TXA and Corona Virus 2019 (COVID19) in Outpatients

NCT04338074 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: TXACOVID1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Hospitalization

  Participant admission to hospital for COVID-19 treatment

  Randomization to 7 days after randomization

Study Arms (2)

Tranexamic Acid Treatment

EXPERIMENTAL

Drug: Tranexamic acid tablets

Placebo Treatment

PLACEBO COMPARATOR

Drug: Placebo oral tablet

Interventions

Tranexamic acid tablets DRUG

Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos

Tranexamic Acid Treatment

Placebo oral tablet DRUG

2 tablets p.o. three times per day x 5 days

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 COVID-19 test
• Outpatient
• Age \>/= 19 y.o.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, 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

Results Point of Contact

• Title: Dr. Timothy J Ness
• Organization: University of Alabama at Birmingham

tness@uabmc.edu

205-975-9643

Study Officials

• Timothy J Ness, MD PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy prepares 5 day packs of 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: June 1, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)