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3.
Drug Safety ; 45(10):1233, 2022.
Article in English | EMBASE | ID: covidwho-2085704

ABSTRACT

Introduction: The post-marketing surveillance of COVID-19 mRNA vaccines revealed that urticarial reactions could occur with a delayed time course following both primary vaccinations [1-4] and the booster vaccinations [5,6]. While delayed urticarial reactions following COVID-19 primary vaccinations resolve in general with a median of 2-4 days, delayed urticaria after booster vaccination can show a prolonged and intermittent clinical course requiring treatment for several weeks [5,6]. Shortly after the booster vaccination campaign began in Switzerland in December 2021, an increasing number of delayed urticarial reactions in association with Spikevax was reported to Swissmedic, whereby a safety signal was opened. Objective(s): To characterize cases of delayed urticarial reactions reported in Switzerland following booster vaccination with Spikevax. Method(s): Case-by-case assessment of spontaneously reported delayed urticarial reactions following booster vaccination with Spikevax recorded in the Swiss national pharmacovigilance database up to February 8th, 2022. Result(s): There were 107 cases of delayed urticaria following booster vaccination with Spikevax. Of these, 79 (73.8%) were reported by consumers/non-health professionals. Women were more frequently affected (55, 51.4%) and median age was 38 years (interquartile range, IQR, 34-44 years). Urticaria developed a median of 10 days after booster vaccination (IQR 9-11.5 days). In 55 (51.4%) cases, urticaria was the solely reported adverse event, whilst 52 (48.6%) cases reported urticaria with additional adverse events, including pruritus (n = 27) and angioedema (n = 7). In 81 (75.7%) cases, delayed urticaria had not serious consequences (i.e. did not require/ prolonged hospitalisation, was not disabling/incapacitating, did not determine other clinically relevant conditions). In 69 (64.5%) cases the outcome of urticaria was not recovered at the time of reporting, which occurred a median of 14 days after booster administration (IQR 6-21 days). Conclusion(s): To our knowledge, this is the first case series to date of delayed urticaria following booster vaccination with Spikevax, showing that these reactions were more frequently not self-limiting and with a prolonged course in contrast to delayed urticaria developed after COVID-19 mRNA primary vaccinations. Although these reactions should not discourage from subsequent COVID-19 mRNA vaccinations, further investigations with regard to additional booster vaccinations seem necessary.

4.
Swiss Medical Weekly ; 152(Supplement 261):13S, 2022.
Article in English | EMBASE | ID: covidwho-2057773

ABSTRACT

Introduction: Since the beginning of 2020, the treatment of Covid- 19 patients has been a major challenge in medical everyday life. It is unclear whether the clinical course is more severe in individuals with spinal cord injury (SCI) compared to the general population. While certain studies indicate that individuals with SCI have a higher mortality rate and a higher level of infection with COVID-19 than the general population [1], other studies make it clear that the disease courses are by no means more severe [2]. The aim of this study is to describe the clinical course and length of stay of individuals with SCI and symptomatic Covid-19 infection who required hospital admission to the Swiss Paraplegic Center (SPC). Method(s): Retrospective data analysis of clinical data of individuals with SCI who were hospitalized with Covid-19 at the SPC from March 01, 2020 to December 31, 2021. Result(s): During the mentioned period, 13 individuals with symptomatic Covid-19 infection were hospitalized at the SPC. Of these, 61% were male (n = 8), and the mean age was 59 years (SD 15 years). 60% had a tetraplegia (46% incomplete) and 40% had a paraplegia (54% incomplete). The mean length of stay was 19 days (SD 9.03). Six individuals were treated in the intensive care unit, all of whom were persons with paraplegia. Persons with paraplegia tended to have a longer length of stay (26 SD 5.8) than persons with tetraplegia (13.75 SD 7.6). Two persons (both with a tetraplegia) died during the hospital stay (15%). Conclusion(s): These data provide initial insight into the course of symptomatic Covid-19 infection in individuals with SCI and provide a basis for further research projects.

