Infectious Disease

Warren, A.M., Zolfaghari, K., Fresnedo, M., Bennett, M., Pogue, J., Waddimba, A., Zvolensky, M., Carlbring, P. and Powers, M.B. (2021). “Anxiety sensitivity, COVID-19 fear, and mental health: results from a United States population sample.” Cogn Behav Ther Feb 17;1-13. [Epub ahead of print].

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The COVID-19 pandemic has resulted in unprecedented consequences. Transdiagnostic factors, such as anxiety sensitivity, could be an important component to understand how individuals experience COVID-19 specific fear, depression and anxiety. A US representative sample (5,023) completed measures including the Anxiety Sensitivity Index-3, the Fear of COVID-19 Scale, the Generalized Anxiety Disorder-7 and the Patient Health Questionnaire-8. Analyses controlled for age, sex, race, marital status, education level, working status, household income, and COVID-19 exposure. Results were consistent with prediction. First, higher ASI-3 Total scores were associated with above average COVID-19 fear (β = 0.19). Second, the ASI-3 physical concerns subscale was the strongest predictor of COVID-19 fear; one SD increase on the ASI-3 physical concerns subscale was associated with almost a twofold risk of reaching above average levels of COVID-19 (OR = 1.93). Third, higher ASI-3 Total scores were associated with higher anxiety (β = 0.22) and depression (β = 0.20). Finally, COVID-19 fear mediated the relationship between ASI-3 Total scores and anxiety (17% of effect mediated) as well as ASI-3 Total scores and depression (16% of effect mediated). These data support the role of anxiety sensitivity in predicting fear of COVID-19 and resulting mental health.

Aldujeli, A., Hamadeh, A., Tecson, K.M., Krivickas, Z., Maciulevicius, L., Stiklioraitis, S., Sukys, M., Briedis, K., Aldujeili, M., Briede, K., Braukyliene, R., Pranculis, A., Unikas, R., Zaliaduonyte, D. and McCullough, P.A. (2021). “Six-Month Outcomes for COVID-19 Negative Patients with Acute Myocardial Infarction Before Versus During the COVID-19 Pandemic.” Am J Cardiol Feb 23;S0002-9149(21)00161-2. [Epub ahead of print].

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The Coronavirus disease 2019 (COVID-19) pandemic has changed the way patients seek medical attention and how medical services are provided. We sought to compare characteristics, clinical course, and outcomes of patients presenting with acute myocardial infarction (AMI) during the pandemic compared with before it. This is a multicenter, retrospective cohort study of consecutive COVID-19 negative patients with AMI in Lithuania from March 11, 2020 to April 20, 2020 compared with patients admitted with the same diagnosis during the same period in 2019. All patients underwent angiography. Six-month follow-up was obtained for all patients. A total of 269 patients were included in this study, 107 (40.8%) of whom presented during the pandemic. Median pain-to-door times were significantly longer (858 [quartile 1=360, quartile 3 = 2,600] vs 385.5 [200, 745] minutes, p <0.0001) and post-revascularization ejection fractions were significantly lower (35 [30, 45] vs 45 [40, 50], p <0.0001) for patients presenting during vs. prior to the pandemic. While the in-hospital mortality rate did not differ, we observed a higher rate of six-month major adverse cardiovascular events for patients who presented during versus prior to the pandemic (30.8% vs 13.6%, p = 0.0006). In conclusion, 34% fewer patients with AMI presented to the hospital during the COVID-19 pandemic, and those who did waited longer to present and experienced more 6-month major adverse cardiovascular events compared with patients admitted before the pandemic.

Howell, A., Havens, L., Swinford, W. and Arroliga, A. (2021). “PPE Effectiveness – Yes, the Buck and Virus can Stop Here.” Infect Control Hosp Epidemiol Feb 19;1-3. [Epub ahead of print].

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We conducted an observational study of a multi-center healthcare system to determine the effectiveness of our infection control/PPE program during the care of COVID-19 patients. The COVID-19 conversion rate in the patient care setting was 0.70%. Comparatively, the conversion rate noted in the non-patient care/community setting was 15.17%.

Gottlieb, R.L., Nirula, A., Chen, P., Boscia, J., Heller, B., Morris, J., Huhn, G., Cardona, J., Mocherla, B., Stosor, V., Shawa, I., Kumar, P., Adams, A.C., Van Naarden, J., Custer, K.L., Durante, M., Oakley, G., Schade, A.E., Holzer, T.R., Ebert, P.J., Higgs, R.E., Kallewaard, N.L., Sabo, J., Patel, D.R., Klekotka, P., Shen, L. and Skovronsky, D.M. (2021). “Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.” Jama 325(7): 632-644.

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IMPORTANCE: Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19. OBJECTIVE: To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020. INTERVENTIONS: Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156). MAIN OUTCOMES AND MEASURES: The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29). RESULTS: Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49 for 7000 mg, -4.37 for combination treatment, and -3.80 for placebo. Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group were statistically significant for 10 of 84 end points. The proportion of patients with COVID-19-related hospitalizations or ED visits was 5.8% (9 events) for placebo, 1.0% (1 event) for 700 mg, 1.9% (2 events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment. CONCLUSIONS AND RELEVANCE: Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11; no significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04427501.

Wu, M.J., Chung, J.R., Kim, S.S., Jackson, M.L., Jackson, L.A., Belongia, E.A., McLean, H.Q., Gaglani, M., Reis, M., Beeram, M., Martin, E.T., Monto, A.S., Nowalk, M.P., Zimmerman, R., Santibanez, T.A., Singleton, J.A., Patel, M. and Flannery, B. (2021). “Influenza vaccination coverage among persons seeking outpatient medical care for acute respiratory illness in five states in the United States, 2011-2012 through 2018-2019.” Vaccine Feb 15;S0264-410X(21)00106-7. [Epub ahead of print].

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BACKGROUND: In the United States (U.S.), annual influenza vaccination has been recommended for all persons aged ≥6 months with the Healthy People 2020 coverage target of 70%. However, vaccination coverage has remained around 42-49% during the past eight influenza seasons. We sought to quantify influenza vaccination coverage and factors associated with vaccination in persons seeking outpatient medical care for an acute respiratory illness (ARI). METHODS: We enrolled outpatients aged ≥6 months with ARI from >50 U.S. clinics from 2011 to 2012 through 2018-2019 influenza seasons and tested for influenza with molecular assays. Vaccination status was based on documented receipt of the current season’s influenza vaccine. We estimated vaccination coverage among influenza-negative study participants by study site, age, and season, and compared to state-level influenza coverage estimates in the general population based on annual immunization surveys. We used multivariable logistic regression to examine factors independently associated with receipt of influenza vaccines. RESULTS: We enrolled 45,424 study participants with ARI who tested negative for influenza during the study period. Annual vaccination coverage among influenza-negative ARI patients and the general population in the participating states averaged 55% (range: 47-62%), and 52% (range: 46-54%), respectively. Among enrollees, coverage was highest among adults aged ≥65 years (82%; range, 80-85%) and lowest among adolescents aged 13-17 years (38%; range, 35-41%). Factors significantly associated with non-vaccination included non-White race, no college degree, exposure to cigarette smoke, absence of high-risk conditions, and not receiving prior season influenza vaccine. CONCLUSIONS: Influenza vaccination coverage over eight seasons among outpatients with non-influenza respiratory illness was slightly higher than coverage in the general population but 15% lower than national targets. Increased efforts to promote vaccination especially in groups with lower coverage are warranted to attain optimal health benefits of influenza vaccine.