Unvaccinated Patients Research Articles

Intrinsic factors behind long COVID: III. Persistence of SARS‐CoV‐2 and its components

AbstractConsiderable research has been done in investigating SARS‐CoV‐2 infection, its characteristics, and host immune response. However, debate is still ongoing over the emergence of post‐acute sequelae of SARS‐CoV‐2 infection (PASC). A multitude of long‐lasting symptoms have been reported several weeks after the primary acute SARS‐CoV‐2 infection that resemble several other viral infections. Thousands of research articles have described various post‐COVID‐19 conditions. Yet, the evidence around these ongoing health problems, the reasons behind them, and their molecular underpinnings are scarce. These persistent symptoms are also known as long COVID‐19. The persistence of SARS‐CoV‐2 and/or its components in host tissues can lead to long COVID. For example, the presence of viral nucleocapsid protein and RNA was detected in the skin, appendix, and breast tissues of some long COVID patients. The persistence of viral RNA was reported in multiple anatomic sites, including non‐respiratory tissues such as the adrenal gland, ocular tissue, small intestine, lymph nodes, myocardium, and sciatic nerve. Distinctive viral spike sequence variants were also found in non‐respiratory tissues. Interestingly, prolonged detection of viral subgenomic RNA was observed across all tissues, sometimes in multiple tissues of the same patient, which likely reflects recent but defective viral replication. Moreover, the persistence of SARS‐CoV‐2 RNA was noticed throughout the brain at autopsy, as late as 230 days following symptom onset among unvaccinated patients who died of severe infection. Here, we review the persistence of SARS‐CoV‐2 and its components as an intrinsic factor behind long COVID. We also highlight the immunological consequences of this viral persistence.

Comparative analysis of clinical characteristics of COVID-19 among vaccinated and unvaccinated patients in a major treatment facility in Ghana.

To compare clinical characteristics of COVID-19 among vaccinated and unvaccinated patients in a major treatment facility in Ghana. A retrospective study drawing on data from COVID-19 patients' records visiting the facility from March 2021 to December 2021. Ghana Infectious Disease Centre, Ga East Municipality, Greater Accra Region, Ghana. In-patients and outpatients who reported to the facility from 1st March 2021 to December 2021 were included in the study, and patients with missing data on vaccination were excluded. underlying conditions, symptoms, case management information, hospital service rendered (OPD, HDU or ICU), length of hospital stay, treatment outcome. The study included 775 patient records comprising 615 OPD and 160 hospitalised cases. Less than one-third (26.25%; 42) of the patients hospitalised were vaccinated compared to almost 40.0% (39.02%; 240) of the patients seen at the OPD. Vaccinated individuals were nearly three times (aOR = 2.72, 95%CI:1.74-4.25) more likely to be managed on an outpatient basis as compared to the unvaccinated. The death rate among the vaccinated group and the unvaccinated were (0.71%; 2) and (3.45%; 17), respectively, with a significant reduction in the risk of dying among the vaccinated compared to the unvaccinated (aOR = 0.13, 95%CI: 0.028 0.554). Less than half of the in-patient and OPD patients were vaccinated. Mild infections, fewer days of hospitalisation, outpatient treatment and higher chances of survival were associated with being vaccinated against SARS-CoV-2. Prudent measures should be implemented to encourage the general public to take up SARS-CoV-2 vaccines. None declared.

Epidemiological and clinical features of SARS-CoV-2 Omicron variant infection in Quanzhou, Fujian province: a retrospective study

Epidemiological and clinical data of patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant (BA.2) admitted to three designated hospitals in Quanzhou City, Fujian Province, China, were collected and analyzed. Overall, 2,541 patients infected with BA.2, comprising 1,060 asymptomatic, 1,287 mild, and 194 moderate infections, were enrolled. The percentage of moderate infections was higher in patients aged ≥ 60 years than in those aged < 18 years and 18–59 years. The median hospitalization duration was 17 days. Among the 2,541 patients, 43.52% had a clear history of close contact. The vaccination rate was 87.92%, and the percentage of asymptomatic infections was higher in vaccinated than in unvaccinated patients. Moreover, patients with underlying diseases, including hypertension and diabetes mellitus, had more moderate infections than those without underlying diseases. The three most common clinical manifestations were fever, dry cough, and sore throat. The albumin-to-globulin (A/G) ratio and lymphocyte count decreased in cases with mild and moderate infections, while procalcitonin, erythrocyte sedimentation rate, interleukin-6, D-dimer, and C4 levels increased. Advanced age, non-vaccination, and underlying comorbid diseases were high-risk factors for disease progression in patients. However, dynamic monitoring of blood routine parameters, A/G ratio, and inflammatory indicators facilitated the prediction of disease progression.

Inactivated vaccines reduce the risk of liver function abnormality in NAFLD patients with COVID-19: a multi-center retrospective study

BackgroundAbnormal liver function was frequently observed in nonalcoholic fatty liver disease (NAFLD) patients infected with SARS-CoV-2. Our aim was to explore the effect of SARS-CoV-2 inactivated vaccines on liver function abnormality among NAFLD patients with COVID-19. MethodsThe multi-center retrospective cohort included 517 NAFLD patients with COVID-19 from 1 April to 30 June 2022. Participants who received 2 doses of the vaccine (n = 274) were propensity score matched (PSM) with 243 unvaccinated controls. The primary outcome was liver function abnormality and the secondary outcome was viral shedding duration. Logistic and Cox regression models were used to calculate the odds ratio (OR) and hazard ratio (HR) for the outcomes. Sensitivity analysis was conducted to assess robustness. FindingsPSM identified 171 pairs of vaccinated and unvaccinated patients. Liver function abnormality was less frequent in the vaccinated group (adjusted OR, 0.556 [95% CI (confidence interval), 0.356-0.869], p = 0.010). Additionally, the vaccinated group demonstrated a lower incidence of abnormal bilirubin levels (total bilirubin: adjusted OR, 0.223 [95% CI, 0.072-0.690], p = 0.009; direct bilirubin: adjusted OR, 0.175 [95% CI, 0.080-0.384], p < 0.001) and shorter viral shedding duration (adjusted HR, 0.798 [95% CI, 0.641-0.994], p = 0.044) than the unvaccinated group. Further subgroup analysis revealed similar results, while the sensitivity analyses indicated consistent findings. InterpretationSARS-CoV-2 vaccination in patients with NAFLD may reduce the risk of liver dysfunction during COVID-19. Furthermore, vaccination demonstrated beneficial effects on viral shedding in the NAFLD population.Funding 23XD1422700, Tszb2023-01, Zdzk2020-10, Zdxk2020-01, 2308085J27 and JLY20180124.

ABO blood group associated with cerebral venous thrombosis after Oxford-AstraZeneca COVID-19 vaccination: a case-control study.

To determine whether blood group influences development of cerebral venous thrombosis (CVT) after administration of the coronavirus disease 2019 (COVID-19) AstraZeneca ChAdOx1-S vaccine. A case-control study. Univariate and multivariate logistic regression was used to determine the association between blood type and COVID-19 vaccination status. Vaccinated and unvaccinated patients recruited from the international Bio-Repository to Establish the Aetiology of Sinovenous Thrombosis study and the Cerebral Venous Sinus Thrombosis With Thrombocytopenia Syndrome Study Group. All patients were of European descent and age and sex matched. Cases (n = 82) were patients ≥18 years old who suffered a CVT within 28 days of a first dose of ChAdOx1-S vaccine. Controls (n = 441) were unvaccinated CVT patients ≥18 years old. All patients were of European descent. Frequency of blood type and ABO allele distribution by vaccination status. Blood group O was found to be more prevalent among CVT patients with vaccine-induced thrombotic thrombocytopenia (VITT-CVT) after ChAdOx1-S vaccination compared with unvaccinated CVT cases (43% vs. 17%, respectively, p < 0.001). Blood group A was less prevalent, though still high, in the vaccinated group compared with the unvaccinated group (47% vs. 71%, respectively, p < 0.001). No significant differences were observed in the VITT-CVT non-ChAdOx1-S vaccine group and unvaccinated pre-COVID-19 CVT group for blood group. Blood group O is more prevalent among patients with VITT-CVT after ChAdOx1-S vaccination compared with unvaccinated cases, independent of well-established CVT risk factors. A larger dataset may be able to determine whether those of blood groups B and/or AB may be safely vaccinated with the low cost, readily available and easily transported ChAdOx1-S rather than adopting a complete ban.

Ten-year analysis of the efficacy of vaccination against pneumococcal infection in patients with chronic obstructive pulmonary disease

Major problems in the course of chronic obstructive pulmonary disease (COPD) include frequent exacerbations and related deaths. The use of pneumococcal vaccines, primarily a 13-valent polysaccharide conjugate vaccine, is a generally recognized tool for reducing the number of exacerbations.The aim of the study was to analyze the prospective clinical efficacy of vaccine prophylaxis with conjugated pneumococcal vaccine Prevenar-13 (PCV13) in patients with COPD over 10 years.Methods. A total of 362 male patients who were treated or monitored at the Regional Pulmonological Center of Chelyabinsk in 2012 – 2022 were enrolled in the study. The main efficacy endpoints of observation over 10 years were: the dynamics of dyspnea (mMRC score), forced expiratory volume in 1st second, the number of exacerbations, hospitalizations, the number of pneumonias. After confirming the diagnosis of COPD, the patients were divided into two observation groups. The first group (n = 150) included patients vaccinated with PCV13. The second group (n = 212) included patients with COPD who had not received pneumococcal vaccination for various reasons.Results. Severe forms of the disease and frequent exacerbations predominated in both groups. 96 (27%) deaths were recorded in the PCV13-vaccinated group, and 171 (47%) deaths in the unvaccinated group. The difference between vaccinated and unvaccinated is statistically significant (p &lt; 0.05). In the unvaccinated patients, there was a steady progression of shortness of breath with an increase by 12% compared to baseline (p &lt; 0.05) by the 10th year. A positive trend in FEV1 was noted in patients vaccinated with PCV13. They also showed a significant decrease in BODE prognostic index.Conclusion. The use of PCV13 allows for stabilization of the main clinical and functional indicators of the respiratory system in patients with COPD in the long term (at least 10 years of follow-up). Vaccination maintains a low risk of adverse events according to the BODE index; an increase in patient survival was noted over a 10-year horizon (odds ratio – 2.35; 95% confidence interval – 1.45; 3.77), including cases with acute viral damage with COVID-19 (COronaVIrus Disease 2019).

Comparison of the incidence of smell and taste disorders between influenza and COVID-19

ObjectiveSmell and taste disorders among patients with COVID-19 has become increasingly reported in the literature, however the prevalence varies. Post-infectious respiratory dysfunction has also been linked to influenza. In this study, we aimed to compare the rates of smell and taste disorders between COVID-19 and Influenza in unvaccinated patients. Study designRetrospective cohort study. SettingTriNetX research network. MethodsTwo queries were made on 7/1/2023 to include Influenza without a diagnosis of COVID-19 and a COVID-19 without a diagnosis of Influenza. The queries included patients from January 1 to December 31, 2022 from 102 Healthcare Organizations. The resultant population of patients with ICD-10 codes for COVID-19 and Influenza were matched using demographic characteristics to evaluate the risk of smell disorders. ResultsThe overall 3-month incidence of smell and taste disorders was 0.73 % in the COVID-19 population and 0.1 % in the influenza population. The 3-month matched risk ratios were 11.1 [95 % CI (8.8,13.8)]; p < 0.001) times higher for disorders of the smell and taste secondary to COVID-19 compared to influenza. ConclusionsDisorders of the smell and taste are more common among patients with COVID-19 compared to patients with Influenza. Beyond smell loss, patients experience additional nasal and sinus-related rhinological symptoms, pointing to COVID-19's and influenza's wider impact on overall rhinological health. We believe that due to the transient nature of these disorders, they might go underreported.

SARS-CoV-2 vaccine hesitancy in patients with heart failure: relationship with patient characteristics and pre-pandemic quality of life – a cohort study

Heart failure (HF) patients are vulnerable to a complicated course of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This research analysed the relationship between the decision not to be immunised against SARS-CoV-2, clinical and epidemiological factors, and the pre-pandemic health-related quality of life (HRQoL) of HF patients. Before the onset of the SARS-CoV-2 pandemic, hospitalised HF patients were enrolled as a prospective cohort and interviewed using the World Health Organization's Quality of Life Brief Version questionnaire. On October 30, 2021, the immunisation status was verified. The association of vaccination hesitancy with epidemiological and clinical parameters and pre-pandemic questionnaire results was tested. Subsequently, independence from confounding factors such as age, sex, the New York Heart Association (NYHA) scale, and left ventricular ejection fraction (LVEF) was analyzed. Among the 136 included patients, 77.9% were vaccinated. Unvaccinated patients were younger (51.2±13.2 vs 56.6±10.3; p = 0.018) and more frequently had non-ischaemic aetiology of HF (73.3% vs 46.7%; p=0.013). It was significant after adjustment for age, sex, NYHA class, and LVEF. There was no association of overall HRQoL or domain scores with vaccination status. Younger age as a factor associated with vaccine avoidance in this population is consistent with data from the general population despite higher exposure to the severe course of the disease.

Liver dysfunction and clinical outcomes of unvaccinated COVID-19 patients with and without chronic hepatitis B

BackgroundLiver dysfunction is common during coronavirus disease 2019 (COVID-19), while its clinical impact and association with chronic hepatitis B (CHB) remain uncertain. We aimed to investigate liver dysfunction in COVID-19 patients and its impacts on those with/without CHB. MethodsWe conducted a retrospective cohort study of COVID-19 patients at National Taiwan University Hospital, stratified according to hepatitis B surface antigen (HBsAg) serostatus, with demographics, laboratory data, and hospitalization course reviewed, and clinical outcomes compared through multivariable analyses. ResultsWe enrolled 109 COVID-19 patients unvaccinated against SARS-CoV-2 by August 2021. The HBsAg-positive group (n = 34) had significantly higher alanine aminotransferase (ALT) (26 vs. 16 U/L, P = 0.034), platelet (224 vs. 183 k/μL, P = 0.010) and longer hospitalizations (17 vs. 13 days, P = 0.012) compared with HBsAg-negative group (n = 75), while percentages of hepatitis (2-fold ALT elevation), oxygen supplementation, ventilators usage, COVID-specific treatment, intensive care unit (ICU) admission and mortality were comparable. Older age (odds ratio [OR]: 1.04, 95 % confidence interval [CI]: 1.00–1.08, P = 0.032) and higher aspartate aminotransferase (AST) (OR: 1.08, 95 % CI: 1.004–1.16, P = 0.038) were associated with oxygen supplementation according to multivariable analyses. Higher AST predicted ICU admission (OR: 1.11, 95 % CI: 1.03–1.19, P = 0.008). Oxygen usage (OR: 5.64, 95 % CI: 1.67–19.09, P = 0.005) and shock (OR: 5.12, 95 % CI: 1.14–22.91, P = 0.033) were associated with liver dysfunction. ConclusionsCHB patients had higher ALT levels and longer hospitalizations during COVID-19. Higher AST levels predict severe COVID-19 and ICU admission.

CLINICAL &amp; SUBCLINICAL CHARACTERISTICS OF PATIENTS HOSPITALIZED WITH SARS-COV-2 INFECTION IN FIELD HOSPITALS, VINH PHUC PROVINCE

CLINICAL &amp; SUBCLINICAL CHARACTERISTICS OF PATIENTS HOSPITALIZED WITH SARS-COV-2 INFECTION IN FIELD HOSPITALS, VINH PHUC PROVINCE

Comorbid Conditions in a Cohort of Inpatients with SARS-CoV-2 and their Association with In-Hospital Mortality During the Early Phases of the Pandemic.

Introduction: Studies determined that age and associated comorbidities are associated with worse outcomes for COVID-19 patients. The aim of the present study is to examine previous electronic health records of SARS-CoV-2 patients to identify which chronic conditions are associated with in-hospital mortality in a nationally representative sample. Materials and Methods: The actual study is a cross-sectional analysis of SARS-CoV-2 infected patients who were treated in repurposed hospitals. The study includes a cohort of patients treated from 06-11-2020 to 15-03-2021 for COVID-19 associated pneumonia. To examine the presence of comorbidities, electronic health records were examined and analyzed. Results: A total of 1486 in-patients were treated in the specified period, out of which 1237 met the criteria for case. The median age of the sample was 65 years. The overall in-hospital mortality in the sample was 25.5%, while the median length of stay was 11 days. From whole sample, 16.0% of the patients did not have established diagnoses in their electronic records, while the most prevalent coexisting condition was arterial hypertension (62.7%), followed by diabetes mellitus (27.3%). The factors of age, male gender, and the number of diagnoses showed a statistically significant increase in odds ratio (OR) for in-hospital mortality. The presence of chronic kidney injury was associated with the highest increase of OR (by 3.37) for in-hospital mortality in our sample. Conclusion: The study reaffirms the findings that age, male gender, and the presence of comorbidities are associated with in-hospital mortality in COVID-19 treated and unvaccinated patients. Our study suggests that chronic kidney injury showed strongest association with the outcome, when adjusted for age, gender, and coexisting comorbidities.

Impact of coronavirus disease 2019 vaccination on live birth rates after in vitro fertilization

ObjectiveTo investigate COVID-19 vaccination on live birth rates in patients undergoing in vitro fertilization. DesignRetrospective cohort study SubjectsPatients who underwent fresh or frozen embryo transfer (FET) cycles at an academic center between January 1, 2020 and December 31, 2021. ExposureCOVID-19 vaccination, defined as completing a two-dose regimen (Pfizer or Moderna) or one dose regimen (Johnson & Johnson/Janssen) prior to cycle initiation. Main Outcome MeasuresThe primary outcome was live birth rate per embryo transfer. Secondary outcomes included positive hCG and clinical pregnancy rates per embryo transfer. Outcomes from cycles among vaccinated and unvaccinated patients were compared. Descriptive statistics were used to analyze demographic and cycle characteristics with Student’s t, Wilcoxon rank sum, Pearson Chi-square, and Fisher’s exact tests as appropriate for univariable analysis. Generalized estimating equation models were used to examine the strength of the relationship between vaccination status and pregnancy outcomes. ResultsAmong 709 unvaccinated and 648 vaccinated fresh cycles, there were no statistically significant differences between the number of oocytes retrieved, oocyte maturity, fertilization, and blastocyst utilization rates. In adjusted multivariable analysis, there was no statistically significant difference between fresh cycles among vaccinated patients compared to unvaccinated patients with rates of positive hCG (aOR 1.37, 95% CI 0.84-2.25), clinical pregnancy (aOR 1.22, 95% CI 0.73-2.03), or live birth (aOR 1.37, 95% CI 0.79-2.25) per embryo transfer. Among 264 unvaccinated and 423 vaccinated FET cycles, vaccinated patients had higher odds of positive hCG (aOR 1.54, 95% CI 1.08-2.20), clinical pregnancy (aOR 1.80, 95% CI 1.27-2.56), and live birth (aOR 2.31, 95% CI 1.60-3.32) per embryo transfer compared to unvaccinated patients. ConclusionPatients who were COVID-19 vaccinated prior to FET had higher rates of biochemical pregnancy, clinical pregnancy, and live birth. Vaccination was not associated with pregnancy or live birth rates after fresh cycles. This study contributes to evidence supporting COVID-19 vaccination for patients attempting pregnancy.

A comparative study on COVID-19 disease severity and outcome among patients admitted before and after vaccination at tertiary care hospital.

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by SARS CoV-2 that emerged in Wuhan, China, and has rapidly spread worldwide. The mortality rate of critically ill COVID-19 patients is high. The objective of the study was to assess the COVID-19 disease severity and outcome among COVID-19 positive patients admitted before and after vaccination. A prospective observational study conducted among all patients aged more than 18 years were included in the study. The patients who were positive before vaccination and received at least one dose of vaccine and positive after receiving two doses of vaccination included in the study. Disease severity was assessed in terms of high-resolution computed tomography (HRCT) score, intensive care unit (ICU) admission, SpO2 maintained, oxygen, plasma exchange, steroids received and on mechanical ventilation, and outcome was assessed on prognosis and stabilized/discharged to home. A total of 172 were participated in the study with 101 (58.7%) males and 71 (41.3) females, respectively. Amongst them, 92 were affected before vaccination and 80 were affected before vaccination. The patients admitted in the ICU were 56 (32.6%) and 116 (67.4%) were not admitted in the ICU; among the patient admitted in ICU 42 (45.7%) before vaccination, and 14 (17.5%) were after vaccination, and difference was statistically significant with P- value <0.001. SPO2, steroids given, plasma exchange, oxygen >10 litres given and mechanical ventilation were positively associated with the vaccine received and disease severity with P- value <0.05. The severe COVID-19 had the worst outcome in the unvaccinated patients in terms of severity. Most partially vaccinated patients got infected before developing immunity; receiving at least one vaccination dose significantly reduced illness severity.

Trauma as a Public Health Moment: Addressing Vaccine Uptake in Trauma Patients.

Our objective was to identify factors associated with COVID-19 vaccination in trauma patients and to provide an opportunity for patients to engage in conversations about vaccination. The trauma surgery service offers a unique opportunity to promote preventative health interventions in hard-to-reach populations. Trauma inpatients in Chicago, IL were recruited for this mixed-methods study from February 2022 to April 2022. Participants completed a survey on demographics, COVID-19 vaccination status, and Experiences of Discrimination Scale adapted for medical settings. Differences between vaccinated and unvaccinated patients were analyzed using the Wilcoxon-rank sum test. A semistructured, qualitative interview was completed. Qualitative data was transcribed and analyzed using Grounded Theory Methodology. Fifty-eight trauma patients were surveyed, representing 88% of patients approached. Only 23 (40%) patients reported full vaccination to COVID-19. Previous vaccination (at least 1 dose) was associated with greater concern for COVID-19 (OR 3.47, 95% CI 1.987-6.964, P < 0.001) and higher income (OR 1.21, 95% CI 1.02-1.44, P = 0.03). Higher Experiences of Discrimination Scale scores were associated with decreased likelihood of prior vaccination (OR 0.97, 95% CI 0.95-0.99, P = 0.04). On qualitative analysis, recurrent themes included vaccination motivated by either community-based or personal health-related values, and disinterest in vaccination based on perceived low need or skepticism of experimentation. Fifteen patients (26%) eligible for a vaccine dose consented to onsite vaccination after the survey. Trauma patients who have experienced more discrimination in medical settings have lower rates of COVID-19 vaccination. Vaccination rates in our population were over 2 times lower than citywide rates, but admission to the trauma service can increase comprehensive care.

The effect of comprehensive rehabilitation on post-COVID-19 syndrome

BackgroundThe present study aimed to investigate the efficacy of a comprehensive rehabilitation program on quality of life, anxiety, fatigue, and functional status in post-COVID-19 patients admitted to a specialized rehabilitation unit. The secondary objective of the study was to compare the differences between vaccinated and unvaccinated patients.ResultsThe single-center prospective study was conducted. Demographics, comorbidities, vaccination, clinical signs and symptoms, and oxygen saturation were assessed. The rehabilitative protocol was created considering the condition of patients, age, the direct impact of COVID-19 on the systems, sequelae, severity of disease, and comorbidities. The comprehensive rehabilitation program through a multidisciplinary team is applied in a stepwise graded manner. The Nottingham Health Profile (NHP), Fatigue Severity Scale (FSS) The Functional Ambulation Categories (FAC), the modified Medical Research Council (mMRC), the Modified Borg Scale, post-COVID-19 Functional Status (PCFS) scale, Hospital Anxiety and Depression Scale (HADS), and the Barthel Index (BI) were used. In total, 39 patients (61.5% men, age 59.7.0 ± 15.6 years) participated in the study. They were discharged home after 37.5 ± 17.6 days stay in the hospital. The most frequently reported persistent symptoms were dyspnea (76.9%), fatigue (69.2%), and myalgia (64.1%). There was a statistically significant improvement in baseline outcomes including BI, HADS, PCFS, FSS, MMRC, Modified Borg Scale, FAC, O2 support, and NHP after the comprehensive rehabilitation program (p < 0.001). The vaccinated patients had older age, high BMI, and shorter duration of rehabilitation (p = 0.003, p = 0.040, p = 0.022, respectively), while unvaccinated patients had higher BI, FSS, PCFS, and FAC.ConclusionThe comprehensive rehabilitation program improves quality of life, reduces fatigue, anxiety, and depression, and regains function in patients with post-COVID-19 syndrome. In addition, vaccinated patients had older ages and shorter duration of rehabilitation, while unvaccinated patients achieved higher functional status and had significantly higher levels of fatigue at discharge.

Comparison of Salivary Secretion, pH, and Buffer Capacity Between COVID-19 Vaccinated and Unvaccinated Child Patients Visiting Dental Clinics of University Hospitals in Riyadh City, Saudi Arabia.

This study aimed to assess and compare the salivary secretion, pH, and buffer capacity between COVID-19 vaccinated and unvaccinated child patients visiting the clinics of private university dental hospitals in Riyadh, Saudi Arabia. This is the first comparative assessment of salivary parameters between unvaccinated and COVID-19-vaccinated child patients. The study sample comprised COVID-19 unvaccinated (n = 66) and vaccinated (n = 66) pediatric dental patients aged 4-12 years seeking dental care in clinics of private university hospitals. Paraffin-stimulated saliva was collected from unvaccinated and vaccinated study participants, and the amount of saliva secreted per minute was noted. Salivary pH and buffering capacity (by 5 mmol Hydrochloric acid titration) were measured using a benchtop digital pH meter. The data obtained were compared between unvaccinated and vaccinated participants using an independent t-test. The results showed a significantly higher salivary secretion rate in unvaccinated than vaccinated study participants (0.83 ± 0.24 mL/min vs 0.67 ± 0.24 mL/min, p = 0.001). Similarly, unvaccinated subjects compared to vaccinated subjects exhibited a significantly higher pH (7.33 ± 0.39 vs 7.04 ± 0.46, p < 0.001) and buffering capacity (6.31 ± 1.55 vs 5.40 ± 1.22, p < 0.001). Moreover, unvaccinated females demonstrated a significantly higher salivary secretion (0.87 ± 0.23 vs 0.71 ± 0.25, t = 2.627, p = 0.011) and buffering capacity 6.19 ± 1.52 vs 5.34 ± 1.25, t = 2.404, p = 0.019) than vaccinated females. Similarly, unvaccinated male exhibited significantly higher salivary secretion (0.80 ± 0.25 vs 0.64 ± 0.23, t = 2.670, p = 0.009), salivary pH (7.39 ± 0.45 vs 6.94 ± 0.41, t=4.309, p<0.001) and buffering capacity (6.42 ± 1.60 vs 5.45 ± 1.21, t = 2.875, p = 0.005) than the vaccinated male subjects. The vaccinated subjects showed a significantly lower mean salivary secretion, pH, and buffering capacity than unvaccinated participants. Hence, COVID-19 vaccination is likely to affect salivary parameters among pediatric patients.

COVID-19 in cancer patients: The impact of vaccination on outcomes early in the pandemic.

With the rapid evolution of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the development of effective and safe vaccines was of utmost importance to protect vulnerable individuals, including cancer patients. Studies comparing the clinical outcomes of cancer patients with or without vaccination against coronavirus disease 2019 (COVID-19) have not demonstrated clear benefit. We aimed to determine the protective effects of COVID-19 vaccination by comparing vaccinated and unvaccinated cancer patients after the initial phase of vaccine roll-out and to identify risk factors associated with hospitalization, severe COVID-19, and 30-day COVID-19 attributable mortality. We performed a retrospective cohort study of cancer patients with COVID-19 diagnosed by polymerase chain reaction on nasal swabs between January 1, 2021 and July 30, 2021. Outcomes of interest included hospitalization, severe COVID-19, and 30-day COVID-19 attributable mortality. Univariate and multivariate analyses were performed to identify factors associated with clinical outcomes, using vaccination status as a variable of interest in all models. Key risk factors, such as age ≥ 60 years; comorbidities including diabetes mellitus, heart failure, and lung diseases; and specific cancer types (leukemia and lymphoma) were independently associated with hospital admission for COVID-19, severe COVID-19, and 30-day COVID-19 attributable mortality in cancer patients regardless of their vaccination status. Vaccinated patients were protected against severe COVID-19 but with no impact on hospitalization or mortality due to COVID-19. Our study highlights a significant benefit of COVID-19 vaccination for cancer patients-specifically its protection against severe COVID-19.

Risk of extended viral shedding of Omicron BA.2 in Shanghai: Implications for vaccination strategy optimization

BackgroundIn late March 2022, an outbreak of coronavirus disease 2019 (COVID-19) caused by the Omicron BA.2 strain occurred in Shanghai, China. This retrospective study aimed to investigate the clinical characteristics, laboratory parameters, and vaccine protectiveness related to this disease in China. MethodsWe conducted a single-center retrospective study on 735 patients with COVID-19 hospitalized from March 17 to May 14, 2022. Clinical characteristics were analyzed based on vaccination status and viral shedding time (VST). The least absolute shrinkage and selection operator (LASSO) regression and 5-fold cross-validation were applied to screen factors linked to the rate of the VST. Generalized linear models were further applied to estimate the odds ratios for factors influencing the VST. ResultsThe median VST of unvaccinated patients was 13 (11–16) days, which was longer than that of patients vaccinated with one or two doses (11 [9–13] days) and with completed booster doses (11 [8–12] days). A LASSO regression model and 5-fold cross-validation showed that age of ≥60 years (β = 0.01), pneumonia (β = 0.53), and higher number of comorbidities (β = 0.69) were positively associated with the VST, whereas the platelet count (β = −8.0×10−5) was inversely associated with the VST. Subgroup analysis revealed that the number of vaccinations was significantly associated with a decreased VST among patients with renal dysfunction (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.44–0.97; P = 0.034) and patients with two or more comorbidities (OR, 0.09; 95% CI, 0.03–0.28; P < 0.001). The lymphocyte count was significantly associated with a decreased VST among patients aged <60 years (OR, 0.51; 95% CI, 0.30–0.85; P = 0.011), patients with normal renal function (OR, 0.41; 95% CI, 0.21–0.80; P = 0.009), and patients with fewer than two comorbidities (OR, 0.49; 95% CI, 0.30–0.80; P = 0.005). ConclusionOur preliminary results suggest that the complete and booster vaccination contributes to the viral clearance of Omicron BA.2 variants, while the protectiveness of vaccination is most imperative in patients with impaired renal function and more comorbidities.

Impact of SARS-CoV-2 infection in patients with cardiac amyloidosis: Results of a multicentre registry

BackgroundDescriptions on impact of SARS-CoV-2 infection in patients with cardiac amyloidosis (CA) are lacking. Our aim was to describe the prognosis of those patients. MethodsRetrospective observational study of unvaccinated patients with CA who developed SARS-CoV-2 infection enrolled in eleven centres (March 2020 to May 2021). Descriptive analysis of basal characteristics, hospitalization, mortality, and severe clinical course was performed. Comparisons to a population-based control group were made. ResultsForty-one patients were identified. Most patients had wild-type transthyretin CA (61%) and were on NYHA Class II–III (80.5%). CA patients were commonly hospitalized (73.2%) and those were more symptomatic than outpatients (p=0.035). The 24.4% of CA patients died as consequence of SARS-CoV-2 infection. Patients with CA had an increased risk of hospitalization [OR 6.23 (3.05–12.74), p<0.001] and mortality [OR 2.18 (1.01–4.68), p=0.047] when compared to control population after adjustment by age and sex. After a medium follow-time of 311 days, 41.5% of the CA cohort died. ConclusionsSARS-CoV-2 infection is associated with high mortality and hospitalization rates in patients with CA, which exceed that expected by their sex and advanced age.

493. ENDURANCE - EffectiveNess of Evusheld for COVID-19 Pre-exposUre PRophylAxis iN ImmunoCompromised PatiEnts – A Pilot Study

Abstract Background In December 2021, Evusheld, a cocktail of 2 monoclonal antibodies (mAB), was granted EUA for COVID-19 pre-exposure prophylaxis (PrEP) of immunocompromised patients (Table 1). The EUA was updated June 2022 to recommend repeating a dose every 6 months for patients needing ongoing protection. However, EUA was revoked in January 2023 due to identified resistance of Omicron lineage. Clinical trials about a new mAB for PrEP are continuing. Real-world data on the effectiveness of Evusheld may help develop strategies for the administration of new mAB. ENDURANCE is a complex retrospective study to assess Evusheld's effectiveness by evaluating and comparing treatment outcomes among 4 groups of patients classified based on the timing of treatment and the number of repeated Evusheld treatments (Figure 1). This pilot study describes treatment outcomes in the first analyzed group (gr. A) treated before Omicron development. Table 1 EUA criteria for Evusheld use, used as inclusion criteria for our study. * Patients with moderate to severe immunosuppression due to a medical condition or receipt of immunosuppressive medications and may not mount an adequate immune response to COVID-19 vaccination. Figure 1 ENDURANCE Study design. 459 patients who received the initial dose of Evusheld were followed for 180 days (group A, n=151, and group B, n=308). Patients who received repeated treatment (group A’, n=151) were followed for 180 days following an additional dose while patients who did not receive repeated treatment (group B’, n=308) were followed for an additional 180 days (181 till 360 days after the initial dose). Primary outcome is defined as confirmed symptomatic COVID-19 infection. We hypothesize a significantly lower rate of COVID-19 infections in the period before Omicron emergence (Groups A and B), disregarding if patients received repeated doses of Evusheld (Group A’) or not (Group B’). A Pilot Study describes the treatment outcomes in group A. Methods We conducted a retrospective chart review of patients treated with Evusheld under EUA between January 18 and June 21, 2022, to assess their response to treatment by evaluating outcomes listed in Figure 2. Patients were classified in tiers based on the degree of underlying immunosuppression (Table 2). In addition, COVID-19 anti-Spike antibodies were requisitioned before treatment. Figure 2 Evaluated outcomes. Primary outcome was positive COVID test at any point during the study period. Secondary outcomes were measured through the number of all-cause ED visits, hospitalizations, ICU admissions and deaths within 30 days from the positive COVID-19 test. Table 2 Tiered system for prioritizing patients based on severity of immunosuppression should resources be scarce. Results From 151 patients, the majority were vaccinated (95%), seropositive (66%), and classified as Tier 1 at the time of treatment (58%) (Table 3). All seronegative patients (39) were vaccinated (Figure 3). 16/159 (11%) developed symptomatic COVID-19 infection within 180 days from treatment (mean 119.8 days); 10/16 patients received antiviral treatment outpatient (Table 4). None visited ED, were hospitalized, or died. Table 3 Patients’ vaccination status and anti-Spike antibody (serology) results per tiers. *All seronegative patients were vaccinated; unvaccinated patients (8) were either seropositive (5) or with unknown serology (3). Figure 3 Serum anti-Spike antibody results in vaccinated and unvaccinated patients. All seronegative patients (n=39) were vaccinated. Unvaccinated patients were either seropositive (n=5) or with unknown serology results. Table 4 Characteristics of COVID-19 positive patients, compared to patients not diagnosed with COVID-19. Conclusion Our pilot data suggests that Evusheld may be effective against susceptible strains, as demonstrated by the low number of symptomatic infections, which all were mild and did not require ED or hospital utilization (Figure 4). A tier system may help prioritize patients in scarce resource conditions. Further studies are needed to identify risk factors for severe COVID in immunocompromised patients and understand their immunological response to vaccines and natural infection to create the most helpful tier system. Figure 4 Treatment outcomes. 10% (16/151) of Evusheld recipients developed mild symptomatic COVID-19. Number of all cause ED visits, hospitalizations, and deaths within 30 days from testing positive for COVID-19 was 0, suggesting possible beneficial effect of Evusheld use in immunocompromised population. Disclosures All Authors: No reported disclosures