TerminatedPhase 2

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

Stopped: Unable to enroll in timely manner due to nature of COVID

United States21 participantsStarted 2021-07-27

Plain-language 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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;
✕

Number of Participants With Treatment Emergent Adverse Events (TEAE)

Timeframe: Day 1 to Day 70 (or date of final measurement, if sooner)

NCT IDNCT04778059

SponsorUS Biotest, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-10

Results submitted2023-09-11