Evidence map›Paper›PMID 34755269›Full record

Trial reportJournal of general internal medicine2022

Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID).

Abdiel Absalón-Aguilar, Marina Rull-Gabayet, Alfredo Pérez-Fragoso, Nancy R Mejía-Domínguez, Carlos Núñez-Álvarez, David Kershenobich-Stalnikowitz, José Sifuentes-Osornio, Alfredo Ponce-de-León, Fernanda González-Lara, Eduardo Martín-Nares and 8 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of general internal medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04367168 phase2terminatednot on this map

Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection

TypeinterventionalSponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRan2020 to 2021Enrolled116ConditionsCOVIDArmsColchicine, Placebo oral tablet
NCT07654231 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2026 to 2027Enrolled60ConditionsChronic Kidney Disease Mineral and Bone Disorder, Hypertension, Diabetes, DyslipidemiaArmsLow-dose Colchicine at 0.5mg daily, Usual Care
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Severe COVID-19: Drugs and Clinical Trials.Journal of clinical medicine · 2023
    Review
  10. Article
  11. Article
  12. Coagulopathy in COVID-19 and anticoagulation clinical trials.Best practice & research. Clinical haematology · 2022
    Review
  13. Review
  14. Review
  15. Review
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 3 institutions in 1 country.

Abdiel Absalón-Aguilar *Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Marina Rull-Gabayet *Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Alfredo Pérez-FragosoDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Nancy R Mejía-DomínguezBioinformatics, Biostatistics and Computational Biology Unit, Red de apoyo a la investigación Coordinación de Investigación Científica, Universidad Nacional Autónoma de México, Mexico City, Mexico.
Carlos Núñez-ÁlvarezDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
David Kershenobich-StalnikowitzDepartment of Gastroenterology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.
José Sifuentes-OsornioDepartment of Infectious Diseases, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.
Alfredo Ponce-de-LeónDepartment of Infectious Diseases, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.
Fernanda González-LaraDepartment of Infectious Diseases, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.
Eduardo Martín-NaresDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Sharon Montesinos-RamírezDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Martha Ramírez-AlemónDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Pamela Ramírez-RangelDepartment of Cardiology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
Manlio F MárquezDepartment of Clinical Investigation, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
Juan Carlos Plata-CoronaDepartment of Cardiology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
Guillermo Juárez-VegaFlow Cytometry Unit, Red de Apoyo a La Investigacion, Coordinacion de Investigacion Cientifica, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
Diana Gómez-MartínDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
Jiram Torres-RuizDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico. josetorresruiz85@gmail.com.ORCID 0000-0002-7882-1488
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXInstituto Nacional de Cardiología · MXUniversidad Nacional Autónoma de México · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColchicine is an available, safe, and effective anti-inflammatory drug and has been suggested as a COVID-19 treatment, but its usefulness in hospitalized severe COVID-19 patients has not been thoroughly demonstrated.

objectiveTo address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19.

designWe conducted a triple-blind parallel non-stratified placebo-controlled clinical trial.

participantsWe recruited 116 hospitalized patients with severe COVID-19 in Mexico.

interventionsPatients were randomized to receive 1.5 mg of colchicine or placebo at the time of the recruitment in the study (baseline) and 0.5 mg BID PO to complete 10 days of treatment. MAIN MEASURES: The primary composite outcome was the progression to critical disease or death. Besides, we evaluated immunological features at baseline and after recovery or disease progression in 20 patients. KEY

resultsFifty-six patients were allocated to colchicine and 60 patients received placebo. The study was suspended after the second interim analysis demonstrated colchicine had no effect on the primary outcome (OR 0.83, 95%CI 0.35-1.93, P = 0.67), nor in the days of ICU and hospital stays. Adverse events were similar between groups (OR 1.63, 95% CI 0.66-3.88, P = 0.37). After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A.

conclusionsColchicine is safe but not effective in the treatment of severe COVID-19.

trial registrationClinicalTrials.gov Identifier: NCT04367168.

Indexed as

COVID-19 Drug TreatmentColchicineHospitalizationHumansSARS-CoV-2Treatment OutcomeColchicine

Identifiers

PMID34755269
PMCPMC8577644
OpenAlexW3211764856

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.