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.
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 enzyme that converts angiotensin II to angiotensin 1-7 (known as
TXA127). COVID-19 reduces levels of ACE-2 and therefore angiotensin 1-7 and as a result,
angiotensin II levels are going to be increased. Many clinical observations in COVID-19 have
shown the high incidence of acute kidney injury that may be due to excessive levels of
angiotensin II. The investigators hypothesize that administration of angiotensin (1-7)
replaces levels of ACE-2 in COVID-19 and thereby ameliorates deterioration of multi-organ
failure and specifically acute kidney injury.
Drug: TXA127
0.5 mg/kg per day
Other Name: angiotensin-(1-7)
Drug: Placebo
0.5 mg/kg per day
Other Name: control
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).
Columbia University Irving Medical Center
New York, New York, United States
Jeanine D'Armiento, MD, PhD, Principal Investigator
Associate Professor of Medicine in Anesthesiology