Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.
Phase 2a randomised, placebo-controlled, double-blinded, trial.
Hospitals in Canada, Turkey and the USA.
A total of 61 subjects with moderate-to-severe COVID-19.
Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.
The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.
At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.
In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.
To explore youth, caregiver and staff perspectives on their vision of trauma-informed care, and to identify and understand potential considerations for the implementation of a trauma-informed care programme in an inpatient mental health unit within a paediatric hospital.
We applied the Interpretive Description approach, guided by complexity theory and the Implementation Roadmap, and used Applied Thematic Analysis methods.
Twenty-five individuals participated in individual or group interviews between March and June 2022, including 21 healthcare professionals, 3 youth and 1 caregiver. We identified two overarching themes. The first theme, ‘Understanding and addressing the underlying reasons for distress’, related to participants’ understanding and vision of TIC in the current setting comprising: (a) ‘Participants’ understanding of TIC’; (b) ‘Trauma screening and trauma processing within TIC’; (c) ‘Taking “a more individualized approach”’; (d) ‘Unit programming’; and (e) “Connecting to the community”. The second theme, ‘Factors that support or limit successful TIC implementation’ comprises: (a) ‘The need for a broad “cultural shift”’; (b) ‘The physical environment on the unit’; and (c) ‘Factors that may limit successful implementation’.
We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of engagement with youth, caregivers and staff in trauma-informed care delivery and implementation, (b) trauma-informed care core programme components, (c) factors that may support or limit success in implementing trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration (partnering with external organizations and sectors).
When implementing TIC, there is an ongoing need to increase clarity regarding TIC interventions and implementation initiatives. Youth, caregiver and healthcare professional participants shared considerations important for planning the delivery and implementation of trauma-informed care in their setting. We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of relational engagement, (b) trauma-informed care programme components, (c) factors that may support or limit successful implementation of trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration. Organizations wishing to implement trauma-informed care should consider ongoing engagement with all relevant knowledge user groups throughout the process.
Standards for Reporting Qualitative Research (SRQR).
The local hospital research institute's Patient and Family Advisory Committee reviewed the draft study methods and provided feedback.
To reduce obesity-related disparities, reaching economically disadvantaged and/or minority status adolescents to assist them in meeting physical activity (PA) and nutrition recommendations is important. To address the problem, a 16-week intervention called Guys/Girls Opt for Activities for Life (GOAL) was designed. The purpose of this randomised controlled trial is to evaluate any effect of the intervention, compared with a control condition, on improving: (1) adolescents’ % body fat (primary outcome), moderate-to-vigorous PA (MVPA), diet quality and cardiorespiratory fitness from 0 to 4 months; (2) body mass index (BMI), overweight/obesity percentage and quality of life from 0 to 4 months and to 13 months; and (3) perceived social support, self-efficacy and motivation from 0 to 4 months with evaluation of any mediating effect on adolescent PA and diet quality. An exploratory aim is to evaluate any effect of the intervention, compared with the control, on improving parents’/guardians’ home environment, MVPA and diet quality from 0 to 4 months; and BMI from 0 to 4 months and to 13 months.
Adolescents (fifth to eighth grade) in 14 schools located in underserved urban communities are randomly assigned to the intervention or usual school offerings. One parent per adolescent is enrolled (882 dyads total). Cohort 1 includes four schools (2022–2023). Cohorts 2 and 3 include 5 schools in 2023–2024 and 2024–2025, respectively. The 16-week intervention has three components: (1) after-school GOAL club for adolescents to engage in PA and healthy eating/cooking activities; (2) three parent–adolescent meetings to empower parents to assist adolescents; and (3) GOAL social networking website for parents to share how they helped their adolescent.
The Michigan State University Biomedical Institutional Review Board provided ethical approval for the study. Findings will be shared via the trial registration database, peer-reviewed publications, conferences and community-oriented strategies.
To examine the contributions of psychosocial factors (attitude towards drinking, perceived drinking norms [PDNs], perceived behavioural control [PBC]), and biological sex on drinking intention and behaviours among rural Thai adolescents.
A cross-sectional study design.
In 2022, stratified by sex and grade, we randomly selected 474 rural Thai adolescents (M age = 14.5 years; SD = 0.92; 50.6% male) from eight public district schools in Chiang Mai Province, Thailand, to complete a self-administered questionnaire. Structural equation modelling with the weighted least square mean and variance adjusted was used for data analysis.
All adolescents' psychosocial factors contributed significantly to the prediction of drinking intention, which subsequently influenced their drinking onset, current drinking and binge drinking pattern in the past 30 days. PDNs emerged as the strongest psychosocial predictor of drinking intention, followed by PBC. Rural adolescents' drinking intention significantly mediated the relationship between all psychosocial factors and drinking behaviours either fully or partially. The path coefficient between drinking attitude and drinking intention was significantly different between males and females.
Different from previous studies focus on adolescents' drinking attitude, rural Thai adolescents' PDNs play a significant role on their drinking intention and subsequently their drinking onset and patterns. This nuanced understanding supports a paradigm shift to target adolescents' perceived drinking norms as a means to delay their drinking onset and problematic drinking behaviours.
Higher levels of perceived drinking norms significantly led to the increase in drinking intention among adolescents. Minimizing adolescents' perceptions of favourable drinking norms and promoting their capacity to resist drinking, especially due to peer pressure, are recommended for nursing roles as essential components of health education campaigns and future efforts to prevent underage drinking.
In this study, there was no public or patient involvement.