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

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

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

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2 Infection; Respiratory Distress Syndrome, Adult; Adult Respiratory Distress Syndrome; COVID-19 Virus Infection; SARS Coronavirus 2 Infection; 2019 Novel Coronavirus Infection
• Intervention / Treatment: Drug: USB002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).
Experimental: USB002	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: US Biotest, Inc.
• Investigators: Principal Investigator: Sairam Parthasarathy, MD, The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Coronavirus Infections; Syndrome; Infections; Communicable Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: USB002-2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No