TXA127 for the Treatment of Severe COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401423
• Other study ID #: AAAT0535
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: July 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• TXA127
0.5 mg/kg per day
• Placebo
0.5 mg/kg per day

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Constant Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Serum Creatinine	Calculated from baseline (at enrollment) to end of study	Day 1 and Day 10
Primary	Number of Participants Requiring Intubation		From Day 1 to Day 10
Secondary	Number of Participants Requiring Dialysis		Up to Day 10
Secondary	Number of Participants Requiring a Vasopressors		Up to Day 10
Secondary	Percent Change in Supplemental Oxygen Requirements		Day 1 and Day 10
Secondary	Days of Hospital Stay and Drug Administration		Day 1 to Day 10
Secondary	Cytokine Levels on the Day of Drug/TXA Administration		Day 1
Secondary	Cytokine Levels on the Day 5 of Drug/TXA Administration		Day 5
Secondary	Mortality		Day 1 to Day 10