NCT04622332

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sironax USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
DRUG	SIR1-365	Route of administration: oral
DRUG	Matching Placebo	Route of administration: oral

Timeline

• Start date: 2020-12-18
• Primary completion: 2021-11-27
• Completion: 2021-11-27
• First posted: 2020-11-09
• Last updated: 2025-11-12
• Results posted: 2025-11-12

Locations

9 sites across 3 countries: United States, Mexico, Pakistan

Regulatory

• FDA-regulated drug study