CD2H COVID-19

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

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

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

Arm	Description	Assigned 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.