Evidence map›Paper›PMID 34488841›Full record

ArticleTrials2021

The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study.

Elena Bustamante Estebanez, Lucía Lavín Alconero, Beatriz Josa Fernández, Monica Gozalo Marguello, Juan Carlos López Caro, Jonathan Diez Vallejo, Marta Fernandez Sampedro, Pedro Muñoz Cacho, Carlos Richard Espiga, María Mar García Saiz

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04416334 (PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% 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.

NCT04416334 phase3completednot on this map

PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)

TypeinterventionalSponsorInstituto de Investigación Marqués de ValdecillaRan2020 to 2022Enrolled70ConditionsSARS-CoV-2 Infection (COVID-19)ArmsColchicine plus symptomatic treatment (paracetamol), Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

10 authors at 3 institutions in 1 country.

Elena Bustamante EstebanezManagement of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de Salud, C. Vargas 57, 39010, Santander, Cantabria, Spain.
Lucía Lavín AlconeroMarqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39012, Santander, Cantabria, Spain. lucialavinalconero@gmail.com.
Beatriz Josa FernándezManagement of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de Salud, C. Vargas 57, 39010, Santander, Cantabria, Spain.
Monica Gozalo MarguelloMarqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39012, Santander, Cantabria, Spain.
Juan Carlos López CaroManagement of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de Salud, C. Vargas 57, 39010, Santander, Cantabria, Spain.
Jonathan Diez VallejoManagement of primary health care centers, Area I, Area II, Area III and Area IV, Servicio Cantabro de Salud, C. Vargas 57, 39010, Santander, Cantabria, Spain.
Marta Fernandez SampedroMarqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39012, Santander, Cantabria, Spain.
Pedro Muñoz CachoMarqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39012, Santander, Cantabria, Spain.
Carlos Richard EspigaMarqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39012, Santander, Cantabria, Spain.
María Mar García SaizMarqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39012, Santander, Cantabria, Spain.
Servicio Cántabro de Salud · ESInstituto de Investigación Marqués de Valdecilla · ESMarqués de Valdecilla University Hospital · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients.

methodsThe COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. DISCUSSION: This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system.

trial registrationClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.

Indexed as

COVID-19SARS-CoV-2AgedColchicineHumansMiddle AgedMulticenter Studies as TopicPandemicsPragmatic Clinical Trials as TopicPrimary Health CareRandomized Controlled Trials as TopicTreatment OutcomeColchicineColchicineCoronavirusEarly treatmentNo hospitalizedPrimary health care

Identifiers

PMID34488841
PMCPMC8419390
OpenAlexW3196898366

What OpenQuestion 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 OpenQuestion graph.