Trials / Terminated
TerminatedNCT04778059
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- US Biotest, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2021-07-27
- Primary completion
- 2022-05-10
- Completion
- 2022-05-10
- First posted
- 2021-03-02
- Last updated
- 2023-12-01
- Results posted
- 2023-12-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04778059. Inclusion in this directory is not an endorsement.