Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Objective

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.

Design

Phase 2a randomised, placebo-controlled, double-blinded, trial.

Setting

Hospitals in Canada, Turkey and the USA.

Participants

A total of 61 subjects with moderate-to-severe COVID-19.

Interventions

Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.

Primary and secondary outcome measures

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.

Results

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.

Conclusion

In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.

Trial registration number

NCT04402957.

Prevalence of undernutrition and associated factors among street adolescents in adama town, oromia regional state, Ethiopia, 2023: A cross sectional study

Por: Tsinukal Tesfaye · Ebissa Bayana Kebede · Vinod Bagilkar · Fentahun Meseret

by Tsinukal Tesfaye, Ebissa Bayana Kebede, Vinod Bagilkar, Fentahun Meseret

Background

Undernutrition remains a serious public health problem in developing countries, including Ethiopia. In particular, street adolescents are more at risk for undernutrition because they are the most underprivileged population. However, there is a paucity of information about undernutrition among street adolescents in Ethiopia.

Objective

To assess the prevalence of undernutrition (stunting and thinness) and factors associated with undernutrition among street adolescents in Adama town, Oromia regional state, Ethiopia, 2023.

Method

A community-based cross sectional study was conducted among 358 street adolescents from January 15–30, 2023. A convenience sampling technique was used to select the required sample size. A structured, interviewer-administered questionnaire was used to collect the data from the respondents. The collected data were checked, coded, entered into Epidata 4.6 and exported to Statistical Package for Social Sciences version 25. Both Bivariable and Multivariable logistic regression analyses were conducted to determine the factors that are associated with thinness and stunting. P values below 0.05 at the 95% confidence interval were considered indicative of a statistically significant association. Finally, statements, graphs, tables and charts were used for result presentation.

Result

This study revealed that, the prevalence of undernutrition was 47.2%. Thinness and stunting accounted for 20.4% and 34.1% respectively and 7.3% both thinness and stuting. Age (adusted odd ratio = 1.41; 95% confidence interval: 1.17–1.71), skipped one or more meals per day ((adusted odd ratio = 3.50; 95% confidence interval: 1.23–9.94), drinking unprotected water source ((adusted odd ratio = 3.23; 95% confidence interval: 1.49–6.98) and use of mastish ((adusted odd ratio = 2.91; 95% confidence interval: 1.19–7.12) were factors statistically associated with thinness. Being skipped one or more meals per day ((adusted odd ratio = 4.14; 95% confidence interval: 1.87–9.14), washing hands before meals ((adusted odd ratio = 0.46; 95% confidence interval: 0.26–0.81) and moderate depression ((adusted odd ratio = 2.93; 95% confidence interval: 1.05–8.15) were factors significantly associated with stunting.

Conclusion and recommendation

In conculusion, the prevalence of undernutrition (thinness, stunting or both together) was high among street adolescents. To enhance street adolecents’ nutritional status, targeted nutritional treatments, providing health services and good hygiene and sanitatios practices are urgently needed.

FreshRSS

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Prevalence of undernutrition and associated factors among street adolescents in adama town, oromia regional state, Ethiopia, 2023: A cross sectional study