TXA and Corona Virus 2019 (COVID19) in Outpatients (TCOutpatient)

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

A controlled trial of the drug tranexamic acid (TXA) in outpatients who were recently diagnosed with COVID-19. It is hypothesized that TXA will reduce the infectivity and virulence of the virus.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Tranexamic acid tablets; Drug: Placebo oral tablet

Detailed Description

A recent report in Physiological Reviews proposed that the endogenous protease plasmin acts on the 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. 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 our institution, 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 diagnosed with COVID19 as an outpatient. 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 apixaban 5 mg p.o. BID. The primary endpoint for the study would be a need for hospitalization. Contact would consist of daily phone contact. Care for COVID19 would otherwise be standard of care.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Positive COVID-19 test
• Outpatient
• Age >/= 19 y.o.

Exclusion Criteria:

• Allergic reaction to tranexamic acid
• History of hypercoagulation disorders (deep venous thrombosis, pulmonary thromboembolism)
• Ongoing anticoagulation
• History of GI bleeding
• History of Seizures
• Cardiac or other vascular stents
• History of severe renal disease
• History of intracranial hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Treatment	Drug: Placebo oral tablet; 2 tablets p.o. three times per day x 5 days
Experimental: Tranexamic Acid Treatment	Drug: Tranexamic acid tablets; Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Participant admission to hospital for COVID-19 treatment	Randomization to 7 days after randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): April 21, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXACOVID1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No