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A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19

Corona Virus Infection Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19

Clinical Trial 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

Clinical Trial Description

Study duration per participant is approximately 28 days including a 14-day treatment period ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04622332
Study type Interventional
Source Sironax USA, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 18, 2020
Completion date November 27, 2021
View Details
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