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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
USB002
  • 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).
Placebo Comparator
Placebo
  • 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).

Recruiting Locations

More Details

NCT ID
NCT04778059
Status
Terminated
Sponsor
US Biotest, Inc.