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1.
European Stroke Journal ; 7(1 SUPPL):572, 2022.
Article in English | EMBASE | ID: covidwho-1928145

ABSTRACT

Background and aims: Hyperglycaemia in acute ischaemic stroke (AIS) is common, reduces the efficacy of stroke thrombolysis and thrombectomy, with worse clinical outcomes. Insulin therapies are difficult to implement and maintain, and may cause symptomatic hypoglycaemia. An alternative treatment is Exenatide, a GLP-1 agonist that lowers blood glucose with a very low risk of hypoglycaemia. Methods: The Trial of Exenatide in Acute Ischaemic Stroke (TEXAIS) enrolled adult patients with AIS ≤9 hours of stroke onset to receive treatment with short-acting Exenatide (5μg bid subcutaneous injection) or Standard care for 5 days, or until hospital discharge (whichever sooner).Primary outcome: proportion of patients with ≥8 point improvement in NIHSS score (or NIHSS 0-1) at 7 days. Results: 350 patients randomised, median age 71 years (IQR 62, 79), and median NIHSS 4 (IQR 2, 8). Planned recruitment (n=528) stopped early due to Covid and time constraints. On Admission the median blood glucose was 6.7 (IQR 5.70, 8.50), and 42% patients had hyperglycaemia (>7.0 mmol/L). Primary outcome occurred in 97/171 (56.7%) in Standard care group vs 104/170 (61.2%) in Exenatide group [aOR: 1.22 (CI 0.79, 1.88) p=0.38]. Mean daily per-patient frequency of hyperglycaemia was significantly less in the Exenatide group (p=0.002). No episodes of hypoglycaemia reported over the treatment period. Nausea/vomiting occurred in 7/174 (4.0%) patients on Exenatide. Conclusions: In this Phase 2 trial Exenatide did not significantly reduce neurological disability at 7 days. Exenatide significantly reduced frequency of hyperglycaemic events, and was safe to use. These results warrant further investigation with larger Phase 3 trials.

2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-296619

ABSTRACT

ABSTRACT AIM The CoKids study aimed to estimate the community incidence of symptomatic and asymptomatic SARS-CoV-2 in children and parents and to assess the symptomatology of SARS-COV-2 infections relative to SARS-CoV-2 negative respiratory episodes. METHODS In this prospective study, households with at least one child <18 years were recruited from three existing Dutch cohorts. Participation included SARS-CoV-2 screening at 4-6 weeks intervals for all household members during 23 weeks of follow-up and active reporting of new onset respiratory symptoms until July 1 st 2021. Follow-up was temporarily intensified following new onset respiratory symptoms in a household member or a SARS-CoV-2 positive screening test and included daily symptom recording, repeated PCR testing (nose-throat, saliva and fecal samples) and SARS-CoV-2 antibody measurement (paired dried blood spots) in all household members. Age-stratified incidence rates for SARS-CoV-2 positive and negative episodes were calculated. Symptomatology and disease burden of respiratory episodes were compared by SARS-CoV-2 status and age. RESULTS In total 307 households were enrolled including 1209 subjects. We detected 64 SARS-CoV-2 positive and 118 SARS-CoV-2 negative respiratory outbreaks. The highest incidence rate was found in children <12 years for SARS-CoV-2 negative episodes (0.93/ person-year (PY);95%CI: 0.88-0.96). The SARS-CoV-2 incidence in this age-group was 0.21/PY for confirmed only, and 0.41/PY if probable cases were included. SARS-CoV-2 incidence did not differ by age group (p>0.27). Nasal congestion/runny nose, with or without cough and fatigue were the three most prevalent symptom clusters for both SARS-CoV-2 positive and negative respiratory episodes. Among children, no differences were observed in the symptomatology and severity of SARS-CoV-2 positive versus negative respiratory episodes, whereas among adults, SARS-CoV-2 positive episodes had a higher number and severity of symptoms and with a longer duration p<0.001). CONCLUSION Using active, longitudinal household follow up, we detected a high incidence rate of SARS-CoV-2 infections in children that was similar to adults. The findings suggest that after 20 months of COVID-19 pandemic, up to 2/3 of Dutch children < 12 years have been infected with SARS-CoV-2. Symptomatology and disease severity of SARS-CoV-2 in children is similar to respiratory illness from other causes. In adults, SARS-COV-2 positive episodes are characterized by more and prolonged symptoms, and higher severity. These findings may assist decisions on COVID-19 policies targeting children.

