Novel 3D printable powered air purifying respirator for emergency use during PPE shortage of the COVID-19 pandemic: a study protocol and device safety analysis

ObjectivesTo design a low-cost 3D printable powered air-purifying respirator (PAPR) that meets National Institute for Occupational Safety and Health (NIOSH) standard for flow rate and Occupational Safety and Health Administration (OSHA) standard for particle filtration for loose-fitting PAPRs and that can be made with a 3D printer and widely available materials.DesignDetailed description of components, assembly instructions and testing of a novel PAPR design in an academic laboratory following respective protocols. The assembled PAPR must meet NIOSH standards of flow rate, 170 L/min;OSHA fit factor for particle filtration, ≥250 and maintain positive pressure during regular and deep breathing.Main outcome measuresThe PAPR design was run through a series of tests: air flow (L/min), particle filtration (quantitative and qualitative) and positive pressure measured inside the helmet (mm Hg).ResultsFlow rate was 443.32 L/min (NIOSH standard: minimum 170 L/min) and overall fit factor for particle filtration was 1362 (OSHA pass level: ≥500), n=1. The device passed qualitative particle filtration, n=2, and measured peak pressure of 6mm Hg (>0 mm Hg indicates positive pressure) in the helmet, n=1.ConclusionsThe Hygieia PAPR is a low-cost, easily accessible, just-in-time 3D printable PAPR design that meets minimum NIOSH and OSHA standards for flow-rate and particle filtration for loose-fitting PAPR devices to be made and used when industry-made designs are unavailable.

Altered mental status is a predictor of poor outcomes in COVID-19 patients: A cohort study.

INTRODUCTION: Several studies have described typical clinical manifestations, including fever, cough, diarrhea, and fatigue with COVID-19 infection. However, there are limited data on the association between the presence of neurological manifestations on hospital admission, disease severity, and outcomes. We sought to investigate this correlation to help understand the disease burden. METHODS: We delivered a multi-center retrospective study of positive laboratory-confirmed COVID-19 patients. Clinical presentation, laboratory values, complications, and outcomes data were reported. Our findings of interest were Intensive Care Unit (ICU) admission, intubation, mechanical ventilation, and in-hospital mortality. RESULTS: A total of 502 patients with a mean age of 60.83 ± 15.5 years, of them 71 patients (14.14%) presented with altered mental status, these patients showed higher odds of ICU admission (OR = 2.06, 95%CI = 1.18 to 3.59, p = 0.01), mechanical ventilation (OR = 3.28, 95%CI = 1.86 to 5.78, p < 0.001), prolonged (>4 days) mechanical ventilation (OR = 4.35, 95%CI = 1.89 to 10, p = 0.001), acute kidney injury (OR = 2.18, 95%CI = 1.28 to 3.74, p = 0.004), and mortality (HR = 2.82, 95%CI = 1.49 to 5.29, p = 0.01). CONCLUSION: This cohort study found that neurological presentations are associated with higher odds of adverse events. When examining patients with neurological manifestations, clinicians should suspect COVID-19 to avoid delayed diagnosis or misdiagnosis and lose the chance to treat and prevent further transmission.

Interleukin-22 mitigates acute respiratory distress syndrome (ARDS).

BACKGROUND: The goal of this study was to determine if IL-22:Fc would Acute Respiratory Distress Syndrome (ARDS). SUMMARY BACKGROUND DATA: No therapies exist for ARDS and treatment is purely supportive. Interleukin-22 (IL-22) plays an integral component in recovery of the lung from infection. IL-22:Fc is a recombinant protein with a human FC immunoglobulin that increases the half-life of IL-22. STUDY DESIGN: ARDS was induced in C57BL/6 mice with intra-tracheal lipopolysaccharide (LPS) at a dose of 33.3 or 100 ug. In the low-dose LPS group (LDG), IL-22:FC was administered via tail vein injection at 30 minutes (n = 9) and compared to sham (n = 9). In the high-dose LPS group (HDG), IL-22:FC was administered (n = 11) then compared to sham (n = 8). Euthanasia occurred after bronchioalveolar lavage (BAL) on post-injury day 4. RESULTS: In the LDG, IL-22:FC resulted in decreased protein leak (0.15 vs. 0.25 ug/uL, p = 0.02). BAL protein in animals receiving IL-22:Fc in the HDG was not different. For the HDG, animals receiving IL-22:Fc had lower BAL cell counts (539,636 vs 3,147,556 cells/uL, p = 0.02). For the HDG, IL-6 (110.6 vs. 527.1 pg/mL, p = 0.04), TNF-α (5.87 vs. 25.41 pg/mL, p = 0.04), and G-CSF (95.14 vs. 659.6, p = 0.01) levels were lower in the BAL fluid of IL-22:Fc treated animals compared to sham. CONCLUSIONS: IL-22:Fc decreases lung inflammation and lung capillary leak in ARDS. IL-22:Fc may be a novel therapy for ARDS.

Annual flu shot: Does it help patients with COVID-19?

AIM OF THE STUDY: The impact of annual flu vaccination on the patients' clinical course with COVID-19 and the outcome were tested. METHODS: A total of 149 patients with COVID-19-positive admitted from March 20 to May 10, 2020, were retrospectively enrolled. RESULTS: Ninety-eight (65.8%) patients received at least a single annual flu shot in the last year, and fifty-one (34.2%) were never vaccinated. On presentation, vaccinated patients were more likely to present with gastrointestinal symptoms (P < .05). There were no significant differences between study groups in laboratory findings or clinical outcomes. In multivariate analysis, receiving the annual shot did not influence risk of intensive care unit admission (OR = 1.17, 95%CI = 0.50-2.72, P = .72), intubation (OR = 1.40, 95%CI = 0.60-3.23, P = .43), complications (OR = 1.08, 95%CI = 0.52-2.26, P = .83) or mortality (OR = 1.29, 95%CI = 0.31-5.29, P = .73). CONCLUSION: Although the benefits of the influenza vaccine for preventing disease and reducing morbidity in influenza patients are well established, no differences in outcomes for hospitalised patients with COVID-19 who received their annual influenza vaccination versus the non-vaccinated cohort were evident. There is a need for future meta-analyses, including randomised controlled studies in which the number of cases is increased to validate these findings.

Cancer and COVID-19: analysis of patient outcomes.

Background: We sought to investigate the outcomes associated with COVID-19 disease in cancer patients. Methods: We conducted a retrospective cohort study of laboratory-confirmed COVID-19 patients. Results: Of the 206 patients included, 57 had at least one preexisting malignancy. Cancer patients were older than noncancer patients. Of the 185 discharged cases, cancer patients had a significantly higher frequency of unplanned reintubation (7.1% vs 0.9%, p < 0.049), and required longer hospital stay (8.58 ± 6.50 days versus 12.83 ± 11.44 days, p < 0.002). Regression analysis revealed that obesity and active smoking were associated with an increased risk of mortality. Conclusion: Outcomes in COVID-19 appear to be driven by obesity as well as active smoking, with no difference in mortality between cancer and noncancer patients.

In this study, we aimed to investigate how COVID-19 affected cancer patients and whether this altered their survival outcomes. To do this, we examined data from a database of patients who have passed through our institution ­ a retrospective cohort analysis. Of the 206 patients we included in the study from this database, 57 had at least one preexisting cancer. Cancer patients tended to be older than noncancer patients. Of the 185 discharged patients, cancer patients required longer hospital stays, but there was no difference in mortality. Disease complications and intensive care unit admission with obesity and active smoking put patients in our cohort at increased risk of death. To conclude, outcomes in COVID-19 patients appear to be driven by obesity as well as active smoking, with no difference in mortality between cancer and noncancer patients.

Maintaining trauma center operational readiness during a pandemic.

The coronavirus disease 2019 (COVID-19) pandemic is a slow-moving global disaster with unique challenges for maintaining trauma center operations. University Medical Center New Orleans is the only level 1 trauma center in New Orleans, LA, which became an early hotspot for COVID-19. Intensive care unit surge capacity, addressing components including space, staff, stuff, and structure, is important in maintaining trauma center operability during a high resource-strain event like a pandemic. We report management of the trauma center's surge capacity to maintain trauma center operations while assisting in the care of critically ill COVID-19 patients. Lessons learned and recommendations are provided to assist trauma centers in planning for the influx of COVID-19 patients at their centers.

Vitamin D insufficiency as a potential culprit in critical COVID-19 patients.

BACKGROUND: As an immune modulator, vitamin D has been implicated in the coronavirus disease-2019 (COVID-19) outcome. We aim to systematically explore the association of vitamin D serum levels with COVID-19 severity and prognosis. METHODS: The standardized mean difference (SMD) or odds ratio and 95% confidence interval (CI) were applied to estimate pooled results from six studies. The prognostic performance of vitamin D serum levels for predicting adverse outcomes with detection of the best cutoff threshold was determined by receiver operating characteristic curve analysis. Decision tree analysis by combining vitamin D levels and clinical features was applied to predict severity in COVID-19 patients. RESULTS: Mean vitamin D serum level of 376 patients, was 21.9 nmol/L (95% CI = 15.36-28.45). Significant heterogeneity was found (I2 = 99.1%, p < .001). Patients with poor prognosis (N = 150) had significantly lower serum levels of vitamin D compared with those with good prognosis (N = 161), representing an adjusted standardized mean difference of -0.58 (95% Cl = -0.83 to -0.34, p < .001). CONCLUSION: Serum vitamin D levels could be implicated in the COVID-19 prognosis. Diagnosis of vitamin D deficiency could be a helpful adjunct in assessing patients' potential of developing severe COVID-19. Appropriate preventative and/or therapeutic intervention may improve COVID-19 outcomes.

African Americans Struggle With the Current COVID-19.

OBJECTIVES: Our study aims to explore the differential impact of this pandemic on clinical presentations and outcomes in African Americans (AAs) compared to white patients. BACKGROUND: AAs have worse outcomes compared to whites while facing heart diseases, stroke, cancer, asthma, influenza and pneumonia, diabetes, and HIV/AIDS. However, there is no current study to show the impact of COVID-19 pandemic on the AA communities. METHODS: This is a retrospective study that included patients with laboratory-confirmed COVID-19 from 2 tertiary centers in New Orleans, LA. Clinical and laboratory data were collected. Multivariate analyses were performed to identify the risk factors associated with adverse events. RESULTS: A total of 157 patients were identified. Of these, 134 (77%) were AAs, whereas 23.4% of patients were Whites. Interestingly, AA were younger, with a mean age of 63 ± 13.4 compared to 75.7 ± 23 years in Whites (P < 0.001). Thirty-seven patients presented with no insurance, and 34 of them were AA. SOFA Score was significantly higher in AA (2.57 ± 2.1) compared to White patients (1.69 ± 1.7), P = 0.041. Elevated SOFA score was associated with higher odds for intubation (odds ratio = 1.6, 95% confidence interval = 1.32-1.93, P < 0.001). AA had more prolonged length of hospital stays (11.1 ± 13.4 days vs 7.7 ± 23 days) than in Whites, P = 0.01. CONCLUSION: AAs present with more advanced disease and eventually have worse outcomes from COVID-19 infection. Future studies are warranted for further investigations that should impact the need for providing additional resources to the AA communities.

Multisystem inflammatory syndrome in pediatric COVID-19 patients: a meta-analysis.

BACKGROUND: We aimed to systematically review the clinical and laboratory features of patients with the multisystem inflammatory syndrome in pediatrics diagnosed during the COVID-19 pandemic. DATA SOURCES: A literature search in Web of Science, PubMed, Scopus, and Science Direct was made up to June 29, 2020. RESULTS: Analysis of 15 articles (318 COVID-19 patients) revealed that although many patients presented with the typical multisystem inflammatory syndrome in pediatrics, Kawasaki-like features as fever (82.4%), polymorphous maculopapular exanthema (63.7%), oral mucosal changes (58.1%), conjunctival injections (56.0%), edematous extremities (40.7%), and cervical lymphadenopathy (28.5%), atypical gastrointestinal (79.4%) and neurocognitive symptoms (31.8%) were also common. They had elevated serum lactic acid dehydrogenase, D-dimer, C-reactive protein, procalcitonin, interleukin-6, troponin I levels, and lymphopenia. Nearly 77.0% developed hypotension, and 68.1% went into shock, while 41.1% had acute kidney injury. Intensive care was needed in 73.7% of cases; 13.2% were intubated, and 37.9% required mechanical ventilation. Intravenous immunoglobulins and steroids were given in 87.7% and 56.9% of the patients, respectively, and anticoagulants were utilized in 67.0%. Pediatric patients were discharged after a hospital stay of 6.77 days on average (95% CI 4.93-8.6). CONCLUSIONS: Recognizing the typical and atypical presentation of the multisystem inflammatory syndrome in pediatric COVID-19 patients has important implications in identifying children at risk. Monitoring cardiac and renal decompensation and early interventions in patients with multisystem inflammatory syndrome is critical to prevent further morbidity.

Meta-analysis on Serial Intervals and Reproductive Rates for SARS-CoV-2.

OBJECTIVE: The aim of this study was to systematically review and meta-analyze all literature reporting the basic reproductive number (R0), effective reproductive number (Re or Rt), and the serial interval (SI) values of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection. SUMMARY BACKGROUND DATA: To assess the rate at which an infectious disease can spread in a population, the 2 measures, R0 and Re or Rt, are widely used. One of the parameters which influence the calculations is the SI, the period between symptom onset in an infector and an infectee. METHODS: Web of Science, PubMed, Scopus, and Science Direct searching up to May 10, 2020, was performed. A continuous random-effect model was applied using the DerSimonian-Laird (inverse variance) method. Heterogeneity and publication bias were assessed. RESULTS: A total of 39 articles met the eligibility criteria. Our results demonstrated the mean SI was 5.45 days, with the 95% confidence interval (CI) of 4.23 to 6.66. Pooled estimates for reproduction rates was 3.14 (95% CI: 2.69-3.59) for R0 and 3.18 (95% CI: 2.89-3.47) for Rt. Subgroup analysis by geographical region and date of publication revealed variations over both time and geography in calculated R0 and Rt values. As time has progressed, predicted R0 and Rt values had decreased globally. CONCLUSIONS: The study findings indicate that one SARS-CoV-2-infected person is likely to infect 3 persons, supporting that COVID-19 is a highly contagious disease. As an essential objective metrics implied in risk assessment for this emerging pandemic, monitoring R0 and Re is necessary to indicate the effectiveness or failures of mitigation efforts.

Time-varying Reproductive Rates for SARS-CoV-2 and its Implications as a Means of Disease Surveillance on Lockdown Restrictions.

OBJECTIVE: To quantify the time-varying reproductive rates for SARS-CoV-2 and its implication in Louisiana. SUMMARY OF BACKGROUND DATA: Basic reproductive number (R0) and effective reproductive number (Re or Rt) are 2 measures of the ability of an infectious agent to spread in the environment. They differ in that R0 assumes zero immunity in the population, while Re or Rt accounts for change over time. Reproductive number modeling is influenced by several factors, including serial interval, the time between the onset of symptoms in an infector, and a secondary case. Quantification of the ability of a pathogen to spread is essential in guiding policy. METHODS: Here, we construct epidemic curves and calculate daily Rt values for the state of Louisiana and each of its 9 regions. RESULTS: Our results demonstrated variation over both time and geography in calculated R0 and Rt values. Generally, as time has progressed, predicted R0 and Rt values have decreased. In Louisiana, mean Rt was calculated at 3.07 in March and 0.82 by May. A reproductive number less than one is important as it indicates infectious spread will decline with time. The most recent finding of mean Rt = 0.82 is important. It stands in stark contrast to the situation in April when New Orleans, Louisiana, had the highest per capita coronavirus mortality rate in the United States - twice that of New York City and 4 times the rate in Seattle. CONCLUSION: As locations around the world begin to lift restrictions, monitoring of infectious spread will be essential.

Asthma in COVID-19 patients: An extra chain fitting around the neck?

INTRODUCTION: The novel coronavirus disease 2019 (COVID-19) has rapidly spread across the globe. Pre-existing comorbidities have been found to have a dramatic effect on the disease course. We sought to analyze the effect of asthma on the disease progression and outcomes of COVID-19 patients. METHODS: We conducted a multi-center retrospective study of positively confirmed COVID-19 patients. The primary outcome of interest was in-hospital mortality. Secondary outcomes were the Intensive Care Unit (ICU) admission, intubation, mechanical ventilation, and length of hospital stay. RESULTS: A total of 502 COVID-19 adult patients (72 asthma and 430 non-asthma cohorts) with mean age of 60.7 years were included in the study. The frequency of asthma in hospitalized cohorts was 14.3%. Univariate analysis revealed that asthma patients were more likely to be obese (75% versus 54.2%, p = 0.001), with a higher frequency of intubation (40.3% versus 27.8%, p = 0.036), and required a longer duration of hospitalization (15.1 ± 12.5 versus 11.5 ± 10.6, p = 0.015). After adjustment, multivariable analysis showed that asthmatic patients were not associated with higher risk of ICU admission (OR = 1.81, 95%CI = 0.98-3.09, p = 0.06), endotracheal intubation (OR = 1.77, 95%CI = 0.99-3.04, p = 0.06) or complications (OR = 1.37, 95%CI = 0.82-2.31, p = 0.23). Asthmatic patients were not associated with higher odds of prolonged hospital length of stay (OR = 1.48, 95%CI = 0.82-2.66, p = 0.20) or with ICU stay (OR = 0.76, 95%CI = 0.28-2.02, p = 0.58). Kaplan-Meier curve showed no significant difference in the overall survival of the two groups (p = 0.65). CONCLUSION: Despite the increased prevalence of hospitalization in elder asthmatic COVID-19 patients, after adjustment for other variables, it was neither associated with increased severity nor worse outcomes.

Neutrophil-to-Lymphocyte Ratio and Outcomes in Louisiana COVID-19 Patients.

BACKGROUND: Due to the rapidly escalating number of cases and the low baseline of overall health in Louisiana, we sought to determine the prognostic value of the neutrophil-to-lymphocyte ratio (NLR) in hospitalized COVID patients in two major metropolitan areas with the highest prevalence of cases and exceedingly high rates of obesity and other comorbid conditions. We hypothesized that elevated NLR would be a prognostic indicator of mortality. METHODS: This was a review of a prospective registry of adult (18+ years) hospitalized Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) patients from two large urban safety net hospitals in Louisiana. Blood cell counts at days 2 and 5 were used to obtain NLR. Receiver operating characteristic curve analysis assessed predictive capacity of NLR on mortality. Kaplan-Meier survival analysis and Cox regression models examined the effect of NLR on survival. RESULTS: The study population of 125 patients was majority African American (88.6%) and female (54.8%) with a mean age and body mass index of 58.7 years and 34.2. Most (96.0%) had comorbidities of which hypertension (72.0%), obesity (66.7%), and diabetes (40.0%) were the most common. Mortality was 18.4%. NLR > 4.94 on day 1 predicted intubation (P = 0.02). NLR above established cutoff values on hospital days 2 and 5 each significantly predicted mortality (P < 0.001 and P = 0.002, respectively). CONCLUSIONS: NLR is a prognostic factor for endotracheal intubation upon hospital admission and independent predictor for risk of mortality in SARS-CoV-2 patients on subsequent hospital days. Clinical research efforts should examine effects of strategies such as arginase inhibition alone and/or inhaled nitric oxide to ameliorate the effects of elevated NLR.

Association of cardiac biomarkers and comorbidities with increased mortality, severity, and cardiac injury in COVID-19 patients: A meta-regression and decision tree analysis.

BACKGROUND: Coronavirus disease-2019 (COVID-19) has a deleterious effect on several systems, including the cardiovascular system. We aim to systematically explore the association of COVID-19 severity and mortality rate with the history of cardiovascular diseases and/or other comorbidities and cardiac injury laboratory markers. METHODS: The standardized mean difference (SMD) or odds ratio (OR) and 95% confidence intervals (CIs) were applied to estimate pooled results from the 56 studies. The prognostic performance of cardiac markers for predicting adverse outcomes and to select the best cutoff threshold was estimated by receiver operating characteristic curve analysis. Decision tree analysis by combining cardiac markers with demographic and clinical features was applied to predict mortality and severity in patients with COVID-19. RESULTS: A meta-analysis of 17 794 patients showed patients with high cardiac troponin I (OR = 5.22, 95% CI = 3.73-7.31, P < .001) and aspartate aminotransferase (AST) levels (OR = 3.64, 95% CI = 2.84-4.66, P < .001) were more likely to develop adverse outcomes. High troponin I more than 13.75 ng/L combined with either advanced age more than 60 years or elevated AST level more than 27.72 U/L was the best model to predict poor outcomes. CONCLUSIONS: COVID-19 severity and mortality are complicated by myocardial injury. Assessment of cardiac injury biomarkers may improve the identification of those patients at the highest risk and potentially lead to improved therapeutic approaches.