Status:
COMPLETED
TXA127 for the Treatment of Severe COVID-19
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Constant Therapeutics LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Part...
Detailed Description
Corona virus disease 2019 (COVID-19) has been associated with severe respiratory and multiorgan failure. Research shows that COVID-19 reduces levels of angiotensin-converting enzyme-2 (ACE-2), an enzy...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04401423
Start Date
February 10 2021
End Date
June 10 2021
Last Update
July 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032