Evidence map›Paper›PMID 34539185›Full record

Trial reportInternational journal of general medicine2021

Colchicine in Recently Hospitalized Patients with COVID-19: A Randomized Controlled Trial (COL-COVID).

Domingo A Pascual-Figal, Aychel E Roura-Piloto, Encarnación Moral-Escudero, Enrique Bernal, Helena Albendín-Iglesias, M Teresa Pérez-Martínez, Jose Antonio Noguera-Velasco, Iria Cebreiros-López, Álvaro Hernández-Vicente, David Vázquez-Andrés and 5 more

Registry-linked trialOpen access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in International journal of general medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04350320 (Administration of Colchicine Plus Standard Treatment vs. Standard Therapy, in Hospitalized Patients With COVID-19, Within the First 48 Hours, and no Severity Criteria.), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT04350320 phase3completednot on this map

Administration of Colchicine Plus Standard Treatment vs. Standard Therapy, in Hospitalized Patients With COVID-19, Within the First 48 Hours, and no Severity Criteria.

TypeinterventionalSponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaRan2020 to 2020Enrolled102ConditionsCOVID19ArmsColchicine Tablets, Standard therapy for COVID-19 according to the stablished hospital protocols.
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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  10. NLRP3, the inflammasome and COVID-19 infection.QJM : monthly journal of the Association of Physicians · 2023
    Review
  11. Review
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  13. Article
  14. Article
  15. Review
  16. Article
  17. Coagulopathy in COVID-19 and anticoagulation clinical trials.Best practice & research. Clinical haematology · 2022
    Review
  18. Article
  19. Colchicine for COVID-19: targeting NLRP3 inflammasome to blunt hyperinflammation.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2022
    Review
  20. Article
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

15 authors at 5 institutions in 2 countries.

Domingo A Pascual-FigalCardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.ORCID 0000-0002-4993-9540
Aychel E Roura-PilotoInfectious Diseases and Internal Medicine Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Encarnación Moral-EscuderoInfectious Diseases and Internal Medicine Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Enrique BernalInfectious Diseases and Internal Medicine Department, Hospital Universitario Reina Sofia, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Helena Albendín-IglesiasInfectious Diseases and Internal Medicine Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
M Teresa Pérez-MartínezCardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Jose Antonio Noguera-VelascoClinical Biochemistry Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Iria Cebreiros-LópezClinical Biochemistry Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Álvaro Hernández-VicenteCardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
David Vázquez-AndrésCardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Carmen Sánchez-PérezCentro de Investigación Biomédica en Red Enfermedades Cardiovasculares, (CIBERCV), Madrid, Spain.
Amjad KhanDepartment of Chemistry, University of Oxford, Oxford, UK.
Fátima Sánchez-CaboCentro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Elisa García-VázquezInfectious Diseases and Internal Medicine Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
COL-COVID Investigators
Hospital Universitario Virgen de la Arrixaca · ESSpanish National Centre for Cardiovascular Research · ESCentro de Investigación en Red en Enfermedades Cardiovasculares · ESHospital Universitario Reina Sofía · ESUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColchicine has been proposed as a potential therapy in coronavirus disease 2019 (COVID-19) due to their anti-inflammatory actions.

methodsThe COL-COVID study was a prospective, randomized, controlled and open-label clinical trial that compared colchicine added to standard treatment vs standard treatment in hospitalized COVID-19 patients that do not need mechanical ventilatory support. Colchicine was initiated within the first 48 hours of admission at a 1.5 mg loading dose, followed by 0.5 mg b.i.d. for one week and 0.5 mg per day for 28 days. The study endpoints were clinical status (7-points WHO ordinal scale) and inflammatory biomarkers (IL-6 and CRP).

resultsA total of 103 patients (51±12 years, 52% male) were randomly allocated to colchicine arm (n=52) and control arm (n=51). At day 28, all patients in the colchicine group were alive and discharged, whereas in the control group, two patients died in-hospital and one patient remained hospitalized. Clinical improvement in terms of changes on WHO scale at day 14 and 28 and time to 1-point clinical improvement did not differ between the two groups. Clinical deterioration (increase of at least 1-point in WHO scale) was observed in a higher proportion of cases in colchicine group (13.8%) vs control group (5.8%) (p=0.303); after adjustment by baseline risk factors and concomitant therapies, colchicine therapy was associated with a lower risk of clinical deterioration (p=0.030). Inflammatory biomarkers CRP and IL-6 concentrations course did not differ between the two arms.

conclusionIn hospitalized COVID-19 patients, colchicine treatment neither improved the clinical status, nor the inflammatory response, over the standard treatment. Nevertheless, a preventive effect for further clinical deterioration might be possible.

trial registrationNCT04350320.

Indexed as

colchicineCOVID-19inflammation

Identifiers

PMID34539185
PMCPMC8445096
OpenAlexW3200635158

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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.