- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338126
Tranexamic Acid (TXA) and Corona Virus 2019 (COVID19) in Inpatients (TCInpatient)
Exploratory Studies of the Effect of Tranexamic Acid Treatment on the Progression of COVID19 in Inpatients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A recent report in Physiological Reviews proposed that the endogenous protease plasmin acts on 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. Fortunately, 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 UAB, 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 admitted to the regular hospital (non-Intensive Care Unit; ICU) for the diagnosis of COVID19 is proposed. 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 daily anticoagulation as directed by their primary care team. The primary endpoint for the study would be a need for transfer to an ICU. Contact would be daily and via remote processes. Care for the COVID19 patient would otherwise be standard of care and directed by the primary caretakers of the patient.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Positive COVID19 test
- Admission to hospital without immediate plans for Intensive Care Unit transfer
- Age >/= 19 y.o.
Exclusion Criteria:
- Allergic reaction to tranexamic acid
- History or active evidence of hypercoagulation disorders including but not limited to deep vein thrombosis, pulmonary hypertension, diffuse intravascular coagulopathy
- Preadmission 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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic Acid Treatment
Oral dosing of tranexamic acid at dose of 1300 mg p.o. three times per day x 5 days; alternative dosing intravenously with loading dose of 10 mg/kg followed by 1 mg/kg/hr infusion x 5 days
|
previously described
|
Placebo Comparator: Placebo Treatment
2 tablets of placebo three times per day x 5 days; alternative dosing intravenous normal saline at volumes similar to those use for experimental arm
|
previously described
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Admission to Intensive Care Unit
Time Frame: Randomization to 7 days after randomization
|
Transfer to Intensive Care Unit for deteriorating clinical condition
|
Randomization to 7 days after randomization
|
Collaborators and Investigators
Investigators
- Principal Investigator: Timothy J Ness, MD PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- TXACOVID2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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