Status:
TERMINATED
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Lead Sponsor:
US Biotest, Inc.
Conditions:
2019 Novel Coronavirus Infection
COVID-19 Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04778059
Start Date
July 27 2021
End Date
May 10 2022
Last Update
December 1 2023
Active Locations (1)
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1
The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
Tucson, Arizona, United States, 85724