A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Status:
Recruiting
Trial end date:
2021-12-15
Target enrollment:
Participant gender:
Summary
Primary Objective:
• To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19
Secondary Objectives:
- To assess the clinical efficacy of SIR1-365 in patients with severe COVID-19
- To assess the effects of SIR1-365 on multiple inflammatory biomarker levels including
C-reactive protein (CRP), ferritin, lymphocyte and neutrophil counts, cytokines, and
chemokines
- To assess the effects of SIR1-365 on biomarkers indicative of target engagement in
patients with severe COVID-19
- To assess the effects of SIR1-365 on biomarkers indicative of kidney injury in patients
with severe COVID-19
- To assess the effects of SIR1-365 on biomarkers indicative of cardiovascular endothelial
cell damage in patients with severe COVID-19
- To characterize plasma pharmacokinetics (PK) of SIR1-365 in patients with severe
COVID-19