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

NCT04778059 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: USB002-2020-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

USB002

EXPERIMENTAL

Drug: USB002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

USB002 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).

USB002

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Biotest, Inc.: lead

Study Sites (1)

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

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

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.

Results Point of Contact

• Title: Dr. Gere diZerega
• Organization: US Biotest, Inc.

gere.dizerega@usbiotest.com

8055951300

Study Officials

• Sairam Parthasarathy, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: July 27, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)