Corona Virus InfectionPhase 1NCT04622332
A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
A Phase 1 study testing SIR1-365 in people with Corona Virus Infection, run by Sironax USA, Inc. at 9 sites in 3 countries.
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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- SIR1-365
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 18 Dec 2020to 27 Nov 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 < 300 mmHg.
- Men or women ≥18 but ≤80 years of age at the time of signing the informed consent.
- Patient is able to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Who cannot join
- Patient requires endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States3 sites
Baptist Medical Center
Jackson, Mississippi, 39202
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Triple O Research Institute
West Palm Beach, Florida, 33407
Mexico3 sites
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 14050
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
Media Sur - Medica Sur Tlalpan
Tlalpan, Mexico City, 14050
Pakistan3 sites
Dow University Hospital, Ojha Karachi
Karachi, Sindh, 74200
Sindh Infectious Disease Hospital
Karachi, Sindh, 74200
Aga Khan University Hospital
Karachi, Sindh, 74800
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Primary Objective:
- To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19
Read more
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
Read the detailed description
Study duration per participant is approximately 28 days including a 14-day treatment period
- Conditions
- Corona Virus Infection
- Being tested
- SIR1-365, Matching Placebo
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR1-365Drug
Also called Pharmaceutical form: tablets
Route of administration: oral
Matching PlaceboDrug
Also called Pharmaceutical form: tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SIR1-365 | Experimental | SIR1-365 dose 1 daily for 14 days Receives: Drug: SIR1-365 |
| Matching placebo | Placebo comparator | Matching placebo dose 1 daily for 14 days Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14
Number of participants who experienced at least one treatment-emergent adverse event (TEAE), defined as any adverse event with an onset date on or after the first dose of study drug and up to and including Day 14 post-baseline, regardless of causality. TEAEs are reported per standard MedDRA terminology and severity grading. This is a safety endpoint assessed in the safety population.
Measured: Baseline to Day 14
Secondary outcomes (8)
Secondary Safety Endpoint - 1 : Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 28
This secondary safety endpoint assesses the overall tolerability of the study intervention by counting the number of participants who experienced one or more treatment-emergent adverse events (TEAEs) during the specified treatment period
Measured: Baseline to Day 28
Secondary Safety Endpoint -2 : Proportion of Patients With Any SAEs During the Study Baseline to Day 14
This secondary safety endpoint evaluates the proportion of patients in the study population who experienced one or more serious adverse events (SAEs), as defined by regulatory standards (e.g., resulting in death, life-threatening events, hospitalization, persistent disability, or other medically significant conditions), occurring from baseline (Day 0) through Day 14 (inclusive)
Measured: Baseline to Day 14
Secondary Safety Endpoint -3 : Number of Patients With Any SAEs During the Study Baseline to Day 28
This secondary safety endpoint evaluates the proportion of patients in the study population who experienced one or more serious adverse events (SAEs), as defined by regulatory standards (e.g., resulting in death, life-threatening events, hospitalization, persistent disability, or other medically significant conditions), occurring from baseline (Day 0) through Day 28 (inclusive)
Measured: Baseline to Day 28
Secondary Safety Endpoint -4 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 14
This secondary safety endpoint assesses the incidence of any TEAE deemed related to the study drug (investigator-assessed causality) from baseline (Day 1, pre-dose) through Day 14 (inclusive). TEAEs are defined as adverse events (AEs) with an onset date on or after the first dose of study drug, regardless of severity or seriousness
Measured: Baseline to Day 14
Secondary Safety Endpoint -5 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 28
This secondary safety endpoint assesses the incidence of any TEAE deemed related to the study drug (investigator-assessed causality) from baseline (Day 1, pre-dose) through Day 28 (inclusive). TEAEs are defined as adverse events (AEs) with an onset date on or after the first dose of study drug, regardless of severity or seriousness
Measured: Baseline to Day 28
Secondary Efficacy Endpoint -1 : Change in Derived PaO2/FiO2 Ratio From Baseline
The PaO2/FiO2 ratio is a clinical measure of oxygenation efficiency, calculated as the arterial partial pressure of oxygen (PaO2, in mmHg) divided by the fraction of inspired oxygen (FiO2, expressed as a decimal between 0 and 1). The endpoint assesses the absolute change in this ratio from baseline (defined as the value at randomization or study entry, typically within 24 hours prior to intervention) to the specified post-baseline time point(s) (e.g., Day 7, End of Treatment, or as per protocol)
Measured: Baseline to EOT(Day 14)
Secondary Efficacy Endpoint -2 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 14)
This secondary efficacy endpoint quantifies the cumulative number of days, from baseline (defined as the start of study intervention or randomization) through Day 14 (inclusive), during which participants did not require supplemental oxygen therapy
Measured: Baseline to Day 14
Secondary Efficacy Endpoint -3 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 28)
This secondary efficacy endpoint quantifies the cumulative number of days, from baseline (defined as the start of study intervention or randomization) through Day 28 (inclusive), during which participants did not require supplemental oxygen therapy
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start18 Dec 2020
- Primary completion27 Nov 2021
- Study completion27 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sironax USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clare Qu, Study director, Sironax USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622332
- Sponsor's protocol ID
- SIR365-US-101
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2020
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chavez-Tapia N, Sayeed MA, Luxmi S, Kasper DJ, Xue F, Shen Y, Fan W, Yuan W, Du B. Safety and efficacy of selective RIPK1 inhibitor SIR1-365 in hospitalized patients with severe COVID-19: A multicenter, randomized, double-blind, phase 1b trial. J Intensive Med. 2024 Sep 12;5(1):70-78. doi: 10.1016/j.jointm.2024.07.003. eCollection 2025 Jan.
PubMed 39872839