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

Phase 2

Terminated

• Conditions: COVID-19 Virus Infection; SARS Coronavirus 2 Infection; SARS-CoV-2 Infection; 2019 Novel Coronavirus Infection; Respiratory Distress Syndrome, Adult; Adult Respiratory Distress Syndrome
• Interventions: Drug: Placebo; Drug: USB002

• Registration Number: NCT04778059
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-02
• Study Start: 2021-07-27
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Results First Submitted: 2023-09-11
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Results First Posted: 2023-12-01
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
USB002	USB002	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAE)	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)

Trial Locations

Locations (1)

The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals; 🇺🇸 Tucson, Arizona, United States