Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure (TXACOVIDPREV)
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ClinicalTrials.gov Identifier: NCT04550338 |
Recruitment Status :
Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Tranexamic acid Drug: Placebo | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Placebo-controlled, double-blind, randomized, controlled trial |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Once patient is consented, pharmacy will randomize to one of two arms and prepare coded sets of drugs |
Primary Purpose: | Prevention |
Official Title: | Antiviral Effects of Tranexamic Acid (TXA) as a Preventative Treatment Following COVID-19 Exposure |
Estimated Study Start Date : | August 1, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | March 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Tranexamic Acid Treatment |
Drug: Tranexamic acid
Oral administration of blinded medications |
Placebo Comparator: Placebo Treatment |
Drug: Placebo
Oral administration of blinded medications |
- Conversion from negative to positive COVID-19 test [ Time Frame: Repeat testing after 7 days ]RNA testing of nasopharyngeal swabs

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT04550338
Contact: Timothy J Ness, MD PhD | 205-907-9743 | tness@uabmc.edu |
Responsible Party: | Timothy Ness, MD, Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT04550338 |
Other Study ID Numbers: |
TXA.COVID.3 |
First Posted: | September 16, 2020 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | all de-identified data would be available upon request |
Supporting Materials: |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
COVID-19 tranexamic acid preventative therapy prophylactic therapy |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |