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TXA127 for the Treatment of Severe COVID-19

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TXA127

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, multi-organ failure, acute kidney injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TXA127

Placebo

Arm Description

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).

Outcomes

Primary Outcome Measures

Change of Serum Creatinine

Calculated from baseline (at enrollment) to end of study

Number of Participants Requiring Intubation

Secondary Outcome Measures

Number of Participants Requiring Dialysis

Number of Participants Requiring a Vasopressors

Percent Change in Supplemental Oxygen Requirements

Days of Hospital Stay and Drug Administration

Cytokine Levels on the Day of Drug/TXA Administration

Cytokine Levels on the Day 5 of Drug/TXA Administration

Mortality

Full Information

NCT ID

NCT04401423

First Posted

May 21, 2020

Last Updated

July 4, 2022

Sponsor

Columbia University

Collaborators

Constant Therapeutics LLC

1. Study Identification

Unique Protocol Identification Number

NCT04401423

Brief Title

TXA127 for the Treatment of Severe COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 10, 2021 (Actual)

Primary Completion Date

June 10, 2021 (Actual)

Study Completion Date

June 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Constant Therapeutics LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, multi-organ failure, acute kidney injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double-blinded, placebo-control, randomized clinical trial

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TXA127

Arm Type

Experimental

Arm Description

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).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

TXA127

Other Intervention Name(s)

angiotensin-(1-7)

Intervention Description

0.5 mg/kg per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

control

Intervention Description

0.5 mg/kg per day

Primary Outcome Measure Information:

Title

Change of Serum Creatinine

Description

Calculated from baseline (at enrollment) to end of study

Time Frame

Day 1 and Day 10

Title

Number of Participants Requiring Intubation

Time Frame

From Day 1 to Day 10

Secondary Outcome Measure Information:

Title

Number of Participants Requiring Dialysis

Time Frame

Up to Day 10

Title

Number of Participants Requiring a Vasopressors

Time Frame

Up to Day 10

Title

Percent Change in Supplemental Oxygen Requirements

Time Frame

Day 1 and Day 10

Title

Days of Hospital Stay and Drug Administration

Time Frame

Day 1 to Day 10

Title

Cytokine Levels on the Day of Drug/TXA Administration

Time Frame

Day 1

Title

Cytokine Levels on the Day 5 of Drug/TXA Administration

Time Frame

Day 5

Title

Mortality

Time Frame

Day 1 to Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeanine D'Armiento, MD, PhD

Organizational Affiliation

Associate Professor of Medicine in Anesthesiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35902867

Citation

Wagener G, Goldklang MP, Gerber A, Elisman K, Eiseman KA, Fonseca LD, D'Armiento JM. A randomized, placebo-controlled, double-blinded pilot study of angiotensin 1-7 (TXA-127) for the treatment of severe COVID-19. Crit Care. 2022 Jul 28;26(1):229. doi: 10.1186/s13054-022-04096-9. No abstract available.

Results Reference

derived

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TXA127 for the Treatment of Severe COVID-19

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