Safety and Efficacy of USB002 for Respiratory Distress Du... | NCT04778059

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
USB002	Experimental		Drug: USB002
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
USB002	Drug	USB002 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (A-II), and is suspended in a vehicle as a sterile solution of USB002. Depending upon cohort assignment, subjects in the USB002 group will receive one of four doses of USB002 administered intravenously (IV).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAE)	Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)	Day 1 to Day 70 (or date of final measurement, if sooner)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Sairam Parthasarathy, MD	The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals		Tucson	Arizona	85724	United States

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	USB002 90 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
FG001	USB002 300 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 17, 2022	Aug 14, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	USB002 90 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
BG001	USB002 300 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
BG002	USB002 600 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
BG003	USB002 900 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
BG004	Placebo	Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG0023 BG0032 BG00410 BG00521

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.0± 18.25 BG00157.0± 8.66 BG00261.0± 12.17 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0003 BG0013 BG002

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 Participants With Treatment Emergent Adverse Events (TEAE)

Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

All enrolled subjects who received a USB002 or Placebo infusion were included in the analysis population for all outcomes analyzed.

Posted

Count of Participants

Participants

Day 1 to Day 70 (or date of final measurement, if sooner)

ID	Title	Description
OG000	USB002 90 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
OG001	USB002 300 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
OG002	USB002 600 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
OG003	USB002 900 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
OG004	Placebo	Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0013 OG0022 OG003

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	USB002 90 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.	2	3	2	3	2	3
EG001	USB002 300 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.	2	3	2	3	3	3
EG002	USB002 600 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.	1	3	1	3	2	3
EG003	USB002 900 ug/kg/Day	Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.	1	2	1	2	2	2
EG004	Placebo	Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.	1	10	1	10	8	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Withdrawal of life support	Surgical and medical procedures	MedDRA 24	Systematic Assessment	Care Withdrawn	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG0030 events0 affected2 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24	Systematic Assessment	Multiorgan dysfunction/Failure	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 24	Systematic Assessment	Brain Hemorrhage	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	Worsening Covid Pneumonia	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment		EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Septic shock	Infections and infestations	MedDRA 24	Systematic Assessment	Septic shock likely due to COVID-19 pneumonia and bacterial pneumonia	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Death	General disorders	MedDRA 24	Systematic Assessment	Death, unknown	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 24	Systematic Assessment	Worsening hypotension secondary to septic shock	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	Worsening hypercapnic respiratory failure requiring intubation and mechanical ventilation	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG0030 events0 affected2 at risk EG0041 events1 affected10 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Right ventricular dysfunction	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0020 events0 affected3 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Swelling face	General disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0003 events2 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0020 events0 affected3 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Sepsis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Septic shock	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Fibrin D dimer increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
International normalised ratio increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Tremor	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0020 events0 affected3 at risk EG003
Delirium	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Haematoma	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 24	Systematic Assessment	EG0002 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Shock	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003

Per protocol, this clinical trial was designed to include two parts (Part 1 - dose escalation phase; Part 2 - dose expansion phase). Part 2 did not proceed due to enrolment difficulty. Sponsor encountered challenges in finding subjects that met study eligibility criteria. This was likely due to the role COVID-19 vaccinations played, limiting the spread and hospitalizations of COVID-19 patients. Sponsor terminated the trial early, when 21 subjects (all Part 1) had been enrolled.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders