TerminatedNCT04778059Updated Dec 1, 2023Results posted

Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19

A Phase 2 interventional study of USB002 and Placebo in 2019 Novel Coronavirus Infection, COVID-19 Virus Infection and SARS Coronavirus 2 Infection, sponsored by US Biotest, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by US Biotest, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

Unable to enroll in timely manner due to nature of COVID

Phase: Phase 2
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.

Conditions studied

2019 Novel Coronavirus Infection
COVID-19 Virus Infection
SARS Coronavirus 2 Infection
SARS-CoV-2 Infection
Respiratory Distress Syndrome, Adult
Adult Respiratory Distress Syndrome

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 21 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

US Biotest, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Signed informed consent from patient or legal representative;
Age 18 or greater;
Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10 days);
Respiratory rate > 20 RR;
SpO2 \< 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ECMO;
Chest X-ray confirming bilateral pulmonary infiltrates;
Body mass index of ≤ 40 units/kg/m2;
Adequate method of birth control.

Exclusion criteria

Exclusion Criteria:

Terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma;
Hospitalization expected to be \< 96 hours due to medical improvement;
Interstitial lung disease;
Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) > 450 ms;
History of hypotension (mean arterial blood pressure \< 65 mmHg), unrelated to CoVID-19 infection;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal;
Participating concurrently on another clinical trial for the experimental treatment of COVID-19;
Active chemotherapy use;
Pregnant and/or lactating women.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 21 participants (actual)

Study arms

Experimental
USB002
Drug: USB002
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugUSB002
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).
DrugPlacebo
The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).

What researchers measure

Primary outcomes

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

Results

Posted Dec 1, 2023

Limitations and caveats

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.

Participant flow

Participant flow — Overall Study
Milestone	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo
Started	3	3	3	2	10
Completed	1	1	2	1	7
Not completed	2	2	1	1	3
Withdrew: Death	2	2	1	1	1
Withdrew: Lost to follow-up	0	0	0	0	1
Withdrew: Telemed not done due to internal miscommunication.	0	0	0	0	1

Outcome measures

PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAE)

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

Time frame:: Day 1 to Day 70 (or date of final measurement, if sooner)
Reported as:: Count of participants · Participants

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Participants	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo
Number of Participants With Treatment Emergent Adverse Events (TEAE)	2	3	2	2	8

Adverse events

Collected over Up to 70 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
USB002 90 ug/kg/Day	2/3 (66.7%)	2/3 (66.7%)	2/3 (66.7%)
USB002 300 ug/kg/Day	2/3 (66.7%)	2/3 (66.7%)	3/3 (100%)
USB002 600 ug/kg/Day	1/3 (33.3%)	1/3 (33.3%)	2/3 (66.7%)
USB002 900 ug/kg/Day	1/2 (50%)	1/2 (50%)	2/2 (100%)
Placebo	1/10 (10%)	1/10 (10%)	8/10 (80%)

Most frequent serious events

Most frequent serious events
Event	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo
DeathGeneral disorders	0/3	0/3	0/3	1/2	0/10
Withdrawal of life supportSurgical and medical procedures	1/3	0/3	0/3	0/2	0/10
Multiple organ dysfunction syndromeGeneral disorders	1/3	0/3	0/3	0/2	0/10
Cerebral haemorrhageNervous system disorders	0/3	1/3	0/3	0/2	0/10
COVID-19 pneumoniaInfections and infestations	0/3	1/3	0/3	0/2	0/10
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	0/3	0/3	1/3	0/2	1/10
Septic shockInfections and infestations	0/3	0/3	1/3	0/2	0/10
HypotensionVascular disorders	0/3	0/3	0/3	0/2	1/10
Respiratory FailureRespiratory, thoracic and mediastinal disorders	0/3	0/3	0/3	0/2	1/10

Most frequent other events

Showing 10 of 59

Most frequent other events
Event	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo
NauseaGastrointestinal disorders	1/3	2/3	0/3	0/2	0/10
PneumoniaInfections and infestations	2/3	1/3	0/3	0/2	0/10
Pneumonia fungalInfections and infestations	0/3	2/3	0/3	0/2	1/10
AnxietyPsychiatric disorders	0/3	2/3	0/3	0/2	1/10
HypoalbuminaemiaMetabolism and nutrition disorders	0/3	0/3	0/3	1/2	0/10
Acute kidney injuryRenal and urinary disorders	1/3	0/3	1/3	1/2	1/10
RashSkin and subcutaneous tissue disorders	0/3	0/3	0/3	1/2	1/10
LeukocytosisBlood and lymphatic system disorders	1/3	1/3	0/3	0/2	0/10
ThrombocytopeniaBlood and lymphatic system disorders	0/3	1/3	0/3	0/2	1/10
Acute myocardial infarctionCardiac disorders	0/3	1/3	0/3	0/2	0/10

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo	Total
Mean	52.0 ± 18.25	57.0 ± 8.66	61.0 ± 12.17	78.5 ± 0.71	59.8 ± 8.18	57.9 ± 16.2

Sex: Female, Male
Sex: Female, Male(Participants)	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo	Total
Female	2	0	2	1	0	5
Male	1	3	1	1	10	16

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo	Total
Hispanic or Latino	2	1	2	0	5	10
Not Hispanic or Latino	1	2	1	2	5	11
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	1	0	0	1
Black or African American	0	0	0	0	0	0
White	3	3	2	2	10	20
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	USB002 90 ug/kg/Day	USB002 300 ug/kg/Day	USB002 600 ug/kg/Day	USB002 900 ug/kg/Day	Placebo	Total
United States	3	3	3	2	10	21

Study locations

1 site

The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
Tucson, Arizona 85724, United States

References and documents

Study documents

Study protocol · Feb 17, 2022
Statistical analysis plan · Dec 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04778059
Lead sponsor: US Biotest, Inc.
Responsible party: Sponsor
First posted: Mar 2, 2021
Start date: Jul 27, 2021
Primary completion: May 10, 2022
Completion: May 10, 2022
Results posted: Dec 1, 2023
Last update: Dec 1, 2023

Study contacts

Sairam Parthasarathy, MD

principal investigator · The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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