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

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

Official Title
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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

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

Intervention / Treatment
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* Drug: USB002
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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) |