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Intro: This study aimed at evaluating healthcare-related sepses caused by three multi-drug resistant Gram-negative bacteria (Acinetobacter baumannii, Klebsiella pneumoniae and Pseudomonas aeruginosa) in a tertiary hospital in 2018-2020, particularly concerning therapy, antibiotic-resistance and outcomes, by also comparing the pre-COVID (2018-2019) and COVID (2020) periods. Method(s): An observational, retrospective-cohort analysis was based on data related to patients admitted to the "SS. Antonio e Biagio e Cesare Arrigo" Hospital in Alessandria (Italy) between 2018 and 2020, with septic episodes from bacteria of the examined species, whose antibiogram proved resistance to >= 2 antimicrobial classes indicated by the European Centre for Disease Prevention and Control. Data were retrieved from patients' medical records and the hospital's computer-based application. Statistics involved Fisher-test comparisons and cumulative incidence analyses. Finding(s): Inclusion criteria led to enrolment of 174 patients. Comparison between 2020 and 2018-2019 showed a relative increase in A. baumannii cases, at the expense of the other species (p<0.0001), and an increasing resistance trend for K. pneumoniae, with a higher proportion of cases resistant to 3-4 classes of antimicrobials (p<0.0001). Overall, most patients were treated with carbapenems (72.4%), although the COVID period saw a significant rise in the use of polymyxins, particularly colistin (62.5% vs 36%, p=0.0005). In both periods, more than half patients recovered (53-57%) and around one third died (27-34%), but with different outcomes according to the infecting bacterium, generally better for P. aeruginosa (70% recovered at 60 days) and worse for A. baumannii (55% recovered). Discussion(s): The study confirmed the importance of the burden connected to healthcare-related sepses. Moreover, since the COVID outbreak, a trend could be spotted towards higher relative incidence of complex cases, caused by antimicrobial-resistant bacteria and thus requiring second-line therapy. Conclusion(s): These findings underline the importance of appropriate antimicrobial stewardship and infection control in view of the evolving healthcare needs.Copyright © 2023
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Background: The COVID-19 pandemic disproportionally affected Black communities who were at greater risk of SARS-CoV-2 acquisition, morbidity, and mortality than those of White ethnicity. We describe the clinical epidemiology of COVID-19 in the GEN-AFRICA cohort of Black people with HIV in two South London clinics. Method(s): First reported episodes of COVID-19 up to 12/2021 were ascertained by direct questioning and/or medical records review. The cumulative incidence of COVID-19 and vaccination was determined by Nelson- Aalen methods. Pre-pandemic immunovirological and comorbidity status obtained prior to 01/2020 was used to identify risk factors for COVID-19 using Cox regression. We compared characteristics of participants with mild/ moderate (not requiring hospitalization) and severe (requiring hospitalization or resulting in death) COVID-19. Result(s): COVID-19 status was available for 1184 (95%) of 1289 GEN-AFRICA participants (mean age 49.1 years;55% female;median CD4 565;93% HIV RNA <200), and SARS-CoV-2 vaccination status for 1160;998 (86%) had received at least one vaccine dose (administered to 50% by 16/02/2021). A total of 310 participants (26.2%) reported a first episode of COVID-19 (any severity), with a cumulative incidence of 6%, 14%, 15% and 22% following the initial, alpha, delta, and omicron waves. Women, people of East African ancestry, and those with detectable HIV RNA were more likely to report COVID-19 (Table). CD4 (current/nadir), class of antiretroviral therapy (ART), and comorbidity status were not associated with COVID-19. Findings were similar when restricted to episodes in 2020 (prior to vaccine availability) or testconfirmed COVID-19. Severe COVID-19 cases (N=34) were more often male (p=0.002), of West-African ancestry (p=0.01), with lower CD4 cell counts (p=0.002), and they more often had a history of AIDS, diabetes mellitus, cardiovascular disease, and chronic kidney disease (all p=0.001) compared to mild/moderate cases;they were also more likely to be on protease inhibitor (PI)- containing ART (p=0.01). Conclusion(s): By the end of the second year of the pandemic, 22% of black people with HIV in South London had experienced COVID-19. Immune and comorbidity status were not associated with COVID-19 when all cases were considered but strongly associated with severe COVID-19 disease, as were West-African ancestry and being on a PI. (Table Presented).
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Background: Pregnant individuals are at increased risk of coronavirus disease 2019 (COVID-19) hospitalization and death, and primary and booster COVID-19 vaccination is recommended for this population. Method(s): Among a cohort of pregnant individuals who received prenatal care at 3 healthcare systems in the United States, we estimated the cumulative incidence of hospitalization with symptomatic COVID-19 illness. We also identified factors associated with COVID-19 hospitalization using a multivariable Cox proportional hazards model with pregnancy weeks as the timescale and a time-varying adjustor that accounted for severe acute respiratory syndrome coronavirus 2 circulation;model covariates included site, age, race, ethnicity, insurance status, prepregnancy weight status, and selected underlying medical conditions. Data were collected primarily through medical record extraction. Result(s): Among 19 456 pregnant individuals with an estimated due date during 1 March 2020-28 February 2021, 75 (0.4%) were hospitalized with symptomatic COVID-19. Factors associated with hospitalization for symptomatic COVID-19 were Hispanic ethnicity (adjusted hazard ratio [aHR], 2.7 [95% confidence interval {CI}, 1.3-5.5]), Native Hawaiian or Pacific Islander race (aHR, 12 [95% CI, 3.2-45.5]), age <25 years (aHR, 3.1 [95% CI, 1.3-7.6]), prepregnancy obesity (aHR, 2.1 [95% CI, 1.1-3.9]), diagnosis of a metabolic disorder (aHR, 2.2 [95% CI, 1.2-3.8]), lung disease excluding asthma (aHR, 49 [95% CI, 28-84]), and cardiovascular disease (aHR, 2.6 [95% CI, 1.5-4.7]). Conclusion(s): Although hospitalization with symptomatic COVID-19 was uncommon, pregnant individuals should be aware of risk factors associated with severe illness when considering COVID-19 vaccination. Copyright © 2022 Published by Oxford University Press on behalf of Infectious Diseases Society of America. This work is written by (a) US Government employee(s) and is in the public domain in the US.
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Remdesivir (GS-5734) is a new direct-acting antiviral drug in the nucleotide analogue class with antiviral activity against SARS-CoV-2 and the ability to inhibit RNA-dependent RNA polymerase. Preliminary results from phase III randomized clinical trials of remdesivir are inconsistent. Understanding the fact of the limited world experience with the use of remdesivir in COVID-19 required further study of its efficacy and safety in real clinical practice. The aim of the study is to evaluate the efficacy and safety of remdesivir in the treatment of patients with COVID-19. Material and methods. The study included 1422 patients with a novel coronavirus infection (COVID-19) who received remdesivir as part of complex therapy in a hospital setting at medical organizations of the Moscow public health system. Additionally, standard therapy was carried out, regulated by the Interim Guidelines "Prevention, Diagnosis and Treatment of Novel Coronavirus Infection (COVID-19)" of the Ministry of Healthcare of the Russian Federation, the current version. The efficacy of the drug was assessed based on primary and secondary efficacy points. Primary variable: 1) cumulative incidence of clinical outcomes in patients with COVID-19 treated with remdesivir as part of complex therapy;2) median time to clinical improvement according to the World Health Organization ordinal categorical scale (under clinical improvement, the patient is assumed to move >2 categories towards improvement in clinical condition). Secondary variables: 1) median time to achieve <2 NEWS scores lasting at least 24 hours or hospital discharge;2) mortality from all causes;3) duration of fever (>38 degreeC), days;4) duration of hospitalization, days;5) time to achieve elimination of the pathogen from the upper respiratory tract (no SARS-CoV-2 RNA), days. The safety of remdesivir was assessed based on the registration of adverse events using the method of spontaneous reports. Results. The analysis of clinical outcomes of treatment showed that 1195 (84.1%) patients recovered, death from all causes occurred in 227 (15.9%) patients. The median improvement in clinical status on the World Health Organization ordinal categorical scale was 6 days. The median time to reach a NEWS score of <2, lasting at least 24 hours, or hospital discharge was 4 days. The median duration of fever was 3 days from the start of remdesivir administration. The median length of hospital stays for patients included in the Register was 9 days. Adverse reactions associated with the use of remdesivir were recorded in 11 (0.7%) patients. Serious adverse reactions were not registered. During hospitalization, all adverse reactions were resolved. Conclusion. A retrospective analysis of data from the Registry of 1422 patients with COVID-19 who received remdesivir as part of complex therapy in medical organizations of the state healthcare system of Moscow in routine clinical practice showed clinical efficacy and a favorable safety profile of remdesivir (Remdeform, lyophilizate for solution for intravenous administration 100 mg, manufactured by JSC Pharmasyntez, Russia). The data obtained are consistent with previous randomized clinical trials of remdesivir and allow us to recommend its further use in patients with COVID-19 as part of complex therapy.Copyright © The Author(s), 2022.
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There are many unknowns surrounding COVID-19 and the ongoing pandemic. Standard epidemiological methods helped to determine the initial and ongoing distribution of COVID-19 in time and space, with unprecedented global coverage in almost real-time, and the forecasting methods used already had a reasonable predictive ability. Cumulative incidence and other complex epidemiological estimators have been widely disseminated via the media and are becoming lay terms thanks to persistent use, but their thresholds to determine public health interventions are yet to achieve consensus. The natural history of SARS-CoV-2, the interplay of risk factors and the effectiveness of mitigating factors in subpopulations remain unmet challenges. Establishing standard definitions of COVID-19 and its consequences is essential to the implementation of research. Pending widespread vaccine coverage, the world is experiencing unleashed community transmission in many countries, and the COVID-19 endgame is a distant goal. Several characteristics differentiate the transmissibility of SARS-CoV-2 from other viruses, making COVID-19 much more difficult to control with universal hygiene interventions. Epidemiology remains a necessary discipline to help end the COVID-19 pandemic;economic, social and health policy decision-making analysis are also needed.Copyright © ERS 2021.
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Background: Breats cancer is a major health problem in elderly ( >= 70 years) women. Increase incidence with age and the progressive increase in life expectancy mean that the numbers in elderly breast cancer diagnosis are increasing. These patients do not always receive the proper treatment and despite this the survival of this population is not always depends on cancer, there are other competing causes of death typical of the aging population. Method(s): A retrospective observational analysis of women >= age 70 diagnosed with breast carcinoma in HUPHM between 2014 and 2020 was made. Clinical, pathological data and stages at diagnosis were analyzed. We checked our patients with the national death center (official national registry) thus obtaining an exact date of death and the cause of death. Data updated in January 2023 , ensuring a minimum follow-up of 24 months. We excluded deaths from Covid or of unknown cause to avoid bias. Result(s): A total of 421 patients were analyzed, mean age of 78.6 years and median follow-up of 48 months. 28% of patients had died at the time of analysis, 11% due to cancer and 17% from other causes. If we analyze the population deceased by cancer, no deaths are detected in patients diagnosed with carcinoma in situ (4% of the population), in stage I (30% of the population) the cumulative incidence of cancer death at 5 years is 3%, 7% In stage II (30% of the population), 15% in stage III (16%) and 70% in stage IV (12%). Death by other causes are more frequent in early breast cancer, the cumulative incidence at 5 years are 10% in stage I, 22% in stage II, 44% in satge III and just 10% in stage IV. The most frequent causes of death in this population were caridovascular events and infections. There are no differences in 5-year mortality according to histological subtypes 20%, 12%, 25% and 12% for triple negative, Rh+/HER2-, RH+/her2+ and RH-/HER2+ respectively. Conclusion(s): Although elderly patients do not receive optical treatments, mortality from cancer in early stages is incidental at 5 years, a different scenario is seen in metastatic disease in which the patient's prognosis depends mainly on the oncological disease, Therefore, an effort should be made in the treatment of these patients with metastatic breast cancer since adequate treatments can have a clearly positive impact on the survival of patients. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2023
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Background: Antivirals and monoclonal antibodies (mAbs) were approved for early treatment of COVID-19 based on data from trials conducted in unvaccinated people before the Omicron era. The comparative effectiveness of different treatments is unknown. We present the results of the interim analysis of MONET trial (EudraCT: 2021-004188-28). Method(s): In this ongoing multicenter, open-label, phase 4 trial, we randomly assigned, in a 1:1:1 ratio, non-hospitalized patients with early symptomatic Covid-19 (<=5 days after symptoms onset) and >=1 risk factor for disease progression, to receive 500 mg of intravenous sotrovimab (SOT) or 600 mg of intramuscular tixagevimab/cilgavimab (TIX/CIL) or oral 5-days course of NMV/r 300/100 mg BID. Primary outcome was hospitalization or death for any cause within 29 days after randomization, reported as cumulative incidence per 100 (95% CI), and P-value calculated by Fisher's exact test. Inflammatory marker (CRP, d-dimer, and neutrophils-to-lymphocytes ratio) and antibody level (serum anti-S IgG and anti-N IgG) analysed by mixed linear regression with random intercept and P-values for time trend calculated by ANOVA-style test with Bonferroni correction. Result(s): Prespecified interim analysis, including 400 patients (SOT =133, TIX/ CIL=130, NMV/r=137) enrolled from Mar 4 to Nov 16, 2022 (Fig.1A). Overall, 5 pts (3/5 immunosuppressed) had disease progression leading to hospitalization [1.25% (95% CI 0.4%-2.89%)], 1 in SOT (0.75%, 95% CI 0.01%-4.1%), 4 in TIX/CIL (3.08%, 95% CI 0.84%-7.69%) and none in NMV/r arm (P=0.030). No deaths or ICU admissions were observed. Among the hospitalized pts, 3 were infected with BA.2 (1 SOT, 2 TIX/CIL), one with BA.4/5, and one BQ.1.1 (both TIX/ CIL). No serious adverse events and no kidney or liver toxicity were reported. Temporal trend of inflammation markers was similar in the three arms, and their estimates are shown in Fig.1B. Kinetics of antibody was reported in Fig.1C. The plot shows a rapid increase of anti-S in both mAb arm and a linear increase of IgG in the NMV/r arm. Anti-N IgG kinetics was similar in the three arms. Conclusion(s): By these data the overall cumulative risk of clinical failure in mild Covid-19 occurring in the Omicron era is low. The hypothesis that differences in clinical progression among the three arms could be related to different activity against the Omicron subvariant observed in vitro should be further investigated. Type of treatment does not seem to influence the development of the natural antibody response.
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Introduction: The aim of this study was to determine whether there is an association between extravascular lung water index (EVLWi) and physiological respiratory dead space (VDphys/VT) and to determine if these factors are associated with the possibility to being discharged alive on day 28. Method(s): We analyzed a prospective cohort of patients with COVID ARDS supported with invasive mechanical ventilation (IMV) admitted in our ICU who were monitored with volumetric capnography and transpulmonary thermodilution (TPTD). First day TDTP and VDphys/VT were considered. Bohr-Enghoff formula was used to obtain VDphys/ VT. This protocol was approved by the local IRB and informed consent was waived. Result(s): 31 patients with matched TPTD and VDphys/VT during the first 24 h were analyzed in who EVLWi correlated with VDphys/VT (r = 0.599 p = 0.002), however, EVLWi did not associated with PaFi. Patients with EVLWi > 10 ml/kg had higher APACHE II and VDphys/VT. These patients had a lower cumulative incidence to be discharged alive on day 28 with aHR 7.3 [1.4-39.1] p = 0.02 (adjusted by APACHE II and VDphys/VT, Fig. 1A). Remarkably, patients with EVLWi > 10 ml/ kg + VDphys/VT > 57% had worse outcome compared to those who had EVLWi > 10 ml/kg + VDphys/VT < 57% (25% vs 75%, p = 0.032, Fig. 1B). Conclusion(s): In patients with COVID ARDS supported with IMV, VDphys/VT give prognostic data additional to EVLWi.
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Introduction: As of 29 July 2022, SARS-CoV-2 has infected 4.7 million Malaysians. Reinfection, defined as a new infection 90 days from initial infection is now rising due to the emergence of new variants. Studies have shown that healthcare workers (HCW) are 3.4 times more likely to test positive for COVID-19. This study aims to describe the reinfection rate of COVID-19 and protection effectiveness (PE) from past infection among HCWs in public hospitals in Malaysia. Method(s): A prospective cohort study was conducted from March 2021. HCWs were followed up to determine the post BNT162b2 vaccination humoral response to SARS-CoV-2. Additionally, participants were prompted to self-report a positive COVID-19 result. Reinfection rates were calculated using the total number of patients who had a prior infection as denominator. Infection rates were analysed at a predetermined period throughout our follow-up. Protection offered by prior infection was calculated as one minus the ratio of infection rate for COVID-19 positive patients and COVID-19 naive patients (1 - RR x 100%). Result(s): In this cohort, the cumulative incidence rate for SARS-CoV-2 is 44.6% (246/551). Reinfection rate is 6.5% (16/246). The PE at 3 and 6 months were 100% respectively while the PE at 9 and 12 months were 72.1% and 56.2%. Conclusion(s): Past infection offers 100% protection against reinfection up to 6 months but this protection steadily declines with the emergence of Omicron variant, even among vaccinated and boosted individuals. As variant-specific vaccines are still in development, reducing exposure and compliance to COVID-19 prevention guidelines are imperative to avoid infection.
