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1.
Journal of Laboratory Physicians ; 2022.
Article in English | Web of Science | ID: covidwho-1967690

ABSTRACT

Background Rapid antigen detection tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) play a crucial role in the control of the current coronavirus disease 2019 (COVID-19) pandemic. Data about the real diagnostic performance of such tests is still insufficient and hence their evaluation is of high priority. Objectives The aim of this study was to evaluate the diagnostic performance of BIOCREDIT COVID-19 antigen test alone and in combination with either C-reactive protein (CRP) or neutrophil/lymphocyte ratio (NLR) in comparison to real-time quantitative polymerase chain reaction (RT-qPCR). Additionally, we investigated the selection criteria of the suspect for best performance of the antigen test. Materials and Methods Paired nasopharyngeal (NP) swabs were collected from 200 suspected COVID-19 subjects for SARS-CoV-2 RNA by RT-qPCR and for antigen detection by BIOCREDIT test. Simultaneously, for all suspect, clinical presentations were recorded as well as CRP level and NLR were determined. Results Among 200 tested NP swabs, 125 (62.5%) were RT-PCR positive. Overall sensitivity, specificity and accuracy of BIOCREDIT test were 34.4, 98.7, and 58.5%, respectively. Sensitivity of the BIOCREDIT test was higher in COVID-19 suspect, with high viral load (100%), severely ill (56.2%), with fever alone (40%), elevated CRP (41.1%), and high NLR (36.2%). In combination with NLR or CRP, sensitivity of BIOCREDIT test increased to 89.4 and 81.6%, respectively, while its specificity decreased to 67 and 59%, respectively. Conclusion The overall low sensitivity of BIOCREDIT/COVID-19 antigen test does not permit its use as a single diagnostic test for COVID-19. However, its use should be restricted only if it is combined with either CRP or NLR in suspect with certain criteria.

2.
Laryngo- Rhino- Otologie ; 101:S307, 2022.
Article in English | EMBASE | ID: covidwho-1967677

ABSTRACT

Introduction As part of the immune response to the COVID-19-vaccine a multitude of anti-COVID-antibodies is formed. A part of these antibodies can bind to the body-s own tissue and facilitate autoinflammatory processes. Such autoimmune-inflammatory processes are suspected to be behind various symptoms of the COVID disease and the long-COVID syndrome. So far, numerous reports on neuro-otological symptoms in the context of COVID infection have been published. The present report describes patients who presented in a university ENT outpatient department with vestibulo-cochlear symptoms in connection with a COVID vaccination. Methods All patients who presented with dizziness, tinnitus and hearing impairment for the first time in a direct temporal context (max. 3 days after vaccination) tot he vaccination were examined by an ENT specialist and further examined using subjective and objective audiometry and, depending on the symptoms, using vestibular diagnostics. Results An otitis media was not found in any patient. A cochlear genesis of the vestibulo-cochlear symptoms could be demonstrated in all patients. One patient has isolated symptoms with hearing loss, all others also suffered from tinnitus or dizziness. In all patients, the symptoms resolved after drug therapy was carried out. Discussion Vaccine-associated hearing loss has also been described in the case of influenza vaccination. We were unable to provide direct evidence of the COVID vaccination as the triggering factor for the vestibulo-cochlear symptoms. An association of these symptoms with the vaccination cannot be ruled out though. The most likely mechanism is an immunoglobulin-triggered specific autoimmune response.

3.
Laryngo- Rhino- Otologie ; 101:S243, 2022.
Article in English | EMBASE | ID: covidwho-1967666

ABSTRACT

Aim The project aims to examine chemosensory dysfunction in long-COVID with a focus on olfactory function about 9 months after SARS-CoV-II-infection. Material and Methods In this population-based cross sectional study, PCR-confirmed SARS-CoV-2 outpatients were examined between November and June 2020 at Kiel university hospital. Data on medical history and chemosensory function were collected via questionnaires and a Visual Analogue Scale (VAS), olfactory performance was psychophysically objectified using the Sniffin' Sticks test. Results A total of 376 female and 290 male patients were included with a mean age of 48.2 years ranging from 19 to 87 years. The mean follow-up was 9.09 months (range 1.64-15.18) after initial positive PCR-testing. The prevalence for olfactory dysfunction (OD) during infection was 66,1 %. 33,7 % of the subjects reported persistent OD subjectively at the time of examination (female 28,8 %, male 42,3 %). T-test analysis showed a significant decline of reported olfactory evaluation from before COVID-19 to the time of examination based on VAS (p < 0.001). 34,6 % of the subjects were tested hyposmic or anosmic by Sniffin' Sticks. A significant correlation was shown between a subjective estimation of OD by the patients and an objectively tested OD (p < 0.001). The TDI-score correlated positively with the amount of time (in months) that passed since PCR-testing (p < 0.001). Discussion OD in SARS-CoV-II-infection is frequent and can be persistent long beyond the acute phase of ilness. We demonstrated that anamnestic OD is significantly related to psychophysically tested OD. Therefore one can conclude that a subjective OD is a likely predictor of an actual objective OD. Furthermore, OD shows a tendency to improve over time.

4.
ACS ES&T Water ; 2022.
Article in English | Web of Science | ID: covidwho-1967578

ABSTRACT

The use of wastewater-based epidemiology (WBE) as a disease surveillance tool during the COVID-19 pandemic has been mainly to achieve two goals: early warning and determining changes in infection numbers over time. This study focused on the utilization of WBE as an early warning tool for COVID-19 infection in the eThekwini municipality of South Africa. Four wastewater treatment plants treating mainly domestic wastewater were chosen for this study. A central wastewater treatment plant was first used to determine the early warning potential of WBE, and thereafter, the tool was applied at three other locations. Viral concentrations in the raw wastewater were determined via the droplet digital polymerase chain reaction (PCR) method. The SARS-CoV-2 concentration varied from 4 to 7 Log(10)/100 mL of raw wastewater during the study period. The changes in viral concentration corresponded with the active COVID-19 cases within the study area. As an early warning tool, the WBE data was able to detect increasing infections in the community at least 5 weeks prior to increasing clinical cases during the third wave of COVID-19 infections in the country. Similarly, SARS-CoV-2 concentrations began increasing on November 30, 2021 prior to an increase in clinical cases on December 14, 2021, giving an almost a 2 week lead time. However, statistically, a 2-3 week lead time was determined to show the highest relationship with increasing COVID-19 cases. This study therefore identified the lead time as being between 2 and 3 weeks for early warning of COVID-19 infections using WBE data. Application of the early warning system at the three other catchments during the fourth wave of COVID-19 infections gave similar results of a lead time of 2 weeks. Therefore, the findings in this study further support the use of WBE as an early warning system. However, further studies are still required to address the challenges hindering the accurate and efficient use of this tool.

5.
Gastroenterology ; 162(7):S-1280, 2022.
Article in English | EMBASE | ID: covidwho-1967447

ABSTRACT

Introduction: Solid organ transplant recipients have 2-5 times increased mortality after coronavirus disease 2019 (COVID-19) infection as compared to general population. These patients also have lower protection after vaccination against COVID-19. Therefore, the risk of breakthrough infection and hospitalization are also significantly higher in this patient population. Studies on efficacy of COVID-19 vaccination in post liver transplant (LT) patients are limited. We aimed to investigate the rate of mortality, hospitalization, and breakthrough infection and assess possible risk factors in COVID-19 infection mortality post LT. Methods: A retrospective chart review study. All post liver transplant patients at Carolinas Medical Center (CMC) who were tested positive for respiratory syndrome coronavirus 2 (SARS-CoV- 2) PCR test from Dec. 2020 (when first COVID-19 vaccine was approved in the US for emergency use authorization) until Nov. 2021 were included in this study. Breakthrough infection was defined as COVID-19 infection ≥14 days after full vaccination. Data was analyzed using Prism (GraphPad Software, San Diego, CA) and reported as mean ± SEM. T- test and chi square tests were applied for analyzing the data. Results: Thirty-six patients were identified and 66.1±9.6 months post liver transplantation (LT). Mean age was 61.2±1.6 years-old, male (72.2%) and Caucasian (91.6%). Ten patients (27.7%) expired. Chronic kidney disease (CKD) was present in 70.0% of expired patients as compared to 53.3% of recovered (p=0.0003). Type 2 diabetes (T2DM) was present in 70.0% vs. 25.0% of expired and recovered patients, respectively (p<0.0001). Hypertension (HTN) was present in 90.0% vs. 55.0% of expired and recovered patients, respectively (p<0.0001). No statistically significant difference was observed in weight of expired vs. recovered patients (50% vs. 65% obesity;p=0.4). Only 9 patients were vaccinated. Breakthrough infection rate was 25% and 2/9 (22.2%) died vs. 29.6% of non-vaccinated patients (p=0.4). COVID-19 infection occurred 4.9±0.86 months after vaccination. Hospitalization (44.4% vs. 55.5%) and ICU admission (22.2% vs. 37.0%) was not statistically different among vaccinated and non-vaccinated patients. Conclusion: T2DM and CKD were significantly higher among COVID-19 infected patients who expired, which are similar risk factors in patients who have not had a liver transplant. However, obesity was not significantly correlated with mortality as it was shown before in non-immunocompromised population. Although COVID-19 vaccine is effective in post LT patients, larger studies are warranted to evaluate its efficacy in this population. Our study also highlights that the efficacy of current COVID-19 vaccines decreases in 4-6 months after full vaccination, which warrants evaluating the efficacy of booster dose(s) in post LT patients

6.
Gastroenterology ; 162(7):S-1253, 2022.
Article in English | EMBASE | ID: covidwho-1967443

ABSTRACT

Introduction. Solid organ transplant recipients were excluded from the pivotal clinical trials of COVID-19 vaccines. Therefore, the safety and efficacy data of the different types of available vaccines in this susceptible population is scarce. The goal of the present analysis was to evaluate the humoral response to the COVID-19 vaccines in orthotopic liver transplant (OLT) recipients. Methods. Participants were included from February to September 2021. No prioritized vaccination was performed for OLT patients, and they were included in the regular schedule according to age and place of residency. Controls were otherwise healthy people, mainly family members of patients. All subjects completed the full vaccination schemes, and blood samples were taken after at least 15 days of the complete vaccine doses. The samples were analyzed according to the manufacturer instructions using Liaison XL platform from DiaSorin, LIAISON® SARS-CoV-2 S1/S2 IgG (DiaSorin S.p.A., Italy), and SARS-COV-2 IgG II Quant (COV-2 IgG II) (Abbott Diagnostics, IL, USA). Results. In all, 187 participants (133 OLT, 54 controls, median age: 60 years, 58.8% women) were included for the analysis;74.3% had at least one comorbidity (31.6% had hypertension, 32.6% diabetes, 7% neoplasia, and 23% obesity). By vaccine brands, 50.3% received Pfizer-BioNTech, 13.9% received Oxford-AstraZeneca, 10.7% received Sinovac, 7.0% Cansino;16% Sputnik-V and 2.1% received Moderna. The serologic response in OLT patients was lower than in controls (median 549 AU/mL vs. 3450 AU/mL, respectively;p 0.001). A positive humoral response was found in 133 OLT individuals: 89.2% with Pfizer-BioNTech, 60% Oxford-AstraZeneca, 76.9% Sinovac, 55.6% Cansino, 68.2% Sputnik-V, and 100% with Moderna. In controls, only Cansino had a 75% humoral response;all other vaccines had a 100% response. In a multivariable model adjusted for relevant confounders, the antecedent of COVID-19 and Pfizer-BioNTech inoculation were associated positively with the serologic response, while the use of prednisone (compared with other immunosuppressants) interfere with this response. Conclusion. The serologic response to COVID-19 vaccines in OLT patients is lower than otherwise healthy controls. In these patients, the Pfizer-BioNTech vaccine was associated with a higher serologic response. Other variables significantly associated with the humoral response were the COVID-19 antecedent (positively) and prednisone exposure (negatively). At the moment, further analysis is necessary to determine whether this serological response is associated with SARS-COV2 infection or reinfection. (Figure Presented)

7.
Gastroenterology ; 162(7):S-1250, 2022.
Article in English | EMBASE | ID: covidwho-1967436

ABSTRACT

Background: The 2019 novel coronavirus (COVID-19) has been associated with elevated liver enzymes, which has seen to be associated with a higher mortality rate in COVID-19 infected patients. With a global vaccination rate under 50%, as of November 2021, we will continue to see patients admitted for COVID-19 infection. We have done this study to further evaluate the relationship between development of transaminitis and its relation to vaccination status and to see if vaccination prevented liver injury in COVID-19 patients. Methods: A retrospective study was performed between October 2019 and October 2021 on patients infected with COVID-19. A total of three hundred and fifty patient charts were included in the study. Patient data regarding age, sex, comorbidities, vaccination status, vaccine manufacturer, mortality, and length of stay data were reviewed. Patients were then divided into two groups (Vaccinated vs Unvaccinated ), data was then matched for their age, sex, and comorbidities using propensity score matching. Results: Each group had thirty-nine patients after propensity score matching. The average age in both groups was 58.4±13.3. Twenty-one females were in a non-vaccinated group and twenty females in the vaccinated group. The average number of days to infection from the last COVID-19 vaccine was 132±57. The vaccinated group showed a significant reduction in the incidence of liver injury with respect to AST (42±13 vs. 93.3±35, P< 0.02, 95% CI), ALT (50±10 vs. 97.4±45.5 P<0.04), and ALP 65±15.2 vs. 93±35.6 P<0.01) compared to unvaccinated patients. The vaccinated patient group showed a reduced length of stay compared to the unvaccinated group ( 10.6 ± 4.8 vs. 18.1 ± 8.1, P<0.05). The vaccinated patient group showed a decrease in mortality as compared to the unvaccinated group (17 vs. 8, P<0.05). Conclusion: After a thorough review of COVID infected patients, liver enzyme abnormalities were evaluated in vaccinated and unvaccinated patients. ALT, AST, and ALP in vaccinated patients were found to be significantly lower in as compared to unvaccinated patients. Hospital length of stay and mortality rate were both found to be lower in vaccinated patients compared to unvaccinated patients. Recent vaccination status leading to decreased infection severity may relate to the lack of significant and dramatic increase in liver enzyme levels and may present as confounding factors. Major limitation in the study was the small sample size and future studies with a larger sample size can deliver a better perspective.

8.
Gastroenterology ; 162(7):S-1247-S-1248, 2022.
Article in English | EMBASE | ID: covidwho-1967430

ABSTRACT

Introduction COVID-19 vaccines have been shown to be effective in preventing hospitalization due to COVID-19 infection. However, safety remains a concern. Some studies have linked the vaccine to the development of autoimmune diseases such as myocarditis and immune thrombocytopenic purpura. During the summer of 2021, an increasing number of case reports began to emerge documenting a small number of individuals who developed autoimmune hepatitis (AIH) following COVID-19 vaccination. These cases are rare, novel, and very little is known. In our systematic review, we analyzed every published case of AIH and reviewed their characteristic findings, treatment, and outcomes. Methods We searched PubMed, Embase, and Web of Science from 1 December 2019 to 1 November 2021. Keywords included but were not limited to “COVID-19,” “vaccine,” and “autoimmune hepatitis.” Two researchers independently extracted information from the articles about vaccine type, patient history, characteristics, laboratory values, histology results, treatment regimens, and disease course. Results Thirty-two patients developed AIH after receiving a COVID-19 vaccine (16 Pfizer-BioNTech, 13 Moderna, 3 Oxford-AstraZeneca), of whom 17 were from the United States, 11 were from Europe, 3 were from Asia, and 1 was from Australia. Sixty-nine percent of patients were women and 58% had no history of liver or autoimmune disease. Jaundice was the most common symptom (81%). Nineteen percent of patients were initially asymptomatic and presented with abnormal liver enzymes found during routine bloodwork. (Table 1) Mean ALT, AST, and bilirubin were 1231 U/L, 921 U/L, and 14 mg/dL. Anti-nuclear antibody and anti-smooth muscle antibody were positive in 56% and 28% of patients. Liver biopsy was performed in 81% of patients with findings strongly suggestive of AIH. Corticosteroids were used in 74% of patients with a mean time to disease resolution of 28 days. Improvement or complete resolution was seen in 97% of patients. (Table 2) One patient died despite aggressive steroid treatment. Discussion COVID- 19 vaccine-induced AIH is extremely rare with just 32 documented cases in the literature. Although causality cannot be proved, this phenomenon should not be treated as coincidence. Clinicians should be aware of this rare but real complication and suspect vaccine-induced AIH in patients who present with jaundice and abnormal liver enzymes following COVID- 19 vaccination. Treatment with corticosteroids appears to be highly effective, with improvement or resolution in 97% of patients. Our findings highlight the rarity of COVID-19 vaccine-induced AIH and should under no circumstances deter individuals from getting vaccinated as the benefits of vaccination far outweigh the risks. (Table Presented)

