Comparison of COVID-19 home-testers vs. laboratory-testers in New York State (excluding New York City), November 2021 to April 2022.

Background: Though the use of coronavirus disease 2019 (COVID-19) home testing kits is increasing, individuals who use home tests are not accounted for in publicly reported COVID-19 metrics. As the pandemic and the methods for tracking cases evolve, it is critical to understand who the individuals excluded are, due to their use of home testing kits, relative to those included in the reported metrics. Methods: Five New York State databases were linked to investigate trends in home-tested COVID-19 cases vs. laboratory-confirmed cases from November 2021 to April 2022. Frequency distributions, multivariate logistic regression adjusted odds ratios (aOR), and 95% confidence intervals (CI) were used to compare the characteristics of the home-tested and laboratory-tested people. Results: Of the 591,227 confirmed COVID-19 cases interviewed, 71,531 (12%) of them underwent home tests, 515,001 (87%) underwent laboratory tests, and 5,695 (1%) underwent both home tests and laboratory tests during this period. Home-tested COVID-19 cases increased from only 1% in November 2021 to 22% in April 2022. Children aged 5-11 years with an aOR of 3.74 (95% CI: 3.53, 3.96) and adolescents aged 12-17 years with an aOR of 3.24 (95% CI: 3.07, 3.43) were more likely to undergo only home tests compared to adults aged 65 years and above. On the one hand, those who were "boosted" (aOR 1.87, 95% CI: 1.82, 1.93), those in K-12 school settings (aOR 2.33, 95% CI: 2.27, 2.40), or those who were possibly infected by a household member (aOR 1.17, 95% CI: 1.13, 1.22) were more likely to report home testing instead of laboratory testing. On the other hand, individuals who were hospitalized (aOR 0.04, 95% CI: 0.03, 0.06), who had underlying conditions (aOR 0.85, 95% CI: 0.83, 0.87), who were pregnant (aOR 0.76, 95% CI: 0.66, 0.86), and who were Hispanic (aOR 0.50: 95% CI: 0.48, 0.53), Asian (aOR 0.31, 95% CI: 0.28, 0.34), or Black (aOR 0.45, 95% CI: 0.42, 047) were less likely to choose home testing over laboratory testing. Conclusion: The percentage of individuals with confirmed COVID-19 who used only home testing kits continues to rise. People who used only home testing were less likely to be hospitalized and were those with a lower likelihood of developing a severe disease given factors such as age, vaccination status, and underlying conditions. Thus, the official COVID-19 metrics primarily reflected individuals with severe illness or the potential for severe illness. There may be racial and ethnic differences in the use of home testing vs. laboratory testing.

COVID-19 Vaccination and Hospitalization Among Persons Living With Diagnosed HIV in New York State.

BACKGROUND: Persons living with diagnosed HIV (PLWDH) have higher COVID-19 diagnoses rates and poorer COVID-19-related outcomes than persons living without diagnosed HIV. The intersection of COVID-19 vaccination status and likelihood of severe COVID-19 outcomes has not been fully investigated for PLWDH. SETTING: New York State (NYS). METHODS: We matched HIV surveillance, immunization, and hospitalization databases to compare COVID-19 vaccination and COVID-19-related hospitalizations among PLWDH during B.1.617.2 (Delta) and B.1.1.529 (Omicron) predominance. RESULTS: Through March 4, 2022, 69,137 of the 101,205 (68%) PLWDH were fully vaccinated or boosted for COVID-19. PLWDH who were virally suppressed or in care were more often to be fully vaccinated or boosted compared with PLWDH who were not virally suppressed (77% vs. 44%) or without evidence of care (74% vs. 33%). Overall hospitalization rates were lower among virally suppressed PLWDH. During Delta predominance, PLWDH with any vaccination history who were in care had lower hospitalization rates compared with those not in care; during Omicron predominance, this was the case only for boosted PLWDH. CONCLUSIONS: Approximately 28% (28,255) of PLWDH in NYS remained unvaccinated for COVID-19, a rate roughly double of that observed in the overall adult NYS population. PLWDH of color were more often than non-Hispanic White persons to be unvaccinated, as were the virally unsuppressed and those without evidence of HIV-related care, threatening to expand existing disparities in COVID-19-related outcomes. Vaccination was protective against COVID-19-related hospitalizations for PLWDH; however, differences in hospitalization rates between fully vaccinated and unvaccinated PLWDH were smaller than those among all New Yorkers.

Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State.

Importance: Hydroxychloroquine, with or without azithromycin, has been considered as a possible therapeutic agent for patients with coronavirus disease 2019 (COVID-19). However, there are limited data on efficacy and associated adverse events. Objective: To describe the association between use of hydroxychloroquine, with or without azithromycin, and clinical outcomes among hospital inpatients diagnosed with COVID-19. Design, Setting, and Participants: Retrospective multicenter cohort study of patients from a random sample of all admitted patients with laboratory-confirmed COVID-19 in 25 hospitals, representing 88.2% of patients with COVID-19 in the New York metropolitan region. Eligible patients were admitted for at least 24 hours between March 15 and 28, 2020. Medications, preexisting conditions, clinical measures on admission, outcomes, and adverse events were abstracted from medical records. The date of final follow-up was April 24, 2020. Exposures: Receipt of both hydroxychloroquine and azithromycin, hydroxychloroquine alone, azithromycin alone, or neither. Main Outcomes and Measures: Primary outcome was in-hospital mortality. Secondary outcomes were cardiac arrest and abnormal electrocardiogram findings (arrhythmia or QT prolongation). Results: Among 1438 hospitalized patients with a diagnosis of COVID-19 (858 [59.7%] male, median age, 63 years), those receiving hydroxychloroquine, azithromycin, or both were more likely than those not receiving either drug to have diabetes, respiratory rate >22/min, abnormal chest imaging findings, O2 saturation lower than 90%, and aspartate aminotransferase greater than 40 U/L. Overall in-hospital mortality was 20.3% (95% CI, 18.2%-22.4%). The probability of death for patients receiving hydroxychloroquine + azithromycin was 189/735 (25.7% [95% CI, 22.3%-28.9%]), hydroxychloroquine alone, 54/271 (19.9% [95% CI, 15.2%-24.7%]), azithromycin alone, 21/211 (10.0% [95% CI, 5.9%-14.0%]), and neither drug, 28/221 (12.7% [95% CI, 8.3%-17.1%]). In adjusted Cox proportional hazards models, compared with patients receiving neither drug, there were no significant differences in mortality for patients receiving hydroxychloroquine + azithromycin (HR, 1.35 [95% CI, 0.76-2.40]), hydroxychloroquine alone (HR, 1.08 [95% CI, 0.63-1.85]), or azithromycin alone (HR, 0.56 [95% CI, 0.26-1.21]). In logistic models, compared with patients receiving neither drug cardiac arrest was significantly more likely in patients receiving hydroxychloroquine + azithromycin (adjusted OR, 2.13 [95% CI, 1.12-4.05]), but not hydroxychloroquine alone (adjusted OR, 1.91 [95% CI, 0.96-3.81]) or azithromycin alone (adjusted OR, 0.64 [95% CI, 0.27-1.56]), . In adjusted logistic regression models, there were no significant differences in the relative likelihood of abnormal electrocardiogram findings. Conclusions and Relevance: Among patients hospitalized in metropolitan New York with COVID-19, treatment with hydroxychloroquine, azithromycin, or both, compared with neither treatment, was not significantly associated with differences in in-hospital mortality. However, the interpretation of these findings may be limited by the observational design.

A stakeholder-driven framework for measuring potential change in the health risks of people who inject drugs (PWID) during the COVID-19 pandemic.

BACKGROUND: People who inject drugs (PWID) have likely borne disproportionate health consequences of the COVID-19 pandemic. PWID experienced both interruptions and changes to drug supply and delivery modes of harm reduction, treatment, and other medical services, leading to potentially increased risks for HIV, hepatitis C virus (HCV), and overdose. Given surveillance and research disruptions, proximal, indirect indicators of infectious diseases and overdose should be developed for timely measurement of health effects of the pandemic on PWID. METHODS: We used group concept mapping and a systems thinking approach to produce an expert stakeholder-generated, multi-level framework for monitoring changes in PWID health outcomes potentially attributable to COVID-19 in the U.S. This socio-ecological measurement framework elucidates proximal and distal contributors to infectious disease and overdose outcomes, many of which can be measured using existing data sources. RESULTS: The framework includes multi-level components including policy considerations, drug supply/distribution systems, the service delivery landscape, network factors, and individual characteristics such as mental and general health status and service utilization. These components are generally mediated by substance use and sexual behavioral factors to cause changes in incidence of HIV, HCV, sexually transmitted infections, wound/skin infections, and overdose. CONCLUSION: This measurement framework is intended to increase the quality and timeliness of research on the impacts of COVID-19 in the context of the current pandemic and future crises. Next steps include a ranking process to narrow the drivers of change in health risks to a concise set of indicators that adequately represent framework components, can be written as measurable indicators, and are quantifiable using existing data sources, as well as a publicly available web-based platform for summary data contributions.

SARS-CoV-2 Vaccine Breakthrough by Omicron and Delta Variants, New York, USA.

Recently emerged SARS-CoV-2 variants have greater potential than earlier variants to cause vaccine breakthrough infections. During emergence of the Delta and Omicron variants, a matched case-control analysis used a viral genomic sequence dataset linked with demographic and vaccination information from New York, USA, to examine associations between virus lineage and patient vaccination status, patient age, vaccine type, and time since vaccination. Case-patients were persons infected with the emerging virus lineage, and controls were persons infected with any other virus lineage. Infections in fully vaccinated and boosted persons were significantly associated with the Omicron lineage. Odds of infection with Omicron relative to Delta generally decreased with increasing patient age. A similar pattern was observed with vaccination status during Delta emergence but was not significant. Vaccines offered less protection against Omicron, thereby increasing the number of potential hosts for emerging variants.

Public Health Response to a Case of Paralytic Poliomyelitis in an Unvaccinated Person and Detection of Poliovirus in Wastewater - New York, June-August 2022.

On July 18, 2022, the New York State Department of Health (NYSDOH) notified CDC of detection of poliovirus type 2 in stool specimens from an unvaccinated immunocompetent young adult from Rockland County, New York, who was experiencing acute flaccid weakness. The patient initially experienced fever, neck stiffness, gastrointestinal symptoms, and limb weakness. The patient was hospitalized with possible acute flaccid myelitis (AFM). Vaccine-derived poliovirus type 2 (VDPV2) was detected in stool specimens obtained on days 11 and 12 after initial symptom onset. To date, related Sabin-like type 2 polioviruses have been detected in wastewater* in the patient's county of residence and in neighboring Orange County up to 25 days before (from samples originally collected for SARS-CoV-2 wastewater monitoring) and 41 days after the patient's symptom onset. The last U.S. case of polio caused by wild poliovirus occurred in 1979, and the World Health Organization Region of the Americas was declared polio-free in 1994. This report describes the second identification of community transmission of poliovirus in the United States since 1979; the previous instance, in 2005, was a type 1 VDPV (1). The occurrence of this case, combined with the identification of poliovirus in wastewater in neighboring Orange County, underscores the importance of maintaining high vaccination coverage to prevent paralytic polio in persons of all ages.

Factors associated with SARS-CoV-2-related hospital outcomes among and between persons living with and without diagnosed HIV infection in New York State.

BACKGROUND: Persons living with diagnosed HIV (PLWDH) are at increased risk for severe illness due to COVID-19. The degree to which this due to HIV infection, comorbidities, or other factors remains unclear. METHODS: We conducted a retrospective matched cohort study of individuals hospitalized with COVID-19 in New York State between March and June 2020, during the first wave of the pandemic, to compare outcomes among 853 PLWDH and 1,621 persons without diagnosed HIV (controls). We reviewed medical records to compare sociodemographic and clinical characteristics at admission, comorbidities, and clinical outcomes between PLWDH and controls. HIV-related characteristics were evaluated among PLWDH. RESULTS: PLWDH were significantly more likely to have cardiovascular (matched prevalence-ratio [mPR], 1.22 [95% CI, 1.07-1.40]), chronic liver (mPR, 6.71 [95% CI, 4.75-9.48]), chronic lung (mPR, 1.76 [95% CI, 1.40-2.21]), and renal diseases (mPR, 1.77 [95% CI, 1.50-2.09]). PLWDH were less likely to have elevated inflammatory markers upon hospitalization. Relative to controls, PLWDH were 15% less likely to require mechanical ventilation or extracorporeal membrane oxygenation (ECMO) and 15% less likely to require admission to the intensive care unit. No significant differences were found in in-hospital mortality. PLWDH on tenofovir-containing regimens were significantly less likely to require mechanical ventilation or ECMO (risk-ratio [RR], 0.73 [95% CI, 0.55-0.96]) and to die (RR, 0.74 [95% CI, 0.57-0.96]) than PLWDH on non-tenofovir-containing regimens. CONCLUSIONS: While hospitalized PLWDH and controls had similar likelihood of in-hospital death, chronic disease profiles and degree of inflammation upon hospitalization differed. This may signal different mechanisms leading to severe COVID-19.

Point of Care Lung Ultrasound Injury Score-A simple and reliable assessment tool in COVID-19 patients (PLIS I): A retrospective study.

BACKGROUND: In COVID-19 patients, lung ultrasound is superior to chest radiograph and has good agreement with computerized tomography to diagnose lung pathologies. Most lung ultrasound protocols published to date are complex and time-consuming. We describe a new illustrative Point-of-care ultrasound Lung Injury Score (PLIS) to help guide the care of patients with COVID-19 and assess if the PLIS would be able to predict COVID-19 patients' clinical course. METHODS: This retrospective study describing the novel PLIS was conducted in a large tertiary-level hospital. COVID-19 patients were included if they required any form of respiratory support and had at least one PLIS study during hospitalization. Data collected included PLIS on admission, demographics, Sequential Organ Failure Assessment (SOFA) scores, and patient outcomes. The primary outcome was the need for intensive care unit (ICU) admission. RESULTS: A total of 109 patients and 293 PLIS studies were included in our analysis. The mean age was 60.9, and overall mortality was 18.3%. Median PLIS score was 5.0 (3.0-6.0) vs. 2.0 (1.0-3.0) in ICU and non-ICU patients respectively (p<0.001). Total PLIS scores were directly associated with SOFA scores (inter-class correlation 0.63, p<0.001), and multivariate analysis showed that every increase in one PLIS point was associated with a higher risk for ICU admission (O.R 2.09, 95% C.I 1.59-2.75) and in-hospital mortality (O.R 1.54, 95% C.I 1.10-2.16). CONCLUSIONS: The PLIS for COVID-19 patients is simple and associated with SOFA score, ICU admission, and in-hospital mortality. Further studies are needed to demonstrate whether the PLIS can improve outcomes and become an integral part of the management of COVID-19 patients.

New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status - New York, May 3-July 25, 2021.

Data from randomized clinical trials and real-world observational studies show that all three COVID-19 vaccines currently authorized for emergency use by the Food and Drug Administration* are safe and highly effective for preventing COVID-19-related serious illness, hospitalization, and death (1,2). Studies of vaccine effectiveness (VE) for preventing new infections and hospitalizations attributable to SARS-CoV-2, the virus that causes COVID-19), particularly as the B.1.617.2 (Delta) variant has become predominant, are limited in the United States (3). In this study, the New York State Department of Health linked statewide immunization, laboratory testing, and hospitalization databases for New York to estimate rates of new laboratory-confirmed COVID-19 cases and hospitalizations by vaccination status among adults, as well as corresponding VE for full vaccination in the population, across all three authorized vaccine products. During May 3-July 25, 2021, the overall age-adjusted VE against new COVID-19 cases for all adults declined from 91.8% to 75.0%. During the same period, the overall age-adjusted VE against hospitalization was relatively stable, ranging from 89.5% to 95.1%. Currently authorized vaccines have high effectiveness against COVID-19 hospitalization, but effectiveness against new cases appears to have declined in recent months, coinciding with the Delta variant's increase from <2% to >80% in the U.S. region that includes New York and relaxation of masking and physical distancing recommendations. To reduce new COVID-19 cases and hospitalizations, these findings support the implementation of a layered approach centered on vaccination, as well as other prevention strategies such as masking and physical distancing.

Covid-19 Vaccine Effectiveness in New York State.

BACKGROUND: Population-based data from the United States on the effectiveness of the three coronavirus disease 2019 (Covid-19) vaccines currently authorized by the Food and Drug Administration are limited. Whether declines in effectiveness are due to waning immunity, the B.1.617.2 (delta) variant of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or other causes is unknown. METHODS: We used data for 8,690,825 adults in New York State to assess the effectiveness of the BNT162b2, mRNA-1273, and Ad26.COV2.S vaccines against laboratory-confirmed Covid-19 and hospitalization with Covid-19 (i.e., Covid-19 diagnosed at or after admission). We compared cohorts defined according to vaccine product received, age, and month of full vaccination with age-specific unvaccinated cohorts by linking statewide testing, hospital, and vaccine registry databases. We assessed vaccine effectiveness against Covid-19 from May 1 through September 3, 2021, and against hospitalization with Covid-19 from May 1 through August 31, 2021. RESULTS: There were 150,865 cases of Covid-19 and 14,477 hospitalizations with Covid-19. During the week of May 1, 2021, when the delta variant made up 1.8% of the circulating variants, the median vaccine effectiveness against Covid-19 was 91.3% (range, 84.1 to 97.0) for BNT162b2, 96.9% (range, 93.7 to 98.0) for mRNA-1273, and 86.6% (range, 77.8 to 89.7) for Ad26.COV2.S. Subsequently, effectiveness declined contemporaneously in all cohorts, from a median of 93.4% (range, 77.8 to 98.0) during the week of May 1 to a nadir of 73.5% (range, 13.8 to 90.0) around July 10, when the prevalence of the delta variant was 85.3%. By the week of August 28, when the prevalence of the delta variant was 99.6%, the effectiveness was 74.2% (range, 63.4 to 86.8). Effectiveness against hospitalization with Covid-19 among adults 18 to 64 years of age remained almost exclusively greater than 86%, with no apparent time trend. Effectiveness declined from May through August among persons 65 years of age or older who had received BNT162b2 (from 94.8 to 88.6%) or mRNA-1273 (from 97.1 to 93.7%). The effectiveness of Ad26.COV2.S was lower than that of the other vaccines, with no trend observed over time (range, 80.0 to 90.6%). CONCLUSIONS: The effectiveness of the three vaccines against Covid-19 declined after the delta variant became predominant. The effectiveness against hospitalization remained high, with modest declines limited to BNT162b2 and mRNA-1273 recipients 65 years of age or older.

Adjusting COVID-19 Seroprevalence Survey Results to Account for Test Sensitivity and Specificity.

Population-based seroprevalence surveys can provide useful estimates of the number of individuals previously infected with serious acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and still susceptible, as well as contribute to better estimates of the case-fatality rate and other measures of coronavirus disease 2019 (COVID-19) severity. No serological test is 100% accurate, however, and the standard correction that epidemiologists use to adjust estimates relies on estimates of the test sensitivity and specificity often based on small validation studies. We have developed a fully Bayesian approach to adjust observed prevalence estimates for sensitivity and specificity. Application to a seroprevalence survey conducted in New York State in 2020 demonstrates that this approach results in more realistic-and narrower-credible intervals than the standard sensitivity analysis using confidence interval endpoints. In addition, the model permits incorporating data on the geographical distribution of reported case counts to create informative priors on the cumulative incidence to produce estimates and credible intervals for smaller geographic areas than often can be precisely estimated with seroprevalence surveys.

New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status - New York, May 3-July 25, 2021.

Data from randomized clinical trials and real-world observational studies show that all three COVID-19 vaccines currently authorized for emergency use by the Food and Drug Administration* are safe and highly effective for preventing COVID-19-related serious illness, hospitalization, and death (1,2). Studies of vaccine effectiveness (VE) for preventing new infections and hospitalizations attributable to SARS-CoV-2, the virus that causes COVID-19), particularly as the B.1.617.2 (Delta) variant has become predominant, are limited in the United States (3). In this study, the New York State Department of Health linked statewide immunization, laboratory testing, and hospitalization databases for New York to estimate rates of new laboratory-confirmed COVID-19 cases and hospitalizations by vaccination status among adults, as well as corresponding VE for full vaccination in the population, across all three authorized vaccine products. During May 3-July 25, 2021, the overall age-adjusted VE against new COVID-19 cases for all adults declined from 91.7% to 79.8%. During the same period, the overall age-adjusted VE against hospitalization was relatively stable, ranging from 91.9% to 95.3%. Currently authorized vaccines have high effectiveness against COVID-19 hospitalization, but effectiveness against new cases appears to have declined in recent months, coinciding with the Delta variant's increase from <2% to >80% in the U.S. region that includes New York and relaxation of masking and physical distancing recommendations. To reduce new COVID-19 cases and hospitalizations, these findings support the implementation of a layered approach centered on vaccination, as well as other prevention strategies such as masking and physical distancing.