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

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ClinicalTrials.gov Identifier: NCT04778059
Recruitment Status : Not yet recruiting
First Posted : March 2, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
US Biotest, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
2019 Novel Coronavirus Infection COVID-19 Virus Infection SARS Coronavirus 2 Infection SARS-CoV-2 Infection Respiratory Distress Syndrome, Adult Adult Respiratory Distress Syndrome Drug: USB002 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events (TEAE) [ Time Frame: Day 1 to Day 70 (or date of final measurement, if sooner) ]
    Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 < 92% 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778059


Contacts
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Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com
Contact: Shelagh Verco, PhD 805-704-1179 shelagh.verco@usbiotest.com

Sponsors and Collaborators
US Biotest, Inc.
Investigators
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Principal Investigator: Sairam Parthasarathy, MD The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
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Responsible Party: US Biotest, Inc.
ClinicalTrials.gov Identifier: NCT04778059    
Other Study ID Numbers: USB002-2020-001
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory Tract Infections
Lung Injury