9.
Gastroenterology ; 162(7):S-1247, 2022.
Article in English | EMBASE | ID: covidwho-1967428

ABSTRACT

Introduction Vaccines have emerged as our primary line of defence against the scourge of COVID-19. Patients with cirrhosis have a higher risk of severe COVID-19 and mortality and are thus high priority patients for vaccination. However, cirrhotics were excluded from the phase 2 and 3 trials of COVID-19 vaccines. Hence, we aimed to assess the seroconversion rate and safety of currently available COVID-19 vaccines in India, namely COVISHIELD (ChAdOx1 nCoV-19) and COVAXIN (BBV 152), in patients with cirrhosis. Methods All patients who had attended tele-hepatology services at our institute from March 2020 to June 2021 and diagnosed with cirrhosis as per their medical records were telephonically interviewed in July 2021 using a pre-specified questionnaire. Patients who had completed full course of vaccine (with the 2nd dose being administered at least 2 weeks back) and without history of documented COVID-19 infection (pre or post vaccination) were tested for SARS-CoV-2 IgG antibodies using an automated chemiluminescent assay (Orthoclinical Diagnostics). Our primary outcome was seroconversion in patients with cirrhosis who had received complete COVID-19 vaccination. Secondary outcomes included vaccine acceptance, documented COVID-19 infection post-vaccination and adverse effects of COVID-19 vaccines in cirrhosis. Results We identified and interviewed 784 patients with cirrhosis [compensated: 213 (27.2%), decompensated 561 (72.8%)] with a mean age of 51.07 ± 8.53 years. Two eighty-three (36.1%) patients had received at least 1 dose of COVID-19 vaccine [COVISHIELD: 231 (29.5%), COVAXIN: 52 (6.6%)] and 159 (20.3%) patients had completed full course of vaccination with 2 doses [COVISHIELD: 134 (17.1%), COVAXIN: 25 (3.2%)]. Documented COVID-19 (on RT-PCR) was reported in 3.2% (9/283) patients who had received at least one dose of COVID-19 vaccine while breakthrough COVID-19 (at-least 2 weeks after administration of 2nd dose) was reported in 3.1% (5/159). Adverse events were reported by 19.8% (56/283) patients with the most common being fever (13.1%), myalgia (5.6%) and sore throat (1.1%). No grade III/IV adverse events were reported. So far, 100 fully vaccinated patients (COVISHIELD: 88, COVAXIN: 12) have been tested for seroconversion. Seroconversion rate with COVISHIELD and COVAXIN were 92% (81/88) and 91.7% (11/ 12), respectively. Seropositive patients were divided into high, moderate, and low antibody responses based on the observed signal/cut-off response and no differences were observed between patients with compensated and decompensated cirrhosis (Table 1). There was no correlation between antibody signal/cut-off ratios and CTP (tau: 0.07, p=0.32) or MELD (tau: 0.08, p=0.29) scores. Conclusion Our preliminary data suggests that currently available COVID-19 vaccines in India are safe with high seroconversion rates in patients with cirrhosis. (Table Presented)

10.
Gastroenterology ; 162(7):S-1246-S-1247, 2022.
Article in English | EMBASE | ID: covidwho-1967427

ABSTRACT

Introduction: Exacerbation of pre-existing autoimmune disease and de novo vaccine-related autoimmunity after SARS-CoV-2 vaccine has been reported. These observations could lead to vaccine hesitancy among autoimmune hepatitis (AIH) patients. We aimed to assess hesitancy as well as prevalence of flare and disease onset after vaccination in an online AIH cohort. Methods: Electronic invitation to complete a vaccine-specific questionnaire was posted weekly to the Autoimmune Hepatitis Association (www.aihep.org) social media communities (membership: 4700) over 3-weeks. Individuals 18 years or older with AIH diagnosis made by a physician were eligible. Vaccine hesitancy was defined as not receiving SARS-CoV-2 vaccine. AIH flare was defined as abnormal liver tests, when previously normal for 1 year, requiring escalation of immunosuppression within 2 months of SARS-CoV-2 vaccine. Continuous variables were summarized as means and standard deviations and pvalues were obtained using the Student's T-test. P-values for discrete variables were obtained from the Chi-Square test. The study was approved by local institutional review board. Results: A total of 643 individuals, 91.9% female, 91.8% white, mean age of 54 years and disease duration of 7 years, completed the questionnaire. A majority (599, 93.2%) had received at least 1 dose of vaccine including Pfizer-BioNTech (50.2%), Moderna (35.2%), AstraZeneca (11.1%), and Johnson & Johnson (3.5%). Hesitant patients were less likely female (79.5% vs 92.8%), younger (48 vs 55 years) and had higher prevalence of COVID- 19 infection (27.3% vs 10.2%) compared to vaccinated (p < 0.005 for all). Among those eligible, 95.3% received a second dose and 53.7% a third dose. Five patients did not receive a second vaccine dose because of prior adverse reactions or liver test elevations. A third dose was not administered to 263 patients because it was too early (57%), patient choice (21%), adverse side effects (9%), initial vaccine was Johnson & Johnson (7%), or abnormal liver tests (6%). Among those with normal liver tests prior to vaccination, 5% (15/288) reported increased tests after first or second dose. Liver test elevations were more likely in non-white (67% vs 95%, p = 0.001) and Hispanic/Latino patients (27% vs 4%, p = 0.001) compared to those without elevations. Only 2 patients had disease flare after first dose, whereas no AIH flares were reported after second. New diagnosis of AIH was reported 2 months beyond vaccination in 7% of vaccinated patients (42/599): 16 after first dose and 26 after second dose. Conclusion: SARS-CoV-2 vaccine hesitancy among AIH patients was minimal compared to the national average. Reports of liver test elevation and disease flare were rare after vaccination. New AIH diagnosis near vaccine was reported, yet new diagnosis was also observed in vaccine hesitant patients. (Table Presented)

11.
Gastroenterology ; 162(7):S-1008, 2022.
Article in English | EMBASE | ID: covidwho-1967396

ABSTRACT

BACKGROUND: Immune-modulating medications for inflammatory bowel diseases (IBD) have been associated with suboptimal vaccine responses. There is conflicting data with SARS-CoV-2 vaccination. METHODS: We measured SARS-CoV-2 vaccine immunogenicity at 2 weeks post 2nd mRNA vaccine in IBD patients as compared to normal healthy donors (NHD). We measured humoral immune responses to SARS-CoV-2: anti-spike Immunoglobulin G (IgG) and anti-receptor binding domain (RBD) IgG were measured by ELISA, and neutralizing antibody titers were measured using recombinant, reporter SARS-CoV-2. Antigen specific memory B cells were measured using recombinant SARS-CoV-2 proteins. Activation induced marker T cell (AIM) assays were performed using SARS-CoV-2 spike megapools. Immunophenotyping was performed by flow cytometry. RESULTS: We enrolled 29 patients with IBD (19 with Crohn's disease, 10 with ulcerative colitis) on infliximab (IFX) monotherapy (N=9), IFX combination therapy with a thiopurine (N=9), vedolizumab monotherapy (N= 11) as compared to matched NHD (N=12). At 2 weeks post vaccination, all subjects made detectable anti-spike IgG and anti-RBD IgG. There were no differences in anti-spike IgG titers among the different groups. IBD patients on IFX monotherapy, but not IBD patients on IFX combination therapy or vedolizumab monotherapy, had lower anti-RBD and neutralization titers as compared to NHD (p-value: 0.041 and 0.023, respectively) (Fig. 1). There were no significant differences in the percentage of spike-specific or RBD-specific memory B cells in IBD patients as compared to NHD (Fig. 1). There were no differences in the percentage of spike-specific CD4+ or CD8+ T cells in all IBD patients as compared to NHDs (Fig. 2). CONCLUSIONS: We demonstrate overall comparable and perserved cell-mediated immunity to SARS-CoV-2 vaccination in a small cohort of IBD patients treated with a range of different immune-modulating medications as compared to healthy controls. Larger numbers of patients are needed to validate these findings.

