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1.
Infection, Epidemiology and Microbiology ; 9(1):71-78, 2023.
Article in English | EMBASE | ID: covidwho-20235785

ABSTRACT

Backgrounds: This study aimed to analyze the applicability of platelet parameters in assessing the severity of COVID-19 disease. Material(s) and Method(s): Patients with RT-PCR confirmed COVID-19 in the Pathology department of a tertiary care hospital in south India from June to December 2020 were included in this study. Clinical details and laboratory parameters of these patients were obtained. The difference between the studied variables in two groups was assessed using independent t-test. The optimum cut-off value of platelet to lymphocyte ratio (PLR) to differentiate between the tested groups was estimated using ROC (receiver operator curve) analysis. Finding(s): This study was conducted on 218 COVID-19 patients, of whom 17.9% showed thrombocytopenia at the time of admission. Among the hematological parameters, PLR, absolute lymphocyte count (ALC), platelet distribution width (PDW), D-dimer, and erythrocyte sedimentation rate (ESR) were significantly different between the ICU (intensive care unit) and non-ICU groups. Increased PLR values were associated with the disease severity. Conclusion(s): PLR could be used as an additional biomarker in assessing the severity of COVID-19 disease, and a cut-off value of 210.27 is optimal to differentiate severe COVID-19 disease from its mild and moderate forms with 79% specificity.Copyright © 2023, TMU Press.

2.
Clinical Immunology ; Conference: 2023 Clinical Immunology Society Annual Meeting: Immune Deficiency and Dysregulation North American Conference. St. Louis United States. 250(Supplement) (no pagination), 2023.
Article in English | EMBASE | ID: covidwho-20232155

ABSTRACT

Introduction: TBX1 haploinsufficiency is an inborn error of immunity with the phenotype of DiGeorge Syndrome. DiGeorge Syndrome has variable immunodeficiency associated with grade of thymic hypoplasia ranging from mild with no infections to severe requiring thymus implant. Enterovirus is an example of an opportunistic infection that can be fatal in these patients. Case Presentation: A 1 year old girl with TBX1 haploinsufficiency complicated by Tetralogy of Fallot, pulmonary atresia, high arched palate, and vesicovaginal fistula presented for elective cardiac repair surgery from another country due to failure to thrive and cyanosis. She had no prior infectious history but was on sulfamethoxazole-trimethoprim for prophylaxis. She was asymptomatic with a negative COVID test but no other infectious studies performed. Immediately postoperatively, she was febrile and nasal respiratory viral panel was positive for rhinovirus/enterovirus with increased procalcitonin and leukocytosis with left shift. She decompensated with multi-organ failure and cardiac arrest on postoperative day two. She was cannulated to veno-arterial extracorporeal membrane oxygenation (ECMO). Pre-operatively, she had a normal absolute lymphocyte count. No thymus tissue was observed in surgery. She had profound CD3 lymphopenia to 130 cells/cmm when critically ill. Enteroviral meningitis was suspected as no infectious, cardiac, or other pathology could be identified causing decompensation. Enteroviral serum polymerase chain reaction (PCR) test was negative while lumbar puncture deferred due to clinical status. She was treated with immunoglobulin. Offlabel investigational drug pocapavir was considered but deferred to patient's irreversible neurological status. The patient was disconnected from ECMO and expired. Discussion(s): Though we cannot confirm that this patient had enteroviral meningitis, invasive enteroviral infections are associated with elevated transaminases, coagulopathy, and seizures all present in our patient. There has also been reported negative serum enteroviral PCR but positive CSF enteroviral PCR in an immunodeficient patient. Additionally, this case highlights the importance of immunologic evaluation in patients with DiGeorge Syndrome and questions if asymptomatic viral screening for viruses like enterovirus should be considered pre-operatively in patients with inborn errors of immunity. This case highlights potential treatment options for invasive enteroviral infections in patients with inborn errors of immunity: high dose immunoglobulin, fluoxetine, and pocapavir.Copyright © 2023 Elsevier Inc.

3.
Hepatology International ; 17(Supplement 1):S158, 2023.
Article in English | EMBASE | ID: covidwho-2324043

ABSTRACT

Objective: To study the prevalence and risk factors for acute liver injury in COVID-19 patients and to assess the clinical outcome of COVID-19 in patients with acute liver injury in cohort ward, Somdejphrachaotaksin Maharaj Hospital. Method(s): A cross-sectional study was done in moderate-to-severe COVID-19 patients who hospitalized in cohort ward, Somdejphrachaotaksin Maharaj Hospital. Demographic data, laboratory results and clinical data were collected during 1st April to 31st October 2021. Result(s): From total of 93 COVID-19 patients, the prevalence of acute liver injury (ALI) were 28% (95%CI 18.6-37.2). Factor associated with acute liver injury was male (p<0.05). Mean absolute lymphocyte count of ALI patients and non-ALI patients were 1154.77 and 1530.02 respectively (p = 0.063). There was no difference in vasopressor support, ventilator support, length of stay and dead of COVID-19 patients between ALI group and non-ALI group. Conclusion(s): The prevalence of acute liver injury among COVID-19 patients was high. Factor associated with acute liver injury were male and tendency of lower absolute lymphocyte count. There were differences in clinical outcome of COVID-19 patients between acute liver injury and non-acute liver injury.

4.
Topics in Antiviral Medicine ; 31(2):138-139, 2023.
Article in English | EMBASE | ID: covidwho-2316655

ABSTRACT

Background: Studies have shown that lymphopenia and a decreased CD4/ CD8 ratio are correlated with the severity of COVID-19 infections. As people with HIV (PWH) can have altered CD4/CD8 ratios at baseline, this study examined the relationship between lymphocyte and T-cell subsets with COVID-19 disease outcomes among PWH. Method(s): This retrospective study included adult PWH (identified by HIV ICD codes, HIV RNA or antibody results, or antiretroviral therapy use excluding preexposure prophylaxis) in the Optum COVID-19 EHR database with positive SARSCoV- 2 PCR or antigen tests from February 2020 to December 2021. Outcomes included 30-day hospitalization, ICU stay, mechanical ventilation, and death from COVID-19. Absolute lymphocyte counts and percent and CD4:CD8 ratios were collected prior to SARS-CoV-2 positivity (baseline) and then weekly for four weeks post-SARS-CoV-2 positivity. We examined lymphocyte trajectories in PWH who had available data at all time points, and we compared changes in counts and percentages at each week post-SARS-CoV-2 to baseline values, using Wilcoxon rank sum test. Result(s): Of a total of 4,525 PWH who tested positive for SARS-CoV-2, 102 PWH had available lymphocyte counts at all study time points. Compared to non-hospitalized PWH (n=38), hospitalized PWH (n=64) and PWH who were in the ICU (n=32) or ventilator dependent (n=27) experienced a larger drop in lymphocyte percentage in the first two weeks post-SARS-CoV-2 diagnosis with only a partial recovery in subsequent weeks. In patients who died (n=19), lymphocyte percentage recovered even more slowly. Hospitalized PWH, as compared to non-hospitalized PWH, had a significant decrease in lymphocyte percentage post-SARS-CoV-2 infection in the first week (-0.19 vs -0.05;< 0.001), second week (-0.23 vs -0.02;< 0.001), third week (-0.20 vs 0.00;< 0.001), and fourth week (-0.10 vs 0.00;0.001), a trend seen in the ICU, mechanically ventilated, and deceased groups as well (Table 1). By the first week, CD4/CD8 ratio in COVID-19 positive patients was lower in the deceased (-0.18 vs 0.00;p=0.4), ventilator dependent (-0.15 vs 0.00;p=0.2), and ICU (-0.15 vs 0.00;p=0.4) groups. Conclusion(s): Our study showed that not only is lymphopenia a marker of COVID-19 disease severity in PWH but also a failure of lymphocyte percentage recovery is associated with worse outcomes. There was also a trend towards worse outcomes associated with a lower CD4/CD8 ratio in the first week after COVID-19 infection. (Figure Presented).

5.
Transplantation and Cellular Therapy ; 29(2 Supplement):S376, 2023.
Article in English | EMBASE | ID: covidwho-2312872

ABSTRACT

Background: Despite the transformative potential of chimeric antigen receptor T (CAR-T) therapy, more tools to assist with identifying patients with increased likelihood of benefitting from this therapy will be helpful, particularly given the logistical complexity and socio-economic demands for CAR-T relative to other therapies. Health care resource restriction during the COVID-19 pandemic highlights the need for these tools. We present a simple survival score that uses 3 readily available clinical labs: platelet (plt), absolute lymphocyte count (ALC), and Lactate dehydrogenase (LDH), to predict the risk of dying within 6 months of CAR-T therapy in patients with aggressive lymphoma. Method(s): We conducted a retrospective chart review of patients with aggressive non-Hodgkin lymphoma (NHL) who received FDA-approved CAR-T between Jan 2018 to Jan 2022 at Mayo Clinic Rochester.(Table Presented)Results: Among a total of 110 pts who received CAR-T, 27 (25%) pts died within the first 6 months post CAR-T infusion (OS <= 6 months). Disease progression was the main cause of death (18/25, 72%), followed by infection (4/25, 16%), CAR-T related (HLH/MAS, 2/25, 8%), second primary malignancy (1/25, 4%) and unknown (2/25, 8%).Baseline demographics were comparable between the OS>6months and <=6months groups (Table 1). Patients' ECOG, Karnofsky performance status and 11 labs at the time of evaluation for CAR-T therapy (initial eligibility assessment, prior to leukapheresis) were compared between those who died from any cause within 6 months of CAR-T infusion and those who did not. Hemoglobin, plt, ALC, absolute monocyte count, CRP, ferritin, and LDH were selected as clinically and/or statistically significant variables for multivariate testing. Multivariate regression with boot-strap testing identified plt, ALC, and LDH as the most predictive variables with 80.9+/-11.7% accuracy for predicting death within 6 months of CAR-T infusion. Patients were scored 0-3 using these 3 labs, with 1 point assigned for plt <= 100 X109/L, ALC <= 0.4 X109/L, or LDH > 222 U/L (upper limit of normal). OS by this survival score is shown in Figure 1.(Figure Presented)Discussion: Due to the curative potential of CAR-T, patients with broader characteristics than those treated on registration studies have been treated in standard of care practice. While an estimated 5%-10% risk of CAR-T associated deaths in the first 3 months is seen across all patients in clinical trials, predictors for early death after CAR-T in real-world patient populations can provide additional context for pts and providers when selecting treatment. This survival score is important proof of concept that a simple model using readily accessible clinical labs at the time of CAR-T evaluation could provide additional context to help with additional clinical decision-making. Multicenter prospective studies will help define and validate the definitive survival scoring system.Copyright © 2023 American Society for Transplantation and Cellular Therapy

6.
Journal of Neurology, Neurosurgery and Psychiatry ; 93(9):56, 2022.
Article in English | EMBASE | ID: covidwho-2292648

ABSTRACT

Introduction Lymphopenia is a known adverse event of dimethyl fumarate (DMF) with treatment dis-continuation recommended for patients with severe prolonged (>=6 months) lymphopenia. Because of the COVID-19 pandemic burden on healthcare systems, we retrospectively examined the impact of absolute lymphocyte count (ALC) monitoring frequency (every-3-months vs every-6-months) on lym-phopenia detection. Methods Samples from patients enrolled in phase 3 trials (DEFINE/CONFIRM) and the extension study (ENDORSE) were retrospectively analysed using 3-month or 6-month intervals. Lymphopenia was defined as ALC <0.91x109/L and severe lymphopenia as ALC <0.5x109/L. Times to the first lymphopenia event and first severe lymphopenia event were estimated using Kaplan-Meier methods. Results The analysis included 741 patients. There were 355 lymphopenia cases (76 severe) with 3-month monitoring, and 314 cases (70 severe) with 6-month monitoring. Over 120 months, incidence of first lympho-penia event was significantly different for 3-month vs 6-month monitoring (difference range: 2.64%-6.54%;P=0.0088). Incidence of first severe lymphopenia event was not significantly different for the two intervals (P=0.5866). Proportions of patients with severe prolonged lymphopenia with 3-month and 6-month moni-toring were similar (4.0% vs 4.2%). Conclusions The results of this study may be informative to clinicians managing pandemic-related health-care resource burdens.

7.
Rivista Italiana della Medicina di Laboratorio ; 18(3):148-156, 2022.
Article in English | EMBASE | ID: covidwho-2298362

ABSTRACT

Background: Vaccination is considered the most effective preventive strategy to fight COVID-19. The aim of this study was to evaluate two critical concerns about: 1) the kinetic response of IgG and IgM, and: 2) the hematological abnormalities in a longitudinal cohort of health-care workers (HCW) who had received 2 doses of BNT162b2 mRNA-based vaccine. Method(s): Blood and nasopharyngeal swabs were collected from 46 volunteers' participants, previous written consensus, with presumable no symptoms of COVID-19. Anti-SARS-CoV-2 serum immunoglobulin G (IgG) and M (IgM) and hematological parameters were examined. Multivariable mixed-effects models for repeated measure analysis were adopted to evaluate time changes in IgG, IgM and hematological parameters, and to investigate associations with vaccination response. Result(s): Forty-six subjects (N.=46;31.8% men;68.2% women;mean age near 36 years-old) were enrolled among healthcare workers of IRCCS MultiMedica (Milan, Italy). Overall, increase in serological IgG concentration appeared mainly between 21-28 days after the 1st dose, whereas IgM did not reach positivity in all cases. Mean blood cells counts were in normal range but we observed a significant reduction of total white blood cells and absolute lymphocyte counts after the 1st dose, persisting until the day 28. The increase of monocytes and neutrophils the day after the 1st dose subsequently decayed significantly. Eosinophils concentration showed a tendency to increase over time. Peripheral blood smear showed a growing frequency of atypical lymphocytes (lympho-variants), and of plasmacytoid forms, whereas no difference was found in large granular lymphocytes (LGL), although a decay after the boost was evident. The stratification of subjects, relative to the timing of IgG increase, showed the occurrence of 3 different patterns after vaccination, namely early-responders (R+), late-responders (R-) and pauci-responders (PR) with a peculiar kinetics of hematological parameters. Lymphocytes were significantly associated with total IgG: lower in R+ and PR compared to R- (P=0.0193 and P=00054, respectively). Conclusion(s): In healthy subjects, anti SARS-CoV-2 vaccination induced a variety of non-pathologic abnormalities. The response to vaccination was not equal in the groups examined. In PR group a major difference occurred with respect to R- and R+. This work adds novel insight into the puzzle of changes induced by SARS-CoV-2 virus.Copyright © 2022 EDIZIONI MINERVA MEDICA.

8.
Jurnal Infektologii ; 14(5):14-25, 2022.
Article in Russian | EMBASE | ID: covidwho-2265665

ABSTRACT

Aim: to build, a predictive model for severe COVID-19 prediction in young adults using deep learning methods. Material(s) and Method(s): data from 906 medical records of patients aged. 18 to 44 years with laboratory-confirmed SARS- CoV-2 infection during 2020-2021 period, was analyzed. Evaluation of laboratory and. instrumental data was carried out using the Mann-Whitney U-test. The level of statistical significance was p<0,05. The neural network was trained, using the Pytorch. framework. Result(s): in patients with mild to moderate SARS-CoV-2 infection, peripheral oxygen saturation, erythrocytes, hemoglobin, total protein, albumin, hematocrit, serum, iron, transferrin, and. absolute peripheral blood, eosinophil and. lymphocyte counts were significantly higher than in patients with severe SOVID-19 (p< 0,001). The values of the absolute number of neutrophils, ESR, glucose, ALT, AST, CPK, urea, LDH, ferritin, CRP, fibrinogen, D-dimer, respiration rate, heart rate, blood, pressure in the group of patients with mild and. moderate severity were statistically significantly lower than in the group of severe patients (p < 0.001). Eleven indicators were identified as predictors of severe COVID-19 (peripheral oxygen level, peripheral blood erythrocyte count, hemoglobin level, absolute eosinophil count, absolute lymphocyte count, absolute neutrophil count, LDH, ferritin, C-reactive protein, D-dimer levels) and. their threshold, values. A model intended, to predict COVID-19 severity in young adults was built. Conclusion. The values of laboratory and instrumental indicators obtained in patients with SARS-CoV-2 infection upon admission significantly differ. Among them, eleven indicators were significantly associated with the development of a severe COVID-19. A predictive model based, on artificial intelligence method, with high, accuracy predicts the likelihood, of severe SARS-CoV-2 course development in young adults.Copyright © 2022 Interregional public organization Association of infectious disease specialists of Saint-Petersburg and Leningrad region (IPO AIDSSPbR). All rights reserved.

9.
Jurnal Infektologii ; 14(5):14-25, 2022.
Article in Russian | EMBASE | ID: covidwho-2265663

ABSTRACT

Aim: to build, a predictive model for severe COVID-19 prediction in young adults using deep learning methods. Material(s) and Method(s): data from 906 medical records of patients aged. 18 to 44 years with laboratory-confirmed SARS- CoV-2 infection during 2020-2021 period, was analyzed. Evaluation of laboratory and. instrumental data was carried out using the Mann-Whitney U-test. The level of statistical significance was p<0,05. The neural network was trained, using the Pytorch. framework. Result(s): in patients with mild to moderate SARS-CoV-2 infection, peripheral oxygen saturation, erythrocytes, hemoglobin, total protein, albumin, hematocrit, serum, iron, transferrin, and. absolute peripheral blood, eosinophil and. lymphocyte counts were significantly higher than in patients with severe SOVID-19 (p< 0,001). The values of the absolute number of neutrophils, ESR, glucose, ALT, AST, CPK, urea, LDH, ferritin, CRP, fibrinogen, D-dimer, respiration rate, heart rate, blood, pressure in the group of patients with mild and. moderate severity were statistically significantly lower than in the group of severe patients (p < 0.001). Eleven indicators were identified as predictors of severe COVID-19 (peripheral oxygen level, peripheral blood erythrocyte count, hemoglobin level, absolute eosinophil count, absolute lymphocyte count, absolute neutrophil count, LDH, ferritin, C-reactive protein, D-dimer levels) and. their threshold, values. A model intended, to predict COVID-19 severity in young adults was built. Conclusion. The values of laboratory and instrumental indicators obtained in patients with SARS-CoV-2 infection upon admission significantly differ. Among them, eleven indicators were significantly associated with the development of a severe COVID-19. A predictive model based, on artificial intelligence method, with high, accuracy predicts the likelihood, of severe SARS-CoV-2 course development in young adults.Copyright © 2022 Interregional public organization Association of infectious disease specialists of Saint-Petersburg and Leningrad region (IPO AIDSSPbR). All rights reserved.

10.
Indian Journal of Clinical Biochemistry ; 37(Supplement 1):S82-S83, 2022.
Article in English | EMBASE | ID: covidwho-2254275

ABSTRACT

Medicinal plants are a mainstay in most Asian countries and have been used successfully for thousands of years to modulate immune system function. Therefore, two of the polyherbal formulations, lnfuza and Kulzam were assessed for the prevention of COVID-19 infection as a repurposed medication. Four hundred seven high-risk subjects were recruited in an open-label randomized controlled clinical trial for eligibility. After assessment for eligibility, remaining 251 subjects were randomized to the test and control groups. Further, 52 high-risk subjects in lnfuza, 51 in Kulzam, 51 in lnfuza & Kulzam and 53 in control group completed the 14 days of intervention/assessment. To assess the immunomodulatory effects of polyherbal formulations, the phenotyping of lymphocytes at baseline (0 day) and after 14 days of treatment was carried out by flow cytometry assays. A total of 15.09% high-risk subjects in control group turned positive as compared to only 7.69% in Infuza, 3.92% in Kulzam and 1.96% in Infuza & Kulzam groups. The rate of conversion to COVID-19 infection in Infuza & Kulzam group was minimal and statistically significant as compared to control group (p0.017). The intervention of polyherbal formulations showed that T, B, NK cells, absolute lymphocyte count and cytokine levels were balanced in test group as compared to control group to fight against COVID- 19 infection. In conclusion, the combination of Infuza and Kulzam may synergistically prevent COVID-19 infection in high-risk subjects of COVID- 19 due to the immunomodulatory efficacy of polyherbal formulations.

11.
Journal of Crohn's and Colitis ; 17(Supplement 1):i643-i644, 2023.
Article in English | EMBASE | ID: covidwho-2253532

ABSTRACT

Background: Ozanimod, an oral sphingosine 1-phosphate receptor modulator, is approved in the European Union and United States for the treatment of moderately to severely active ulcerative colitis (UC) and relapsing multiple sclerosis (RMS). A previous analysis of data from UC and multiple sclerosis (MS) open-label extension (OLE) studies showed that most patients with confirmed coronavirus infection (COVID-19) had nonserious infections, recovered, and did not require ozanimod discontinuation. Some immunomodulators and biologics may attenuate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine response;therefore, this analysis evaluated humoral immune responses and predictors of response to SARS-CoV-2 vaccination in patients with RMS treated with ozanimod. Method(s): RMS participants who completed a phase 1-3 ozanimod trial could enter an OLE trial (DAYBREAK;NCT02576717) of ozanimod 0.92 mg/d. This analysis (January 2020-October 2021) included DAYBREAK participants receiving mRNA or non-mRNA SARS-CoV-2 vaccines (1-2 doses, vaccine-dependent) with no evidence of recent infection (ie, nucleocapsid antibody negative). Receptor binding domain (RBD) antibody titers were analysed (Elecsys Anti-SARS-CoV-2 assay;Roche Diagnostics, Basel, Switzerland) prevaccination, after 1 dose, and <4, 4-8, 8-12, and >12 weeks after full vaccination. Fisher's exact tests and regression models determined association with seroconversion and log2 antibody levels. Result(s): Demographics were similar between the mRNA and nonmRNA vaccine recipients (Table). Seroconversion (>=0.8 U/mL spike RBD antibody) occurred in 100% (80/80) of fully vaccinated mRNA recipients and 62% (18/29) of fully vaccinated non-mRNA vaccine recipients. Higher spike RBD antibody levels were seen with mRNA (grand mean: 512.6 U/mL, range: 1.3-4572.0) vs non-mRNA (grand mean: 39.3 U/mL, range: 0.4-368.5) vaccines at all time points studied. Vaccination with a non-mRNA vaccine predicted lower antibody levels (beta: -5.90 [95% CI: -6.99 to -4.82];P<0.0001) and less seroconversion (Fisher's exact: P<0.0001), whereas age, sex, body mass index, and absolute lymphocyte count (ALC) did not. Conclusion(s): Participants receiving ozanimod developed humoral immune response to SARS-CoV-2 vaccines, with 100% seroconversion after mRNA vaccination;this was independent of demographic characteristics and ALC levels at time of vaccination. However, some participants developed lower antibody concentrations and may benefit from booster doses. These findings provide important information for physicians managing ozanimod-treated patients with UC or MS.

12.
Journal of Crohn's and Colitis ; 17(Supplement 1):i689-i690, 2023.
Article in English | EMBASE | ID: covidwho-2278030

ABSTRACT

Background: Infections are an important safety concern in patients with IBD and may be due to its therapies, such as corticosteroids. Etrasimod is an investigational, once-daily, oral, selective sphingosine 1-phosphate receptor 1,4,5 (S1P1,4,5) modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). The biologic effect of etrasimod leads to selective and reversible lymphocyte retention in lymph nodes with a decrease in peripheral lymphocyte count. We report the infection events from the phase 3 ELEVATE programme. Method(s): Infection events were evaluated in the pivotal UC pooled safety analyses set comprising two phase 3 studies: ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369). Subjects (16- 80 years) with moderately to severely active UC were randomised 2:1 to once-daily etrasimod 2 mg or placebo (PBO). We report the n (%) and exposure-adjusted incidence rate (EAIR) of infections including serious infections, severe infections, opportunistic infections (including tuberculosis), and herpes infections. Infections were considered adverse events of special interest (AESI) if they were severe (>= CTCAE Grade 3), were opportunistic infections, or were herpes zoster or herpes simplex infections. Result(s): From the pooled ELEVATE UC 12 and ELEVATE UC 52 trials, 527 subjects received >=1 dose of etrasimod 2 mg (265.6 subject-years of exposure) and 260 subjects were randomised to PBO (103.0 subjectyears of exposure). Infections were similar between treatment groups (etrasimod: 99 [18.8%], EAIR=0.41;PBO: 46 [17.7%], EAIR=0.52). The most frequent infections in both groups were COVID-19, urinary tract infections, and nasopharyngitis (Table 1). Serious infections occurred in 3 (0.6%) subjects in the etrasimod arm (EAIR=0.01) and 5 (1.9%) in PBO arm (EAIR=0.05). Two cases of herpes zoster were reported in each treatment group (etrasimod: 0.4%, EAIR<0.01;PBO: 0.8%, EAIR=0.02);these were localised and nonserious. One opportunistic infection was reported in each arm (etrasimod: Subject withdrew from the study on day 20, the AE of Cytomegalovirus infection [Grade 2] was reported on day 36;PBO: Tuberculosis [Grade 2]). Overall, 3 cases of infection led to discontinuation: 2 in the etrasimod arm (both mild) and 1 in the PBO arm (Table 2). No subject with an absolute lymphocyte count <0.2x109/L subsequently reported a serious/ severe or opportunistic infection. There were no deaths. Downloaded from https://academic.oup.com/ecco-jcc/article/17/Supplement-1/i689/7010119 by guest on 04 February 2023 Sample output to test PDF Combine only i690 Poster presentations In these trials, etrasimod-treated subjects reported no in-crease in infections relative to PBO. Serious infections and herpes zoster were more commonly reported in the PBO-treated group. Longer-term follow-up data from the ongoing 5-year open-label extension will fur-ther characterize the etrasimod safety profile.

13.
General Medicine ; 24(6):66-72, 2022.
Article in English | EMBASE | ID: covidwho-2263880

ABSTRACT

Introduction: Coronavirus disease has had a catastrophic effect on the world's demographics, resulting in more than 5.8 million deaths worldwide and more than 422 million confirmed cases reported globally. The aim of this study was to assess the utility of the neutrophil-lymphocyte ratio (NLR), a simple, widely available, and inexpensive laboratory examination, as a reliable inflammatory biomarker for COVID-19 patients. By comparing the NLR with the D-dimer plasma level, we also want to analyze gender differences between hematological and hemostatic parameters in patients with COVID-19. Method(s): This study was carried in 2021 in Public Health Organization Clinical Hospital "Dr. Trifun Panovski" in Bitola in 2021. Our study describes the laboratory characteristics of 40 COVID-19 patients hospitalized in the Department of Infective Diseases. Result(s): The overall mean count of white blood cells count was 9 +/- 0.28 x 109. The overall mean of NLR was 9.3 +/- 5.6. The overall mean of CRP and D-dimer was 58.7 +/- 41.22 mg/l and 5624 +/- 1944 FEU ng/ml, respectively. NLR, CRP and D-dimer in the male and female groups in patients with COVID-19 did not show statistically significant differences. We confirmed a significant correlation between NLR and D-dimer levels in patients with COVID-19. Conclusion(s): NLR was found to correlate well with the established inflammatory marker CRP and coagulation marker D-Dimer, which is capable of predicting severe COVID-19. Therefore, NLR that is easily calculated at the emergency department using routine laboratory tests, even in a remote area, may serve as a practical and cost-effective marker for guiding the physician in awareness regarding the need for intensive care.Copyright © 2022, Central Medical Library Medical University - Sofia. All rights reserved.

14.
International Journal of Pharmaceutical Sciences Review and Research ; 78(1):88-93, 2023.
Article in English | EMBASE | ID: covidwho-2244800

ABSTRACT

Introduction: Blood tests play an important role in the early detection of disease given that they provide doctors with information about inflammatory processes. A complete blood count (CBC) is easy and inexpensive to perform. These parameters can be used alone as markers of inflammation. Their mutual ratio is also an indicator of early inflammation.4 In light of previous studies, the use of circulating biomarkers instead of inflammation and immune system has been considered a prognostic indicator for COVID-19 positive patients. Aims/ objective: To examines the role of biomarkers from peripheral blood samples in the diagnosis of hospitalized COVID-19 patients with a history of fever. Materials and Method: Haematological biomarkers and coagulation profile was compared between RT-PCR positive and negative patients. Systemic inflammatory index (SII) was calculated by multiplying thrombocyte count with neutrophil count and dividing the value by lymphocyte count. Neutrophil lymphocyte ratio (NLR) was calculated by dividing absolute neutrophil count by absolute lymphocyte count. Platelet lymphocyte ratio (PLR) was calculated by dividing absolute platelet by absolute lymphocyte count. Fisher exact test and unpaired t-test were used to compare categorical and continuous data respectively. Results: Analysis was done on 57 retrospective cases of RT-PCR positive patients and 61 RT-PCR negative patients with history of fever. COVID-19 positive patients showed leukopenia, neutropenia, thrombocytopenia, and lymphocytosis. SII and NLR decreased and PLR increased. PT and APTT were generally within normal limits in most of the patients. There was significant difference between two groups with respect to lymphocyte counts and PLR. Conclusion: The most standardized non-invasive and inexpensive tests such as CBC, coagulation and biochemical tests are available to assess disease severity for wise allocation of medical resources in developing countries such as India where resources and care are limited.

15.
Erciyes Medical Journal ; 45(1):104-105, 2023.
Article in English | EMBASE | ID: covidwho-2228654

ABSTRACT

Background: In early 2020, severe acute respiratory syndrome-corona virus 2 (SARS-CoV-2) pandemics caused previously unheard of health, social, and economic problems worldwide. The disease can affect different organs such as the lungs, heart, pancreas, kidney, and unusual symptoms can be seen. Information on the clinical impact of SARS-CoV-2 infection on renal function among pediatric age groups is scarce. Case Report: In this report, we presented a 13-year-old boy who was admitted to our hospital with the relapse of nephrotic syndrome caused by COVID-19. The patient had mild upper respiratory tract symptoms, eyelid edema and progressive swelling of the lower extremities. Clinical remission was achieved with oral prednisolone therapy without the use of any antiviral drugs. Conclusion(s): Patients with nephrotic syndrome presenting with relapse should be evaluated for potential COVID-19 infection during the pandemic. The use of routine doses of prednisolone appears to be safe in mild disease. Copyright © 2023 by Erciyes University Faculty of Medicine.

16.
American Journal of the Medical Sciences ; 365(Supplement 1):S311-S312, 2023.
Article in English | EMBASE | ID: covidwho-2234603

ABSTRACT

Purpose of Study: In areas endemic for murine typhus, it can be difficult to distinguish from other febrile syndromes. During COVID-19 surges, we identified several cases of typhus. Presenting symptoms and quantitative lab values at and during admission were compared between patients who were diagnosed with murine typhus or multisystem-inflammatory syndrome in children (MIS-C). Methods Used: Retrospective data was collected at a tertiary care center from July 2020 to March 2022. Inclusion criteria were patients under 21 years of age diagnosed at discharge with murine typhus or MIS-C based on clinical and laboratory evidence, serologic data, and expert consultation. Patients found to have an alternate diagnosis, and those without serologic testing were excluded. Subjects were grouped as either MIS-C or typhus based final diagnosis. Categorical data included headache, fatigue, mucocutaneous changes, rash, con-junctival injection, sore throat, rhinorrhea, palpitations, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, myalgia, and appetite change at initial presentation. The categorical data were compared using chi-square test. Quantitative data included age, maximum temperature in first 24 hours of hospitalization, duration of symptoms prior to admission, C-reactive protein, erythrocyte sedimentation rate, platelet count, white blood cell count (WBC), absolute neutrophil count (ANC), absolute lymphocyte count, serum sodium, alanine aminotransferase, hemoglobin (Hgb), and albumin (Alb). Means of the quantitative data were compared with a one-tailed 2- Sample T-Test. The maximum and minimum laboratory values during admission were also compared. Additional demographic data including gender and date of initial presentation was also collected. Summary of Results: There were 7 patients in the MIS-C group and 19 in the typhus group. The average age of MIS-C patients, 6.5 years of age vs. 11.5,was significantly lower (p < 0.5) than the typhus group. Initial mean WBC (cells x 103/mm3) was higher in MIS-C than typhus (12.21, SD = 3.52, vs. 7.85, SD = 3.52, p < 0.05), as was ANC (8.9, SD = 3.7vs. 5.12, SD = 2.05, p < 0.05). During hospitalization, minimum Hgb (g/dL) was 9.3, SD = 2.07, and11.49, SD = 1.67, in MIS-C and typhus respectively (p < 0.05). Minimum albumin (g/dL) was also lower in MIS-C than typhus (2.32, SD = 0.86 vs. 2.8, SD = 0.45, p < 0.05). There were no other statistically significant differences in categorical or quantitative data. Typhus cases typically occurred in the summer and fall months. There was no clear seasonality of MIS-C, but occurred during local COVID-19 surges. Conclusion(s): The initial presenting symptoms of typhus and MIS-C were similar. WBC and ANC were higher in MIS-C, while age, Hgb and Alb were lower. These parameters may aid in distinguishing the diseases. A high clinical suspicion for both typhus and MIS-C in endemic areas for typhus is crucial. A rapid detection for typhus would aid in distinguishing these diseases and allow prompt treatment interventions. Copyright © 2023 Southern Society for Clinical Investigation.

17.
International Journal of Laboratory Hematology ; 45(Supplement 1):134-135, 2023.
Article in English | EMBASE | ID: covidwho-2218907

ABSTRACT

Introduction: Inflammation mechanisms play a critical role in Coronavirus disease 2019 (COVID-19) severity Systemic immune inflammation (SII) index is reported to have a diagnostic value in COVID-19 diagnosis Sysmex XN-1000 analyzer provides during routine full blood count two parameters for neutrophil activation measurement;NE-SSC, which represents the inner complexity of neutrophils and is strongly related to granularity and NE-SFL, which reveals the neutrophil nucleic acid/protein content and is related to production or release of proteins and reactive oxygen intermediates and one parameter for lymphocytes;the high- fluorescent lymphocyte count (HFLC) as antibody-producing plasma cells. The aim of our retrospective study is the evaluation of SSI index and NE-SSC, NE-SFL & HFLC parameters in COVID-19 patients treated with the relevant medical intervention as outpatients or inpatients. Method(s): Patients admitted to our hospital with COVID-19 diagnosed through real-time reverse transcription polymerase chain reaction, and had a complete blood count (on Sysmex XN-1000 hematology analyzer) within 24 hours of diagnosis were included. We retrospectively recorded the demographic data, the laboratory findings upon admission (NE-SSC, NE-SFL & HFLC) retrieved from the hospital electronic database system and calculated the SII index as followed: platelet count x absolute neutrophil count / absolute lymphocyte count Patients were divided in two groups: patients discharged and treated as outpatients (N = 105) and patients hospitalized in COVID-19 inpatient wards (N = 174) Statistical analysis: Mann-Whitney U test was applied P value of < 0.05 was considered significant. Result(s): The two groups do not differ in genders (P = 0.183) but inpatients are older [70 (58-79) vs 60 (39-71) years, P = 0.000]. Results are summarized in Table 1. SII index values are higher in inpatients in a statistically significant degree (P = 0.000). There is no statistically significant difference in NE-SSC, NE-SFL & HFLC values between the two groups (all P >0.05). Table 1. Results (Table Presented) hospitalization present systemic inflammation in a higher degree as compared to outpatients without any differentiation in neutrophil activation or lymphocyte morphology as indicated by morphology - associated white blood cells studied parameters.

18.
Immuno-Oncology and Technology ; Conference: ESMO Immuno-Oncology Congress 2022. Geneva Switzerland. 16(Supplement 1) (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2210535

ABSTRACT

Background: As management and prevention strategies against Coronavirus Disease-19 (COVID-19) evolve, it is still uncertain whether prior exposure to immune checkpoint inhibitors (ICIs) affects COVID-19 severity in patients (pts) with cancer. Method(s): In a joint analysis of ICI recipients from OnCovid (NCT04393974) and ESMO CoCARE registries, we assessed severity and mortality from SARS-CoV-2 in vaccinated and unvaccinated pts with cancer and explored whether prior immune-related adverse events (irAEs) influenced outcome from COVID-19. Result(s): The study population consisted of 240 pts diagnosed with COVID-19 between Jan 2020 and Feb 2022 exposed to ICI within 3 months prior to COVID-19 diagnosis, with a 30-day case fatality rate (CFR30) of 23.6% (95%CI: 17.8-30.7%). 42 (17.5%) were fully vaccinated prior to COVID-19 and experienced decreased CFR30 (4.8% vs 28.1%, p=0.001), hospitalization rate (27.5% vs 63.2%, p<0.001), requirement of oxygen therapy (15.8% vs 41.5%, p=0.003), COVID-19 complication rate (11.9% vs 34.6%, p=0.004), and COVID-19-specific therapy (26.3% vs 57.9%, p=0.001) compared with unvaccinated pts. IPTW-fitted multivariable analysis, following a clustered-robust correction for the data source (OnCovid vs ESMO CoCARE), confirmed that vaccinated pts experienced a decreased risk of death at 30 days (aOR 0.08, 95%CI: 0.01-0.69). 38 pts (15.8%) experienced at least 1 irAE of any grade at any time prior to COVID-19, at a median time of 3.2 months (0.13-48.7) from COVID-19 diagnosis. IrAEs occurred independently of baseline characteristics except for primary tumour (p=0.037) and were associated with a significantly decreased CFR30 (10.8% vs 26.0%, p=0.0462) additionally confirmed by the IPTW-fitted multivariable analysis (aOR: 0.47, 95%CI: 0.33-0.67). Pts who experienced irAEs also presented a higher median absolute lymphocyte count at COVID-19 (1.4 vs 0.8 109 cells/L, p=0.009). Conclusion(s): Anti-SARS-CoV-2 vaccination reduces morbidity and mortality from COVID-19 in ICI recipients. History of irAEs might identify pts with pre-existing protection from COVID-19, warranting further investigation of adaptive immune determinants of protection from SARS-CoV-2. Clinical trial identification: NCT04393974 OnCovid. Legal entity responsible for the study: Imperial College London & ESMO. Funding(s): Imperial Biomedical Research Centre ESMO. Disclosure: A. Cortellini: Financial Interests, Personal, Advisory Board: MSD, OncoC4;Financial Interests, Personal, Invited Speaker: Eisai, AstraZeneca;Financial Interests, Personal, Expert Testimony: Iqvia. D.J. Pinato: Financial Interests, Personal, Invited Speaker: ViiV Healthcare, Bayer, BMS, Roche, Eisai, Falk Foundation;Financial Interests, Personal, Advisory Board: Mina Therapuetics, Eisai, Roche, DaVolterra, AstraZeneca. All other authors have declared no conflicts of interest. Copyright © 2022 European Society for Medical Oncology

19.
Journal of Clinical and Diagnostic Research ; 17(1):SC01-SC06, 2023.
Article in English | EMBASE | ID: covidwho-2203491

ABSTRACT

Introduction: Inflammatory markers have been used as predictors of adverse outcomes in adults with Coronavirus Disease-2019 (COVID-19) infection. Children mostly have mild infections and raised inflammatory markers have been reported only with severe COVID-19 or Multisystem Inflammatory Disorder (MIS-C). Studies in children showing the role of inflammatory markers in disease prognosis are few, and findings are not conclusive. Aim(s): To find out correlation, if any, between the inflammatory markers {Interleukin-6 (IL-6), C-reactive Protein (CRP), procalcitonin, Pro-B-type natriuretic Peptide (Pro-BNP), ferritin, D-dimer} with clinical presentation, prognosis, and outcome in children with acute COVID-19. Material(s) and Method(s): The prospective, observational study was conducted at a tertiary care COVID-19 Paediatric Intensive Care Unit {PICU (Vardhaman Medical College and Hospital, New Delhi)}, Northern India, between September 2020 and December 2020. All children aged less than 12 years, with a positive COVID-19 report were enrolled and investigated. Data was collected for clinical presentation, severity, treatment and outcome. The following variables were recorded: Complete Blood Count (CBC), Kidney Function Test (KFT) and Liver function Test (LFT), Absolute Lymphocyte Count (ALC), Absolute Neutrophil Count (ANC), Neutrophil-lymphocyte Ratio (NLR), Platelet Count (PLT), C-reactive Protein (CRP), Procalcitonin (PCT), serum ferritin, Lactate Dehydrogenase (LDH), fibrinogen, and Erythrocyte Sedimentation Rate (ESR) and ProBNP. Coagulation parameters like Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), International Normalised Ration (INR), D-dimer were taken. Data was analysed using Statistical Package for the Social Sciences (SPSS) software version 21.0. Result(s): A total of 35 children were admitted during the study period. Seventeen children met the criteria for severe disease. Seven children met the criteria for MIS-C. Children presenting with conjunctivitis (n=3) were more likely to have signs of peripheral inflammation hypotension (n=4), tachycardia (n=6), and raised IL-6 levels (pg/mL) as well as the need for inotropic support. IL-6 values were higher in children (Mean+/-SD= 182.47+/-149.83). Median IL-6 value 199.8 (96.17-275.24) was highest in children with CRP <10 mg/dL (p-value<0.01). Children with raised D-dimer (Mean+/-SD=1881.94+/-1265.66 mg/dL) had a longer duration of stay (p-value=0.031). conclusion: The study didn't find any correlation between inflammatory markers with clinical presentation and the outcome of COVID-19 infection in children. Copyright © 2023 Journal of Clinical and Diagnostic Research. All rights reserved.

20.
Indian Journal of Nephrology ; 32(7 Supplement 1):S13, 2022.
Article in English | EMBASE | ID: covidwho-2201609

ABSTRACT

BACKGROUND: Chronic Kidney Disease (CKD) Stage V patients on hemodialysis are a vulnerable group who have reported high rates of morbidity and mortality with Covid-19 infection. Covid-19 vaccination has been reported to be immunoprotective, and these patients are prioritized for Covid-19 vaccination. It is reported that dialysis patients develop lower seroconversion to vaccines. Indeed, this lower postvaccine response led to the adaptation of hepatitis B and influenza immunization schedules. Data are lacking on the humoral immune response to indigenously manufactured BBV152 (inactive) vaccine. In this study, we estimate the serologic response to BBV152 vaccine in hemodialysis patients in our Nephrology unit AIM OF THE STUDY: 1. To estimate the humoral immune response (conversion from seronegative to seropositive state) to inactivated SARS CoV2 vaccine administered as per The Government of India protocol in CKD stage V patients on maintenance HD 2. To correlate demographic clinical and biochemical/hematologic parameters with the humoral response METHODS: This study was a cross-sectional observational study conducted between September 2021 and March 2022 at the Department of Nephrology Tirunelveli Medical College Hospital. Ethics Committee approval was obtained. All CKD V patients on maintenance HD for at least three months who were willing to take BBV152 vaccine were enrolled in the study. Patients suffering from intercurrent illness those who had a prior PCR confirmed diagnosis of Covid-19, and patients who had positive baseline antibody titers were excluded from the study. Sample size was calculated according to the standard sample size calculator for observational study with a qualitative variable which computed a minimum sample size of 82. Detailed history taking clinical examination hematological and biochemical investigations assessment of nutritional status was performed as per structured questionnaire. For each patient, the following parameters were noted: Age, gender, BMI, native kidney disease comorbidities whether on immunosuppressant drugs, Hb absolute lymphocyte count, ESR serum albumin, and adequacy of dialysis by calculating spKt/V. Patients were then administered two doses of COVAXIN. Antibody titers were measured at baseline and four weeks after the first and second dose. Anti-SARS-CoV-2 IgG antibodies were measured using Access 2 Immunoassay System - Beckman Coulter by Chemiluminescence Microparticle Immunoassay which detects neutralizing antibodies against Receptor-Binding Domain of spike protein with a high sensitivity and specificity. The result of antibody titer was reported as nonreactive or reactive based on S/CO (Signal/Cut-Off ratio). S/CO 0.8 was nonreactive and S/CO 1 was reactive. Data was collected in MS-Excel, and IBM SPSSv26.0 was used for statistical analysis. RESULT(S): A total of 119 patients were enrolled out of which 107 patients completed the study. 75.7% (81 out of 107) patients achieved seroconversion after two doses of BBV152 which is lesser than seen in healthy controls. The rate of seroconversion was 66.4% after the first dose. Analysis of factors associated with poor seroconversion in this study showed increasing age, presence of diabetes, atherosclerotic cardiovascular disease, severe anemia, higher ESR, and severe hypoalbuminemia (Serum albumin < 2.5 g/dl) to be statistically significant. Patients who had lower BMI and spKt/V >1.2 showed a better seropositivity response in this study. HD vintage and absolute lymphocyte counts were not significantly associated with serologic response. Poor seroconversion is generally associated with immunosuppressant therapy, but this was not seen in our study which could be due to the small number (4 patients) in the study. Unique association of diabetes and severe anaemia with poor seroconversion was noted in this study CONCLUSION(S): 75.7% patients on maintenance hemodialysis achieved seroconversion after two doses of inactivated SARS CoV2 BBV152 vaccine. Increasing age, presence of diabetes, atherosclerotic cardiovascular disease, ana mia, inadequate hemodialysis, and hypoalbuminemia were associated with a lesser antibody response to the vaccine in this study. Revising future vaccine strategies with an aim at improving immunologic response in patients on hemodialysis with high-risk factors like diabetes mellitus brought out in our study could prove worthwhile.

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