TXA127 for the Treatment of Severe COVID-19

NCT04401423 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAT0535
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change of Serum Creatinine

  Calculated from baseline (at enrollment) to end of study

  Day 1 and Day 10

• Number of Participants Requiring Intubation

  From Day 1 to Day 10

Secondary Outcomes (7)

• Number of Participants Requiring Dialysis

  Up to Day 10

• Number of Participants Requiring a Vasopressors

  Up to Day 10

• 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 of Drug/TXA Administration

  Day 1

Study Arms (2)

TXA127

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

TXA127 DRUG

0.5 mg/kg per day

Also known as: angiotensin-(1-7)

TXA127

Placebo DRUG

0.5 mg/kg per day

Also known as: control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• Constant Therapeutics LLC: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 35902867 DERIVED

MeSH Terms

Conditions

COVID-19; Multiple Organ Failure; Acute Kidney Injury

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Jeanine D'Armiento / Principal Investigator
• Organization: Columbia University Irving Medical Center

jmd12@cumc.columbia.edu

212-305-3745

Study Officials

• Jeanine D'Armiento, MD, PhD

  Associate Professor of Medicine in Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (in Anesthesiology)

Model Details: Double-blinded, placebo-control, randomized clinical trial

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: February 10, 2021
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: July 27, 2022
• Results First Posted: July 27, 2022

Record last verified: 2022-07

Locations

US (1)