12.
Gastroenterology ; 162(7):S-1005-S-1006, 2022.
Article in English | EMBASE | ID: covidwho-1967391

ABSTRACT

INTRODUCTION Patients with inflammatory bowel disease (IBD) may be more susceptible to certain infections including COVID-19. There are concerns regarding the safety and efficacy of the current available COVID-19 vaccines among IBD patients. The aim of this study is to perform a systematic review regarding the willingness of IBD patients to receive these types of vaccines, assess the reported adverse events and the efficacy of the vaccine among IBD patients. METHODS Medline, Embase, Scopus, Web of Science, and Cochrane databases were reviewed since inception till November 11th, 2021, by two independent reviewers. Relevant conference s were manually reviewed to identify additional studies. Studies that reported the willingness or rate of COVID vaccination, the adverse events, and/or efficacy of the COVID vaccine among IBD patients were included. Efficacy was defined as the ability of a vaccine to produce detectable antibodies. Meta-analysis was performed using a bivariate random-effects model. RESULTS 2049 studies were identified through database search and additional 10 conference s were extracted. 24 studies, with the majority (79%) from North America or Europe were included. Four studies reported the rate of adverse events of vaccines ranging from 39% to 74% after the first and second doses of vaccine, respectively. Pooled estimates of nine studies showed that only 59% of IBD patients (95% confidence interval (CI):39%-79%) were willing or had already received a vaccine. Pooled estimates of six studies showed the vaccine was 96% (95% CI: 92%-99%) effective in creating seroconversion in IBD patients. Three studies reported the incidence of break-through infection following COVID vaccination;The pooled estimates showed no statistically significant difference between the risk ratio of IBD patients versus healthy control (Risk difference:0.02 (95%CI: -0.02, 0.06), P-value:0.3). Mean values of antibody level were statistically significantly lower in IBD patients receiving immunosuppression compared with those who were not on immunosuppression (Standardized mean difference: -0.38 (95% CI: -0.58, -0.18), P-value:0.002). CONCLUSION COVID vaccines are protective against preventing COVID-19 infection in IBD patients. However, patients on immunosuppression may have reduced response and could benefit from a booster dose. More importantly, there should be more efforts in encouraging IBD patients towards vaccination. Additionally, is scarce data and further studies are required to assess the global effect of the COVID vaccine in IBD patients, particularly in underdeveloped countries. (Figure Presented)

13.
Gastroenterology ; 162(7):S-676, 2022.
Article in English | EMBASE | ID: covidwho-1967361

ABSTRACT

Background: COVID-19 associated gut microbiome dysbiosis has been strongly linked to more severe disease and has most recently been shown to persist long after symptomatic recovery. While studies have correlated the depletion of gut commensals, like Faecalibacterium and Bifidobacterium, to disease severity, little is known about specific microbes that may be protective against disease, especially in the context of vaccination against SARS-CoV-2. We aimed to characterize changes in the gut microbiota following COVID-19 vaccination and associate them with antibody titers against SARS-CoV-2. Methods: We obtained paired stool samples from a cohort of 8 patients, the first sample taken within 10 days before the beginning of their COVID-19 mRNA vaccine series and the second taken within 10 days after their second vaccine. 16s rRNA gene sequencing and principal coordinate analysis were performed. In parallel, blood samples were also collected at 1, 3, 6, and 12 months to enumerate serum IgG antibody titers. Patients were stratified into 2 groups—medium and high—based on IgG titers following vaccination, wherein the `high' response group maintained significantly higher titers beyond 6 months follow-up. We used linear discriminant analysis effect size (LefSe) to estimate which microbes significantly differed at baseline between the 2 response groups. Results: The gut microbiome composition differed before and after vaccination for all patients, with medium responders showing significant differences by both Bray-Curtis dissimilarity (p = 0.04, pairwise PERMANOVA) and unweighted UniFrac (p = 0.03, pairwise PERMANOVA) beta diversity metrics (Figure 1), while differences within high responders were non-significant. The most abundant families present before vaccination in all subjects included Lachnospiraceae, Bacteroidaceae, Ruminococcaceae, and Enterobacteriaceae. Following vaccination, a stark contraction in the relative abundance of the family Bacteroidaceae occurred in all subjects, and in the majority of cases was accompanied by a concomitant increase in the abundance of Lachnospiraceae. The relative abundances of Ruminococcaceae, Bifidobacteriaceae, and Streptococcaceae were also increased in the majority of post-vaccination samples. Post-vaccination samples were also increased in community evenness and community richness for both response groups. LefSe analysis indicated that the orders Bifidobacteriales and Lactobacillales were significantly associated with high responders (Figure 2). Conclusion: Altogether, these findings demonstrate an association between the gut microbiota and COVID-19 immunity and highlight a potential link between specific taxa and the strength of humoral responses following vaccination. (Figure Presented) (Figure Presented)

14.
Gastroenterology ; 162(7):S-600-S-601, 2022.
Article in English | EMBASE | ID: covidwho-1967348

ABSTRACT

Background This study aimed to compare the risk of COVID-19 in patients with IBD versus the general population, and to evaluate predictors of infection acquisition, progression to severe forms, and risk of developing persistent COVID-19. We also assess the differences between cases across the different COVID-19 pandemic waves in our target population. Methods This single-center prospective, cohort study included consecutive IBD patients diagnosed of COVID-19 either by a positive polymerase chain reaction test and/or antigen test in nasopharyngeal swabs, or by anti-SARS-CoV-2 antibodies, and that they had a followup of at least 4 months. Using logistic regression, we evaluated cases versus IBD controls included in the IBD Unit database for predictors of COVID-19 acquisition. COVID-19 cases were distributed according to pandemic waves. Cox regression analysis was used for predictors of severe and persistent COVID-19. Results By May 31, 2021, 160 out of 1911 IBD patients (8.3%) were diagnosed with COVID-19. IBD patients had a similar adjusted incidence of COVID-19 (OR 0.94;95% CI 0.86-1.02;P=0.42), and a similar associated mortality ratio (OR 0.83;95% CI 0.6-1.06;P=0.48), compared to the general population. In multivariable analysis, treatment with biologics was associated with a higher risk (OR 2.22, 95% CI 1.54-3.2, P<0.001), and treatment with salicylates with a lower risk (OR 0.71, 95% CI 0.50-0.99, P=0.048) of contracting COVID-19. Sixty-two COVID-19 cases were diagnosed during the first wave of pandemic (until the end of June 2020), and 54 and 44 cases during the second and third waves (until the end of December 2020 and May 2021, respectively). (Figure 1) In multivariate analysis, first wave cases were associated with a higher risk of progression to severe forms of infection (OR 4.76, 95% CI 1.83-12.37, P= 0.001), and development of persistent COVID-19 (OR 2.4, 95% CI 1.16-4.95, P=0.018). Twenty-nine patients (18.1%) required hospitalization and were classified as severe COVID- 19, which was associated in multivariable analysis with age>48 (HR 3.68, P=0.007), cases diagnosed in the first wave (HR 6.04, P<0.001), and comorbidities (evaluated with Duke Severity of Illness Checklist [DUSOI], P<0.001). (Table 1) During a median follow-up of 8.4 months, 68 patients (42.5%) were diagnosed with persistent COVID-19. Multivariable analysis identified UC (OR 2.00, 95% CI 0.99-4.03, P=0.053), comorbidities (P=0.090), and being diagnosed during the first wave (OR 2.48, 95% CI 1.23-5.00, P=0.011) as risk factors for persistent COVID-19. Conclusion IBD patients have a similar risk of COVID- 19 and associated mortality as the general population. Cases diagnosed during the first wave of the pandemic had severe and persistent forms of COVID-19 more frequently. Age and comorbidity were the main risk factors for severe forms of the disease. (Figure Presented) (Table Presented)

15.
Gastroenterology ; 162(7):S-600, 2022.
Article in English | EMBASE | ID: covidwho-1967347

ABSTRACT

Introduction Despite the global impact of the COVID-19 pandemic, vaccine hesitancy remains common in the general public. Adults who were on immunosuppressive medications were among the earlier groups recommended by the Centers for Disease Control and Prevention to receive the COVID-19 vaccine. It is unclear whether similar vaccine hesitancy is seen in patients with inflammatory bowel disease (IBD), especially those who are on immunosuppressive medications. We sought to examine rate of vaccine hesitancy in patients with IBD as well as associated demographic and socioeconomic risk factors. Methods We performed a retrospective chart review in November 2021 of 1383 patients with IBD seen at University of Maryland Medical Center, a tertiary referral medical center, between November 2020 and October 2021. Data obtained from patients' charts included demographics;disease characteristics including disease phenotype, number of years since diagnosis, number of IBD-related surgeries;and IBD therapy including biologics, thiopurines or methotrexate, corticosteroids, and mesalamine. Information on COVID vaccination and routinely recommended vaccines were also collected which included annual influenza vaccine, Prevnar/ Pneumovax, and Shingrix. Those with no recorded COVID-19 vaccine were contacted by nurses for updated vaccine status. Results 72% (990/1383) of patients in this cohort were on a biologic, 17% (232/1383) were on corticosteroids, and 16% (224/1383) were on thiopurine or methotrexate, indicating a cohort of patients with moderate to severe disease phenotype. Fifty-seven percent (792/1383) of patients received either the Pfizer, Moderna, or Johnson & Johnson vaccine. In a multivariate regression analysis, COVID vaccination was found to be positively associated with a number of factors including older age (p-value= 4.92e-4), female sex (p=1.61e-3), Asian and Caucasian races (p=9.13e-3, 6.47e-06), number of years since diagnosis (p=2.73e-2), number of clinic visits in the past 12 months (p= 2.66e-10), and biologic use (p=4.41e-4). This remained the case while controlling for IBD disease type;marital status;insurance (Commercial vs Medicaid vs Medicare);and tobacco, alcohol, and substance use history. Patients who received other routinely recommended vaccines (influenza, Prevnar/Pneumovax, Shingrix) were not more likely to receive COVID- 19 vaccine. Discussion Although majority of patients in this cohort were on an immunosuppressive medication, COVID-19 vaccination rate is only recorded to be at 57%. Number of clinic visits, presumably more education and conversation with healthcare providers, had a positive impact on COVID-19 vaccination. In this cohort, younger adults, males, and African Americans were less likely to receive COVID-19 vaccine. Healthcare providers need to recognize these potential risk factors for COVID-19 vaccine hesitancy.

16.
Gastroenterology ; 162(7):S-599-S-600, 2022.
Article in English | EMBASE | ID: covidwho-1967346

ABSTRACT

Objective: Patients with inflammatory bowel disease (IBD) have attenuated responses to current vaccinations. There is a limited body of evidence suggesting patients with IBD receiving TNF antagonists have an attenuated response to vaccination against COVID-19. We sought to determine the impact of IBD and various medications for the treatment of IBD on antibody responses to vaccination against COVID-19. Design: Patients with IBD (n=270) and healthy controls (HC, n=116) were recruited prospectively and quantitative antibody responses assessed following COVID-19 vaccination. The impact of IBD and medications for treatment of IBD on vaccine response rates was investigated. Results: All HC seroconvert post complete vaccination with two vaccine doses [100%]. A small proportion of patients with IBD failed to seroconvert [2%]. Median anti-spike protein (SP) immunoglobulin (Ig)G levels post one vaccination and complete vaccination in our IBD cohort was significantly lower than HC [2,613 AU/mL versus 6,871 AU/mL, p=<0.001] [Figure 1]. A diagnosis of IBD was independently associated with lower anti-SP IgG levels [β coefficient -0.2, p = 0.001] whereas use of mRNA vaccines was independently associated with higher anti-SP IgG levels [β coefficient 0.25, p = < 0.001]. Patients with IBD receiving anti-TNF therapy had significantly lower anti-SP IgG levels [2444.6 AU/mL] than IBD patients not receiving these agents [3867.6 AU/mL] [p = < 0.001]. Patients with IBD not receiving TNF inhibitors still showed attenuated responses compared to HC receiving a similar vaccine [p = 0.001] [Figure 2]. 58 patients had an additional follow-up serology sample at a median of 12 weeks to complete vaccination to allow assessment of the durability of the response after their initial post-vaccination IgG level. There was a significant drop in IgG levels from 3952.85 AU/mL at the first timepoint checked post-complete vaccination to 921.1 AU/mL (343.1 – 2102.7) on follow-up sampling (p = <0.001). Median anti-SP IgG levels were numerically lower in our cohort receiving anti-TNF therapy (794.8 AU/mL) compared to those not receiving anti-TNF therapy (3136.9 AU/mL) on final follow-up samples (p =0.28). HC participants with previous COVID-19 infection (n= 5) had significantly higher anti-SP IgG levels post complete vaccination (20,719.6 AU/mL) compared to IBD patients (n=4) with prior infection (3,938.2 AU/mL) (p = < 0.001). Conclusions: Patients with IBD have attenuated serological responses to SARS-CoV-2 vaccination. Patients with IBD who do not seroconvert post-vaccination against COVID-19 are a particularly vulnerable cohort. Use of anti-TNF therapy negatively impacts anti-SP IgG levels. Impaired responses to vaccination in our study highlights the importance of booster vaccination programmes for patients with IBD. (Figure Presented) Differences in median IgG levels across three time points (Figure Presented) Differences in median anti-SP Levels dependent on medication for treatment of IBD.

