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Primary Objective:
• To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19
Secondary Objectives:
Study duration per participant is approximately 28 days including a 14-day treatment period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIR1-365 | Experimental | SIR1-365 dose 1 daily for 14 days |
|
| Matching placebo | Placebo Comparator | Matching placebo dose 1 daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIR1-365 | Drug | Route of administration: oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Qu | Sironax USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Triple O Research Institute | West Palm Beach | Florida | 33407 | United States | ||
| OSF St. Francis Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39872839 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SIR1-365 | SIR1-365 dose 1 daily for 14 days SIR1-365: Route of administration: oral |
| FG001 | Matching placebo | Matching placebo dose 1 daily for 14 days Matching Placebo: Route of administration: oral |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set
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| ID | Title | Description |
|---|---|---|
| BG000 | SIR1-365 | SIR1-365 dose 1 daily for 14 days SIR1-365: Route of administration: oral |
| BG001 | Matching Placebo | Matching placebo dose 1 daily for 14 days Matching Placebo: Route of administration: oral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographics is based on safety set |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Set | Posted | Count of Participants | Participants | Baseline to Day 14 |
|
Baseline to Day 28
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SIR1-365 | SIR1-365 dose 1 daily for 14 days SIR1-365: Route of administration: oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Pulmonary embolism |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fitzgerald, Senior Director Clinical Operation | Sironax | 781-201-3892 | Lisa.Fitzgerald@sironax.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2021 | Sep 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2021 | Sep 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Blinded
| Matching Placebo | Drug | Route of administration: oral |
|
|
| 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) | 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) | 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 | 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 | 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) | 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 | 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 | Baseline to Day 28 |
| Peoria |
| Illinois |
| 61637 |
| United States |
| Baptist Medical Center | Jackson | Mississippi | 39202 | United States |
| Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco | 14050 | Mexico |
| Media Sur - Medica Sur Tlalpan | Tlalpan | Mexico City | 14050 | Mexico |
| Hospital Universitario "Dr. José Eleuterio González" | Monterrey | Nuevo León | 64460 | Mexico |
| Dow University Hospital, Ojha Karachi | Karachi | Sindh | 74200 | Pakistan |
| Sindh Infectious Disease Hospital | Karachi | Sindh | 74200 | Pakistan |
| Aga Khan University Hospital | Karachi | Sindh | 74800 | Pakistan |
| Adverse Event |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|
| Secondary | 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 | Safety Set | Posted | Count of Participants | Participants | Baseline to Day 28 |
|
|
|
| Secondary | 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) | Safety Set | Posted | Count of Participants | Participants | Baseline to Day 14 |
|
|
|
| Secondary | 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) | Safety Set | Posted | Count of Participants | Participants | Baseline to Day 28 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Baseline to Day 14 |
|
|
|
| Secondary | 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 | Safety Set | Posted | Count of Participants | Participants | Baseline to Day 28 |
|
|
|
| Secondary | 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) | ITT Set | Posted | Median | Full Range | Ratio | Baseline to EOT(Day 14) |
|
|
|
| Secondary | 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 | ITT Set | Posted | Median | Full Range | Days | Baseline to Day 14 |
|
|
|
| Secondary | 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 | ITT Set | Posted | Median | Full Range | Days | Baseline to Day 28 |
|
|
|
| 0 |
| 23 |
| 3 |
| 23 |
| 7 |
| 23 |
| EG001 | Matching placebo | Matching placebo dose 1 daily for 14 days Matching Placebo: Route of administration: oral | 0 | 19 | 5 | 19 | 11 | 19 |
|
| Encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Encephalopathy |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment | Neck pain |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Respiratory distress |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Acute respiratory failure |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment | Acute myocardial infarction |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Haemoptysis |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Pneumonia |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Respiratory failure |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Burning sensation |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Dizziness |
|
| Encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Encephalopathy |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Hypoaesthesia |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Peripheral sensory neuropathy |
|
| Fungal skin infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Fungal skin infection |
|
| Dengue fever | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Dengue fever |
|
| Oral candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Oral candidiasis |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Urinary tract infection |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment | Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment | Aspartate aminotransferase increased |
|
| Troponin I increased | Investigations | MedDRA 23.1 | Systematic Assessment | Troponin I increased |
|
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment | Hypertension |
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment | Hypotension |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment | Orthostatic hypotension |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment | Constipation |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment | Paraesthesia oral |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment | Hyperkalaemia |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment | Lactic acidosis |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment | Acute myocardial infarction |
|
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment | Chest pain |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment | Neck pain |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Pneumonia |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Pulmonary embolism |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Acute respiratory failure |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Haemoptysis |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Pulmonary oedema |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Respiratory distress |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment | Respiratory failure |
|
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| D007239 |
| Infections |