5.
Drug Safety ; 45(10):1233, 2022.
Article in English | ProQuest Central | ID: covidwho-2046319

ABSTRACT

Introduction: The post-marketing surveillance of COVID-19 mRNA vaccines revealed that ürticarial reactions coüld occür with a delayed time course following both primary vaccinations [1-4] and the booster vaccinations [5,6]. While delayed urticarial reactions following COVID-19 primary vaccinations resolve in general with a median of 2-4 days, delayed urticaria after booster vaccination can show a prolonged and intermittent clinical course requiring treatment for several weeks [5,6]. Shortly after the booster vaccination campaign began in Switzerland in December 2021, an increasing number of delayed urticarial reactions in association with Spikevax® was reported to Swissmedic, whereby a safety signal was opened. Objective: To characterize cases of delayed urticarial reactions reported in Switzerland following booster vaccination with Spikevax®. Methods: Case-by-case assessment of spontaneously reported delayed urticarial reactions following booster vaccination with Spikevax® recorded in the Swiss national pharmacovigilance database up to February 8th, 2022. Results: There were 107 cases of delayed urticaria following booster vaccination with Spikevax®. Of these, 79 (73.8%) were reported by consumers/non-health professionals. Women were more frequently affected (55, 51.4%) and median age was 38 years (interquartile range, IQR, 34-44 years). Urticaria developed a median of 10 days after booster vaccination (IQR 9-11.5 days). In 55 (51.4%) cases, urticaria was the solely reported adverse event, whilst 52 (48.6%) cases reported urticaria with additional adverse events, including pruritus (n = 27) and angioedema (n = 7). In 81 (75.7%) cases, delayed urticaria had not serious consequences (i.e. did not require/ prolonged hospitalisation, was not disabling/incapacitating, did not determine other clinically relevant conditions). In 69 (64.5%) cases the outcome of urticaria was not recovered at the time of reporting, which occurred a median of 14 days after booster administration (IQR 6-21 days). Conclusion: To our knowledge, this is the first case series to date of delayed urticaria following booster vaccination with Spikevax®, showing that these reactions were more frequently not self-limiting and with a prolonged course in contrast to delayed urticaria developed after COVID-19 mRNA primary vaccinations. Although these reactions should not discourage from subsequent COVID-19 mRNA vaccinations, further investigations with regard to additional booster vaccinations seem necessary.

6.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005655

ABSTRACT

Background: CRC still is one of the leading causes of cancer related death though prognosis has improved through guideline based management. The COVID-19 pandemic lead to re-allocation of resources subordinating all sections of care for CRC patients. We present data on changes of CRC care during the pandemic from 22 German AIO CC and our high volume Institute of Pathology (pathology). Methods: Data was collected retrospectively comparing the months (mo) of the first wave (fw) (4-6/2020) and second wave (sw) (11-12/2020) of the pandemic with corresponding periods (cp) in 2019 focusing on the number of precancerous (ICD-O/0+2) and malignant (ICD-O/ 3+6) colorectal lesions (CRL) diagnosed by our pathology, the number/stage of primary diagnoses (PD) and the number of surgeries (surg) at AIO CC. There, quality criteria of CRC care were also assessed (number of PD discussed within a multidisciplinary tumor board (tb), received social service (soc)/ psychological (psy) counseling or recruited into a clinical trial). Statistical analysis was performed using students t-test for paired data. Results: Numbers of CRL detected upon histology (row 1-3), number of cases, surg and quality criteria from AIO CC (row 4-9) are displayed in the table. We saw a dip in diagnosed CRL and number of surg (p=0.007) only during fw, whereas PD dipped significantly in both waves. A significant reduction in diagnosis of stage III CRC was detected for 2019 vs. 2020 (p=0.001), not for other stages. Quality criteria showed a significant reduction in clinical trial inclusion, a small dip in soc/psy counseling and persistently high tb presentation. Conclusions: We detected a significant decrease of premalignant lesions and primary cancers during the first year of the pandemic which may impact cancer mortality in the future. Certified German CC provided CRC care with significant reduction in clinical trial inclusion only, suggesting high stability of established certified cancer care infrastructure.

7.
Transfusionsmedizin ; 12(03):157-162, 2022.
Article in English | Web of Science | ID: covidwho-2004809

ABSTRACT

For more than two years the whole world is suffering from the COVID-19 pandemic. Before introduction of vaccination strategies the administration of fresh frozen plasma from convalescent donors seemed a promising therapeutic approach, especially if administered during the early phase of disease. The outcomes in multicenter trials on huge cohorts, however, did not meet the expectations. This is one reason why German guidelines do not recommend the use of convalescent plasma. One explanation could be varying and often low concentrations of COVID-19 antibodies in a majority of plasma units at the beginning of plasma applications, which could account for the lack of a convincing clinical efficacy. Therefore, we follow a strategy to selectively collect and concentrate human immunoglobulins using immunoadsorption as the method of antibody donation.

8.
Topics in Antiviral Medicine ; 30(1 SUPPL):78, 2022.
Article in English | EMBASE | ID: covidwho-1880481

ABSTRACT

Background: The aim of this study was to identify the cause of lymphopenia, strongly predictive of survival in COVID-19. Methods: We recruited PCR-positive SARS-CoV-2-infected patients upon admission to Intensive Care Units (ICU, n = 29) and to the Infectious Diseases Department (non-ICU, n = 29) at Nîmes University Hospital, as well as age-and sex-matched healthy controls (HC). Their Angiotensin II plasma levels were measured by ELISA and their monocytic reactive oxygen species (ROS) production and T-cell apoptosis were measured by flow cytometry using dichloro-dihydro-fluorescein diacetate and fluorescent annexin V, respectively. DNA damage and double strand breaks were quantified in immunofluorescence using antibodies specific for-γ-H2AX and 53BP1, respectively. Results: The monocytes of certain COVID-19 patients spontaneously released ROS able to induce DNA damage and apoptosis in neighboring cells. High ROS production was predictive of death. Indeed, in most patients we observed the presence of DNA damage in up to 50% of their peripheral mononuclear blood cells, with double-strand DNA breaks, and T-cell apoptosis. The intensity of this DNA damage was linked to lymphopenia. SARS-CoV-2 is known to induce the internalization of its receptor, Angiotensin Converting Enzyme 2, a protease able to catabolize Angiotensin II. Accordingly, we observed high plasma levels of Angiotensin II in ROS-producing patients. In search of the stimulus responsible for their ability to release ROS, we unveiled that Angiotensin II triggers ROS production by monocytes via Angiotensin receptor I (AT1). ROS released by Angiotensin II-activated monocytes induced DNA damage and apoptosis in neighboring cells. Conclusion: Mononuclear cell apoptosis provoked via DNA damage due to the release of monocytic ROS could play a major role in COVID-19 pathogenesis, inasmuch as ROS are also known to trigger inflammatory cytokine production. Unveiling this new pathogenic pathway opens up new therapeutic possibilities for COVID-19 based on the early association of AT1 antagonists and antioxidants.

9.
Revue d'Épidémiologie et de Santé Publique ; 70:S125-S126, 2022.
Article in French | ScienceDirect | ID: covidwho-1815126

ABSTRACT

Introduction La crise sanitaire liée à la COVID-19 et les différentes restrictions (confinements) mises en place ont pu avoir un impact sur les comportements (ex : activité physique [AP] et comportement sédentaire [CS]) et la santé psychologique (ex : estime de soi ou stratégie d'ajustement pour faire face au évènements stressants) des personnes. L'objectif de cette étude était d'identifier des profils d'AP et de CS, et de rechercher leurs associations avec les caractéristiques socioéconomiques et psychologiques en population adulte française pendant la période de crise sanitaire liée à la COVID-19. Methodes Les données transversales des adultes ont été recueillies au cours de la crise sanitaire liée à la COVID19 (entre mars 2020 et février 2021) par auto-questionnaire. L'AP et le CS ont été mesurés à l'aide de l'International Physical Activity Questionnaire. L’échelle d'estime de soi de Rosenberg et le questionnaire Brief Cope (14 dimensions) ont été utilisés pour mesurer l'estime de soi et les stratégies d'ajustement, respectivement. Les profils transversaux d'AP et de CS ont été identifiés en utilisant une analyse de classe latente. Des modèles de régression logistique multivariable ont permis de rechercher les associations entre les profils identifiés et les facteurs socioéconomiques, l'estime de soi et les stratégies d'ajustement des adultes. Resultats Parmi les 241 adultes inclus (âge moyen ± écart type : 29,6 ± 13,1 ans), trois profils transversaux d'AP et de CS ont été identifiés ( Figure 1 ) : • marcheur sédentaire (n = 141 ;58,5%) ;• pratiquant d'AP variées (n = 68 ;28,2%) ;• marcheur avec AP intense (n = 32 ;13,3%) Par rapport au profil marcheur sédentaire, le profil marcheur avec AP intense était surreprésenté par des adultes socialement moins favorisés, utilisant davantage la planification et moins la religion comme stratégie d'ajustement aux évènements stressants, et ceux du profil pratiquant d'AP variées utilisaient davantage le déni comme stratégie d'ajustement. Conclusion Plus de la moitié des adultes était dans le profil le moins favorable à la santé (marcheur sédentaire). Ces résultats suggèrent d'utiliser l'AP et le CS comme leviers pour faire face aux évènements stressant de la vie. Mots clés Activité physique ;Comportement sédentaire ;Adulte ;Crise sanitaire liée à la COVID19 Déclaration de liens d'intérêts Les auteurs n'ont pas précisé leurs éventuels liens d'intérêts

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