Trial Outcomes & Findings for A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19 (NCT NCT04622332)
NCT ID: NCT04622332
Last Updated: 2025-11-12
Results Overview
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.
COMPLETED
PHASE1
45 participants
Baseline to Day 14
2025-11-12
Participant Flow
Participant milestones
| Measure |
SIR1-365
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
SIR1-365
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Demographics is based on safety set
Baseline characteristics by cohort
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching Placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=10 Participants • Demographics is based on safety set
|
0 Participants
n=10 Participants • Demographics is based on safety set
|
0 Participants
n=20 Participants • Demographics is based on safety set
|
|
Age, Categorical
Age · Between 18 and 65 years
|
18 Participants
n=10 Participants • Demographics is based on safety set
|
16 Participants
n=10 Participants • Demographics is based on safety set
|
34 Participants
n=20 Participants • Demographics is based on safety set
|
|
Age, Categorical
Age · >=65 years
|
5 Participants
n=10 Participants • Demographics is based on safety set
|
3 Participants
n=10 Participants • Demographics is based on safety set
|
8 Participants
n=20 Participants • Demographics is based on safety set
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=10 Participants
|
14 Participants
n=10 Participants
|
29 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=10 Participants
|
12 Participants
n=10 Participants
|
24 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
18 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=10 Participants
|
4 participants
n=10 Participants
|
11 participants
n=20 Participants
|
|
Region of Enrollment
Mexico
|
10 participants
n=10 Participants
|
11 participants
n=10 Participants
|
21 participants
n=20 Participants
|
|
Region of Enrollment
Pakistan
|
6 participants
n=10 Participants
|
4 participants
n=10 Participants
|
10 participants
n=20 Participants
|
|
Body Mass Index (BMI)
|
29.75 kg/m^2
STANDARD_DEVIATION 6.920 • n=10 Participants
|
30.76 kg/m^2
STANDARD_DEVIATION 6.786 • n=10 Participants
|
30.20 kg/m^2
STANDARD_DEVIATION 6.795 • n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 14Population: Safety Set
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.
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Set
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
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Safety Endpoint - 1 : Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 28
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: Safety Set
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)
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Safety Endpoint -2 : Proportion of Patients With Any SAEs During the Study Baseline to Day 14
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Set
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)
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Safety Endpoint -3 : Number of Patients With Any SAEs During the Study Baseline to Day 28
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 14This 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
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Safety Endpoint -4 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 14
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Safety Set
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
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Safety Endpoint -5 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 28
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to EOT(Day 14)Population: ITT Set
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)
Outcome measures
| Measure |
SIR1-365
n=22 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=20 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Efficacy Endpoint -1 : Change in Derived PaO2/FiO2 Ratio From Baseline
|
241 Ratio
Interval 75.0 to 528.0
|
193 Ratio
Interval 71.0 to 298.0
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: ITT Set
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
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Efficacy Endpoint -2 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 14)
|
0 Days
Interval 0.0 to 7.2
|
0 Days
Interval 0.0 to 7.2
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: ITT Set
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
Outcome measures
| Measure |
SIR1-365
n=23 Participants
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 Participants
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Secondary Efficacy Endpoint -3 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 28)
|
1.60 Days
Interval 0.0 to 27.7
|
3 Days
Interval 0.0 to 22.0
|
Adverse Events
SIR1-365
Matching placebo
Serious adverse events
| Measure |
SIR1-365
n=23 participants at risk
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 participants at risk
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Nervous system disorders
Encephalopathy
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
Other adverse events
| Measure |
SIR1-365
n=23 participants at risk
SIR1-365 dose 1 daily for 14 days
SIR1-365: Route of administration: oral
|
Matching placebo
n=19 participants at risk
Matching placebo dose 1 daily for 14 days
Matching Placebo: Route of administration: oral
|
|---|---|---|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Infections and infestations
Fungal skin infection
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Infections and infestations
Dengue fever
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Infections and infestations
Oral candidiasis
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
15.8%
3/19 • Number of events 3 • Baseline to Day 28
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
10.5%
2/19 • Number of events 2 • Baseline to Day 28
|
|
Investigations
Troponin I increased
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Vascular disorders
Orthostatic hypotension
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Gastrointestinal disorders
Paraesthesia oral
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
General disorders
Chest pain
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
0.00%
0/19 • Baseline to Day 28
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
1/23 • Number of events 1 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/23 • Baseline to Day 28
|
5.3%
1/19 • Number of events 1 • Baseline to Day 28
|
Additional Information
Lisa Fitzgerald, Senior Director Clinical Operation
Sironax
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place