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

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

This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.

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.