Phase 1
N=45
A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Corona Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04622332 ↗Enrolled (actual)
45
Serious AEs
19.1%
Results posted
Nov 2025
Primary outcome: Primary: Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14 — 5; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- SIR1-365 (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sironax USA, Inc.
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14 |
5; 10 | — |
| SECONDARY Secondary Safety Endpoint - 1 : Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 28 |
7; 11 | — |
| SECONDARY Secondary Safety Endpoint -2 : Proportion of Patients With Any SAEs During the Study Baseline to Day 14 |
1; 5 | — |
| SECONDARY Secondary Safety Endpoint -3 : Number of Patients With Any SAEs During the Study Baseline to Day 28 |
3; 5 | — |
| SECONDARY Secondary Safety Endpoint -4 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 14 |
2; 1 | — |
| SECONDARY Secondary Safety Endpoint -5 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 28 |
2; 1 | — |
| SECONDARY Secondary Efficacy Endpoint -1 : Change in Derived PaO2/FiO2 Ratio From Baseline |
241; 193 | — |
| SECONDARY Secondary Efficacy Endpoint -2 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 14) |
0; 0 | — |
| SECONDARY Secondary Efficacy Endpoint -3 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 28) |
1.60; 3 | — |
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
Eligibility Criteria
Inclusion Criteria
- Hospitalized patient with clinical diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.
- Symptoms suggestive of severe systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
- Clinical signs indicative of severe systemic illness with COVID-19, which could include any of the following clinical signs: respiratory rate ≥ 30 per minutes, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air, or PaO2/FiO2 ratio 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure.
- Patient with shock defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressor.
- Patient with multi-organ dysfunction or failure defined by an increase in the Sequential Organ Failure Assessment score of 2 points or more.
- Patient is unlikely to survive beyond 2 days at the discretion of Investigator.
- Patient has used chronic systemic corticosteroids within 2 weeks prior to screening.
- Patient with positive results for human immunodeficiency virus (HIV) or hepatitis B or C test.
- Patient has known active tuberculosis (TB), history of uncontrolled TB, suspected or known systemic bacterial or fungal infections within 4 weeks prior to screening.
- Patient has any other condition, which makes the patient unsuitable for study participation
Data sourced from ClinicalTrials.gov (NCT04622332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.