Phase 2
Completed N=22
TXA127 for the Treatment of Severe COVID-19
Source: ClinicalTrials.gov NCT04401423 ↗Enrolled (actual)
22
Serious AEs
25.0%
Results posted
Jul 2022
Primary outcomePrimary: Change of Serum Creatinine — 0.92; 0.70 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Serum Creatinine |
0.92; 0.70 | — |
| PRIMARY Number of Participants Requiring Intubation |
3; 2 | — |
| SECONDARY Number of Participants Requiring Dialysis |
0; 0 | — |
| SECONDARY Number of Participants Requiring a Vasopressors |
3; 1 | — |
| SECONDARY Percent Change in Supplemental Oxygen Requirements |
0.71; 0.91 | — |
| SECONDARY Days of Hospital Stay and Drug Administration |
11; 7; 4; 5 | — |
| SECONDARY Cytokine Levels on the Day of Drug/TXA Administration |
1.44; 1.0; 20.7; 30.6; 15.9; 7.6 | — |
| SECONDARY Cytokine Levels on the Day 5 of Drug/TXA Administration |
0.88; 0.78; 14.4; 50.6; 17.77; 7.38 | — |
| SECONDARY Mortality |
1; 0 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT04401423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.