Last reviewed · How we verify
NCT03704181: COACH
Colchicine for Patients With Chagas´ Disease( B1 Stage)
Phase 2 trial testing Colchicine 0.5 MG twice day for one year in Chagas Disease in 60 participants. Status unknown.
30 December 2020
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 October 2018 |
| Primary completion | 30 December 2020 |
| Estimated completion | 5 January 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Colchicine 0.5 MG twice day for one year — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Chagas Disease — all drugs for Chagas Disease →
- Colchicine Resistance — all drugs for Colchicine Resistance →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03704181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chagas Disease
Currently open trials in the same condition.
- NCT06632600 — A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease. · Phase 2 · recruiting
- NCT04897516 — Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease · Phase 3 · recruiting
- NCT04984265 — SBRT in Chagas Disease Ventricular Tachycardia · Phase 1, PHASE2 · active not recruiting
- NCT04024163 — Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease · Phase 3 · active not recruiting
Other University of Sao Paulo General Hospital trials
Trials by the same sponsor.
- NCT07275580 — Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases · Phase 4 · not yet recruiting
- NCT07478094 — Longitudinal Outcomes of Patients With Group 3 Pulmonary Hypertension Treated With Iloprost · not yet recruiting
- NCT07341386 — Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases · Phase 4 · not yet recruiting
- NCT07242092 — Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs · Phase 4 · not yet recruiting
- NCT07484152 — Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Essential Tremor · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03704181 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 11 March 2019
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing