TXA127 for the Treatment of Severe COVID-19

Columbia University22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COVID-19

Interventions

TXA127DRUG

0.5 mg/kg per day

PlaceboDRUG

0.5 mg/kg per day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Change of Serum Creatinine

Calculated from baseline (at enrollment) to end of study

Time frame: Day 1 and Day 10

Number of Participants Requiring Intubation

Time frame: From Day 1 to Day 10

Secondary Outcomes

Number of Participants Requiring Dialysis

Time frame: Up to Day 10

Number of Participants Requiring a Vasopressors

Time frame: Up to Day 10

Percent Change in Supplemental Oxygen Requirements

Time frame: Day 1 and Day 10

Days of Hospital Stay and Drug Administration

Time frame: Day 1 to Day 10

Cytokine Levels on the Day of Drug/TXA Administration

Time frame: Day 1

Cytokine Levels on the Day 5 of Drug/TXA Administration

Time frame: Day 5

Mortality

Time frame: Day 1 to Day 10

Data from ClinicalTrials.gov

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