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

NCT ID: NCT04778059

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2022-05-10

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

USB002

Group Type: EXPERIMENTAL

USB002

Intervention Type: 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).

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Biotest, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sairam Parthasarathy, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

USB002-2020-001

Identifier Type: -

Identifier Source: org_study_id