Tranexamic Acid (TXA) and Corona Virus 2019 (COVID19) in Inpatients

NCT04338126 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TXACOVID2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A controlled trial of the drug tranexamic acid (TXA) in inpatients recently admitted to the hospital with the diagnosis of COVID19. It is hypothesized that TXA will reduce the infectivity and virulence of the virus.

Conditions

COVID19

Outcome Measures

Primary Outcomes (1)

• Admission to Intensive Care Unit

  Transfer to Intensive Care Unit for deteriorating clinical condition

  Randomization to 7 days after randomization

Study Arms (2)

Tranexamic Acid Treatment

EXPERIMENTAL

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

Drug: Tranexamic acid

Placebo Treatment

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Tranexamic acid DRUG

previously described

Tranexamic Acid Treatment

Placebo oral tablet DRUG

previously described

Placebo Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive COVID19 test
• Admission to hospital without immediate plans for Intensive Care Unit transfer
• Age \>/= 19 y.o.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Timothy J Ness, MD PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy prepares medications that are coded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, placebo-controlled, double blind comparison

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: September 30, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)