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History of Changes for Study: NCT04550338
Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure (TXACOVIDPREV)
Latest version (submitted April 21, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2020 None (earliest Version on record)
2 February 14, 2021 Study Status
3 April 21, 2021 Recruitment Status, Study Status, Study Design and Contacts/Locations
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Study NCT04550338
Submitted Date:  September 13, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: TXA.COVID.3
Brief Title: Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure (TXACOVIDPREV)
Official Title: Antiviral Effects of Tranexamic Acid (TXA) as a Preventative Treatment Following COVID-19 Exposure
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Not yet recruiting
Study Start: December 1, 2020
Primary Completion: December 31, 2022 [Anticipated]
Study Completion: March 31, 2023 [Anticipated]
First Submitted: September 13, 2020
First Submitted that
Met QC Criteria:
September 13, 2020
First Posted: September 16, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
September 13, 2020
Last Update Posted: September 16, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Alabama at Birmingham
Responsible Party: Principal Investigator
Investigator: Timothy Ness, MD
Official Title: Professor
Affiliation: University of Alabama at Birmingham
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. 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 COVID-19. 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 the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection.
Detailed Description:

Patients who are self-identified as having had close personal contact with an individual who has tested positive for COVID-19 will be invited to enroll in the study. On Day 1 they will be consented and randomized to one of two arms of the study: Arm 1 will consist of a 5 day treatment with tranexamic acid (TXA; 1300 mg p.o. TID x 5 days) and Arm 2 will consist of a 5 day treatment with an identical appearing placebo. All subjects will be tested using nasopharyngeal RNA swabs for the presence of the SARS-CoV-2 virus on Days 1 and 7. The primary endpoint will be conversion from a negative test for COVID-19 on Day 1, to a positive test on Day 7. Secondary data related to symptoms and co-morbidities will also be gathered.

Subjects who are positive for COVID-19 on Day 1 will not be included in the primary endpoint analysis for this study, but will receive the same 5 days of treatment and their data used for secondary analyses including safety.

All subjects in Arm 1 will also be treated with apixaban (5 mg p.o. BID x 5 days) to mitigate potential risks associated with hypercoagulability which have been noted in COVID-19 patients and which could be made worse with TXA treatment. The subjects in Arm 2 who received placebo in place of TXA will receive a second placebo tablet in place of apixaban.

Patients will be consented via the existent mechanisms associated with outpatient recruitment for all COVID-related studies at UAB. Consent would be performed remotely. All nasopharyngeal swabs will be obtained through the existent mechanisms for COVID-19 testing at UAB. Follow-up would consist of daily phone/internet contact for 7 days unless subjects acquire symptoms consistent with COVID-19, in which case they will be followed until resolution of their symptoms or for a maximum of 30 days.

Open or close this module Conditions
Conditions: COVID-19
Keywords: COVID-19
tranexamic acid
preventative therapy
prophylactic therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Placebo-controlled, double-blind, randomized, controlled trial
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Tranexamic Acid Treatment Drug: Tranexamic acid
Oral administration of blinded medications
Placebo Comparator: Placebo Treatment Drug: Placebo
Oral administration of blinded medications
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Conversion from negative to positive COVID-19 test
[ Time Frame: Repeat testing after 7 days ]

RNA testing of nasopharyngeal swabs
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • self-reported close exposure to individuals who test positive for COVID-19 virus

Exclusion Criteria:

  • pregnancy, allergy to study drugs, history of hypercoagulability or hypocoagulability, use of anticoagulant medications, seizures, presence of intravascular stents or other instrumentation that may lead to the formation of blood clots
Open or close this module Contacts/Locations
Central Contact Person: Timothy J Ness, MD PhD
Telephone: 205-907-9743
Email: tness@uabmc.edu
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
all de-identified data would be available upon request
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
within one month of request
Access Criteria:
institutional approval
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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