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NCT04338074: TCOutpatient

TXA and Corona Virus 2019 (COVID19) in Outpatients

Terminated Phase 2 Results posted Last updated 13 May 2021
What this trial tests

Phase 2 trial testing Tranexamic acid tablets in COVID-19 in 5 participants. Terminated before completion.

Timeline
1 June 2020
Primary endpoint
21 April 2021
21 April 2021

Quick facts

Lead sponsorUniversity of Alabama at Birmingham
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment5
Start date1 June 2020
Primary completion21 April 2021
Estimated completion21 April 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Alabama at Birmingham

Who can join

19 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hospitalization Primary · Randomization to 7 days after randomization

Participant admission to hospital for COVID-19 treatment

GroupValue95% CI
Tranexamic Acid Treatment0
Placebo Treatment0

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic.
    Driggin E, Madhavan MV, Bikdeli B, Chuich T, et al · · 2020 · cited 1272× · PMID 32201335 · DOI 10.1016/j.jacc.2020.03.031
  2. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  3. FDA approved drugs with pharmacotherapeutic potential for SARS-CoV-2 (COVID-19) therapy.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2020 · cited 105× · PMID 32717568 · DOI 10.1016/j.drup.2020.100719
  4. Fibrinolysis and COVID-19: A plasmin paradox.
    Medcalf RL, Keragala CB, Myles PS. · · 2020 · cited 78× · PMID 32543119 · DOI 10.1111/jth.14960
  5. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  6. Thromboembolic events and Covid-19.
    Ribes A, Vardon-Bounes F, Mémier V, Poette M, et al · · 2020 · cited 55× · PMID 32773098 · DOI 10.1016/j.jbior.2020.100735
  7. Fibrinolysis Shutdown in COVID-19: Clinical Manifestations, Molecular Mechanisms, and Therapeutic Implications.
    Meizoso JP, Moore HB, Moore EE. · · 2021 · cited 48× · PMID 33766727 · DOI 10.1016/j.jamcollsurg.2021.02.019
  8. Potential Anti-COVID-19 Therapeutics that Block the Early Stage of the Viral Life Cycle: Structures, Mechanisms, and Clinical Trials.
    Al-Horani RA, Kar S, Aliter KF. · · 2020 · cited 35× · PMID 32718020 · DOI 10.3390/ijms21155224

Verify or expand the search:

Other trials of Tranexamic acid tablets

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04338074.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing