restrictions. Methods: Multicenter, serial cross-sectional study conducted in 11 cancer centers located in the hardest hit Italian areas. The study is composed by 2 surveys administered to unselected adult pts receiving onsite oncologic treatments: the first during the enforcement of containment measures against COVID spread;the second upon the loosening of Government restrictions. A self-administered questionnaire composed by 11 closed questions (only 1 answer) was used. At least 1000 pts per each survey were deemed necessary. Multivariable logistic regression models will be used to identify factors associated to recorded perceptions and opinions. Main outcomes are: 1) perception of the pandemic effect on feelings 2) perception of changes in the relationship with the medical team 3) opinions on healthcare reorganization and on the information campaign This study has been approved by all Ethical Commettees of the centers. Results: The first survey was conducted between March 16th and April 30th. 1027 questionnaires were collected. Mean age was 64 yrs (SD 11.7), 58% were women, 49% had low educational level. 80% and 20% received i.v. and oral treatment, respectively. As for pts feelings, 45.5% indicated that their fears related to cancer increased because hope in recovery diminished (23%). Courage of coping with tumor was increased in 26%, unchanged in 64%;95% perceived a high availability of healthcare facilities and 97.6% declared confidence in the treating teams, while 65.3% stated that the information received from the Government and local bodies was confusing. Conclusions: Although half of the pts had more fears and concerns about the epidemic, they feel reassured, maintain trust in healthcare facilities and a good communication with doctors and nurses. Due to the epidemic course, the second survey could not yet be performed and data will be available by June. Legal entity responsible for the study: Azienda Istituti Ospitalieri di Cremona, Italy. Funding: MEDEA, Medicina e Arte, Onlus, Cremona. Disclosure: All authors have declared no conflicts of interest.