Covid-19 Bivalent Booster Effectiveness in People with and without Immune Dysfunction

Background: Data on the effectiveness of the bivalent booster vaccine against COVID-19 breakthrough infection and severe outcomes is limited. Method(s): Using patient-level data from 54 sites in the U.S. National COVID Cohort Collaborative (N3C), we estimated bivalent booster effectiveness against breakthrough infection and outcomes between 09/01/2022 (bivalent vaccine approval date) to 12/15/2022 (most recent data release of N3C) among patients completed 2+ doses of mRNA vaccine. Bivalent booster effectiveness was evaluated among all patients and patients with and without immunosuppressed/compromised conditions (ISC;HIV infection, solid organ/ bone marrow transplant, autoimmune diseases, and cancer). We used logistic regression models to compare the odds of breakthrough infection (COVID-19 diagnosis after the last dose of vaccine) and outcomes (hospitalization, ventilation/ECMO use, or death <=28 days after infection) in the bivalent boosted vs. non-bivalent boosted groups. Models controlled for demographics, comorbidities, geographic region, prior SARS-CoV-2 infection, months since the last dose of non-bivalent vaccine, and prior non-bivalent booster. Result(s): By 12/15/2022, 2,414,904 patients had received 2+ doses of mRNA vaccination, 75,873 of them had received a bivalent booster vaccine, and 24,046 of them had a breakthrough infection. At baseline, the median age was 52 (IQR 36-67) years, 40% male, 63% white, 10% Black, 12% Latinx, 3.5% Asian American/Pacific Islander, and 14% were patients with ISC. Patients received a bivalent booster were more likely to be female and had comorbidities. Bivalent booster was significantly associated with reduced odds of breakthrough infection and hospitalization (Figure). The adjusted odds ratios comparing bivalent vs. non-bivalent group were 0.28 (95% CI 0.25, 0.32) for all patients and 0.33 (95% CI: 0.26, 0.41) for patients with ISC. Compared to the nonbivalent group, the bivalent group had a lower incidence of COVID-19-related hospitalization (151 vs. 41 per 100,000 persons), invasive ventilation/ECMO use (7.5 vs. 1.3 per 100,000 persons), or death (11 vs. 1.3 per 100,000 persons) in all patients during the study period;the incidence of severe outcomes after bivalent boosting was similar among patients with and without ISC. Conclusion(s): A bivalent booster vaccine was highly effective against COVID-19 breakthrough infection and severe outcomes among patients received 2+ doses of mRNA vaccine and offered similar protection in patients with and without ISC. (Figure Presented).

Green synthesized nanomaterials as antiviral substances

Viruses are obligate intracellular parasites, and infections may lead to mortalities. The outbreaks of several viral infections during the twentieth century increased the demand for both conventional and nonconventional types of antiviral treatments. The recent lethal impact of the coronavirus has increased the scientific investigations into the quest for potent antiviral therapeutics. Many new antiviral drugs approved by FDA have been exploited for the treatment of viral infections. However, owing to the limitations of synthetic antiviral drugs, new technologies have paved the way in an attempt to discover antiviral drugs that can overcome the drug resistance and low bioavailability issues. Green nanoscience offers the potential advantage of designing novel, biocompatible and viral-targeted specific antiviral drugs. Plants, algae, fungi, and bacteria are the preferable greener choices for the synthesis of green antiviral nanomaterials. This chapter summarizes the green antiviral nanomaterials synthesized over the past 5years (2016-21) and surprisingly has found very limited information on the green nanomaterials screened as antiviral agents and their specific modes of the antiviral mechanism. Scientific investigations available regarding green antiviral nanomaterials are restricted to in vitro systems, which demands the translation of these active antiviral nanomaterials into in vivo clinical practice. © 2023 Elsevier Inc. All rights reserved.

Infection Control Cluster Randomized Control Trials and Healthcare Facility Participation: A Need for Readiness Assessment

Background. Validated tools to evaluate organizational readiness exist within the implementation science literature, but readiness assessments for healthcare organization participation in cluster randomized control trials (CRCTs) have not been developed. CRCTs have been important for increasing the evidence base for infection control. This study describes complex contextual factors that can impact participation in a multi-site infection control CRCTs within the VA healthcare system. Methods. To assess study participation eligibility and feasibility, a survey of ten inpatient acute care patient units within five VA healthcare facilities was conducted to evaluate standard eligibility criteria such as facility and patient unit demographics, infection rates, and letters of support from leadership. With study delays we began conducting readiness evaluations through email communications and conference calls. We identified several metrics of readiness including competing priorities, identification of champions/ stakeholder engagement, and research infrastructure. Results. Our Initial survey metrics received from facilities interested in study participation were efficient in detecting study eligibility but lacked efficiency to detect study feasibility. Later metrics identified barriers to feasible study implementation (i.e., readiness), primarily competing priorities, specifically due to the pandemic. Other barriers included the lack of research infrastructure and lack of champion identification/stakeholder engagement. These contextual factors were generally elicited through ongoing communication rather than from the initial survey assessment. Conclusion. Organizational readiness can delay or impede important infection control CRCTs. This study exemplifies the complexity of healthcare organizations participation in clinical studies thatmay not be addressed in existing readiness tools or assessments. The emergence of the covid pandemic amplified the importance of identifying a wide range of contextual factors that need to be captured in ongoing assessments for readiness. An essential first step in developing organizational readiness tools and assessments is to identify and define readiness constructs in complex changing healthcare settings.

Understanding the influence of prior positive COVID-19 infection on 90-day outcomes following elective lumbar spine surgery

BACKGROUND CONTEXT The COVID-19 pandemic has radically impacted and transformed surgical practice over the past couple of years. While a significant proportion of research has rightfully focused on prevention and/or treatment of acutely infected COVID-19 patients, little is known about how a prior history of a positive COVID-19 infection (ie, recovered patients) influences outcomes following major elective surgeries. PURPOSE The purpose of the current study was to study whether previous positive COVID-19 infection has an impact on 90-day medical and surgical complication rates following elective lumbar spine surgeries. STUDY DESIGN/SETTING Retrospective cohort utilizing large all-payer database. PATIENT SAMPLE This study included 49,639 patients undergoing elective lumbar spine surgery between 2019 and 2021. OUTCOME MEASURES Ninety-day medical and surgical complication rates. METHODS The 2019 to 2021 PearlDiver Mariner Database, an all-payer claims database, was used to identify patients undergoing elective 1- to 2-level primary posterior/anterior/combined fusions or 1- to 2-level laminectomies for degenerative lumbar spine pathologies and 1- to 2-level primary microdiscectomies for herniated discs. Patients undergoing fusion for fracture, malignancy, infection and/or those undergoing revision procedures were excluded from the study. The study group was divided into two cohorts — those who had a prior history of a COVID-19 infection within the 6 months before surgery and those who were not infected by the virus. Patients who had a positive coded COVID-19 status on the day of surgery were excluded from the analysis. Multivariate logistic regression analyses were used to assess the impact of prior COVID-19 infection on 90-day medical and surgical complication rates, while controlling for baseline demographics (age, gender, payor type/insurance) and clinical characteristics (Charlson comorbidity index, type of surgery, and prior ventilator dependence). RESULTS A total of 49,639 patients undergoing elective lumbar spine surgery between 2019 and 2021 were included in the study, out of which 150 patients (0.3%) had had a positive COVID-19 status and/or infection in the 6 months prior to the surgery. After adjusting for baseline demographics and clinical characteristics, patients with a prior history of COVID-19 infection were more likely to experience cardiac complications (3.3% vs 1.1%, OR 2.75;p=0.021), thromboembolic complications (6.0% vs 2.3%, OR 2.35;p=0.014) and sepsis (5.3% vs 2.0%, OR 2.31;p=0.024) within 90 days of the index surgery. CONCLUSIONS Based on a national retrospective review of patients undergoing elective lumbar spine surgery, it appears that having harbored a positive COVID-19 infection in the 6 months prior to surgery is associated with higher risks of experiencing thromboembolic events, sepsis and acute myocardial infarctions or acute congestive heart failure. The findings of the study support the need of careful postoperative care monitoring and/or risk-stratification of prior COVID-19 patients. FDA DEVICE/DRUG STATUS This does not discuss or include any applicable devices or drugs.

COVID-19 BOOSTER VACCINE EFFECTIVENESS in PEOPLE with and WITHOUT IMMUNE DYSFUNCTION

Background: Real-world evidence on effectiveness of booster or additional doses of COVID-19 vaccine is limited. Methods: Using patient-level data from 50 sites in the U.S. National COVID Cohort Collaborative (N3C), we estimated COVID-19 booster vaccine effectiveness compared to full vaccination alone (completed 2 doses mRNA or 1 dose Janssen vaccine). At each month following full vaccination, we created comparable cohorts of patients with boosters propensity-score matched to those without boosters by age, sex, race/ethnicity, comorbidities, geographic region, prior COVID-19 infection, and calendar month of full vaccination. Booster efficacy was evaluated among patients with and without immunosuppressed/compromised conditions (ISC;HIV infection, solid organ or bone marrow transplant, autoimmune diseases, and cancer). We used Cox regression models to estimate hazards of breakthrough infection (COVID-19 diagnosis after last dose of vaccine) and logistic regression models to compare the risk of death ≤45 days after a breakthrough infection in the boosted vs. matched non-boosted groups. Results: By 11/18/2021, 656390 patients had received full vaccination, and 125409 fully vaccinated had received an additional booster (median time from last vaccine to booster dose: 7.4 months, IQR:6.6, 8.2). At completion of full vaccination, median age was 50 (IQR 33-64) years, 43% male, 50% white, 11% Black, 18% Latinx, 4.8% Asian American/Pacific Islander, and 20% had ISC. People receiving a booster were more likely to be older, male, white, and have ISC. Booster vaccine was significantly associated with a reduced hazard of breakthrough infection (Table). Booster efficacy ranged from 46% (booster receipt 1-4 months after full vaccination) to 83% (receipt 7 months after full vaccination) in people without ISC. Vaccine efficacy was lower, ranging from 43%-65%, in ISC patients (Table). Compared to fully vaccinated patients without booster receipt, patients with booster had an 83% (OR: 0.17, 95% CI: 0.11, 0.28) reduced risk of COVID-19 related death, independent of demographics, geographic region, comorbidities, ISC, prior COVID-19 infection, and time of full vaccination. Conclusion: A booster dose of COVID-19 vaccine has high effectiveness in reducing breakthrough infection risk among all fully vaccinated individuals, though only with moderate effectiveness among ISC patients. Nonetheless, booster vaccination significantly reduced risk for COVID-19 related death regardless of ISC status.

