Lead Sponsor

US Biotest, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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.

•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.

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