Evidence map›Paper›PMID 36396522›Full record

Trial reportEuropean journal of internal medicine2023

Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial.

Carlo Perricone, Mirko Scarsi, Antonio Brucato, Paola Pisano, Erika Pigatto, Cecilia Becattini, Antonella Cingolani, Francesco Tiso, Roberto Prota, Lina Rachele Tomasoni and 9 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European journal of internal medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Carlo PerriconeReumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
Mirko ScarsiOspedale di Esine, ASST Valcamonica, Esine (BS).
Antonio BrucatoUniversità degli Studi di Milano, ASST Fatebenefratelli-Sacco, Milan, Italy.
Paola PisanoAsl Cagliari, Dipartimento di Area Medica, Struttura Complessa Medicina Interna, Italy.
Erika PigattoOspedale Classificato Villa Salus, Mestre (VE), Italy.
Cecilia BecattiniMedicina Interna, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
Antonella CingolaniFondazione Policlinico Gemelli, IRCCS, Università Cattolica Roma, Italy.
Francesco TisoMedicina d'urgenza, Ospedale Alto Vicentino - AULSS 7 Pedemontana, Santorso (VI), Italy.
Roberto ProtaAzienda Ospedaliera Ordine Mauriziano, Torino, Italy.
Lina Rachele TomasoniASST Spedali Civili di Brescia, Brescia, Italy.
Maurizio CutoloLaboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic Hospital San Martino, Genoa, Italy.
Marika TardellaOspedale Carlo Urbani - Università Politecnica delle Marche, Ancona, Italy.
Davide RozzaCentro Studi SIR, Società Italiana di Reumatologia, Milan, Italy.
Carlo ZerbinoCentro Studi ITS-AIPO, Milan, Italy.
Massimo AndreoniMalattie Infettive, Dipartimento Processi Assistenziali Integrati, Policlinico Tor Vergata, Rome, Italy.
Venerino PolettiDipartimento Toracico, Azienda AUSL Romagna, Ospedale G.B. Morgagni, Forlì, Italy; Department of Respiratory Diseases and Allergy, Aarhus University, Aarhus, Denmark.
Elena BartoloniReumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
Roberto GerliReumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy. Electronic address: roberto.gerli@unipg.it.
COLVID-19 study group, under the auspices of the Italian Society of Rheumatology (SIR), the Italian Society of Infectious and Tropical Diseases (SIMIT) and the Italian Thoracic Society (ITS-AIPO)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19.

designThis interventional, multicenter, randomized, phase 2 study, evaluated colchicine 1.5 mg/day added to SOC in hospitalized COVID-19 patients (COLVID-19 trial) and 227 patients were recruited. The primary outcome was the rate of critical disease in 30 days defined as need of mechanical ventilation, intensive care unit (ICU), or death.

results152 non-anti-SARS-CoV-2-vaccinated patients (colchicine vs controls: 77vs75, mean age 69.1±13.1 vs 67.9±15 years, 39% vs 33.3% females, respectively) were analyzed. There was no difference in co-primary end-points between patients treated with colchicine compared to controls (mechanical ventilation 5.2% vs 4%, ICU 1.3% vs 5.3%, death 9.1% vs 6.7%, overall 11 (14.3%) vs 10 (13.3%) patients, P=ns, respectively). Mean time to discharge was similar (colchicine vs controls 14.1±10.4 vs 14.7±8.1 days). Older age (>60 years, P=0.025), P/F<275 mmHg (P=0.005), AST>40 U/L (P<0.001), pre-existent heart (P=0.02), lung (P=0.003), upper-gastrointestinal (P=0.014), lower-gastrointestinal diseases (P=0.009) and cancer (P=0.008) were predictive of achieving the primary outcome. Diarrhoea (9.1% vs 0%, p=0.0031) and increased levels of AST at 6 days (76.9±91.8 vs 33.5±20.7 U/l, P=0.016) were more frequent in the colchicine group.

conclusionColchicine did not reduce the rate and the time to the critical stage. Colchicine was relatively safe although adverse hepatic effects require caution. We confirm that older (>60 years) patients with comorbidities are characterized by worse outcome.

Indexed as

COVID-19AgedAged, 80 and overColchicineFemaleHumansMaleMiddle AgedPatient DischargeSARS-CoV-2Treatment OutcomeColchicineAnti-IL-1ColchicineCoronavirusCOVID-19InflammationSARS-CoV-2

Identifiers

PMID36396522
PMCPMC9618432

What OpenQuestion holds

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Registered trials

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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.