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TXA127 for the Treatment of Severe COVID-19

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ClinicalTrials.gov Identifier: NCT04401423
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : August 20, 2020
Sponsor:
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)
Estimated Enrollment : 100 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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: TXA127
Participants will receive one 3-hour dosage (0.5 mg/kg), intravenously, for 10 days consecutively.
 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), intravenously, for 10 days consecutively.
 Drug: Placebo
0.5 mg/kg per day


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 and ventilatory support [ Time Frame: Up to Day 10 ]

Secondary Outcome Measures :
  1. Change in number of deceased participants [ Time Frame: Day 1 and Day 10 ]
  2. Number of participants requiring dialysis [ Time Frame: Up to Day 10 ]
  3. Number of participants requiring a vasopressors [ Time Frame: Up to Day 10 ]
  4. Change in blood inflammatory markers [ Time Frame: Day 1 and Day 10 ]
  5. Percent change in supplemental oxygen requirements [ Time Frame: Day 1 and 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


Contacts
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Contact: Jeanine D'Armiento, MD, PhD 212-305-3745 jmd12@cumc.columbia.edu
Contact: Laura Fonseca 212-305-3745 lf2560@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jeanine M D'Armiento, MD, PhD    212-305-3745    jmd12@cumc.columbia.edu   
Contact: Laura D Fonseca, MS    212-305-3745    lf2560@cumc.columbia.edu   
Principal Investigator: Jeanine M D'Armiento, MD, PhD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Jeanine D'Armiento, MD, PhD Associate Professor of Medicine in Anesthesiology
More Information
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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
Last Update Posted: August 20, 2020
Last Verified: August 2020

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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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Angiotensin I (1-7)
Antihypertensive Agents
Vasodilator Agents