Trial Outcomes & Findings for Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19 (NCT NCT04440007)

Last Updated: 2023-01-18

Results Overview

Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities: * Noninvasive positive pressure ventilation or continuous positive airway pressure * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥ 0.5) * Extracorporeal membrane oxygenation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

Randomization to Day 28

Results posted on

2023-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Abivertinib With Standard of Care STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Overall Study STARTED	48	48
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	12	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Abivertinib With Standard of Care STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	3
Overall Study Death	7	2
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	2	1
Overall Study Inability to draw blood for labs and being transferred to a nursing facility with no transportation	1	2
Overall Study Discontinued prior to dosing	0	2

Baseline Characteristics

Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator	Total n=96 Participants Total of all reporting groups
Age, Customized Age	59.9 years STANDARD_DEVIATION 12.38 • n=5 Participants	57.4 years STANDARD_DEVIATION 12.88 • n=7 Participants	58.6 years STANDARD_DEVIATION 12.63 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	33 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	48 participants n=7 Participants	96 participants n=5 Participants
Weight	101.94 kg STANDARD_DEVIATION 30.694 • n=5 Participants	100.12 kg STANDARD_DEVIATION 25.855 • n=7 Participants	101.03 kg STANDARD_DEVIATION 28.243 • n=5 Participants

PRIMARY outcome

Timeframe: Randomization to Day 28

Population: A total of 48 subjects in the STI-5656 group and 48 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Percentage of Subjects Alive and Free of Respiratory Failure at Day 28	40 Participants	38 Participants

SECONDARY outcome

Timeframe: Randomization through study completion to 94 days

Population: A total of 48 subjects in the STI-5656 group and 46 subjects in the placebo group were included in the analysis of the secondary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the secondary endpoint analysis was that they had no baseline value available. 46 subjects were analyzed for the placebo group as 2 subjects were randomized to the placebo group who ET prior to dosing.

Number of Participants with Treatment-emergent Adverse Events

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=46 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Number of Participants With Treatment-emergent Adverse Events	31 Participants	23 Participants

SECONDARY outcome

Timeframe: Randomization to Day 60

Percentage of subjects alive and free of respiratory failure at Day 60

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60	37 Participants	35 Participants

SECONDARY outcome

Timeframe: Day 7

Mean change in CRP on Day 7

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Change in C-Reactive Protein (CRP)	71.43 ng/ml Standard Deviation 527.102	66.67 ng/ml Standard Deviation 755.613

SECONDARY outcome

Timeframe: Day 1

PaO2/FiO2 at Day 1

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)	210.61 mmHG Standard Deviation 112.686	253.34 mmHG Standard Deviation 103.679

SECONDARY outcome

Timeframe: Day 60 and Day 90

All-cause mortality at Day 60 and Day 90

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
All-cause Mortality at Day 60 and Day 90 Day 60	8 Participants	5 Participants
All-cause Mortality at Day 60 and Day 90 Day 90	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Randomization up to Day 28

Number of days alive outside of hospital up to Day 28

Outcome measures

Outcome measures
Measure	Abivertinib With Standard of Care n=48 Participants STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=48 Participants Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Number of Days Alive Outside of Hospital up to Day 28	16.7 days Interval 13.97 to 19.4	17.1 days Interval 14.37 to 19.8

Adverse Events

Abivertinib With Standard of Care

Serious events: 9 serious events

Other events: 31 other events

Deaths: 8 deaths

Placebo With Standard of Care

Serious events: 8 serious events

Other events: 24 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Mike Royal, MD

Sorrento Therapeutics, Inc.

Phone: 858-203-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Abivertinib With Standard of Care n=48 participants at risk STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=46 participants at risk Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	8.3% 4/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	8.7% 4/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Renal and urinary disorders Acute kidney injury	8.3% 4/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	4.3% 2/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.2% 2/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Sepsis	4.2% 2/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Septic shock	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Pneumonia	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Blood and lymphatic system disorders Anaemia	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Cardiac disorders Atrial fibrillation	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
General disorders Brain death	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Nervous system disorders Brain injury	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations COVID-19 pneumonia	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Renal and urinary disorders Haematuria	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Investigations Hepatic enzyme increased	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Hepatobiliary disorders Ischaemic hepatitis	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
General disorders Multiple organ dysfunction syndrome	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.

Other adverse events
Measure	Abivertinib With Standard of Care n=48 participants at risk STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Standard of Care: Standard of Care as determined by the Investigator	Placebo With Standard of Care n=46 participants at risk Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator
Blood and lymphatic system disorders Leukocytosis	12.5% 6/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	4.3% 2/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Blood and lymphatic system disorders Thrombocytopenia	10.4% 5/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Cardiac disorders Bradycardia	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	8.7% 4/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Gastrointestinal disorders Constipation	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Candida infection	2.1% 1/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Pneumonia bacterial	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Urinary tract infection	8.3% 4/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	4.3% 2/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Investigations Alanine aminotransferase increased	8.3% 4/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Metabolism and nutrition disorders Hyperglycaemia	18.8% 9/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Metabolism and nutrition disorders Hypokalaemia	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Metabolism and nutrition disorders Hyponatraemia	4.2% 2/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	8.7% 4/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Psychiatric disorders Anxiety	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	8.7% 4/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Vascular disorders Hypotension	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	4.3% 2/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Blood and lymphatic system disorders Anaemia	4.2% 2/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Infections and infestations Sepsis	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Investigations Hepatic enzyme increased	10.4% 5/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Renal and urinary disorders Acute kidney injury	12.5% 6/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	12.5% 6/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	8.7% 4/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	6.5% 3/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	8.3% 4/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	0.00% 0/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 3/48 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.	2.2% 1/46 • From signing of informed consent until end-of-trial visit, up to 94 days Treatment-emergent adverse events (TEAE) will be defined as any AE occurring post first administration of study drug. AEs will be coded using MedDRA dictionary. AE collection was assessed in the Safety population (total number of subjects dosed including placebo) only 46 participants were considered at risk for AE's in the placebo arm due to 2 participants not being treated with study IP, whereas the All-Cause Mortality was assessed in the FAS population.