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

NCT04778059 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-12-01

Study results available
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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

Interventions

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).

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).

Sponsors & Collaborators

  • US Biotest, Inc.

    lead INDUSTRY

Principal Investigators

  • Sairam Parthasarathy, MD · The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2022-05-10
Completion
2022-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778059 on ClinicalTrials.gov