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1.
J Frailty Aging ; 11(2): 214-223, 2022.
Article in English | MEDLINE | ID: covidwho-1811430

ABSTRACT

BACKGROUND: Frailty in older adults is a rapidly growing unmet medical need. It is an aging-related syndrome characterized by physical decline leading to higher risk of adverse health outcomes. OBJECTIVES: To evaluate the efficacy of Lomecel-B, an allogeneic medicinal signaling cell (MSC) formulation, in older adults with frailty. DESIGN: This multicenter, randomized, parallel-arm, double-blinded, and placebo-controlled phase 2b trial is designed to evaluate dose-range effects of Lomecel-B for frailty on physical functioning, patient-reported outcomes (PROs), frailty status, and biomarkers. SETTING: Eight enrolling clinical research centers, including the Miami Veterans Affairs Medical Center. PARTICIPANTS: Target enrollment is 150 subjects aged 70-85 years of any race, ethnicity, or gender. Enrollment criteria include a Clinical Frailty Score of 5 ("mild") or 6 ("moderate"), a 6MWT of 200-400 m, and serum tumor necrosis factor-alpha (TNF-α) ≥2.5 pg/mL. INTERVENTION: A single intravenous infusion of Lomecel-B (25, 50, 100, or 200 million cells) or placebo (N=30/arm). Patients are followed for 365 days for safety, and the efficacy assessments performed at 90, 180, and 270 days. MEASUREMENTS: The primary endpoint is change in 6MWT in the Lomecel-B-treated arms versus placebo at 180 days post-infusion. Secondary and exploratory endpoints include change in: 6MWT and other physical function measures at all time points; PROs; frailty status; cognitive status; and an inflammatory biomarkers panel. A pre-specified sub-study examines vascular/endothelial biomarkers. Safety is evaluated throughout the trial. RESULTS: The trial is conducted under a Food and Drug Administration Investigational New Drug (IND), with Institutional Review Board approval, and monitoring by an NIH-appointed independent Data Safety Monitoring Board. CONCLUSION: This clinical trial investigates the use of a regenerative medicine strategy for frailty in older adults. The results will further the understanding of the potential for Lomecel-B in the geriatric condition of frailty.


Subject(s)
COVID-19 , Frailty , Aged , Biomarkers , Double-Blind Method , Humans , SARS-CoV-2 , Treatment Outcome
2.
Open Forum Infectious Diseases ; 8(SUPPL 1):S151-S152, 2021.
Article in English | EMBASE | ID: covidwho-1746746

ABSTRACT

Background. Penicillins and cephalosporins (PCN/CEPH) are considered firstline antibiotics for numerous infections for their efficacy, tolerability, and cost effectiveness. Unfortunately, their use may be precluded in approximately 10% of the general adult population who self-report 'allergy'. As a result, suboptimal antimicrobials are substituted which may increase toxicities, length of hospitalizations, and antimicrobial resistance with subsequent expense and morbidity. Multiple organizations endorse beta-lactam allergy skin testing (BLAST) as an essential component of antimicrobial stewardship programs.In an attempt to better describe this patient population as well as to protocolize and improve rates of referral to allergy/immunology clinic, a quality initiative was undertaken at our institution. Methods. Adult inpatients for whom an infectious disease consult was placed over a 6-month period were chart-reviewed for PCN/CEPH allergy. Inappropriately charted allergies were reconciled and patients were recommended referral to allergy/immunology for formal evaluation with BLAST when appropriate. Referrals were placed for agreeable patients who were then evaluated for appropriateness through history and then scheduled for BLAST. Patients who tolerated oral exposures without adverse effects had the allergy removed from their chart and were educated. Results. 322 patients met inclusion criteria for allergy referral. Of those, 103 agreed to further evaluation, and referrals were placed for 100%. Unfortunately, 7 patients died before referrals could be completed, and 88 referred patients did not complete BLAST for other reasons. In total 8 patients completed BLAST, and allergy was de-labeled in 75% (N= 6) of those cases. Conclusion. Our data indicated similar prevalence of reported PCN/CEPH allergy between our institution and the general population. We achieved our aim of improving allergy referral rates among this population, however there was a high rate of attrition in the transitions of care. Qualitative review of selected patients highlights common thematic barriers including the COVID-19 pandemic, fiscal concerns, and acuity of condition. Future directions should include BLAST at the point of care or making referrals from the primary care setting.

3.
Obesity ; 29(SUPPL 2):175, 2021.
Article in English | EMBASE | ID: covidwho-1616084

ABSTRACT

Background: The COVID-19 pandemic has accelerated the adoption of telemedicine in post-surgical follow-up visits. Studies suggest that this practice is appropriate for bariatric surgery patients. One of its limitations, however, is providers' reduced ability to monitor post-op weight loss. This study aims to determine whether bariatric surgery patients' weight loss is accurately reported during virtual follow-up visits, relative to traditional office visits. Methods: We examined the medical records of 227 patients who underwent bariatric surgery in 2019 and 2020. The weights of these patients at their 6-month post-op visits were collected, and it was noted whether the weight was measured in the office or self-reported. The results were stored in a REDCap database. Analysis was performed with R using a Wilcoxon test. Results: Of a potential 227 patients, six-month weights were obtained for 146 patients (94 in-person and 52 self-reported). The in-person group averaged 10.28 (+/-3.59) BMI weight loss while the telemedicine group averaged 12.71 (+/-4.23) BMI weight loss (p < 0.01). The average weight loss at 6 months were 27.8 (+/-13.0) kg and 37.8 (+/-12.8) kg for in-person and telemedicine patients respectively (p < 0.01). Conclusions: We found a significant difference in weight loss between the in-person and telemedicine groups, suggesting that weight changes among the latter group may not be accurately reported. This calls into question the utility of weight loss data obtained from bariatric surgery patients during the pandemic, as the vast majority is self-reported. Limitations of this study include a small sample size, fluctuations in patient weight loss patterns due to the pandemic, and our inability to obtain confirmatory in-office weights from the telemedicine group. However, the significant deviation from the in-person group suggests inaccurate reporting, whether intentional or unintentional. Further studies are needed to establish the accuracy of self-reported weight changes in bariatric surgery patients.

4.
Gastroenterology ; 160(6):S-216, 2021.
Article in English | EMBASE | ID: covidwho-1592835

ABSTRACT

Background: Gastrointestinal (GI) manifestations of COVID-19 have been increasingly reported from many centres but it is not clear as to whether the presence of GI manifestations influences the outcomes of COVID-19. The data from the UK is still emerging and there is significant variability between the North of England and the rest of the UK. Aim of this study: DarCoVE was a single centre epidemiological study initiated over a 3 week period during the peak of the first wave of the COVID-19 pandemic in the United Kingdom. This prospective cohort analysis evaluated the GI and non-GI manifestations of the disease and produced a multi-variate analysis of prognosticators for COVID-19. Methods: Consecutive patients admitted with fever, cough or shortness of breath to the Acute Medical Admissions Service of Darlington Memorial Hospital between 26 March 2020 – 12 April 2020 were recruited to an electronic database, and divided into two cohorts: RT-PCR positive for SARS-CoV-2 (COVID+) and negative (COVID-). Demographic parameters, underlying comorbidities, GI and non-GI symptoms, BMI, haematological and biochemical laboratory parameters, chest radiology, need for supplemental oxygen, need for high dependency and intensive care treatment, length of hospital stay and mortality were recorded. Univariate survival analysis was performed by Cox proportional hazard model in R, multi variate analysis was done by forward selection model, cumulative survival by Kaplan-Meier method using log-rank test. Results: 275 patients formed the dataset for analysis, 130 COVID+. Median age of COVID+ was 70(range 23-95yrs), 63% were over age 65yrs, M:F=1.28. 73% had at least one co-morbidity, diabetes commonest. Median BMI 29.7 (range 13.9-44.9). 60.8% patients had a BMI>30, compared to UK average of 10.9% (p<0.001). GI manifestations included: diarrhoea in 10.1%, vomiting 13%, abdominal discomfort 9.4%, loss of appetite 5.7%, abnormal liver functions 37%, mean ALT 52.4 IU/L, ALT >150 in 5.1%. Of 43 clinical and biochemical factors investigated for prognostic value, 9 factors were associated with outcome at p<0.05 with cough and diarrhoea associated with lower risk of death compared to the other 7 factors. On multivariate analysis, high frailty score > 5, worst oxygenation SpO2 < 93%, platelets < 100 x 109/L and immunocompromised were poor prognosticators. None of the GI manifestations co-related with risk of death in this analysis, with a trend for ALT >150 to be associated with higher mortality. Overall mortality was 30.8% compared to UK national mortality of 26%, with ITU mortality higher at 37%. Conclusion: This study has shown a regional variation in the outcome of COVID-19, with slightly different prognosticators. GI manifestations continue to be significant in COVID-19, with a trend seen with high ALT. The data from this analysis will help management in future pandemics.

