Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04622332
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Sponsor:
Sironax USA, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
• 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
Detailed Description:
Study duration per participant is approximately 28 days including a 14-day treatment period
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: