Hypoalbuminemia and clinical adverse events in children with COVID-19.
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ABSTRACT:
SUBMITTER: Loffredo L
PROVIDER: S-EPMC8013663 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesHypoalbuminemia is a negative acute phase reactant which has been associated with inflammatory response and poor outcome in infectious diseases. The aim of this study was to analyze the value of hypoalbuminemia on admission as a predictor of mortality and adverse events in COVID-19 patients.MethodsWe analyzed retrospective data from a cohort of 609 consecutive patients, with confirmed diagnosis of COVID-19, discharged from hospital (deceased or alive). Demographic characteristics, previous comorbidities, symptoms and laboratory findings on admission were collected. Comorbidities were assessed by Charlson-Age Comorbidity Index.ResultsHypoalbuminemia on admission (<34 g/L) was more frequent in nonsurvivors than survivors (65.6% vs. 38%, p < 0.001) and was significantly associated with the development of sepsis, macrophage activation syndrome, acute heart failure, acute respiratory distress syndrome and acute kidney injury, regardless of Charlson-Age Comorbidity Index. Hypoalbuminemia was a predictor of mortality in multivariable Cox regression analysis (HR 1.537, 95% CI 1.050-2.250, p = 0.027), independently of Charlson-Age Index, gender, lymphocyte count <800/μL, creatinine, high-sensitivity C- reactive protein >8 mg/L, lactate dehydrogenase >250 U/L, bilateral infiltration on chest X-ray and q-SOFA ≥2.ConclusionsHypoalbuminemia was an early predictor of in-hospital mortality in COVID-19, regardless of age, comorbidity and inflammatory markers. It also had significant association with severe adverse events, independently of Charlson-Age Comorbidity Index. Our results suggest that serum albumin determination on admission may help to identify patients with SARS-CoV-2 infection at high risk of developing potential life-threatening conditions and death.
| S-EPMC8088081 | biostudies-literature
Project description:ObjectivesHypoalbuminemia is a negative acute phase reactant which has been associated with inflammatory response and poor outcome in infectious diseases. The aim of this study was to analyze the value of hypoalbuminemia on admission as a predictor of mortality and adverse events in COVID-19 patients.MethodsWe analyzed retrospective data from a cohort of 609 consecutive patients, with confirmed diagnosis of COVID-19, discharged from hospital (deceased or alive). Demographic characteristics, previous comorbidities, symptoms and laboratory findings on admission were collected. Comorbidities were assessed by Charlson-Age Comorbidity Index.ResultsHypoalbuminemia on admission (<34g/L) was more frequent in nonsurvivors than survivors (65.6% vs. 38%, p<0.001) and was significantly associated with the development of sepsis, macrophage activation syndrome, acute heart failure, acute respiratory distress syndrome and acute kidney injury, regardless of Charlson-Age Comorbidity Index. Hypoalbuminemia was a predictor of mortality in multivariable Cox regression analysis (HR 1.537, 95% CI 1.050-2.250, p=0.027), independently of Charlson-Age Index, gender, lymphocyte count <800/μL, creatinine, high-sensitivity C- reactive protein >8mg/L, lactate dehydrogenase >250U/L, bilateral infiltration on chest X-ray and q-SOFA ≥2.ConclusionsHypoalbuminemia was an early predictor of in-hospital mortality in COVID-19, regardless of age, comorbidity and inflammatory markers. It also had significant association with severe adverse events, independently of Charlson-Age Comorbidity Index. Our results suggest that serum albumin determination on admission may help to identify patients with SARS-CoV-2 infection at high risk of developing potential life-threatening conditions and death.
| S-EPMC7843155 | biostudies-literature
Project description:IntroductionStatistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. The unprecedented environment created by the coronavirus disease 2019 (COVID-19) pandemic for vaccine surveillance predisposes commonly applied signal detection methodologies to a statistical issue called the masking effect, in which signals for a vaccine of interest are hidden by the presence of other reported vaccines. This masking effect may in turn limit or delay our understanding of the risks associated with new and established vaccines.ObjectiveThe aim is to investigate the problem of masking in the context of COVID-19 vaccine signal detection, assessing its impact, extent, and root causes.MethodsBased on data underlying the Vaccine Adverse Event Reporting System, three commonly applied statistical signal detection methodologies, and a more advanced regression-based methodology, we investigate the temporal evolution of signals corresponding to five largely recognized adverse events and two potentially new adverse events.ResultsThe results demonstrate that signals of adverse events related to COVID-19 vaccines may be undetected or delayed due to masking when generated by methodologies currently utilized by pharmacovigilance organizations, and that a class of advanced methodologies can partially alleviate the problem. The results indicate that while masking is rare relative to all possible statistical associations, it is much more likely to occur in COVID-19 vaccine signaling, and that its extent, direction, impact, and roots are not static, but rather changing in accordance with the changing nature of data.ConclusionsMasking is an addressable problem that merits careful consideration, especially in situations such as COVID-19 vaccine safety surveillance and other emergency use authorization products.
| S-EPMC9219360 | biostudies-literature
Project description: Not available
| S-EPMC8662292 | biostudies-literature
Project description:The Coptic clergy, due to their specific work involving interaction with many people, could be subjected to increased risk of infection from COVID-19. The aim of this study, a sub-study of the COVID-19-CVD international study of the impact of the pandemic on the cardiovascular system, was to assess the prevalence of COVID-19 among Coptic priests and to identify predictors of clinical adverse events. Participants were geographically divided into three groups: Group-I: Europe and USA, Group II: Northern Egypt, and Group III: Southern Egypt. Participants' demographic indices, cardiovascular risk factors, possible source of infection, number of liturgies, infection management, and major adverse events (MAEs), comprising death, or mechanical ventilation, were assessed. Out of the 1570 clergy serving in 25 dioceses, 255 (16.2%) were infected. Their mean age was 49.5 ± 12 years and mean weekly number of liturgies was 3.44 ± 1.0. The overall prevalence rate was 16.2% and did not differ between Egypt as a whole and overseas (p = 0.23). Disease prevalence was higher in Northern Egypt clergy compared with Europe and USA combined (18.4% vs. 12.1%, p = 0.03) and tended to be higher than in Southern Egypt (18.4% vs. 13.6%, p = 0.09). Ten priests (3.92%) died of COVID-19-related complications, and 26 (10.2) suffered a MAE. The clergy from Southern Egypt were more obese, but the remaining risk factors were less prevalent compared with those in Europe and USA (p = 0.01). In multivariate analysis, obesity (OR = 4.180; 2.479 to 12.15; p = 0.01), age (OR = 1.055; 0.024 to 1.141; p = 0.02), and systemic hypertension (OR = 1.931; 1.169 to 2.004; p = 0.007) predicted MAEs. Obesity was the most powerful independent predictor of MAE in Southern Egypt and systemic hypertension in Northern Egypt (p < 0.05 for both). Obesity is very prevalent among Coptic clergy and seems to be the most powerful independent predictor of major COVID-19-related adverse events. Coptic clergy should be encouraged to follow the WHO recommendations for cardiovascular disease and COVID-19 prevention.
| S-EPMC8269321 | biostudies-literature
Project description:ImportanceSafety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.ObjectivesTo monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, setting, and participantsThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.ExposuresReceipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main outcomes and measuresIncidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.ResultsA total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and relevanceIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.
| S-EPMC8511971 | biostudies-literature
Project description:Purpose: This study aims to characterize the early innate and adaptive responses induced by SARS-CoV-2 infection in children and adults over time up to 8 weeks post symptoms onset (POS). We report the gene signature of COVID-19 over the course of the disease in both age groups. The kinetic of infection was divided in 5-time intervals according to the calculated days POS: interval 1 (0-5), interval 2 (6-14), interval 3 (15-22), interval 4 (23-35), and interval 5 (36-81). Methods: RNA extraction was performed automatically via the PAXgene Blood miRNA Kit and the QIAcube instrument (Qiagen) following the manufacturer’s protocol. RNA concentration and quality were assessed by using the Qubit instrument (Invitrogen) and the Agilent 2100 Bioanalyzer, respectively. The Stranded Total RNA Ribo-Zero Plus kit from Illumina was used for the library preparation with 100 ng of total RNA as input. Library molarity and quality were assessed with the Qubit and Tapestation using a DNA High sensitivity chip (Agilent Technologies). Libraries were pooled at 2 nM for clustering and sequenced on an Illumina HiSeq 4000 sequencer for a minimum of 30 million single-end 100 reads per sample. Main results: (I) we observed an antiviral-IFN-signature and innate-cell-activation within the first 5 days post symptoms onset (POS), while genes associated with CD4 T-cell responses, plasma cells and immunoglobulin were upregulated in both age groups during the first two weeks POS, indicative of SARS-CoV-2-specific adaptive immune responses; (II) in adults, genes associated with IFN antiviral responses and activated dendritic cells were maintained during the second week of disease, and subsided only after 14 days. By contrast, those transcriptome changes subsided already after 5 days in children.
2021-09-22 | GSE166190 | GEO
Project description: Not available
| S-EPMC7537253 | biostudies-literature
Project description:ObjectivesBNT-162b2, mRNA-1273, and Ad26.COV2.S vaccines data regarding adverse events (AEs) are scarce. In this report, we aimed to describe fatal and non-fatal possible AEs after COVID-19 vaccine administration.MethodsAn observational multicenter study investigating the causes of emergency department visits and hospital admissions within 10 days of COVID-19 vaccination. Patients who received first or second doses of COVID-19 vaccines and presented to the emergency department (ED), as well as those admitted to the hospitals or intensive care units (ICUs) were included. Causes of ED, hospital, and ICU admissions and discharges were collected based on the International Classification of Diseases, Tenth Revision (ICD-10) coding system.ResultsBetween December 2020 and March 2021, 1842 patients visited the ED within 10 days of COVID-19 vaccine administration. The mean age was 70.3 years. Overall, 1221 patients presented after the first dose of the vaccine and 653 after the second dose. Trauma (14.9%), hypertensive emergency/urgency (7.8%), generalized pain and arthralgia (5.7%), and chest pain (4.4%) were the most common causes of presentation to the ED. Of all ED presentations, mortality rate was at 2.2% (41 patients) with a median follow-up time of 68.0 days, versus 2.6% in unvaccinated ED patients. Postvaccination acute hypoxemic respiratory failure (46.3%), septic shock (24.4%), and cardiogenic shock (12.2%) were the most common causes of death.ConclusionAlthough reported AEs are not necessarily caused by the vaccination, this study provides further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. This study also supports prior data that serious AEs post vaccination are much lower than primary COVID-19 infections. Further studies are needed to investigate causalities between vaccines and reported AEs across all age groups.
| S-EPMC8514147 | biostudies-literature
Project description: Not available
| S-EPMC10897819 | biostudies-literature