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Completed

NCT Number: NCT04401423

TXA127 for the Treatment of Severe COVID-19

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

TXA127

Drug

0.5 mg/kg per day

Other names: angiotensin-(1-7)

Placebo

Drug

0.5 mg/kg per day

Other names: control

Primary outcomes

  1. Change of Serum Creatinine

    Time frame: Day 1 and Day 10

    Calculated from baseline (at enrollment) to end of study

  2. Number of Participants Requiring Intubation

    Time frame: From Day 1 to Day 10

Secondary outcomes

  1. Number of Participants Requiring Dialysis

    Time frame: Up to Day 10

  2. Number of Participants Requiring a Vasopressors

    Time frame: Up to Day 10

  3. Percent Change in Supplemental Oxygen Requirements

    Time frame: Day 1 and Day 10

  4. Days of Hospital Stay and Drug Administration

    Time frame: Day 1 to Day 10

  5. Cytokine Levels on the Day of Drug/TXA Administration

    Time frame: Day 1

  6. Cytokine Levels on the Day 5 of Drug/TXA Administration

    Time frame: Day 5

  7. Mortality

    Time frame: Day 1 to Day 10

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Constant Therapeutics LLC

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 26, 2020
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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