5.
United European Gastroenterology Journal ; 9(SUPPL 8):882, 2021.
Article in English | EMBASE | ID: covidwho-1490945

ABSTRACT

Introduction: Gastrointestinal (GI) manifestations of COVID-19 have been increasingly reported from many centres but it is not clear as to whether the presence of GI manifestations influences the outcomes of COVID-19. The data from the UK is still emerging and there is significant variability between the North of England and the rest of the UK. Aims & Methods: DarCoVE was a single centre epidemiological study initiated over a 3 week period during the peak of the first wave of the COVID- 19 pandemic in the United Kingdom. This prospective cohort analysis evaluated the GI and non-GI manifestations of the disease and produced a multi-variate analysis of prognosticators for COVID-19. Consecutive patients admitted with fever, cough or shortness of breath to the Acute Medical Admissions Service of Darlington Memorial Hospital between 26 March 2020-12 April 2020 were recruited to an electronic database, and divided into two cohorts: RT-PCR positive for SARS-CoV-2 (COVID+) and negative (COVID-). Demographic parameters, underlying co-morbidities, GI and non-GI symptoms, BMI, haematological and biochemical laboratory parameters, chest radiology, need for supplemental oxygen, need for high dependency and intensive care treatment, length of hospital stay and mortality were recorded. Univariate survival analysis was performed by Cox proportional hazard model in R, multi variate analysis was done by forward selection model, cumulative survival by Kaplan- Meier method using log-rank test. Results: 275 patients formed the dataset for analysis, 130 COVID+. Median age of COVID+ was 70(range 23-95yrs), 63% were over age 65yrs, M:F=1.28. 73% had at least one co-morbidity, diabetes commonest. Median BMI 29.7 (range 13.9-44.9). 60.8% patients had a BMI>30, compared to UK average of 10.9% (p<0.001). GI manifestations included: diarrhoea in 10.1%, vomiting 13%, abdominal discomfort 9.4%, loss of appetite 5.7%, abnormal liver functions 37%, mean ALT 52.4 IU/L, ALT >150 in 5.1%. Of 43 clinical and biochemical factors investigated for prognostic value, 9 factors were associated with outcome at p<0.05 with cough and diarrhoea associated with lower risk of death compared to the other 7 factors. On multivariate analysis, high frailty score > 5, worst oxygenation SpO2 < 93%, platelets < 100 x 109/L and immunocompromised were poor prognosticators. None of the GI manifestations co-related with risk of death in this analysis, with a trend for ALT >150 to be associated with higher mortality. Overall mortality was 30.8% compared to UK national mortality of 26%, with ITU mortality higher at 37%. Conclusion: This study has shown a regional variation in the outcome of COVID-19, with slightly different prognosticators. GI manifestations continue to be significant in COVID-19, with a trend seen with high ALT. The data from this analysis will help management in future pandemics.

6.
Gastroenterology ; 160(6):S216-S216, 2021.
Article in English | Web of Science | ID: covidwho-1250101
7.
Diabetic Medicine ; 38(SUPPL 1):68, 2021.
Article in English | EMBASE | ID: covidwho-1238390

ABSTRACT

Aim: To assess the feasibility and acceptability of remote videoconferencing delivery of the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) programme during the covid-19 pandemic. Method: Stage one: a patient telephone survey, assessed likely engagement with remote delivery, alongside provider and commissioner discussions to establish affordability. Stage two: development of a specification and delivery model for HEAL-D remote delivery, considering referral pathways and platform functionality e.g. delivery of participatory activities (e.g. exercise classes), and fostering of peer support. Stage three: pilot delivery of four courses to 23 patients across three boroughs and evaluation, comprising a pre/post-course questionnaire. Results: Eleven of 16 patients said they would attend a remote programme, one needed support and five had no internet/equipment. Of 80 funded places, only 27 referrals were received;85% (n = 23) accepted a place and four courses were delivered. 70% (n = 16) completed the course (attended ≥six of seven sessions). Service provider barriers to referring included the referral process not embedding within standard referral pathways and pressures associated with covid-19 and flu vaccinations. Patients evaluated the course highly;all agreed/strongly agreed that, as a result of the course, they learned practical skills and feel more motivated and supported to manage their diabetes. Conclusions: Remote delivery of culturally tailored diabetes education is acceptable to patients, however;a better understanding of digital exclusion is needed and ease of referral pathways is pivotal for service providers. More work is required to establish if the on-line programme elements can replicate the engagement and clinical improvements of face-to- face delivery.

9.
International Organization ; 2020.
Article in English | Scopus | ID: covidwho-851139

ABSTRACT

Analysis of the post-COVID world tends to gravitate to one of two poles. For some, the pandemic is a crisis that will reshuffle the decks, producing a fundamental reordering of global politics. For others, the basic principles of the international order are likely to remain much the same, driven largely by the emerging bipolar system between the US and China. We find both narratives dissatisfying, as the former overinterprets the causal role of the pandemic itself, while the latter underappreciates the critical ways in which global politics have been transformed beyond the state-centered system of the Cold War. We argue instead that the pandemic exposes underlying trends already at work and forces scholars to open the aperture on how we study globalization. Most centrally, we contend that globalization needs to be seen not just as a distributional game of winners and losers but rather a more profoundly transformational game that reshapes identities, redefines channels of power and authority, and generates new sites for contentious politics. We draw on emerging work to sketch out a theoretical frame for thinking about the politics of globalization, and assess some of the key policy arenas where COVID-19 is accelerating the transformative effects of globalization. In so doing, we suggest a roadmap to a post-pandemic research agenda for studying global markets that more fully captures these transformations and their implications for world politics. Copyright © The IO Foundation 2020.

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