4.
American Journal of Respiratory and Critical Care Medicine ; 203(9), 2021.
Article in English | EMBASE | ID: covidwho-1277135

ABSTRACT

Background: ARICA (AdheRence to Inhaled Corticosteroids in Asthma) is a comprehensive inhaled corticosteroid (ICS) adherence intervention designed to remediate each patient's unique reason for not taking their ICS as prescribed. Objective: The primary objective was to evaluate the feasibility and acceptability of implementing ARICA in a health system. Methods: 29 Black adults who self-reported ICS nonadherence, had uncontrolled persistent asthma, and a Duke Primary Care provider visit within the past 3 years were randomly assigned to intervention (N=15) or control (N=14) in a waitlist randomized controlled pilot trial. Participants were assigned to 1-3 ARICA components based on adherence barriers selected by participants;including, an asthma selfmanagement program, financial assistance referral program, and/or objective feedback on asthma control. All participants received weekly texts and emails dispelling asthma myths. Activities were delivered virtually due to COVID-19. Primary outcomes were feasibility (e.g., process outcomes) and acceptability (e.g., patient exit interviews) measured at 12 weeks. Secondary asthma (e.g., ACT) and adherence outcomes (e.g., DOSEnonadherence) were measured. Results: Most participants were female (N=27, 93%), nonsmokers (N=26, 70%), poorly controlled with ACT <15 (N=14, 48%), and mean age 49.8. Most (N=14, 93%) completed all assigned intervention components and reported mean 4.8 of 5 on Weiner feasibility, acceptability, and appropriateness of intervention. The intervention group had a greater and statistically significant improvement in ACT (Δ-3.5, CI 6.0,0.96) and Marks AQLQ (Δ 11.5, CI 5.5,17.4) when compared to changes in the control ACT (Δ-2.5, CI-5.2,0.05) and Marks AQLQ (Δ5.7, CI-1.3,12.8), respectively. The improvement in ACT in the intervention group was clinically significant. The intervention group also reported a greater and statistically significant decrease in degree of nonadherence (DOSE Δ 0.74, CI 0.2,1.3) than control (DOSE Δ 0.36, CI-0.04,0.75) and a greater decrease in the number of adherence barriers identified in the intervention group (Δ 2.1, CI 1.2,3.0) versus control group (Δ1.6, CI 0.3,3.0). The study was not powered to assess a statistically significant change between groups. Conclusion: The implementation of ARICA in a cohort of Black adults was feasibly deployed in a health system and acceptable to participants. There was a trend in improvement in asthma control and asthma quality of life and a decrease in nonadherence and barriers to adherence.

5.
Topics in Antiviral Medicine ; 29(1):87, 2021.
Article in English | EMBASE | ID: covidwho-1250335

ABSTRACT

Background: SARS-CoV-2 has claimed over a million lives and remains a global threat. Understanding immune responses to infection and developing validated laboratory assays to measure them is critical to the rapid development, assessment and implementation of effective interventions. Our development of a validated pseudovirus neutralization assay and characterization of neutralizing antibody (nAb) profiles in a diverse post-SARS-CoV-2 cohort can inform preventative and therapeutic efforts, including vaccine and monoclonal antibody development and deployment. Methods:This analysis comprises an observational cohort of n=330 adults in the US (n=168) and Peru (n=162), convalescing from SARS-CoV-2 infection and stratified by age, asymptomatic or symptomatic infection, and hospitalization. NAb titers are measured in serum by SARS-CoV-2.D614G Spike-pseudotyped virus infection of 293T/ACE2 cells. Multiple linear regression is applied to define associations between nAb titers and demographic variables, disease severity and duration, and co-morbidities within and across US and Peruvian cohorts over time. Results: The mean age is 48 years;49% were assigned female sex at birth, 51% male;54% are Latinx;50% identified as Other race, 34% White, 11% Black, 4%Asian. The mean days from SARS-CoV-2 diagnosis to enrollment was 52. NAb titers were higher in participants with a history of severe illness (p<0.001) and peaked 28-42 days post-diagnosis. ID50 (ID80) nAb titers >20 were detected at enrollment in 66% (46%) of asymptomatic, 86% (74%) of symptomatic and 95% (92%) of hospitalized individuals. Median ID50 (ID80) titers at enrollment among asymptomatic, symptomatic and hospitalized individuals were 107 (10), 482 (59) and 1,953 (366), respectively. Two months post-enrollment, median ID50 (ID80) titers among asymptomatic, symptomatic and hospitalized individuals declined to 30 (10), 130 (16) and 564 (103), respectively. Diabetes (p=0.011), age >55yo (p<0.001), male sex (p=0.003) and BMI ≥30 (p=0.021) were associated with higher ID80 titers. Hypertension was associated with lower ID50 titers (p=0.005). Conclusion: NAb titers after SARS-CoV-2 infection correlate with illness severity and underlying co-morbidities, and peak approximately one month postdiagnosis. Large, diverse, well-characterized cohorts of convalescent individuals facilitate development of standardized laboratory methods and reagents to measure immune responses and provide standardized values to benchmark SARS-CoV-2 vaccine-elicited responses.

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