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

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ClinicalTrials.gov Identifier: NCT04338074
Recruitment Status : Not yet recruiting
First Posted : April 8, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Ness, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Tranexamic acid tablets Drug: Placebo oral tablet Phase 2

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 anticoagulation as directed by their primary care team. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, double-blind comparison
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Pharmacy prepares 5 day packs of medications that are coded
Primary Purpose: Treatment
Official Title: Exploratory Studies of the Effect of Tranexamic Acid Treatment on the Progression of COVID19 in Outpatients
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Placebo Comparator: Placebo Treatment Drug: Placebo oral tablet
2 tablets p.o. three times per day x 5 days




Primary Outcome Measures :
  1. Hospitalization [ Time Frame: Randomization to 7 days after randomization ]
    Admission to hospital for COVID-19 treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT04338074


Contacts
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Contact: Timothy J Ness, MD PhD 2059079743 tness@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35222
Contact: Timothy J Ness    205-907-9743    tness@uabmc.edu   
Principal Investigator: Sonya Heath, MD         
Principal Investigator: Brant Wagener, MD PhD         
Principal Investigator: Sadis Matalon, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Timothy J Ness, MD PhD University of Alabama at Birmingham
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Responsible Party: Timothy Ness, MD, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04338074    
Other Study ID Numbers: TXACOVID1
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants