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1.
PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-333774

ABSTRACT

IMPORTANCE: As the United States continues to accumulate COVID-19 cases and deaths, and disparities persist, defining the impact of risk factors for poor outcomes across patient groups is imperative. OBJECTIVE: Our objective is to use real-world healthcare data to quantify the impact of demographic, clinical, and social determinants associated with adverse COVID-19 outcomes, to identify high-risk scenarios and dynamics of risk among racial and ethnic groups. DESIGN: A retrospective cohort of COVID-19 patients diagnosed between March 1 and August 20, 2020. Fully adjusted logistical regression models for hospitalization, severe disease and mortality outcomes across 1-the entire cohort and 2-within self-reported race/ethnicity groups. SETTING: Three sites of the NewYork-Presbyterian health care system serving all boroughs of New York City. Data was obtained through automated data abstraction from electronic medical records. PARTICIPANTS: During the study timeframe, 110,498 individuals were tested for SARS-CoV-2 in the NewYork-Presbyterian health care system;11,930 patients were confirmed for COVID-19 by RT-PCR or covid-19 clinical diagnosis. MAIN OUTCOMES AND MEASURES: The predictors of interest were patient race/ethnicity, and covariates included demographics, comorbidities, and census tract neighborhood socio-economic status. The outcomes of interest were COVID-19 hospitalization, severe disease, and death. RESULTS: Of confirmed COVID-19 patients, 4,895 were hospitalized, 1,070 developed severe disease and 1,654 suffered COVID-19 related death. Clinical factors had stronger impacts than social determinants and several showed race-group specificities, which varied among outcomes. The most significant factors in our all-patients models included: age over 80 (OR=5.78, p= 2.29x10 -24 ) and hypertension (OR=1.89, p=1.26x10 -10 ) having the highest impact on hospitalization, while Type 2 Diabetes was associated with all three outcomes (hospitalization: OR=1.48, p=1.39x10 -04 ;severe disease: OR=1.46, p=4.47x10 -09 ;mortality: OR=1.27, p=0.001). In race-specific models, COPD increased risk of hospitalization only in Non-Hispanics (NH)-Whites (OR=2.70, p=0.009). Obesity (BMI 30+) showed race-specific risk with severe disease NH-Whites (OR=1.48, p=0.038) and NH-Blacks (OR=1.77, p=0.025). For mortality, Cancer was the only risk factor in Hispanics (OR=1.97, p=0.043), and heart failure was only a risk in NH-Asians (OR=2.62, p=0.001). CONCLUSIONS AND RELEVANCE: Comorbidities were more influential on COVID-19 outcomes than social determinants, suggesting clinical factors are more predictive of adverse trajectory than social factors. KEY POINTS: QUESTION: What is the impact of patient self-reported race, ethnicity, socioeconomic status, and clinical profile on COVID-19 hospitalizations, severity, and mortality?FINDINGS: In patients diagnosed with COVID-19, being over 50 years of age, having type 2 diabetes and hypertension were the most important risk factors for hospitalization and severe outcomes regardless of patient race or socioeconomic status. MEANING: In this large sample pf patients diagnosed with COVID-19 in New York City, we found that clinical comorbidity, more so than social determinants of health, was associated with important patient outcomes.

2.
Embase;
Preprint in English | EMBASE | ID: ppcovidwho-327028

ABSTRACT

We address whether T cell responses induced by different vaccine platforms (mRNA-1273, BNT162b2, Ad26.COV2.S, NVX-CoV2373) cross-recognize SARS-CoV-2 variants. Preservation of at least 83% and 85% for CD4+ and CD8+ T cell responses was found, respectively, regardless of vaccine platform or variants analyzed. By contrast, highly significant decreases were observed for memory B cell and neutralizing antibody recognition of variants. Bioinformatic analyses showed full conservation of 91% and 94% of class II and class I spike epitopes. For Omicron, 72% of class II and 86% of class I epitopes were fully conserved, and 84% and 85% of CD4+ and CD8+ T cell responses were preserved. In-depth epitope repertoire analysis showed a median of 11 and 10 spike epitopes recognized by CD4+ and CD8+ T cells from vaccinees. Functional preservation of the majority of the T cell responses may play an important role as a second-level defense against diverse variants.

3.
Clinical Lymphoma, Myeloma and Leukemia ; 21:S2-S3, 2021.
Article in English | EMBASE | ID: covidwho-1517533

ABSTRACT

Background: The role of upfront ASCT for NDTE MM remains under evaluation with high MRD rates following novel induction and consolidation (cons) strategies. K maintenance represents an alternative strategy to lenalidomide maintenance. The CARDAMON trial investigated K maintenance following KCd induction plus either ASCT or KCd cons. Methods: NDTE pts received 4 x KCd induction (K 20/56 mg/m2 biweekly, C 500 mg D 1,8,15, d 40mg weekly) before 1:1 randomisation to ASCT or 4 x KCd cons followed by 18 cycles K maintenance (56mg/m2 D1,8,15). Flow cytometric MRD (10-5) was assessed post induction, pre-maintenance and at 6 months maintenance. Primary endpoints were ≥VGPR post induction and 2-year PFS from randomisation. Secondary endpoints included improvements in disease response and MRD conversion following ASCT/ cons and maintenance. Results: 281 patients were registered, with 218 randomised to either ASCT or cons. The median PFS for ASCT was not yet reached vs 3.4 years for cons, with cons failing to show non-inferiority (difference in 2-year PFS 6.5%, 70% CI 1.0% to 11.1%). 196 patients received K maintenance (99 ASCT, 97 cons), 17 remain on treatment. A median of 16 cycles (1-18) were given over a median of 15.9 months (0-21.5). COVID-19 led to maintenance treatment interruptions in 41 (8 ASCT, 6 Cons) and treatment discontinuation in 15 (9 ASCT, 6 Cons). The median K dose given was 50.6mg/m2 and was similar across both arms (51.2 vs 49.4mg/m2, p=0.03). K maintenance was discontinued for PD in 14.1% (ASCT) vs 22.7% (cons), and for adverse events (AEs) in 7.1% (ASCT) vs 4.1% (cons). Most common AEs were hypertension and infections and more ≥G3 AEs were noted in ASCT vs cons (p=0.01). Patient/ clinician withdrawals from maintenance were low but occurred more in the ASCT arm (9.1% vs 1%). MRD neg patients post ASCT/ Cons had a longer PFS than MRD pos (p=0.002);with a higher MRD neg rate in the ASCT arm (53.6% vs 35.1% in Cons, p=0.01). MRD neg patients at 6 months post maintenance also had longer PFS (p=0.004 cf MRD pos patients);again with higher MRD neg rates in the ASCT arm (58.1% ASCT vs 40.5% Cons, p=0.02). There was no difference in PFS for MRD neg patients according to treatment arm from PBSCH, post-ASCT/ Cons or 6 months maintenance timepoints. Overall, 27.8% of MRD pos patients converted to MRD neg post ASCT/ Cons with more converting with ASCT (39.1% ASCT vs 16.1%, p=0.004). 23.5% of MRD pos patients converted to neg during maintenance (30.6% ASCT, 17.8%: p=0.2). Maintenance of MRD negativity over the first 6 months was similar between ASCT and Cons arms (p=0.3). There was no evidence that the timing of achievement of MRD negativity impacted PFS. Conclusions: K maintenance at 56mg/m2 weekly was deliverable and tolerable, with continued higher MRD neg rates at 6 months post-ASCT compared to post-Cons. However more ≥G3 AEs and discontinuations for AEs/ patient choice were noted for K maintenance after ASCT.

4.
Journal of Investigative Medicine ; 69(5):1087, 2021.
Article in English | EMBASE | ID: covidwho-1343971

ABSTRACT

Introduction/Background This pragmatic cluster randomized clinical trial (cRCT) enrolls patients with multiple chronic diseases (MCDs) who are at highest risk for destabilization (unplanned hospitalizations, increased disability). Patients with multiple chronic diseases are often excluded from clinical trials because of their multiple medical conditions and worse health outcomes, which significantly confound Results. Few evidenced- based strategies exist to comprehensively address the needs of these patients. Objective(s) Among 1920 adult patients with multiple chronic diseases defined as a Charlson Comorbidity Index (CCI) > 4, who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (n=8) and Chicago (n=8), which serve predominantly low income, Black and Latino patients, this pragmatic cluster RCT evaluates the comparative effectiveness of two approaches to preventing significant destabilization ('tipping points') that leads to unplanned hospitalization and increased disability. Methods Federally Qualified Health Centers (FQHCs, n=16) are cluster-randomized to: 1) Patient Centered Medical Home (PCMH) (Usual Care);or 2) PCMH plus a Health Coach (PCMH + HC) intervention that employs a positive affect/ self-affirmation strategy to motivate patients to set life goals, improve self-management and handle psychosocial and other stressors (Experimental). Primary and secondary outcomes include: unplanned hospitalizations and emergency department (ED) visits aggregated by PCORnet Clinical Research Networks, Health Information Exchange (New York City), and hospital alerts (Chicago), at baseline, 6, 12, 24-months and changes in disability. With the COVID-19 pandemic, we shifted to remote recruitment, and added oral consenting, egift cards and mailed letters. Results The PCMH + HC arm is designed to identify and prevent destabilization leading to hospitalization or ED visits that are more often triggered by psychosocial issues-family, community and environmental-than by medical issues. The study is powered to detect a 33% relative reduction in% hospitalized (a 5% absolute reduction) in PCMH + HC compared to PCMH only. Additionally, we expect that reducing hospitalization will result in reduced disability. Conclusion This intervention is designed to help participants manage life events that lead to 'tipping points' or overwhelming situations that result in unplanned hospitalizations and increased disability. FQHCs with PCMH recognition focus on care coordination. Patients need assistance to deal with many social and health related challenges they face and need help in communicating with health care providers and navigating a complex health care system. The PCMH + HC intervention will determine if adding health coaches helps patients to better manage their sources of stress, improve self-care and reduce unplanned hospitalizations. The impact of COVID-19 on changes to study processes and patient outcomes will be examined.

5.
Journal of Agriculture Food Systems and Community Development ; 10(2):291-295, 2021.
Article in English | Web of Science | ID: covidwho-1244303

ABSTRACT

Since the onset of the COVID-19 pandemic, the North Carolina Local Food Council has strengthened its role as a cohesive and effective organization during a public-health crisis to share challenges, devise solutions, and build resilience across local food systems in North Carolina. The Council includes representatives from 21 organizations working across the state, as well as three representatives from regional local food councils. The Council's response to the pandemic addressed three key areas of action: (1) Coordinate responses across multiple sectors;(2) Enhance collaboration across the food supply chain;and (3) Facilitate data collection and public messaging. This paper describes the positive impacts the Council has had across North Carolina on consumers and producers of local food as a result of this collaborative network and long-established relationships across the state. Now, more than ever, the relationships and collaborative efforts of statewide organizations and partners are needed. The Council's crisis response has been strong because of the long-standing relationships of its members and its ability to share resources quickly, allowing it to work toward coordinated responses. The work of the North Carolina Local Food Council can serve as a model for other states that have state-level local food councils or want to develop them. In addition, the Council's work demonstrates how collaborations among statewide partners can foster resilience within local food systems, particularly during a public health crisis.

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