17.
Gastroenterology ; 162(7):S-596-S-597, 2022.
Article in English | EMBASE | ID: covidwho-1967341

ABSTRACT

Background: Initial studies have shown that patients with inflammatory bowel disease (IBD) have a humoral immune response rate of 95–99% to a two-dose SARS-CoV-2 mRNA vaccine series. A third mRNA vaccine dose has been recommended for the IBD population. The aim of our study was to evaluate the humoral immunogenicity a third SARS-CoV-2 mRNA vaccine dose in patients with IBD. Methods: This was a multicenter, prospective, nonrandomized study comprised of patients with IBD and healthy controls (HC) in the HERCULES cohort. IBD subject eligibility criteria included a diagnosis of IBD, stable doses of maintenance therapy (≥ 2 months), and completion of a two-dose mRNA vaccines series. IBD subjects may have received a third mRNA vaccine dose. HC eligibility criteria included absence of immunosuppressive therapy and completion of a two-dose mRNA vaccine series. HC did not receive a third dose. Those with prior COVID-19 infection were excluded. The primary outcome was total serum SARS-CoV-2 anti-spike IgG antibody concentrations following a third dose compared to antibody concentrations following the two-dose series in IBD subjects. In IBD subjects, we measured antibody concentrations at 28–35 days following completion of the two-dose series and 28–65 days following the third dose. In HC, we measured antibody concentrations at 180 days following completion of the twodose series. Antibody concentrations between groups were compared using Mann-Whitney U tests. Results: One hundred thirty-nine IBD subjects and 46 HC were enrolled. Eightyfive IBD subjects received a third dose (Table 1). One hundred thirty-five IBD subjects (97.1%) had detectable antibody concentrations post-two-dose series, while 85 IBD subjects (100%) had detectable antibody concentrations post-third dose. For IBD subjects that received a third dose, antibody concentrations were significantly higher post-third dose compared to post-two-dose series (median 68 (IQR 32–147) vs 31 (IQR 16–61), p<0.001) (Figure 1). Post-third dose, IBD subjects on systemic corticosteroids or anti-TNF combination therapy had significantly lower antibody concentrations than IBD subjects that were not (median 29 (IQR 10–39) vs 72 (IQR 37–164), p<0.001). For HC, antibody concentrations were significantly lower 180 days compared to 30 days post-two-dose series (median 17 (IQR 11–22) vs 120 (IQR 88–190), p<0.001). HC had lower antibody concentrations 180 days post-two-dose series compared to IBD subjects post-third dose (median 17 (IQR 11– 22) vs 68 (IQR 32–147), p<0.001). Conclusion: All patients with IBD receiving a third SARS-CoV-2 mRNA vaccine dose were seropositive, and median antibody concentrations were higher than those measured after the two-dose series. Patients on corticosteroids and anti-TNF combination therapy had lower antibody concentrations than patients not on such therapy following a third dose. (Table Presented) (Figure Presented)

18.
Gastroenterology ; 162(7):S-593-S-594, 2022.
Article in English | EMBASE | ID: covidwho-1967336

ABSTRACT

Background: The immune response of SARS-CoV-2 vaccines is uncertain in those with Inflammatory Bowel Disease (IBD) due to a diverse array of immune-modifying therapies that vary in the mechanism of immunosuppression. Aim: We aimed to quantify the serological response to SARS-CoV-2 vaccines in those with IBD and determine antibody levels across varying therapeutic options. Methods: Individuals with IBD who received a first and/or second dose of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were assessed for serological response (1–8 weeks after first dose;1–8 weeks after second dose, 8–18 weeks after second dose, 18+ weeks after second dose) using the SARS-CoV-2 IgG II Quant assay to the receptor-binding domain of the SARS-CoV-2 spike protein. The cohort was stratified based on age, sex, vaccine received, IBD type, IBD therapeutic, and prior confirmed diagnosis of COVID-19. The primary outcome was seroconversion defined as IgG levels of ³50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). Results: Table 1 describes the characteristics of individuals with IBD (n=466) with serological data following the first dose (n=247) and/or second dose (n=413) of a COVID-19 vaccine. After 1–8 weeks following first dose of the vaccine, 81.4% seroconverted, with the lowest first-dose conversion rates in patients taking anti- TNF monotherapy (80.3%), anti-TNF combination therapy (51.5%), and corticosteroids (50.0%) (Table 1). Overall, 98.4% of the cohort seroconverted within 1–8 weeks of the second dose. Over time, seropositive rates decreased with 95.8% seroconversion within 8– 18 weeks of the second dose and 90.5% after 18 weeks. Seroconversion after second dose was consistently high across all medication classes (range: 94.6%–100.0%), except for oral corticosteroids (62.5%). GMT levels significantly increased (p<0.0001) from first dose (1825 AU/mL [95% CI: 981, 2668 AU/mL]) to second dose at 1–8 week (9059 AU/mL [7698, 10420 AU/mL]) but fell significantly (p<0.0001) to 3649 AU/mL (95% CI: 2562, 4736 AU/ mL) 8–18 weeks from second dose and 2527 AU/mL (95% CI: 883, 4172 AU/mL) 18+ weeks after second dose (Table 1, Figure 1). GMT levels 1–8 weeks after second dose were higher in those with prior COVID-19 (16,770 AU/mL), but lower in those receiving anti- TNF combination therapy (4231 AU/mL) and oral corticosteroids (5996 AU/mL) (Table 1). Conclusion: Seroconversion rates following full-regimen vaccination are high in patients with inflammatory bowel disease across all medication classes except for anti-TNF combination therapy and oral corticosteroids. Antibody titres and seroconversion rates tend to decrease after eight weeks post-full vaccination, which is consistent across medication classes. (Table Presented) Table 1. Patient and vaccine characteristics, seroconversion rates, and geometric mean titres by prior PCR-confirmed COVID-19 status for each medication class. (Figure Presented) Figure 1. Log-transformed anti-SARS-CoV-2 spike antibody concentration per vaccine category. Black points represent GMTs while narrow black bars represent bounds of 95% CI associated with each GMT. Solid blue line represents threshold for positive seroconversion [ln (50 AU/mL)].

