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NCT03704181: COACH

Colchicine for Patients With Chagas´ Disease( B1 Stage)

Status unknown Phase 2 Last updated 11 March 2019
What this trial tests

Phase 2 trial testing Colchicine 0.5 MG twice day for one year in Chagas Disease in 60 participants. Status unknown.

Timeline
1 October 2018
Primary endpoint
30 December 2020
5 January 2021

Quick facts

Lead sponsorUniversity of Sao Paulo General Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment60
Start date1 October 2018
Primary completion30 December 2020
Estimated completion5 January 2021
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 18 to 70, any sex, with Chagas Disease or Colchicine Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease. Forty patients will receive colchicine while twenty patients will receive placebo

Publications & conference data

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

  1. Adding insult to injury - Inflammation at the heart of cardiac fibrosis.
    Smolgovsky S, Ibeh U, Tamayo TP, Alcaide P. · · 2021 · cited 55× · PMID 33166625 · DOI 10.1016/j.cellsig.2020.109828
  2. Colchicine for the treatment of COVID-19 patients: efficacy, safety, and model informed dosage regimens.
    Karatza E, Ismailos G, Karalis V. · · 2021 · cited 26× · PMID 33845715 · DOI 10.1080/00498254.2021.1909782
  3. Chagas Disease: Perspectives on the Past and Present and Challenges in Drug Discovery.
    Mansoldo FRP, Carta F, Angeli A, Cardoso VDS, et al · · 2020 · cited 25× · PMID 33238613 · DOI 10.3390/molecules25225483
  4. Clinical trials for Chagas disease: etiological and pathophysiological treatment.
    Gonzaga BMS, Ferreira RR, Coelho LL, Carvalho ACC, et al · · 2023 · cited 10× · PMID 38188583 · DOI 10.3389/fmicb.2023.1295017
  5. Trypanosomatid-Caused Conditions: State of the Art of Therapeutics and Potential Applications of Lipid-Based Nanocarriers.
    Muraca G, Berti IR, Sbaraglini ML, Fávaro WJ, et al · · 2020 · cited 8× · PMID 33324615 · DOI 10.3389/fchem.2020.601151

Verify or expand the search:

Other recruiting trials for Chagas Disease

Currently open trials in the same condition.

Other University of Sao Paulo General Hospital 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/NCT03704181.

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