Official Title
Randomized Controlled Trial of Angiotensin 1-7 (TXA127) for the Treatment of Severe COVID-19
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. 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.

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 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.

Completed
COVID-19

Drug: TXA127

0.5 mg/kg per day
Other Name: angiotensin-(1-7)

Drug: Placebo

0.5 mg/kg per day
Other Name: control

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Columbia University Irving Medical Center
New York, New York, United States

Jeanine D'Armiento, MD, PhD, Principal Investigator
Associate Professor of Medicine in Anesthesiology

Constant Therapeutics LLC
NCT Number
Keywords
Covid-19
multi-organ failure
Acute Kidney Injury
MeSH Terms
COVID-19
Angiotensin I (1-7)