TXA127 for the Treatment of Severe COVID-19

• Status: Completed
• Trial end date: 2021-06-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if administration of angiotensin-(1-7) (TXA127) prevents acute kidney injury and deterioration into multi-organ failure in patients with severe COVID-19. Participants will undergo a 10-day treatment with either placebo or study drug. The drug will be administered intravenously for 3 hours once each day for 10 days consecutively.

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

Details

• Lead Sponsor: Columbia University
• Collaborator: Constant Therapeutics LLC
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

• Severe COVID-19: Adult patients admitted to the hospital through the Emergency Department (ED) requiring oxygen therapy (any level) to maintain oxygen saturation (SaO2) > 90%

• COVID positive by polymerase chain reaction (PCR) on hospital admission

• Hospitalized patients aged 18 years or greater

Exclusion Criteria:

• Pre-existing chronic kidney disease

• New use of or change in dose of ACE-inhibitors or angiotensin receptor blocker (ARB) within the last 6 months

• Acute kidney injury at the time of enrollment defined as either increase pf serum creatinine by more than 50% or 0.3 mg/dL above baseline or estimated creatinine clearance (by MDRD) of less than 60 ml/min (if no baseline serum creatinine available)

• Pregnant and breastfeeding women

• Contraindicated medications: new use or change of medications from start of trial (start of an ACE inhibitor or ARB within 6 months of trial).