MedTrace Logo

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

NCT04622332 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-11-12

Study results available
· View outcomes & findings →

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

Conditions

  • Corona Virus Infection

Interventions

DRUG

SIR1-365

Route of administration: oral

DRUG

Matching Placebo

Route of administration: oral

Sponsors & Collaborators

  • Sironax USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Clare Qu · Sironax USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2021-11-27
Completion
2021-11-27
FDA Drug
Yes

Countries

  • United States
  • Mexico
  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622332 on ClinicalTrials.gov