Determining Anxiety Disorder in Health Workers who have received COVID-19 Vaccines: A Cross-Sectional Study at Public Health Centers in Tegal District, Indonesia

BACKGROUND: The COVID-19 pandemic has a major impact on health workers' mental health. Health workers in Indonesia have received COVID-19 vaccines to get protection against COVID-19 infection and reduce anxiety while on duty. AIM: This study aims to determine anxiety disorder in health workers at public health centers who have received COVID-19 vaccines. METHOD(S): A cross-sectional study was conducted at six public health centers in Tegal district, Indonesia. Data were collected using questionnaire that given to health workers who had vaccinated COVID-19. Anxiety disorder was determined with generalized anxiety disorder-7 (GAD-7) questionnaire. RESULT(S): There were 137 samples who participated in this study, consisted of 83.2% of women and 16.8% of men. The majority of the samples were 30-39 years old (41.6%), married (93.4%), and midwife (44.5%). There were 6.6% of samples had mild anxiety and others were normal (93.4%). CONCLUSION(S): COVID-19 vaccination program for health workers can reduce anxiety when providing health services. However, assistance is still needed for health workers who have mild anxiety disorder to prevent prolonged symptoms and more severe mental health condition. Copyright © The Authors.

Spike Ab seroconversion following SARS-CoV-2 vaccination in Australian people with Multiple Sclerosis

Background: SARS-CoV-2 antibody responses after COVID-19 vaccination are attenuated in people living with MS on high efficacy DMTs such as Fingolimod and Ocrelizumab. Uncertainties on how to manage vaccination schedule and DMT administration persist. Furthermore, data on effects of newer related DMTs like Siponimod and Ofatumumab are limited. Objective(s): We aimed to determine the seroprevalance of Spike antibody and the longevity of antibody mediatedimmune protection after COVID-19 vaccination in MS patients. Method(s): Spike IgG antibodies against Wuhan SARS CoV-2 were assessed in sera (n=520) of MS patients collected pre-vaccination (baseline n= 304), 1 month post second dose (n=172), 6 months post second dose (n=23) and 1 month post third dose (n=21). Demographic and clinical information including age, gender, DMT treatment and timing of COVID-19 vaccination were collected from 160 of these MS patients. Result(s): 151/172 sera at 1 month post second dose, 20/23 sera at 6 months post second dose, and 15/21 sera at 1 month post third dose were positive for Spike antibodies. Seropositive patients were treated on Alemtuzumab;n=3, Cladribine;n=32, Dimethyl fumarate;n=8, Fingolimod;n=16, IFN;n =4, Ocrelizumab;n=14, Ofatumumab;n=4, Natalizumab;n=11, Siponimod;n=1 and Teriflunomide;n=1. Out of the 21 patients who did not seroconvert at a month post second dose, treatment information was available in 12 patients. n=9 were treated by Ocrelizumab and n=2 were treated by Cladribine and n=1 was treated by Fingolimod, confirming certain DMTs prevent seroconversion. Out of the 151 patients that did seroconvert, 120 had titers that were comparable to controls (healthy general population) and 31 had reduced titres. Treatment information was available in 21/31 of these patients. Interestingly, 9/21 were on Ocrelizumab, 8/21 were on Fingolimod, 2/21 were on Ofatumumab, 1/21 was on Natalizumab and 1/21 was on Siponimod. This finding confirmed that certain DMTs such as Fingolimod, Ocrelizumab, Ofatumumab and Siponimod cause a reduction in post-vaccination Spike antibody titers in MS patients in comparison to general population. Expectedly, 304/304 sera were negative at baseline. Conclusion(s): Some High efficacy DMTs reduce Spike Ab titers or even prevent seroconversion. To maximize vaccine-mediated immune protection against COVID-19, timing of DMT administration and vaccine schedule may need intricate co-ordination in people living with MS.

Features of secretory immunoglobulin A in patients after COVID-19 infection

Secretory immunoglobulin A, as a marker of the immune response in the mucous membrane, is an available indicator for detecting changes in the local immunity of mucous patients who have undergone COVID-19. Objective. To evaluate the dynamics of changes in the level of sIgA in saliva samples and the effectiveness of the use of interferon alpha-2b in individuals after a coronavirus infection. Patients and methods. Patients aged 18 to 60 years after COVID-19 infection (group 1 on therapy, n = 65;group 2 without therapy, n = 65) and conditionally healthy individuals (control group, n = 15) were monitored. The material is saliva samples, where the sIgA level was determined initially and after a month. The drug - interferon alpha-2b, in the form of a gel for topical use (Viferon, dosage 36,000 IU/g) was administered intranasally 2 times a day, for 1 month. Results. In all groups of patients who underwent COVID-19, the level of saliva sIgA was lower compared to the conditional norm of healthy individuals (6,45 +/- 1,81 mg/ml). A month after the administration of interferon alpha-2b the best effect was observed in patients in the time interval of 1-3 months from the infection, where sIgA was noted a statistically significant increase from 1,84 +/- 0,28 to 5,78 +/- 1,96 mg/ml. In the groups of patients with later terms, a moderate increase in sIgA was determined (3-6 months: 2,83 +/- 0,71 to 3,33 +/- 1,78 mg/ml;6-9 months: 3,53 +/- 0,45 to 4,76 +/- 2,3 mg/ml) and the absence of infectious diseases during rehabilitation period. In the group without therapy, in all temporal aspects, a persistent decrease in sIgA indicators below normal values was revealed, and the frequency of incidence of respiratory viral infections was noted in 9,2% of cases. Conclusions. During the rehabilitation period, the greatest changes in sIgA in saliva were observed in patients in the first 3 months after the COVID infection. The administration of interferon alpha-2b to patients in the post-COVID period is accompanied by the normalization of sIgA and prevents the development of respiratory infections. In similar groups, after COVID-19 without therapy, the indicator tends to decrease, and this category of people is at a higher risk of developing other infectious pathologies. Copyright © 2022, Dynasty Publishing House. All rights reserved.

Waning Immunity of Primary Chadox1 Ncov-19 Vaccination in Adults of Various Age Group

Background & Objective: The Covid-19 vaccines in India were introduced after the phase III trial. Though the vaccines have obtained EUA (Emergency Use Authorization) efficacy data and duration of protection is still unknown. This study helps us to understand the vaccine efficacy, sustainability of immune response. Method(s): Blood samples and detailed history were collected. Serum sample are collected after 3 months and 6 months after Covishield vaccine to analyze the presence of Anti SARS IgG antibody to S spike protein. Results : Out of the 550 study population, 2% and 16 % had waning antibody titres by 3 months and 6 months respectively after 2 doses of vaccination. Majority of which had co-morbid health conditions (p<0.5) and O +ve blood group people had more secondary vaccine failures. Increasing age had significant association with wanning immunity. Prolonged interval between the 2 doses had positive effect on the sustainability of immune response at 6 months after 2 doses of ChAdOx1 n CoV-19 vaccination. Interpretation & Conclusions : Notable population had waning immunity after 6 months of ChAdOx1 nCoV-19 vaccination. The current recommendation has to be redefined with respect to various factors such as comorbidities and advancing age to obtain maximum vaccine efficacy. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Prevalence of Depression and its associated factors during COVID-19 pandemic in adult population of Ghaziabad, Uttar Pradesh

Background: COVID-19 pandemic started in India on 30th January 2020. A nationwide lockdown was enforced from 24th March onwards, and most citizens were confined to their homes causing many psychosocial problems. Objective(s): To find the prevalence of depression and its associated factors during COVID-19 pandemic. Method(s): A community based crosssectional study, conducted among the adult population of urban Ghaziabad, Uttar Pradesh, India. Information was collected using a predesigned questionnaire with a sample size of 396 consenting individuals. Result(s): Of the 396 participants, 99 (25%) had depression;with mild, moderate, and severe depression found in 20.45%, 3.53% and 1% individuals, respectively. Females were affected more than males (32.1% vs 18.2%). Prevalence of depression was 50% among individuals living alone, 34.7% among unemployed people, and 30% among individuals whose income was reduced during the lockdown period. Individuals who were quarantined due to positive/suspected COVID-19 infection had a 45.5% prevalence of depression. Individuals who were divorced or separated, had an increased prevalence of depression [OR 9.2, (95% CI 1.2-73.7)]. People who practiced meditation during the lockdown period had lesser prevalence of depression [OR 2.87, (95% CI 1.1-7.7)] than those who did not. Conclusion(s): The COVID-19 pandemic has had a major psycho-social impact on people. The findings from this study can help identify vulnerable individuals and prevent and/or reduce the morbidity of depression in future, both in India and other parts of the world. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Pragmatic implementation science to assess lipid optimization in peripheral artery disease: Design and conduct of the randomized optimize PAD-1 trial

Background: Underutilization of proven therapies in peripheral artery disease (PAD) remains a critical problem. Implementation science aims to improve this, but few trials exist. We describe a randomized trial designed with pragmatic elements in PAD patients. Method(s): OPTIMIZE PAD-1 was designed to evaluate the efficacy of a multidisciplinary vascular care team using an intensive lipid reduction program in PAD patients versus usual care. The primary endpoint is low density lipoprotein-cholesterol (LDL-C) reduction at 12 months. A second objective is to assess the impact of a structured quality assurance program (EQuIP) on variability in 6-minute walk test (6MWT) distance. Due to COVID-19, pragmatic aspects were introduced, including virtual consent/recruitment, home-based subject conducted lab testing, and virtually monitored homebased 6MWT. Result(s): A total of 114 subjects with PAD were recruited over ~18 months at the University of Colorado and randomized to algorithm-driven lipid management by a multidisciplinary vascular care team with pharmacist support or to usual care (Figure). Subjects were also randomized to 6MWT conducted by site versus EQuIP staff. Potential participants and clinical events during follow up were identified via electronic medical records. Adjustments to enable remote study conduct were successfully implemented. Conclusion(s): Pragmatic randomized trials in PAD patients are feasible to strengthen implementation science.

"We Aren't Meant to Go through the Hardest Parts of Our Lives Alone": Caregiver Supports during Covid-19- Related Picu Presence Restrictions: A Mixed Methods Survey Analysis

BACKGROUND AND AIM: In response to the COVID-19 pandemic, multiple Canadian PICUs restricted presence to one caregiver. Though patients could receive support, sources of caregiver support were limited. We sought to examine caregiver support during PICU admission under restricted family presence policies. METHOD(S): We conducted a cross-sectional survey of caregiver experience with restriction policies in Canadian PICUs. Support, or lack thereof, emerged as a dominant theme. Hence, in this sub-study, open-ended questions were analyzed using inductive content analysis, focusing on the concept of support. Likert-scale questions related to being alone at a PICU bedside were summarized using descriptive statistics. RESULT(S): 250 respondents experienced restriction policies (Mean [SD] age 38.8[8.4] years;226[91%] primarily Englishspeaking;230[92%] post-secondary education;208[83%] in a maternal role). Of 187 responses referring to the most difficult aspects of RFP policies, 84 (45%) addressed lack of support. Respondents felt alone in facing the admission and its associated experiences (n=32). RFP resulted in unmet needs for: emotional/moral support (n=42);a specific person's presence (n=28);and respite (n=10). Lack of support impaired medical care, communication, and decisionmaking (n=23). Weighted for strength of agreement, the top situation in which respondents were alone and both wished for a support person (n=9, 81.8%) and felt it was traumatic being alone (n=6, 85.7%) was when their child died. Nonweighted, the highest agreement was when the child's condition worsened (n=99 [89.2%] "wanted support" and n=94 [87.8%] "it was traumatic"). CONCLUSION(S): Restricted family presence policies in PICUs limited caregivers' access to social support systems, resulting in unmet needs and traumatic experiences.

Long-COVID fatigue is associated with altered reward sensitivity during effort-based decision making

Methods: We conducted an online observational cross-sectional study between March 2021 and March 2022. 242 participants (18-65 years, 17% male) with confirmed COVID <4 weeks ago (ACUTE-COVID;n=66), confirmed COVID >8 weeks ago (LONG-COVID;n=83) or no prior COVID (self-reported) (NO-COVID;n=93), performed an effort-based decision-making task, in which they decided whether they wanted to exert physical effort (clicking boxes on the screen, 5 levels) for reward (5 levels). State fatigue was measured by the Profile of Mood States (POMS) prior to the task. Individual effort and reward sensitivity were calculated by binomial regression. Relationships with fatigue were compared between groups using MANOVA with reward and effort sensitivity as dependent variables and group and fatigue as predictors. Age and gender were included as covariates. Result(s): State fatigue was higher in LONG-COVID compared to ACUTE-COVID and NO-COVID groups (both p<0.001). Effort sensitivity was positively associated with fatigue across all groups (fatigue effect on effort: p<0.01). However, reward sensitivity was more negatively associated with fatigue in the LONG-COVID group compared to the NO-COVID group (fatigue*group effect on reward: p<0.05). Conclusion(s): While general fatigue, irrespective of disease state, involves changes in effort sensitivity, fatigue in LONG-COVID involves additional reward-related deficits. These results are in line with current literature suggesting that long-term inflammation may induce long-lasting dysregulation in neural reward processing. Copyright © 2022

Baseline Variation in Lung Point-of-Care Ultrasound Cohorts With COVID: Implications for Prognostication

Study Objectives: Lung point-of-care ultrasound (L-POCUS) is a novel, radiation-free diagnostic tool that could aid in COVID-19 prognosis in non-critically ill patients. Prognostication requires capturing presenting symptoms and outcomes that may change over time. Variations of environment, presenting symptomatology and follow up can introduce uncontrolled heterogeneity impacting outcome. The purpose of our study was to examine demographic, clinical, and 40-day follow up patterns between two national sites enrolling ambulatory COVID patients for the purpose of determining the association between hypoxia at day 40 and initial L-POCUS findings. Method(s): This was a cross sectional study design of patients at two tertiary care institutions in the Northeast (NE) and Midwest (MW) from January 1st, 2021-April 30th, 2022. We included subjects with respiratory complaints who tested positive for COVID-19 and maintained oxygen saturation >=92% for two hours after presentation to the emergency department as part of a larger project focused on describing L-POCUS prognostic characteristics in non-critically ill COVID patients. Initial vital signs and diagnostic data were collected. Blinded L-POCUS operators recorded seven lung windows (two anterior, two lateral and three posterior per lung field). We utilized a rubric that ranged from zero to six with zero being normal lung and six indicating severe lung pathology from COVID to score each image. Pleural findings included indentation, thickening (each one point), or discontinuity (two points). Parenchymal abnormalities included B lines (1-3 B lines =1 point, >3 B lines =2 points, coalescing or "waterfall" B lines=3 points). Subpleural consolidations scored an automatic six points out of a maximum of 42 per lung. Subjects received pulse oximetry use training and were followed by structured chart review or telephone interview 40-days following presentation. Telephone follow up included highest and lowest pulse oximetry at rest and on 60 second ambulatory test and a structured chart review at any health care visit documented evidence of hypoxia. Hypoxia was defined at <=92% 40 days from index visit. We present descriptive data and corresponding parametric or non-parametric statistic. Result(s): We enrolled 154 subjects (MW 122 (80%), NE 32 (21%). The NE population was more likely to be Hispanic (55% vs 18%, p=<.05) while the MW site was more likely to be African American (76% vs 42%, p<.05). There were no sex differences (NE, 63% female, MW 56% female). There were no significant differences between age (NE 40 years (IQR 31-54), MW 42 years (IQR, 30-56), or Body Mass Index (NE 29 (IQR 25-33), MW 29 (IQR, 24-35). CXR was ordered for 128 (83%) subjects and CT for 18 (12%) but there was no difference between sites (NE: CXR 27(93%), CT 5 (17%), MW: CXR 101 (83%), CT 13 (11%)). Median L-POCUS scores were 6 (IQR 5-12) and differed by site (NE 14, (IQR 13-27);MW 2 (IQR 2-10, p<.0001). Forty day telephone follow-up was 40% (59/154) and did not differ by site. We identifed 40 (26%) cases of subsequent hypoxia within 40 days of index visit. Outcome did not differ by site (NE 5/32 (16%): MW35/122 (29%), P=0.18). Conclusion(s): There were no meaningful clinical differences between cohorts at distinct geographical locations although NE subjects score higher on initial L-POCUS. Telephone follow up rates were low at both sites. Prognostication may need to account for L-POCUS scoring variability. No, authors do not have interests to disclose Copyright © 2022

