TXA and Corona Virus 2019 (COVID19) in Outpatients

NCT ID: NCT04338074

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-04-21

Brief Summary

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid Treatment

Group Type: EXPERIMENTAL

Tranexamic acid tablets

Intervention Type: DRUG

Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos

Placebo Treatment

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

2 tablets p.o. three times per day x 5 days

Interventions

Tranexamic acid tablets

Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos

Intervention Type: DRUG

Placebo oral tablet

2 tablets p.o. three times per day x 5 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Timothy Ness, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy J Ness, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TXACOVID1

Identifier Type: -

Identifier Source: org_study_id