Integrating antibiotic stewardship and infection prevention and control programs using a team science approach

Reduction of health care-associated infections is trending in the right direction after decades of work by those involved in infection prevention and control and antibiotic stewardship. With institutional priorities currently pivoting to meet the needs of COVID-19 patients, this may be an advantageous time to promote integration of facility-level antibiotic stewardship and infection prevention and control programs. We propose a team science framework as a tool to leverage the complementary expertise of stewardship and infection prevention and control professionals. This framework considers stages of team development and fluidity needed when working with shifting priorities and can be used by leaders and team members throughout all phases of team building-from developing and launching the team, through evaluating and modifying team activities to best suit local needs. (c) 2021 Published by Elsevier Inc. on behalf of Association for Professionals in Infection Control and Epidemiology, Inc.

Risk Factors and Mortality for Atypical Presentation of COVID-19 Infection in Hospitalized Patients - Lessons From the Early Pandemic

OBJECTIVE: To assess the clinical epidemiology and outcomes of patients hospitalized with COVID-19 who did not experience fever and cough during the early pandemic. METHODS: Retrospective cohort of all patients admitted during March 13, 2020 through May 13, 2020 with laboratory-confirmed COVID-19 to 3 tertiary-care hospitals. Patient-level data (demographic, clinical manifestations, comorbid illnesses, inpatient treatment) were analyzed. The main outcome variable was atypical presentation, defined as any hospitalized patient with COVID-19 infection who did not experience both fever and cough. We identified risk factors for atypical presentation on univariate and multivariate analyses and assessed 30-day mortality differences via survival analysis. RESULTS: Of 163 patients in the study, 39 (24%) were atypical. On univariate analysis, atypical cases were significantly more likely to be older, reside in a long-term-care facility (LTCF), and have underlying diabetes mellitus, stroke, or cardiac disease;present without dyspnea or myalgia, have lower C-reactive proteins (CRP) and higher beta-natriuretic peptides. They were less likely to receive intensive care unit care or specific COVID-19 treatments (P < .05). The incidence of acute respiratory failure was not significantly different between the groups. On logistic regression, atypical cases were significantly more likely to be LTCF residents (P  = 0.003) and have a lower average CRP (P  = 0.01). Atypical cases had significantly higher 30-day mortality (hazard ratio 3.4 [95% CI, 1.6 - 7.2], P  = 0.002). CONCLUSION: During the first pandemic surge, COVID-19 patients without inflammatory signs and symptoms were more likely to be LTCF residents and had higher mortality. Timely recognition of these atypical presentations may have prevented spread and improved clinical outcomes.

Long term care facility residents hospitalized with COVID-19 infection present with atypical symptoms

Background: Fever and cough are frequently reported in COVID-19 infections, although little is known about the subgroup of symptomatic patients who do not manifest these classic symptoms. We aimed to compare clinical manifestations and outcomes for hospitalized COVID-19 patients with typical vs. atypical presentations and identify risk factors for atypical COVID-19 presentations. Methods: We conducted a retrospective cohort of all patients hospitalized with laboratory-confirmed COVID-19 infections during 3/13- 5/13/2020 at UW Health, a network of 3 acute-care hospitals in Midwest. We defined atypical cases as patients hospitalized for COVID-19 related reasons presenting without fever and cough and compared them in univariate analysis with patients manifesting both symptoms (controls). We identified independent risk factors for atypical COVID-19 presentations by logistic regression. Results: Among the 163 patients hospitalized during the 60-day study frame, 39 (24%) had atypical presentations. Table 1 shows demographic, clinical manifestations, and outcomes of atypical vs. typical cases. On univariate analysis, atypical cases were more likely to be older, reside in a long-term-care facility (LTCF), have underlying diabetes mellitus, stroke, cardiac disease, and deny myalgias or dyspnea, despite having no significant difference in the prevalence of hypoxia or radiological lung infiltrates. Atypical cases also had a significantly higher Beta-Natriuretic-Peptide and lower C-Reactive-Protein, although other inflammatory markers were not significantly different. They were less likely to be admitted to the ICU, and more likely to die within 30 days, as older patients with respiratory failure and multiple comorbidities opted for comfort measures and less aggressive care. On multivariate analysis, LTCF residence was the only independent predictor for atypical status (Table 2). Conclusion: LTCF residents are more likely to experience COVID-19 respiratory illness (hypoxia, pneumonia) without classic symptoms (fever, cough, myalgias, dyspnea). Given the excessive pandemic burden in the LTCF setting, timely recognition and diagnosis of these atypical, more subtle presentations is critical. (Table Presented).