A Europe-wide randomized controlled trial of hearing and vision rehabilitation in dementia: Results from the SENSE-Cog trial

Background: Hearing and vision impairments are highly prevalent in people with dementia (PwD) and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimize sensory function improve these outcomes. The SENSE-cog Trial evaluated whether a home-based multi-part 'sensory support' intervention (SSI) is effective in improving quality of life and other key outcomes in PwD (including hearing and/or vision problems), and their care partners. Method(s): This was a pan-European, multi-centre, observer blind, randomized controlled trial (RCT), of PwD with hearing and/or vision impairment and their companions. We compared 'care as usual' (CAU) to a multi-part complex intervention of hearing and vision rehabilitation (SSI) tailored to each participant dyad. The SSI included: assessment and correction of hearing and/or vision impairments;home-based, therapist-delivered sensory support (i.e., adherence with devices;improving the sensory environment, communication training, and signposting to other support agencies). Outcomes were collected at baseline, intervention end (18 weeks) and post-intervention (36 weeks - the primary endpoint) and included: quality of life, sensory and cognitive functional ability, relationship satisfaction, neuropsychiatric symptoms, and mental well-being. Health resource utilization was measured to estimate cost-effectiveness of the intervention. Result(s): Across 7 European centers (UK, France, Cyprus, Greece), 252 participants with dementia (median age 80 years, 53% female, 59% hearing impairment only, 4% visual impairment only and 37% both impairments) were randomized from May 2018 to May 2021 to receive either CAU or SSI (10 visits over 18 weeks). Mitigating strategies to adapt study procedures to the COVID-19 pandemic were implemented. Over 75% of participants completed the primary outcome, the DEM-QoL scale, at 36 weeks. An initial feasibility study yielded positive results for this outcome revealing an average improvement in the DEM-QoL of 4.9 points (> minimum important clinical change). Conclusion(s): Hearing and vision support in PwD is a potentially important and cost-effective means of improving the lived experience of dementia, representing a critical step in the diagnostic and care pathway. Main RCT results will be available in May 2022. Trial registration: ISRCTN17056211. Copyright © 2022 the Alzheimer's Association.

Identification of viral agents in children with acute respiratory infection

Introduction: Acute respiratory infections represent a health problem in children, with high morbidity and high mortality rates. Objective(s): To determine the circulation of respiratory viruses in children admitted with a diagnosis of acute respiratory infection, negative to COVID-19. Method(s): Descriptive observational study in 119 children with acute respiratory infection, in the ages from 0 to 6, and with hospital admission in the period from October 2021 to April 2022. Nasopharyngeal exudate samples were taken for virological study (real-time polymerase chain reaction). The variables studied were: age, sex, clinical diagnosis, period of occurrence and isolation of respiratory viruses. Result(s): The female sex predominated with 51% and the age corresponding to the neonatal period with 50 %, followed by infants between 1 and 11 months (40%), and only 10% in the ages from 1 to 6 years. 42 % of the samples with a predominance of CoV229E (78%) were positive;other viruses such as influenza A (6 %), respiratory syncytial (6 %), CoVOC43 (2%) and rhinovirus (2%) were isolated. CoV229E was common in patients with high acute respiratory infection (48.7%), followed by severe acute respiratory infection (20.5%) and bronchiolitis (28.2%). Viral co-infection was detected only in severe acute respiratory infection, specifically by IFA/CoV229E (4%) and CoV229E/bocavirus (2%). Conclusion(s): The importance of molecular biology for viral isolation is highlighted. The Coronavirus CoV229E has relevance in cases of acute high and severe respiratory infection mainly in children under 1 year old. Copyright © 2022, Editorial Ciencias Medicas. All rights reserved.

Resilience and stress coping strategies of university students in times of pandemic

The objective is to determine if Resilience and stress coping strategies significantly influence each other in college students during the COVID-19 pandemic. A prospective and cross-sectional quantitative design study, 128 students from the National Intercultural University of the Amazon, Peru were selected: 96 men (75.0%) and 32 women (25.0%), mean age 18.3 years (SD = 2.3). The Adapted Resilience Scale of Peru (ERAPE) and the Coping Mode (COPE) were used. Resilience had a significant effect at a moderate level, and coping strategies focused on problems and emotions, with planning, active coping, and lack of emotional support dominating. Effects on proportional inverse correlation can be identified through avoidance strategies: mental and behavioral withdrawal, denial, and substance use. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

COMPARISON OF SARS CoV-2 RT-PCR TEST WITH RAPID ANTIGEN DETECTION KIT AND OTHER NON SPECIFIC TEST

Background: Severe Acute Respiratory Syndrome Corona Virus Disease 2019 (COVID-19) is responsible for the COVID-19 pandemic causing respiratory illness worldwide. Hence there is an urgent need for simple, rapid, and accurate tests for diagnosis. Performance characteristic of Rapid Antigen detection test for identifying sensitivity and specificity with gold standard Real-Time Polymerase Chain Reaction and correlate the significance of non-specific parameters like CRP(C- Reactive Protein), IL-6(Interleukin-6), Procalcitonin for diagnosis of COVID-19. Method(s): The Rapid Antigen Detection test was compared with Real-Time Polymerase Chain Reaction to detect SARS CoV-2 in respiratory specimens. 100 respiratory samples (mainly nasopharyngeal and throat swab) and for CRP, IL6, and Procalcitonin serum samples were obtained from COVID-19 suspected cases, mostly in-patients at Saveetha Medical College from April 2021- to September 2021. Result(s): Out of 100 samples, 67% were positive, 33% were negative for SARS-CoV2 RNA by RT-PCR assay. When compared with Rapid Antigen Test, the RT-PCR test showed 83.8% sensitivity and 59.3% specificity, while non-specific parameters correlation in diagnosis of COVID-19 showed CRP insignificant, IL-6 and Procalcitonin significant. Conclusion(s): RT-PCR is considered the standard gold method for diagnosing COVID-19. On comparing RT-PCR with other non-specific tests like CRP, Procalcitonin, IL-6 showed Procalcitonin and IL-6 can be considered non-specific tests for diagnosing COVID-19. Copyright © 2022 are reserved by International Journal of Pharmaceutical Sciences and Research. This Journal licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.

Clot waveform analysis (CWA) parameters as indicator of Covid-19 outcome

Background: COVID-19- related systemic cytokine response induces the production of procoagulant factors, which predisposes patients to a prothrombotic state. CRP, the main acute inflammatory protein, has been related to the disease outcome. CWA is the global hemostatic assessment that evaluates clot formation kinetics during routine clotting tests. Aim(s): To investigate the ability of CWA parameters to predict the severity of CoVID-19. Method(s): In this retrospective observational study, we evaluated 227 CoVID-19 patients upon hospital admission, prior to the initiation of anticoagulation therapy. CWA were performed on BCSXP System(SIEMENS). The measured CWA parameters of PT, aPTT and Fifrinogen(FIB) were the change in Absorbance(dmA) and the time difference from the starting time of the reaction (mixing of reagent and sample) until a specific absorbance change (absorbance threshold). The patients were divided into 5 groups based on the CRP values:A: < 6mg/l(n = 17), B:6-25mg/ l(n = 51), C:25-50mg/ l(n = 53), D:50-100mg/ dl(n = 43) and E:>100mg/l (n = 58). Variables were tested with Student's t-test or Mann-WhitneyU test for differences in distributions of dmA and dsec among five groups. Pearson's correlation coefficient was used for comparison of the above parameters of 227 patients and their CPR values. P values < 0.05 were considered statistically significant. Result(s): A gradual increase in the values of dmA was detected from A to E group. Statistical significance was present in aPTT among all groups, in PT in groups compared with D and E and finally in FIB in groups compared only with E. In the comparison of dsec, statistical significant decrease was observed in PT among A and C, D, E and between B and E, while in FIB among all groups. The comparison between CoVID-9 patients and duration of hospitalization revealed statistical significant correlation in aPTT (both dsec and dmA) and in dmA of PT(p < 0.001). Conclusion(s): CWA variables upon admission in COVID-19 patients may be used for the prognosis of the patient outcome.

Correlation of Clot Waveform Analysis (CWA) Parameters with the Days of Hospitalization of CoVID-19 Patients

Background: The activation of coagulation is one of the most severe complications of CoVID-19. The automatic optical end-point coagulation analyzers have the ability to present the clot reaction curve of the PT, APTT and Fibrinogen(FIB) which is referred as a clot waveform analysis (CWA). Aim(s): To investigate the ability of CWA parameters for the prognosis of the length of hospital stay of CoVID-19 patients. Method(s): Coagulation tests and CWA on BCSXP System (SIEMENS) were performed in 268 CoVID-19 patients upon hospital admission and prior to the initiation of anticoagulation therapy. The measured CWA parameters of PT, aPTT and FIB were the change in Absorbance(dmA) and the time difference from the starting time of the reaction (mixing of reagent and sample) until a specific absorbance change (absorbance threshold). The patients were divided into 3 groups depending on the duration of hospitalization: A: < 5 days (n = 42), B:6-10 days (n = 81), C:>10days (n = 145). Variables were tested with Student's t-test or Mann-WhitneyU test for differences in distributions of dmA and dsec among three groups. Pearson's correlation coefficient was used for comparison among the above parameters of 268 patients and their days of hospitalization. P values < 0.05 were considered statistically significant. All statistical analyses were performed using SPSS27. Result(s): A gradual increase in the values of dmA was detected from A to C group. Statistical significance was present in aPTT and PT among all groups but in FIB only between B and C. From the comparison of dsec, statistical significant decreased values were found only in FIB between A and C (p = 0.027) and B and C (p = 0.002). The comparison between CoVID-19 patients and duration of hospitalization revealed statistical significant correlation of dmA in PT, aPTT (p < 0.001) and in FIB (p = 0.01). Conclusion(s): CWA variables upon admission in COVID-19 patients, may be utilized for the prognosis of the duration of hospitalization.

Safety of intramuscular COVID-19 vaccination in patients with hemophilia

Background: Guidelines recommend that patients with hemophilia should preferably receive vaccination subcutaneously rather than intramuscularly. COVID-19 vaccines, however, are only licensed for intramuscular application. Aim(s): To assess the safety of intramuscular COVID-19 vaccination in patients with hemophilia. Method(s): This observational multicenter study consisted of two parts. Part A enrolled consecutive patients with hemophilia A (HA) and B (HB) of all ages and severities and assessed injection site bleeding and other complications within 30 days of vaccination. Part B enrolled patients providing informed consent for more detailed data collection including medication and prophylaxis around the time of vaccination. Result(s): Four hundred and sixty-one patients were enrolled by six institutions into part A (HA 389 [84%], HB 72 [16%];severe 291 [63%], moderate 61 [13%], mild 109 [24%]). The primary endpoint injection site bleeding occurred in 7 patients (1.5%, 95% confidence interval 0.6-3.1%), including 5 with severe HA, 1 moderate HA, and 1 mild HB. Analysis of 214 patients in part B revealed that 97% of patients with severe hemophilia, who were not on emicizumab, had received factor prophylaxis before vaccination, either as part of their regular regime (60%) or additionally (40%). Only one patient on emicizumab received additional factor. The bleeding patients with severe HA had received factor within 2-17h before vaccination and had no clinical characteristics that could have explained the bleeding. Factor was also given to 26% and 60% of mild and moderate patients not on regular prophylaxis, respectively. The two bleeding patients in this group had not received concentrate before vaccination. Other side effects of vaccination were comparable with studies in the general population. Conclusion(s): This is the first study reporting on the safety of intramuscular COVID-19 vaccination in hemophilia. The rate of injection site bleeding was below 3%, comparable with the general population.

