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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04778059
• Other study ID #: USB002-2020-001
• Status: Terminated
• Phase: Phase 2
• Start date: July 27, 2021
• Est. completion date: May 10, 2022

Study information

• Verified date: November 2023
• Source: US Biotest, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent from patient or legal representative;

2. Age 18 or greater;

3. Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (=10 days);

4. Respiratory rate > 20 RR;

5. SpO2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ECMO;

6. Chest X-ray confirming bilateral pulmonary infiltrates;

7. Body mass index of = 40 units/kg/m2;

8. Adequate method of birth control.

Exclusion Criteria:

1. Terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma;

2. Hospitalization expected to be < 96 hours due to medical improvement;

3. Interstitial lung disease;

4. Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) > 450 ms;

5. History of hypotension (mean arterial blood pressure < 65 mmHg), unrelated to CoVID-19 infection;

6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal;

7. Participating concurrently on another clinical trial for the experimental treatment of COVID-19;

8. Active chemotherapy use;

9. Pregnant and/or lactating women.

Related Conditions & MeSH terms

• 2019 Novel Coronavirus Infection
• Acute Lung Injury
• Adult Respiratory Distress Syndrome
• Communicable Diseases
• Coronavirus Infections
• COVID-19
• COVID-19 Virus Infection
• Infections
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• SARS Coronavirus 2 Infection
• SARS-CoV-2 Infection
• Syndrome

Intervention

Drug:
• USB002
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).
• Placebo
The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).

Locations

Country	Name	City	State
United States	The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
US Biotest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Day 1 to Day 70 (or date of final measurement, if sooner)