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TXA127 for the Treatment of Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401423
Recruitment Status : Completed
First Posted : May 26, 2020
Results First Posted : July 27, 2022
Last Update Posted : July 27, 2022
Sponsor:
Collaborator:
Constant Therapeutics LLC
Information provided by (Responsible Party):
Jeanine D'Armiento, Columbia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: TXA127 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, placebo-control, randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Angiotensin 1-7 (TXA127) for the Treatment of Severe COVID-19
Actual Study Start Date : February 10, 2021
Actual Primary Completion Date : June 10, 2021
Actual Study Completion Date : June 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TXA127
Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days).
 Drug: TXA127
0.5 mg/kg per day
Other Name: angiotensin-(1-7)
Placebo Comparator: Placebo
Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days).
 Drug: Placebo
0.5 mg/kg per day
Other Name: control


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401423


Locations
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United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Constant Therapeutics LLC
Investigators
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Principal Investigator: Jeanine D'Armiento, MD, PhD Associate Professor of Medicine in Anesthesiology
  Study Documents (Full-Text)

Documents provided by Jeanine D'Armiento, Columbia University:
Study Protocol and Statistical Analysis Plan  [PDF] August 25, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeanine D'Armiento, Associate Professor of Medicine (in Anesthesiology), Columbia University
ClinicalTrials.gov Identifier: NCT04401423    
Other Study ID Numbers: AAAT0535
First Posted: May 26, 2020    Key Record Dates
Results First Posted: July 27, 2022
Last Update Posted: July 27, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeanine D'Armiento, Columbia University:
COVID-19
multi-organ failure
acute kidney injury
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Angiotensin I (1-7)
Antihypertensive Agents
Vasodilator Agents