TXA127 for the Treatment of Severe COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: TXA127; Drug: Placebo

• Registration Number: NCT04401423
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-26
• Study Start: 2021-02-10
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Results First Submitted: 2022-05-09
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-04
• Results First Posted: 2022-07-27
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TXA127	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).
Placebo	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).

Primary Outcome Measures

Name	Time	Method
Change of Serum Creatinine	Day 1 and Day 10	Calculated from baseline (at enrollment) to end of study
Number of Participants Requiring Intubation	From Day 1 to Day 10

Secondary Outcome Measures

Name	Time	Method
Percent Change in Supplemental Oxygen Requirements	Day 1 and Day 10
Days of Hospital Stay and Drug Administration	Day 1 to Day 10
Cytokine Levels on the Day 5 of Drug/TXA Administration	Day 5
Number of Participants Requiring Dialysis	Up to Day 10
Number of Participants Requiring a Vasopressors	Up to Day 10
Mortality	Day 1 to Day 10
Cytokine Levels on the Day of Drug/TXA Administration	Day 1

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States