19.
Gastroenterology ; 162(7):S-593, 2022.
Article in English | EMBASE | ID: covidwho-1967335

ABSTRACT

Background: Several SARS-CoV-2 vaccines are highly effective in preventing most infections, serious disease, hospitalization, and death from COVID-19 in the general population, but data regarding their use and efficacy in patients with inflammatory bowel disease (IBD) are limited. In this study we assessed the use patterns and efficacy of SARS-CoV-2 vaccines in patients with IBD. Methods: We established a multicenter matched case-control cohort of patients with IBD [Crohn's disease (CD), ulcerative colitis (UC)] and COVID-19 between February 2020 and December 2020 for the Surveillance of COVID-19 Impact on Long- Term Outcomes in IBD (SCOUT IBD) study. Cases were defined by the presence of COVID- 19-related symptoms and confirmatory SARS-CoV-2 PCR or IgG testing and non-COVID controls were defined as absence of symptoms and both a negative PCR and IgG in 2020. Cases were matched 1:1 to controls based on age, sex and IBD type. Data were collected on vaccine administration in 2021 and incidence of interval COVID-19 (defined as above) between January and September 2021. Results: The total cohort included 502 patients with IBD [UC (n=222, 44%), CD (n=278, 55%), IBD-undefined (n=2, 1%)] of whom 251 had a history of COVID-19 in 2020. The overall vaccination rate was 61% (n=306) with 189 (62%) patients receiving Pfizer-BioNTech, 101 (33%) Moderna, and 12 (4%) Johnson & Johnson. Vaccinated patients were more likely to be older (P=0.02), female (P=0.07), have a co-morbidity (cardiovascular, respiratory, renal) (P=0.04), or currently be on a biologic (P=0.01), and less likely to have had prior COVID-19 (P<0.001) than patients who did not get vaccinated (Table 1). The overall incidence of interval COVID-19 was 1.6% (N=8), with an infection rate of 0.3% (1/311) in vaccinated patients vs. 3.7% (7/184) in unvaccinated patients (P<0.01). Of infections occurring in unvaccinated patients, 1/7 (14.2%) was severe and required hospitalization requiring ICU admission, and the breakthrough infection in the vaccinated patient was mild and self-limited. COVID-19 reinfection occurred in one patient (0.4%) with prior COVID-19 who was unvaccinated. Under multivariable logistic regression, COVID-19 vaccination (aOR 0.05, 95% CI 0.01-0.41) and prior COVID-19 infection (OR 0.07, 95% CI 0.01-0.63) were highly protective against interval COVID-19. Conclusion: COVID-19 vaccines are effective in patients with IBD and markedly reduce the incidence of COVID-19. Prior COVID-19 is also protective against subsequent infection, although re-infections may occur at a very low rate. These results reaffirm the importance of COVID-19 vaccination in patients with IBD.(Table Presented)(Table Presented)

20.
Gastroenterology ; 162(7):S-488, 2022.
Article in English | EMBASE | ID: covidwho-1967321

ABSTRACT

Introduction: COVID-19 pandemic reportedly caused a significant increase in the utilization of all healthcare sectors. The surge of cases was attributed to the new variants of the virus causing more burden on the system. One of the helpful tools to increase awareness and reduce the chance of transmission is the early recognition of COVID-19 infection symptoms. Educating the public about these symptoms may help patients to seek medical attention early, and be cautious about exposing others to the virus. A significant percentage of infected patients visited our center due to COVID-19 presented with gastrointestinal symptoms. We are reporting our experience related to these issues. Methods: Data was cross-sectional and collected from 2334 charts for patientspresented to the center during the period between 7/26/2021 - 8/11/2021. We collected patients' demographics, vaccine status, reasons for the visit and all presenting symptoms. Abbott Rapid PCR test was used to confirm the infection. We also collected data regarding the visits to the center during the same period in 2017, 2018, 2019, and 2020 for comparison. Results: There has been a significant increase in healthcare utilization due to COVID-19 over previous years during the same periods. In 2017, 2018, and 2019 the average number of visits were 464, while in 2020 the total number was 1387 visits, of which 998 were COVID-19 related visits. In 2021, total visits were 2334 of which 1785 wereCOVID-19 related. These values indicate a 3- and 5-folds' increase in the number of visits respectively, with about 75% of the visits during the last two years being COVID-19 related. 265 Out of the 567 COVID-19 positive patients reported at least one GI symptom, 47 % overall (50% females and 43% males), the loss of taste was 26% (28% females and 25% males), nausea was 22% (23% females, 20% males), diarrhea was 20% (19% females and 20% males), and vomiting was 8% (7% females and 8% males). There were significant differences in symptoms rate between vaccinated and unvaccinated individuals (unvaccinated 48.9%, vaccinated 38.3%). Conclusion: The study demonstrates a significant burden of the current COVID-19 surge on the healthcare system in comparison to previous years. 14% of the COVID-19positive patients were asymptomatic, being tested due to exposure. Most of the patients were symptomatic, 47% of COVID-19 positive patients presented with at least one GI symptom. Symptoms are more prevalent among unvaccinated

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