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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Biotest, Inc.

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 < 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.