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).

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).

Publication date: Mar 15, 2024

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 (O ≥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. NCT04402957.

Open Access PDF

Concepts Keywords
Canada Clinical Trial
Hospitals COVID-19
Invasive INFECTIOUS DISEASES
Kidney Safety
Nct04402957

Original Article

(Visited 1 times, 1 visits today)