COVID-19Phase 2NCT04401423

TXA127 for the Treatment of Severe COVID-19

A Phase 2 study testing TXA127 in people with COVID-19, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: TXA127
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 10 Feb 2021to 10 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

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

Read the 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.

Conditions: COVID-19
Being tested: TXA127, Placebo
Keywords: COVID-19, multi-organ failure, acute kidney injury
Medical subject headings: COVID-19, Multiple Organ Failure, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TXA127Drug
Also called angiotensin-(1-7)
0.5 mg/kg per day
PlaceboDrug
Also called control
0.5 mg/kg per day

Study groups in NCT04401423
Study group	Role	What they receive
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). Receives: 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). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202110 Jun 2021

First posted26 May 2020
Study start10 Feb 2021
Primary completion10 Jun 2021
Study completion10 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blinded, placebo-control, randomized clinical trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04401423
Sponsor's protocol ID: AAAT0535
Status last verified: Jul 2022
First submitted: 21 May 2020
Last updated: 27 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 35902867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Angiotensin 1-7 (TXA127) for the Treatment of Severe COVID-19
ClinicalTrials.gov ID: NCT04401423
Acronym / sponsor ID: AAAT0535
Conditions: COVID-19
Keywords: COVID-19, multi-organ failure, acute kidney injury
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: Constant Therapeutics LLC
Study start: 10 Feb 2021 (actual)
Primary completion: 10 Jun 2021 (actual)
Study completion: 10 Jun 2021 (actual)
First posted: 26 May 2020 (actual)
Results: Posted 27 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Double-blinded, placebo-control, randomized clinical trial

Arm	Type	Receives
TXA127	Experimental	Drug: TXA127Participants 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 comparator	Drug: PlaceboParticipants 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TXA127Also: angiotensin-(1-7)0.5 mg/kg per day	Drug	TXA127
PlaceboAlso: control0.5 mg/kg per day	Drug	Placebo

Primary outcome

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

7 secondary outcomes

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

Results and safety

Results posted to the registry on 27 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TXA127	11	6
Placebo	11	9

Primary outcome: Change of Serum Creatinine

Time frame: Day 1 and Day 10. Mean (Full Range). Unit: mg/dL

Measure	TXA127 n = 11	Placebo n = 9
Value	0.92 (0.56 to 1.26)	0.70 (0.45 to 1.11)

Population analysed: Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis - which is not the same as those who "completed" the study as seen under Participant Flow. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.

Primary outcome: Number of Participants Requiring Intubation

Time frame: From Day 1 to Day 10. Count of participants. Unit: Participants

Measure	TXA127 n = 11	Placebo n = 9
Value	3	2

Population analysed: Only subjects who received at least 1 complete dose of drug/placebo were included in the data analysis. This included 11 out of 11 in the TXA127 group and 9 out of 11 in the Placebo group.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from Day 1 to Day 10 of study drug/placebo administration (or as long as hospitalized if less than 10 days) and at Day 28 and Day 60 (post hospital discharge) during a follow-up phone call.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TXA127	3 of 11 (27.3%)	7 of 11 (63.6%)	2 of 11
Placebo	2 of 9 (22.2%)	5 of 9 (55.6%)	1 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35902867Wagener 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeanine D'Armiento, MD, PhD principal investigator

Associate Professor of Medicine in Anesthesiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TXA127 in people with COVID-19, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Serum Creatinine (time frame: Day 1 and Day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04401423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.