Humoral Response 3 Months After the Booster Dose in Patients on Dialysis: The SENCOVAC Study

Background: Patients on hemodialysis are at high-risk for complications derived from coronavirus disease-19 (COVID-19). The present study aims to evaluate the impact of a booster vaccine dose and breakthrough SARS-CoV-2 infections on humoral immunity three months after the booster dose. Method(s): This is a multicentric and prospective study assessing anti-Spike antibodies 6 and 9 months after initial SARS-CoV-2 vaccination in patients on hemodialysis that had also received a booster dose before the 6-month assessment (early booster) or between the 6-and 9-month assessments (late booster). The impact of breakthrough infections, type of vaccine, time from the booster and clinical variables were assessed. Result(s): 711 patients (67% male, 67 [20-89] years) were included. Of them, 545 (77%) patients had received an early booster and 166 (23%) a late booster. At 6 months, 64 (9%) patients had negative humoral response (3% of early booster and 29% of late booster participants, p=0.001) and 58 (91%) of them had seroconverted at 9 months, when, 5/545 (0.9%) patients in the early booster cohort and 1/166 (0.6%) in the late booster cohort remained antibody negative (p=NS). During follow-up, 35 patients (5%) developed COVID-19. Antibody titers at 9 months were independently associated to lower time from booster (B -0.12, p=0.043), COVID-19 (B 2.29, p<0.001) and mRNA-1273 booster (B 1.17, p=0.001). Conclusion(s): In hemodialysis patients, higher rates of anti-Spike antibody development were associated to mRNA-1273 booster, lower time from booster and breakthrough SARS-CoV-2 infection.

Decreased Mortality From SARS-CoV-2 in Kidney Transplant Recipients Over the Course of the Pandemic

Background: We aimed to investigate the variation in mortality from SARS-CoV-2 infection in kidney transplant recipients Methods: Between March 16, 2020 and May 4, 2022, 537 patients were diagnosed with SARS-CoV-2 infection by RT-PCR. Result(s): 59% were male, median age 58 (IQR: 45-67), predominantly Hispanic (51.2%) and African American (29%). 75.4% received a deceased-donor renal transplant, 55% received anti-thymocyte induction. Most patients were on triple immunosuppression (96% on calcineurin inhibitors, 87% on anti-metabolite, and 99% on prednisone). While the mortality rate was 37 % (47/128) during first peak between March 16 and April 30, 2020, it has significantly decreased to 11% (7/61) from May 1, 2020 to end of December 2020 with social distancing and use of facemask. Between January 1, 2021 and November 5, 2021 with use of vaccination and monoclonal antibodies, the mortality rate further decreased to 7.7% (10/129). Between November 6, 2021 till May 4, 2022 which corresponds to the period when the Omicron variant and subvariants are prevalent, the mortality rate was 5.5% (12/219). Among those diagnosed during the period when Omicron was prevalent, 188/219 (85.8%) have received 2 doses of COVID vaccine and 82/219 (37.4%) have received a third dose. Since the beginning of use of monoclonal antibodies, 93 patients received a combination of casirivimab/imdevimab when initial SARS-CoV-2 variants were dominant and sotrovimab then bebtelovimab during the period of Omicron and its subvariants. Only one death occurred in patients who received monoclonal antibody treatment and that patient was hospitalized for severe COVID-19. We identified 23 re-infections. Most of re-infected patients have already received at least 2 doses of COVID vaccine but only 5 received a third dose. None of the re-infected patients was hospitalized and none of them died. Conclusion(s): In summary, mortality from SARS-CoV-2 infection in kidney transplant recipients has significantly decreased over time. This could be explained by initial exposure to higher viral load due to lack of personal protection and social distancing. However, since the judicious use of monoclonal antibodies and vaccination, in addition to social distancing protocols and use of facemask, the mortality in kidney transplant recipients has decreased over time.