TCInpatient: Tranexamic Acid (TXA) and Corona Virus 2019 (COVID19) in Inpatients

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04338126

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A controlled trial of the drug tranexamic acid (TXA) in inpatients recently admitted to the hospital with the diagnosis of COVID19. It is hypothesized that TXA will reduce the infectivity and virulence of the virus.

Condition or Disease	Intervention/Treatment	Phase
COVID19	Drug: Tranexamic acid Drug: Placebo oral tablet	Phase 2

Detailed Description

A recent report in Physiological Reviews proposed that the endogenous protease plasmin acts on COVID19 virus by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. Patients with hypertension, diabetes, coronary artery disease, cerebrovascular illness, lung disease and kidney dysfunction commonly have elevated levels of plasmin/plasminogen and it was proposed that this may be the mechanism for poorer outcomes in patients with these co-morbidities. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid (TXA) which suppresses this conversion and could be re-purposed for the treatment of COVID19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. three times per day x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at the University of Alabama at Birmingham (UAB) for orthopedic and cardiac bypass surgeries. At UAB, it is commonly employed in hemorrhaging trauma patients and currently is being studied for perioperative use in Cesarean section surgeries. It has also been utilized for spinal surgery, neurosurgery, orthognathic surgeries and even long term for the treatment of cosmetic dermatological disorders with a long track record of safety.

Given the potential benefit and limited toxicity of TXA it would appear warranted to perform a rapid randomized, double-blind placebo controlled exploratory trial at UAB in the treatment of the early phases of COVID19 to determine whether it reduces infectivity and virulence of the COVID19 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints.

An exploratory, randomized, placebo-controlled, double-blind Phase 2 clinical trial in which study patients have just been admitted to the regular hospital (non-Intensive Care Unit; ICU) for the diagnosis of COVID19 is proposed. The overall goal of this exploratory study is to assess both safety and efficacy of 5 days of TXA versus placebo in the COVID19 population. All patients would also receive daily anticoagulation as directed by their primary care team. The primary endpoint for the study would be a need for transfer to an ICU. Contact would be daily and via remote processes. Care for the COVID19 patient would otherwise be standard of care and directed by the primary caretakers of the patient.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, placebo-controlled, double blind comparisonRandomized, placebo-controlled, double blind comparison

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Pharmacy prepares medications that are coded

Primary Purpose:

Treatment

Official Title:

Exploratory Studies of the Effect of Tranexamic Acid Treatment on the Progression of COVID19 in Inpatients

Anticipated Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tranexamic Acid Treatment Oral dosing of tranexamic acid at dose of 1300 mg p.o. three times per day x 5 days; alternative dosing intravenously with loading dose of 10 mg/kg followed by 1 mg/kg/hr infusion x 5 days	Drug: Tranexamic acid previously described
Placebo Comparator: Placebo Treatment 2 tablets of placebo three times per day x 5 days; alternative dosing intravenous normal saline at volumes similar to those use for experimental arm	Drug: Placebo oral tablet previously described

Arm

Intervention/Treatment

Experimental: Tranexamic Acid Treatment

Oral dosing of tranexamic acid at dose of 1300 mg p.o. three times per day x 5 days; alternative dosing intravenously with loading dose of 10 mg/kg followed by 1 mg/kg/hr infusion x 5 days

Drug: Tranexamic acid

previously described

Placebo Comparator: Placebo Treatment

2 tablets of placebo three times per day x 5 days; alternative dosing intravenous normal saline at volumes similar to those use for experimental arm

Drug: Placebo oral tablet

previously described

Outcome Measures

Primary Outcome Measures

Admission to Intensive Care Unit [Randomization to 7 days after randomization]
Transfer to Intensive Care Unit for deteriorating clinical condition

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Positive COVID19 test
Admission to hospital without immediate plans for Intensive Care Unit transfer
Age >/= 19 y.o.

Exclusion Criteria:

Allergic reaction to tranexamic acid
History or active evidence of hypercoagulation disorders including but not limited to deep vein thrombosis, pulmonary hypertension, diffuse intravascular coagulopathy
Preadmission anticoagulation
History of GI bleeding
History of seizures
Cardiac or other vascular stents
History of severe renal disease
History of intracranial hemorrhage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Timothy J Ness, MD PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy Ness, MD, Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04338126

Other Study ID Numbers:

TXACOVID2

First Posted:

Apr 8, 2020

Last Update Posted:

Apr 23, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Tranexamic Acid

Study Results

No Results Posted as of Apr 23, 2021