TXA127 for the Treatment of Severe COVID-19
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ClinicalTrials.gov Identifier: NCT04401423 |
Recruitment Status :
Completed
First Posted : May 26, 2020
Results First Posted : July 27, 2022
Last Update Posted : July 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: TXA127 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 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 |
Actual Study Start Date : | February 10, 2021 |
Actual Primary Completion Date : | June 10, 2021 |
Actual Study Completion Date : | June 10, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 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).
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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 per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days).
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Drug: Placebo
0.5 mg/kg per day
Other Name: control |
- Change of Serum Creatinine [ Time Frame: Day 1 and Day 10 ]Calculated from baseline (at enrollment) to end of study
- Number of Participants Requiring Intubation [ Time Frame: From Day 1 to Day 10 ]
- Number of Participants Requiring Dialysis [ Time Frame: Up to Day 10 ]
- Number of Participants Requiring a Vasopressors [ Time Frame: Up to Day 10 ]
- Percent Change in Supplemental Oxygen Requirements [ Time Frame: Day 1 and Day 10 ]
- Days of Hospital Stay and Drug Administration [ Time Frame: Day 1 to Day 10 ]
- Cytokine Levels on the Day of Drug/TXA Administration [ Time Frame: Day 1 ]
- Cytokine Levels on the Day 5 of Drug/TXA Administration [ Time Frame: Day 5 ]
- Mortality [ Time Frame: Day 1 to Day 10 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
United States, New York | |
Columbia University Irving Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Jeanine D'Armiento, MD, PhD | Associate Professor of Medicine in Anesthesiology |
Documents provided by Jeanine D'Armiento, Columbia University:
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 |
Results First Posted: | July 27, 2022 |
Last Update Posted: | July 27, 2022 |
Last Verified: | July 2022 |
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 |
COVID-19 multi-organ failure acute kidney injury |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Angiotensin I (1-7) Antihypertensive Agents Vasodilator Agents |