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Efficacy of intravenous USB002 to treat patients with respiratory distress due to COVID-19

Richard Lee


A Study On:

  • Coronavirus Infection

Status:

  • Open

Eligibility

18 Years and older (Adult, Older Adult)

Interested in joining this trial?

Official Title

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


Eligibility

You can join if...

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 < 92% 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.

Get in touch with our study team