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Background: SARS-CoV-2 variants resistant to monoclonal antibodies, and drug-drug interactions and potential mutagenicity of direct acting antivirals, heightens the need for additional therapeutics to prevent progression to severe COVID-19. Exogenous interferon beta is a promising therapeutic option against SARS-CoV-2 given its broad-spectrum antiviral activity and data suggesting impaired endogenous IFN production in individuals with severe disease. Method(s): The safety and efficacy of orally inhaled nebulized interferon-beta1a (SNG001) was evaluated in a Phase II randomized controlled trial on the ACTIV-2/ A5401 platform (NCT04518410). Adult outpatients with confirmed SARS-CoV-2 infection within 10 days of symptom onset were randomized to SNG001 once daily for 14 days or blinded pooled placebo. Primary outcomes included treatment-emergent Grade >=3 adverse event (TEAE) through day 28;time to symptom improvement of 13 targeted COVID-19 symptoms collected by daily study diary through day 28;and SARS-CoV-2 RNA < lower limit of quantification (LLoQ) from nasopharyngeal (NP) swabs at days 3, 7, and 14. All-cause hospitalization or death through day 28 was a key secondary outcome. Result(s): Of 221 participants enrolled at 25 US sites between February and August 2021, 220 (110 SNG001, 110 placebo) initiated study intervention, with a median age of 40 years, 55% female, and 20% SARS-CoV-2 vaccinated. There was no significant difference between SNG001 and placebo in Grade >=3 TEAEs (4% vs 8%, Fisher's exact test p=0.25). Median time to symptom improvement was 13 days for SNG001 and 9 days for placebo (Gehan-Wilcoxon test p=0.17). There was no difference in the proportion of participants with SARS-CoV-2 RNA < LLoQ at day 3, 7 or 14 (SNG001 vs placebo, Day 3: 28% vs. 39%;Day 7: 65% vs. 66%;Day 10: 91% vs. 91%;joint Wald test p=0.41). There were fewer hospitalizations with SNG001 (n=1;1%) compared with placebo (n=7;6%), but this difference was not statistically significant (Fisher's exact test p=0.07;Figure). All hospitalizations were due to COVID-19 and occurred among unvaccinated participants without protocol-defined high-risk factors. Conclusion(s): Inhaled nebulized SNG001 was safe and well tolerated but did not reduce SARS-CoV-2 RNA levels in the nasopharynx nor decrease time to improvement of COVID-19 symptoms in outpatients with mild-to-moderate COVID-19. The non-statistically significant decrease in hospitalizations among SNG001 participants warrants further investigation in a phase 3 clinical trial. Cumulative incidence of hospitalization or death comparing SNG001 vs. placebo.
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Background: Coronavirus Disease 2019 (COVID-19) vaccine antigen dosage may affect protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but direct evidence to quantify this effect is lacking. Method(s): A matched, retrospective, cohort study that emulated a randomized control trial was conducted in Qatar between February 3, 2022 and November 8, 2022, to provide a head-to-head, controlled comparison of protection induced by two antigen dosages of the BNT162b2 vaccine. The study compared incidence of omicron infection in the national cohort of adolescents 12 years of age who received the two-dose primary-series of the 30-mug BNT162b2 vaccine to that in the national cohort of adolescents 11 years of age who received the two-dose primary-series of the pediatric 10-mug BNT162b2 vaccine. Associations were estimated using Cox proportional-hazard regression models. Result(s): Among adolescents with no record of prior infection, cumulative incidence of infection was 6.0% (95% CI: 4.9-7.3%) for the 30-mug cohort and 7.2% (95% CI: 6.1-8.5%) for the 10-mug cohort, 210 days after the start of follow-up. Incidence during follow-up was dominated by omicron subvariants including, consecutively, BA.1/BA.2, BA.4/BA.5, BA.2.75*, and XBB. The adjusted hazard ratio comparing incidence of infection in the 30-mug cohort to the 10-mug cohort was 0.77 (95% CI: 0.60-0.98). Corresponding relative effectiveness was 23.4% (95% CI: 1.6-40.4%). Relative effectiveness was -3.3% (95% CI: -68.0- 27.5%) among adolescents with a record of prior infection. Conclusion(s): Three-fold higher BNT162b2 dosage was associated with ~25% higher protection against infection in infection-naive adolescents of similar age. These findings may inform design of future COVID-19 vaccines and boosters for persons of different age groups.
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Background: Stage at time of diagnosis and survival after diagnosis are critical parameters regarding the control of any cancer in any geographical setting. Unlike in resource-rich settings where publicly funded cancer surveillance routinely monitors these parameters, these data are non-existent through routine means in resource-limited areas. This is particularly relevant for Kaposi sarcoma (KS) in East Africa, for which recent changes in HIV treatment and chemotherapy guidelines as well as the COVID-19 pandemic dictate an update regarding stage and survival. Method(s): From October 2021 to August 2022, we evaluated HIV-infected adults (age >= 18 years) with a new diagnosis of KS made in 4 different primary care facilities (or their associated inpatient units) in Kenya and Uganda using a process of rapid case ascertainment. KS diagnosis was confirmed by pathology. Participants were examined, at time of biopsy, to document the extent of lesions and subsequently monitored longitudinally for vital status. Result(s): Among 180 HIV-infected adults identified with new onset KS, 31% were women, and the median (IQR) age was 35 (29-42) years. At time of KS diagnosis, 95% of the participants were taking ART, and the median (IQR) CD4+ T cell count was 197 (46-354) cells/mm3;46%, 20%, 11% and 23% had plasma HIV RNA of < 40, 40-1000, 1001-10,000 and >10,000 copies/ml, respectively. The median number of anatomic sites with KS lesions per participant was 7 (4-11);26% of participants had oral KS lesions that interfered with either eating or speaking, 74% had KS-associated edema, and 86% had ACTG stage T1 (advanced KS). Over a median follow-up of 2.6 months (IQR: 0.75 to 5.5), 56 participants died, and only 3 lost to follow-up. Cumulative incidence of death (95% CI), via Kaplan-Meier estimation, at 2 months, 6 months and 8 months following KS diagnosis was 24% (18%-31%), 33% (26%-42%), and 38% (29- 49%), respectively (Figure). Conclusion(s): In a recently assembled community-based sample of adults with newly-diagnosed HIV-related KS in East Africa, the majority have advanced KS at the time of KS diagnosis, and survival is poor. The findings are stark in absolute terms for the Treat-All era and unchanged from parameters obtained in the 5 years prior, indicating no improvement in these aspects of the control of KS in the region. Along with primary prevention of KS (i.e., reducing its incidence), novel approaches are needed for earlier detection, more efficient linkage to oncologic care, and more potent therapy. Survival Among Adults with HIV-Related Kaposi Sarcoma in East Africa.
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Background and Objectives: Serological studies are based on the detection of antibodies. However, the produced antibodies decrease over time;therefore, such methods cannot provide a valid estimate of prevalence and incidence. The present study aimed to determine the serum prevalence and cumulative incidence in the Ravansar cohort population (Youth and RaNCD Cohort) in October 2020. Method(s): A random sample of 716 people aged > 18 years old were selected from the participants in the Ravansar cohort study in October 2020. Euroimmun anti-SARS COV-2 IgG ELISA kits (Lubeck, Germany) were used to measure antibody levels. Seroprevalence was estimated with considering of cut-off = 1, and cumulative incidence (modified and modified based on test specificity) was determined using modeling. Result(s): In the present study, the serum prevalence of COVID-19 viral infection in the Ravansar cohort population from 22 October 2020 to 18 November 2020 was estimated to be %35.16 (95%CI: %31.64, %38.79). Modified Cumulative incidence and modified based on test characteristics from 20 February to 18 November 2020 were estimated to be %68.85 and %67.71, respectively. Conclusion(s): Although very high cumulative incidence may be a sign of approaching herd immunity, adherence to health protocols is still recommended due to the potential role of asymptomatic cases in transmitting the disease to other members of the community;and the presence of new variants of the virus and reduced antibody levels should be considered.Copyright © 2022 The Authors.
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Background: Coronavirus disease 2019 (COVID-19) has spread fast globally comprising a great variety of clinical presentations. It was reported that 15% of patients required admission to intensive care units (ICU). Previous epidemiological studies have reported higher risk of healthcare-associated infections (HCAI) in those patients requiring invasive mechanical ventilation (iMV) due to COVID-19. Aim(s): To analyze the incidence of HCAI in adults under iMV admitted to ICU of Anchorena San Martin Clinic during COVID-19 pandemic. Method(s): Retrospective cohort study, the analysis of normality was carried out using the Shapiro-Wilk test. The multiple regression analysis was performed automatically, based on backward elimination of the variables (backward selection). For the comparison between the COVID-19 and non-COVID-19 groups, the T test or Wilcoxon test was used, as appropriate;and the chi2 or Fisher's exact test. All cumulative incidence function estimates were made with the cmprsk package. Result(s): 252 patients were included, 40 patients developed HCAI (accumulated incidence was 15.9%), counting for 60 total HCAI events. Age (OR 0.96), number of central venous access devices (CVAD) (OR 2.01), COVID-19 (OR 2.96) and prone positioning (OR 2.78) were associated with HCAI. HCAI was associated with more days of iMV and ICU stay. The accumulated incidence of HCAI in non-COVID-19 patients was lower than in COVID-19 patients. iMV days and mortality were higher in COVID-19. 29.6% of COVID-19 patients developed HCAIs vs 7.1% of non-COVID-19 ones. Conclusion(s): We describe the incidence of HCAI. Age, COVID-19, CVAD, prone positioning and ICU stay were associated with higher probability of HCAIs.Copyright © 2022, Sociedad Chilena de Infectologia. All rights reserved.
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Asymptomatic subjects account for 25 to 45% of SARS-CoV-2 infections, and in particular, subjects on mild immunosuppressive therapy may have symptoms masked and could spread virus for an extended period of time. To determine the cumulative incidence of symptomatic and asymptomatic SARS-CoV-2 infections and associated risk factors, we conducted a prospective clinical and serological survey in a cohort of 278 liver transplant recipients (LTRs) from Central Italy. Three different serology tests were performed every 4 months in 259 LTRs between April 2020 and April 2021: one based on raw extract of whole SARS-CoV-2 virus and two on specific viral antigens (nucleoprotein and receptor binding domain) to detect specific IgG, IgM and IgA. Hundred fifteen LTRs who reported symptoms or close contact with a SARS-CoV-2-positive subject, or had a positive serological result underwent molecular testing by standard screening procedures (RT-PCR on naso-pharyngeal swab). Thirty-one past or active SARS-CoV-2 infections were identified: 14 had positive molecular test (64% symptomatic), and 17 had positive serology only (18% symptomatic). SARS-CoV-2 infection was not statistically related to gender, age, obesity, diabetes, renal impairment, type of anti-rejection therapy or time from transplant. Asymptomatic SARS-CoV-2 cases (61.3%) were more frequent in males and in those with glomerular filtrate rate >50 ml/min. Overall, the addition of repeated serology to standard diagnostic molecular protocols increased detection of SARS-CoV-2 infection from 5.1% to 10.9%. Anti-SARS-CoV-2 seroprevalence among our LTRs (11.2%) is comparable to the general population of Central Italy, considered a medium-impact area. Only one asymptomatic subject (6%) was found to carry SARS-CoV-2 in respiratory tract at the time of serological diagnosis.Copyright © 2021 The Authors
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Background: Several comorbidities, including cardiovascular diseases or myocardial injury, are reported to be associated with poor prognosis in patients with Coronavirus disease 2019 (COVID-19). However, detailed prognostic analysis of myocardial injury by various biomarkers in COVID-19 patients is limited. Purpose(s): This study aims to explore the prognostic values of highsensitive Troponin I (hsTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) for COVID-19 patients using Japanese real-world data. Method(s): The COVID-MI study is a retrospective cohort study that enrolls consecutive laboratory-confirmed COVID-19 patients admitted to the hospital from July 2020 to September 2021. We collected clinical data, including cardiac biomarker values, by chart review. If the prespecified biomarkers in concern were not available, we measured them using the institutional serum blood bank, which enrolled patients prospectively from July 2020. Patients with available biomarkers were analyzed according to the values of hsTnI or NT-proBNP, using the clinically relevant thresholds (hsTnI: 5 ng/L and 99th percentile of the upper reference limit [99%ile URL], and NTproBNP: 125 pg/mL and 900 pg/mL). The primary outcome measure was all-cause death. Secondary outcome measures included acute respiratory distress syndrome, myocardial infarction, myocarditis/pericarditis, venous thromboembolism, cerebral infarction, and bleeding events. Result(s): We enrolled 917 patients with COVID-19 confirmed by viral nucleic acid amplification test. The mean age was 61 years, and 591 patients (64%) were men. On admission, the number of patients classified as severe or critical COVID-19 was 515 (56%) and 85 (8.7%), respectively. Among the 544 patients with hsTnI values, 365 (67%) patients had elevated hsTnI of >=5 ng/L, and 134 patients (25%) had TnI of >=99%ile URL. Besides, among 546 patients with NT-proBNP values, 295 patients (54%) had elevated NT-pro-BNP of >=125 pg/mL, and 93 patients (17%) had NT-proBNP of >=900 pg/mL. The median follow-up period was 31 days (interquartile range: 11-90 days). In cumulative incidence analysis, higher levels of hsTnI and NT-proBNP were associated with significantly higher mortality (hsTnI: <5 ng/L group;8.8%, 5 ng/L to 99%ile URL group;19%, and >=99%ile URL group;37%, P<0.001, and NT-proBNP: <125 pg/mL group;7.8%, 125 to 900 pg/mL group;21%, and >=900 pg/mL group;45%, P<0.001). The adjusted risk for all-cause death remained significant for each threshold of cardiac biomarkers (hsTnI >=99%ile URL: Hazard ratio [HR] 1.98, 95% confidence interval [CI] 1.11-3.54, P=0.02, and NT-proBNP >=900 pg/mL: HR 3.60, 95% CI 1.86-6.98, P<0.001). Conclusion(s): Elevation of hsTnI or NT-proBNP was associated with poor prognosis in the current relatively severely ill COVID-19 patients. Measuring hsTnI or NT-proBNP can be an attractive option for risk stratification and deciding appropriate management in patients with COVID-19.
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The COVID-19 pandemic strongly affected organ procurement and transplantation in France, despite the intense efforts of all participants in this domain. In 2020, the identification and procurement of deceased donors fell by 12% and 21% respectively, compared with the mean of the preceding 2 years. Similarly, the number of new registrations on the national waiting list declined by 12% and the number of transplants by 24%. The 3-month cumulative incidence of death or drop out for worsening condition of patients awaiting a liver transplant was significantly greater in 2020 compared to the previous 2 years. Continuous monitoring at the national level of early post-transplant outcomes showed no deterioration for any organ in 2020. At the end of 2020, less than 1% of transplant candidates and less than 1% of graft recipients - of any organ - had died of COVID-19.Copyright © 2021 The Author(s)
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Background: There is no evidence clearly defining whether the administration of immunomodulatory biologic agents to allergic patients affects their immune response to COVID-19 infection. The current guidelines suggest the continuation of their use in patients who are not infected, while the continuation is individualized in the case of symptomatic disease. We sought to determine the cumulative incidence of symptomatic COVID-19 infection among chronic urticaria (CU) Greek patients, who, until 2/2/2021, were under omalizumab for at least two months. This was the date on which no Greek citizen was considered fully immunized due to vaccination against SARS-CoV- 2. Method(s): The present study extracted data from the first national multicenter registry of patients in Greece with chronic urticaria (GREEk National Urticaria Registry, GREENUR). All patients with CU under omalizumab during the pandemic, and the clinical characteristics of those with COVID-19 symptomatic infection, were recorded. Result(s): 329 patients were included (223 with CSU alone). Only 10/329 (6 women) or 3% had symptomatic COVID-19 infection confirmed by Polymerase Chain Reaction (PCR) analysis. Overall, 6 patients reported fever (up to 39.5degreeC), 5 rhinitis, 3 cough, one of which reported shortness of breath controlled with bronchodilation, 5 hyposmia/anosmia and ageusia, 8 muscle weakness, 5 arthralgia/ myalgia, and 7 headache. None of the patients was admitted to the hospital. According to the Centers for Disease Control and Prevention (CDC), only 1 in 4.2 cases of COVID-19 is being examined, of which 84% are symptomatic. Consequently, the cumulative incidence of symptomatic COVID-19 infection in the general Greek population on 2/2/2021 (number of confirmed cases on that date: 158,716) was estimated at 5.2%, significantly higher than that among patients with CU (p-value = 0.02). Conclusion(s): The cumulative incidence of symptomatic COVID-19 infection among patients with CU under omalizumab treatment is lower than that of the general population. All infected patients had a mild course and short duration of the disease and did not need hospitalization. These findings demonstrate not only the safety but also a protective role of omalizumab in patients with CU during the COVID-19 pandemic.
ABSTRACT
Competing risks data are commonly encountered in randomized clinical trials or observational studies. Ignoring competing risks in survival analysis leads to biased risk estimates and improper conclusions. Often, one of the competing events is of primary interest and the rest competing events are handled as nuisances. These approaches can be inadequate when multiple competing events have important clinical interpretations and thus of equal interest. For example, in COVID-19 in-patient treatment trials, the outcomes of COVID-19 related hospitalization are either death or discharge from hospital, which have completely different clinical implications and are of equal interest, especially during the pandemic. In this paper we develop nonparametric estimation and simultaneous inferential methods for multiple cumulative incidence functions (CIFs) and corresponding restricted mean times. Based on Monte Carlo simulations and a data analysis of COVID-19 in-patient treatment clinical trial, we demonstrate that the proposed method provides global insights of the treatment effects across multiple endpoints.
Subject(s)
COVID-19 , Humans , Proportional Hazards Models , Risk Factors , Survival Analysis , Research DesignABSTRACT
Serosurveys are a key resource for measuring SARS-CoV-2 population exposure. A growing body of evidence suggests that asymptomatic and mild infections (together making up over 95% of all infections) are associated with lower antibody titers than severe infections. Antibody levels also peak a few weeks after infection and decay gradually. We developed a statistical approach to produce estimates of cumulative incidence from raw seroprevalence survey results that account for these sources of spectrum bias. We incorporate data on antibody responses on multiple assays from a post-infection longitudinal cohort, along with epidemic time series to account for the timing of a serosurvey relative to how recently individuals may have been infected. We applied this method to produce estimates of cumulative incidence from five large-scale SARS-CoV-2 serosurveys across different settings and study designs. We identify substantial differences between raw seroprevalence and cumulative incidence of over two-fold in the results of some surveys, and provide a tool for practitioners to generate cumulative incidence estimates with pre-set or custom parameter values. While unprecedented efforts have been launched to generate SARS-CoV-2 seroprevalence estimates over this past year, interpretation of results from these studies requires properly accounting for both population-level epidemiologic context and individual-level immune dynamics.