Back to resultsSafety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Primary Purpose
2019 Novel Coronavirus Infection, COVID-19 Virus Infection, SARS Coronavirus 2 Infection
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
USB002
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 2019 Novel Coronavirus Infection
Eligibility Criteria
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:
- 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.
Sites / Locations
- The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
USB002
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with treatment emergent adverse events (TEAE)
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04778059
Brief Title
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Official Title
Phase 2 Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravenous USB002 to Treat Patients With Respiratory Distress Due to COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll in timely manner due to nature of COVID
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Biotest, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019 Novel Coronavirus Infection, COVID-19 Virus Infection, SARS Coronavirus 2 Infection, SARS-CoV-2 Infection, Respiratory Distress Syndrome, Adult, Adult Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USB002
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
USB002
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events (TEAE)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sairam Parthasarathy, MD
Organizational Affiliation
The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
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