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1.
J Infect Dis ; 2022 May 10.
Article in English | MEDLINE | ID: covidwho-1886452

ABSTRACT

BACKGROUND: mRNA-1273 vaccine demonstrated 93.2% efficacy against Coronavirus disease 2019 (COVID-19) in the Coronavirus efficacy (COVE) trial. The humoral immunogenicity results are now reported. METHODS: Participants received two mRNA-1273 (100 µg) or placebo injections, 28 days apart. Immune responses were evaluated in a pre-specified, randomly-selected per-protocol immunogenicity population (n = 272 placebo; n = 1,185 mRNA-1273). Serum binding (bAb) and neutralizing (nAb) antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-spike protein were assessed at days 1, 29, and 57 by baseline SARS-CoV-2-negative (n = 1,197) and -positive (n = 260) status, age and sex. RESULTS: SARS-CoV-2-negative vaccinees had bAb geometric mean (GM) AU/ml levels of 35,753 at day 29 that increased to 316,448 at day 57 and nAb ID50 titers of 55 at day 29 that rose to 1081 at day 57. In SARS-CoV-2-positive vacinees, the first mRNA-1273 injection elicited bAb and nAb levels that were 11-fold (410,049) and 27-fold (1,479) higher than in SARS-CoV-2-negative vaccinees, respectively, and were comparable to levels after two injections in uninfected participants. Findings were generally consistent by age and sex. CONCLUSION: mRNA-1273 elicited robust serologic immune responses across age, sex, and SARS-CoV-2-status, consistent with its high COVID-19 efficacy. Higher immune responses in those previously-infected support a booster-type effect.ClinicalTrials.gov: NCT04470427.

2.
Crit Care Explor ; 4(4): e0662, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1831398

ABSTRACT

The Seraph100 Microbind Affinity Blood Filter (Seraph 100) (ExThera Medical, Martinez, CA) is an extracorporeal therapy that can remove pathogens from blood, including severe acute respiratory syndrome coronavirus 2. The aim of this study was to evaluate safety and efficacy of Seraph 100 treatment for COVID-19. DESIGN: Retrospective cohort study. SETTING: Nine participating ICUs. PATIENTS: COVID-19 patients treated with Seraph 100 (n = 53) and control patients matched by study site (n = 53). INTERVENTION: Treatment with Seraph 100. MEASUREMENTS AND MAIN RESULTS: At baseline, there were no differences between the groups in terms of sex, race/ethnicity, body mass index, and need for mechanical ventilation. However, patients in the Seraph 100 group were younger (median age, 54 yr; interquartile range [IQR], 41-65) compared with controls (median age, 64 yr; IQR, 56-69; p = 0.009). Charlson comorbidity index scores were lower in the Seraph 100 group (2; IQR, 0-3) compared with the control group (3; IQR, 2-4; p = 0.006). Acute Physiology and Chronic Health Evaluation II scores were also lower in Seraph 100 subjects (12; IQR, 9-17) compared with controls (16; IQR, 12-21; p = 0.011). The Seraph 100 group had higher vasopressor-free days with an incidence rate ratio of 1.30 on univariate analysis. This difference was not significant after adjustment. Seraph 100-treated subjects were less likely to die compared with controls (32.1% vs 64.2%; p = 0.001), a difference that remained significant after adjustment. However, no difference in mortality was observed in a post hoc analysis utilizing an external control group. In the full cohort of 86 treated patients, there were 177 total treatments, in which only three serious adverse events were recorded. CONCLUSIONS: Although this study did not demonstrate consistently significant clinical benefit across all endpoints and comparisons, the findings suggest that broad spectrum, pathogen agnostic, blood purification can be safely deployed to meet new pathogen threats while awaiting targeted therapies and vaccines.

3.
Perioper Care Oper Room Manag ; 27: 100251, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1768440

ABSTRACT

Background: Anesthesiologists are at high risk of developing burnout, a condition which can lead to many deleterious effects for the physician, and far-reaching effects on their patients and hospital systems. The COVID-19 pandemic has presented new challenges that have further exacerbated the risk of burnout in anesthesiologists. It is critical to develop effective strategies to promote well-being and decrease burnout for physicians in this specialty. The purpose of this observational study was to evaluate the impact of a Physician Well-Being Initiative on distress and well-being in anesthesiologists. It was hypothesized that the wellness intervention would promote an improvement in well-being scores. Methods: The Physician Well-Being Initiative was launched in August 2019 in the Department of Anesthesiology, Pain Management and Perioperative Medicine at Henry Ford Hospital in Detroit, Michigan. The Physician Well-Being Initiative was designed to address several of the key factors that improve physician wellness, including 1) a sense of autonomy; 2) positive view of leadership; and 3) flexible schedule opportunities. To assess the impact of the Physician Well-Being Initiative on the well-being and distress scores of participating anesthesiologists, the physicians were emailed the validated Well-Being Index survey at baseline and 3, 6 and 12 months. The Well-Being Index evaluates multiple items of distress in the healthcare setting. The sample size was limited to the 54 anesthesiologists at Henry Ford Hospital. Results: Forty-four of the 54 anesthesiologists completed the baseline questionnaire. A total of 44 physicians answered the questionnaire at baseline, with more male than female physicians (35 males and 7 females) and the majority (17/44) in practice for 5-10 years. Thirty-two physicians completed the survey at 3 and 6 months, and 31 physicians at 12 months after the launch of the Physician Well-Being Initiative. Twenty-one physicians completed the questionnaire at all 4 time points. Although the COVID-19 pandemic started shortly after the 6-month surveys were submitted, results indicated that there was a 0.05 decrease in the Well-Being Index sum score for every 1-month of time (coefficient -0.05, 95% CI -0.01, -0.08, P = 0.013). This study shows that, with the wellness initiative in place, the department was able to maintain and potentially even reduce physician distress despite the concurrent onset of the pandemic. Conclusions: Following the launch of a sustained wellness initiative, this study demonstrates that physician wellness improved with time. This suggests that it takes time for a wellness initiative to have an effect on well-being and distress in anesthesiologists.

4.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-311067

ABSTRACT

Background: Severity of illness and mortality from coronavirus disease 2019 (COVID-19) is consistently lower in women than in men. While this outcome difference is not well understood, focus on sex as a biologic factor may suggest potential therapeutic intervention for this disease. We assessed whether adding progesterone, a steroid hormone with immune-modulatory properties, to standard of care, would improve clinical outcomes of hospitalized men with moderate to severe COVID-19.Method: We conducted a Phase 1, randomised, open-label, controlled trial at a large academic hospital in Los Angeles, CA, USA, of subcutaneous progesterone in men hospitalized with confirmed COVID-19 and evidence of lower respiratory tract involvement. Patients were randomly assigned (1:1), using block randomization and a computer-generated randomization sequence, to receive standard of care (SOC) plus progesterone (100 mg subcutaneously twice daily for up to five days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status based on a 7-point ordinal scale noted at baseline compared to that on Day 7 of the trial. Control patients with significant clinical deterioration or absence of clinical improvement by Day 7 were permitted to cross over to receive progesterone therapy. Intention to treat analysis was performed and the patient’s last clinical assessment prior to receiving the study drug was imputed as the Day 7 assessment. Findings: Forty-two patients were enrolled in the study from April 27 to August 20, 2020;22 were randomised to the control group and 20 to the progesterone group. Of the 20 patients in the progesterone group, two withdrew from the study prior to receiving progesterone and were excluded from analysis. There was an overall improvement in clinical status from baseline to Day 7 in patients in the progesterone group as compared to controls (95% CI: 0-2;P = 0·010). There were no serious adverse events attributable to progesterone.Interpretation: Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to standard of care may represent a safe and novel approach for the treatment in men with moderate to severe COVID-19.Trial Registration: This trial was registered at ClinicalTrials.gov, NCT04365127.Funding Statement: The Institut Biochimique SA (IBSA, Lugano, Switzerland)Declaration of Interests: SG, YM, SP, TK, DN, JH, SC, RIG, JM, CB, ML, VT report grants and nonfinancial support from Institut Biochimique SA (IBSA, Lugano, Switzerland), during the conduct of the study;SG,SP report patent pending on method of use of progesterone agonist for treatment of COVID-19 VT reports grants from NIH/NIAID ACTT (ACTT 1-3), outside the submitted work. DS, HG declare no competing interests.Ethics Approval Statement: This study was approved by the Cedars-Sinai Institutional Review Board (IRB).

5.
Cogn Res Princ Implic ; 7(1): 1, 2022 01 10.
Article in English | MEDLINE | ID: covidwho-1633236

ABSTRACT

The sanitary-mask effect (Miyazaki and Kawahara in Jpn Psychol Res 58(3):261-272, 2016) is the finding that medical face masks prompt an image of disease and thus result in lower ratings of facial attractiveness of the wearer. However, during the COVID-19 pandemic, medical masks have been found to increase attractiveness (Patel et al. in Plast Reconstruct Surg Glob Open 8(8), 2020) although this could have been a general effect of occlusion. To further explore this issue, female participants were presented with a series of male faces of low or high attractiveness that were occluded with a medical mask, cloth mask, book or not occluded and asked to rate them on attractiveness. The results show that faces were considered as most attractive when covered by medical masks and significantly more attractive when occluded with cloth masks than when not occluded. Contrary to expectation, base attractiveness did not interact with the type of occlusion, suggesting that this is not simply due to occlusion of negative features. The present findings are contrary to the sanitary-mask effect and explanations in terms of social desirability, and the association of medical masks with caregiving professions is explored.


Subject(s)
Beauty , COVID-19 , Female , Humans , Male , Masks , Pandemics , SARS-CoV-2
6.
IEEE J Biomed Health Inform ; 25(12): 4317-4327, 2021 12.
Article in English | MEDLINE | ID: covidwho-1555590

ABSTRACT

In this work, we present a particle-based SEIR epidemic simulator as a tool to assess the impact of different vaccination strategies on viral propagation and to model sterilizing and effective immunization outcomes. The simulator includes modules to support contact tracing of the interactions amongst individuals and epidemiological testing of the general population. The particles are distinguished by age to represent more accurately the infection and mortality rates. The tool can be calibrated by region of interest and for different vaccination strategies to enable locality-sensitive virus mitigation policy measures and resource allocation. Moreover, the vaccination policy can be simulated based on the prioritization of certain age groups or randomly vaccinating individuals across all age groups. The results based on the experience of the province of Lecco, Italy, indicate that the simulator can evaluate vaccination strategies in a way that incorporates local circumstances of viral propagation and demographic susceptibilities. Further, the simulator accounts for modeling the distinction between sterilizing immunization, where immunized people are no longer contagious, and effective immunization, where the individuals can transmit the virus even after getting immunized. The parametric simulation results showed that the sterilizing-age-based vaccination scenario results in the least number of deaths. Furthermore, it revealed that older people should be vaccinated first to decrease the overall mortality rate. Also, the results showed that as the vaccination rate increases, the mortality rate between the scenarios shrinks.


Subject(s)
COVID-19 , Epidemics , Aged , Computer Simulation , Humans , SARS-CoV-2 , Vaccination
7.
J Intensive Care Med ; 36(10): 1228-1232, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1405275

ABSTRACT

We present 2 patients with rapidly escalating oxygen requirements from severe acute respiratory syndrome coronavirus 2 infection (COVID-19) treated with the Seraph100 Microbind Affinity Blood Filter under Emergency Use Authorization from the US Federal Drug Administration. The Seraph100 is an extracorporeal hemoperfusion filter previously demonstrated to remove viral particles and pro-inflammatory cytokines from the blood. Treatment with the Seraph100 filter was associated with a rapid improvement in oxygenation and both patients were discharged from the hospital without supplemental oxygen.


Subject(s)
COVID-19 , Hemoperfusion , Pneumonia , Humans , Lung , Pneumonia/therapy , SARS-CoV-2
8.
PLoS One ; 16(8): e0255343, 2021.
Article in English | MEDLINE | ID: covidwho-1344153

ABSTRACT

BACKGROUND: Social and ecological differences in early SARS-CoV-2 pandemic screening and outcomes have been documented, but the means by which these differences have arisen are not well understood. OBJECTIVE: To characterize socioeconomic and chronic disease-related mechanisms underlying these differences. DESIGN: Observational cohort study. SETTING: Outpatient and emergency care. PATIENTS: 12900 Cleveland Clinic Health System patients referred for SARS-CoV-2 testing between March 17 and April 15, 2020. INTERVENTIONS: Nasopharyngeal PCR test for SARS-CoV-2 infection. MEASUREMENTS: Test location (emergency department, ED, vs. outpatient care), COVID-19 symptoms, test positivity and hospitalization among positive cases. RESULTS: We identified six classes of symptoms, ranging in test positivity from 3.4% to 23%. Non-Hispanic Black race/ethnicity was disproportionately represented in the group with highest positivity rates. Non-Hispanic Black patients ranged from 1.81 [95% confidence interval: 0.91-3.59] times (at age 20) to 2.37 [1.54-3.65] times (at age 80) more likely to test positive for the SARS-CoV-2 virus than non-Hispanic White patients, while test positivity was not significantly different across the neighborhood income spectrum. Testing in the emergency department (OR: 5.4 [3.9, 7.5]) and cardiovascular disease (OR: 2.5 [1.7, 3.8]) were related to increased risk of hospitalization among the 1247 patients who tested positive. LIMITATIONS: Constraints on availability of test kits forced providers to selectively test for SARS-Cov-2. CONCLUSION: Non-Hispanic Black patients and patients from low-income neighborhoods tended toward more severe and prolonged symptom profiles and increased comorbidity burden. These factors were associated with higher rates of testing in the ED. Non-Hispanic Black patients also had higher test positivity rates.


Subject(s)
COVID-19 Testing/trends , COVID-19/diagnosis , Socioeconomic Factors , Adult , Aged , COVID-19/economics , COVID-19/psychology , COVID-19 Testing/methods , Cohort Studies , Comorbidity , Female , Hospitalization , Humans , Male , Mass Screening/methods , Mass Screening/psychology , Middle Aged , Ohio/epidemiology , Pandemics , Risk Factors , SARS-CoV-2/pathogenicity
9.
Adv Ther ; 38(8): 4556-4568, 2021 08.
Article in English | MEDLINE | ID: covidwho-1281332

ABSTRACT

INTRODUCTION: Our previous preclinical experiments show that under specific and monitored conditions, ultraviolet A (UVA) exposure reduces certain bacteria, fungi, and viruses including coronavirus-229E without harming mammalian columnar epithelial cells. The goal of this study was to evaluate the safety and effects of narrow-band UVA therapy administered by a novel device via endotracheal tube in critically ill subjects with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: Newly intubated, mechanically ventilated adults with SARS-CoV-2 infection and an endotracheal tube size of at least 7.50 mm were eligible for inclusion in the study. Subjects were treated with UVA for 20 min daily for 5 days and followed for 30 days. RESULTS: Five subjects were enrolled (mean age 56.60 years, three male). At baseline, all subjects scored 9/10 on the World Health Organization (WHO) clinical severity scale (10 = death), with predicted mortality ranging from 21% to 95%. Average endotracheal viral load significantly reduced from baseline to day 5 (- 2.41 log; range - 1.16 to - 4.54; Friedman p = 0.002) and day 6 (- 3.20; range - 1.20 to - 6.77; Friedman p < 0.001). There were no treatment-emergent adverse events, with no changes in oxygenation or hemodynamics during the 20-min treatments. One subject died 17 days after enrollment due to intracranial hemorrhagic complications of anticoagulation while receiving extracorporeal membrane oxygenation. The remaining subjects clinically improved and scored 2, 4, 5, and 7 on the WHO scale at day 30. In these subjects, clinical improvement correlated with reduction of viral load (Spearman's rho = 1, p < 0.001). CONCLUSIONS: In this first-in-human study, endotracheal narrow-band UVA therapy, under specific and monitored settings, appears to be safe and associated with a reduction in respiratory SARS-CoV-2 viral burden over the treatment period. UVA therapy may provide a novel approach in the fight against COVID-19. CLINICAL TRIAL NUMBER: NCT04572399.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Critical Illness , Humans , Male , Middle Aged , Viral Load
10.
Chest ; 160(1): 74-84, 2021 07.
Article in English | MEDLINE | ID: covidwho-1258346

ABSTRACT

BACKGROUND: Severity of illness in COVID-19 is consistently lower in women. A focus on sex as a biological factor may suggest a potential therapeutic intervention for this disease. We assessed whether adding progesterone to standard of care (SOC) would improve clinical outcomes of hospitalized men with moderate to severe COVID-19. RESEARCH QUESTION: Does short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19? STUDY DESIGN AND METHODS: We conducted a pilot, randomized, open-label, controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID-19. Patients were randomly assigned to receive SOC plus progesterone (100 mg subcutaneously twice daily for up to 5 days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status on day 7. Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes. RESULTS: Forty-two patients were enrolled from April 2020 to August 2020; 22 were randomized to the control group and 20 to the progesterone group. Two patients from the progesterone group withdrew from the study before receiving progesterone. There was a 1.5-point overall improvement in median clinical status score on a seven-point ordinal scale from baseline to day 7 in patients in the progesterone group as compared with control subjects (95% CI, 0.0-2.0; P = .024). There were no serious adverse events attributable to progesterone. Patients treated with progesterone required three fewer days of supplemental oxygen (median, 4.5 vs 7.5 days) and were hospitalized for 2.5 fewer days (median, 7.0 vs 9.5 days) as compared with control subjects. INTERPRETATION: Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC, may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.


Subject(s)
COVID-19 , Progesterone/administration & dosage , SARS-CoV-2/isolation & purification , COVID-19/physiopathology , COVID-19/therapy , Clinical Protocols/standards , Drug Monitoring , Humans , Hypoxia/diagnosis , Hypoxia/etiology , Injections, Subcutaneous , Male , Middle Aged , Oxygen Inhalation Therapy/methods , Pilot Projects , Progestins/administration & dosage , Severity of Illness Index , Treatment Outcome
11.
Acad Pathol ; 8: 23742895211011928, 2021.
Article in English | MEDLINE | ID: covidwho-1236539

ABSTRACT

Testing during the COVID-19 pandemic has been crucial to public health surveillance and clinical care. Supply chain constraints-spanning limitations in testing kits, reagents, pipet tips, and swabs availability-have challenged the ability to scale COVID-19 testing. During the early months, sample collection kits shortages constrained planned testing expansions. In response, the University of Vermont Medical Center, University of Vermont College of Medicine, Vermont Department of Health Laboratory, Aspenti Health, and providers across Vermont including 16 area hospitals partnered to surmount these barriers. The primary objectives were to increase supply availability and manage utilization. Within the first month of Vermont's stay-at-home order, the University of Vermont Medical Center laboratory partnered with College of Medicine to create in-house collection kits, producing 5000 per week. University of Vermont Medical Center reassigned 4 phlebotomists, laboratory educators, and other laboratory staff, who had reduced workloads, to participate (requiring a total of 5.3-7.6 full-time equivalent (FTE) during the period of study). By August, automation at a local commercial laboratory produced 22,000 vials of media in one week (reducing the required personnel by 1.2 FTE). A multisite, cross-institutional approach was used to manage specimen collection kit utilization across Vermont. Hospital laboratory directors, managers, and providers agreed to order only as needed to avoid supply stockpiles and supported operational constraints through ongoing validations and kit assembly. Throughout this pandemic, Vermont has ranked highly in number of tests per million people, demonstrating the value of local collaboration to surmount obstacles during disease outbreaks and the importance of creative allocation of resources to address statewide needs.

12.
Int J Environ Res Public Health ; 18(5)2021 02 26.
Article in English | MEDLINE | ID: covidwho-1154358

ABSTRACT

The COVID-19 pandemic has drawn attention to microbial transmission risk via aerosols in dental practice. Demonstration electric toothbrushes are used intra-orally for education. The aim of this investigation was to measure the size of droplets emitted by the brush head of two demonstration oscillating-rotating electric toothbrushes. Measurement of droplet production and size was recorded in vitro using three methods: (1) Malvern Spraytec (LASER particle size measurement device with detectable particle size of 0.1-2500 µm) and brushes mounted on a 3D-printed, two-shell form-fit fixture with a supply of tap water; (2) a DustTrak aerosol measurement device and toothpaste slurry, with brushing simulated in the oral cavity of a phantom head; (3) high-speed visualization in a simulated-use situation in the oral cavity of a phantom head, with individual evaluation of tap water, water with detergent, 70% ethanol, glycerin and toothpaste slurry. Both brushes showed the size of emitted droplets was consistently between 200 and 1200 µm, categorized as splatter (dental aerosols are <50 µm diameter). No significant incremental aerosol-sized matter was detected during toothbrush operation. The high-speed video visualization confirmed only splatter-sized droplets during operation. These findings indicate that oscillating-rotating toothbrushes do not produce aerosol-sized particles during simulated use.


Subject(s)
Aerosols/analysis , Dental Equipment , Toothbrushing/instrumentation , Equipment Design , Toothpastes
13.
14.
IEEE J Biomed Health Inform ; 24(10): 2743-2754, 2020 10.
Article in English | MEDLINE | ID: covidwho-694260

ABSTRACT

In this work, we present an open-source stochastic epidemic simulator calibrated with extant epidemic experience of COVID-19. The simulator models a country as a network representing each node as an administrative region. The transportation connections between the nodes are modeled as the edges of this network. Each node runs a Susceptible-Exposed-Infected-Recovered (SEIR) model and population transfer between the nodes is considered using the transportation networks which allows modeling of the geographic spread of the disease. The simulator incorporates information ranging from population demographics and mobility data to health care resource capacity, by region, with interactive controls of system variables to allow dynamic and interactive modeling of events. The single-node simulator was validated using the thoroughly reported data from Lombardy, Italy. Then, the epidemic situation in Kazakhstan as of 31 May 2020 was accurately recreated. Afterward, we simulated a number of scenarios for Kazakhstan with different sets of policies. We also demonstrate the effects of region-based policies such as transportation limitations between administrative units and the application of different policies for different regions based on the epidemic intensity and geographic location. The results show that the simulator can be used to estimate outcomes of policy options to inform deliberations on governmental interdiction policies.


Subject(s)
Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Epidemics/statistics & numerical data , Models, Biological , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Betacoronavirus , COVID-19 , Computational Biology , Computer Simulation , Coronavirus Infections/transmission , Epidemics/prevention & control , Health Policy , Humans , Italy/epidemiology , Kazakhstan/epidemiology , Models, Statistical , Pandemics/statistics & numerical data , Pneumonia, Viral/transmission , SARS-CoV-2 , Stochastic Processes , Transportation
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