Randomized Controlled Trial

. 2023 Jan:107:30-36.

doi: 10.1016/j.ejim.2022.10.016. Epub 2022 Oct 31.

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

Carlo Perricone¹, Mirko Scarsi², Antonio Brucato³, Paola Pisano⁴, Erika Pigatto⁵, Cecilia Becattini⁶, Antonella Cingolani⁷, Francesco Tiso⁸, Roberto Prota⁹, Lina Rachele Tomasoni¹⁰, Maurizio Cutolo¹¹, Marika Tardella¹², Davide Rozza¹³, Carlo Zerbino¹⁴, Massimo Andreoni¹⁵, Venerino Poletti¹⁶, Elena Bartoloni¹, Roberto Gerli¹⁷; 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)

Collaborators, Affiliations

Collaborators

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):
Giacomo Cafaro¹⁸, Monia Mendeni¹⁹, Enrico Colombo¹⁹, Marta Del Medico²⁰, Paola Cabras²¹, Mauro Giovanni Schiesaro²², Laura Franco²³, Massimo Fantoni²⁴, Lara Friso²⁵, Valter Gallo²⁶, Franco Franceschini²⁷, Sabrina Paolino²⁸, Fausto Salaffi²⁹, Carlo Scirè³⁰, Anna Zanetti³⁰, Claudia Diana³¹, Angelina Passaro³², Rosario Foti³³, Francesco Saverio Serino³⁴, Maurizio Cassol³⁵, Giampaolo Bucaneve³⁶, Rosalba Elisabetta Rocchi³⁶

Affiliations

¹ Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
² Ospedale di Esine, ASST Valcamonica, Esine (BS).
³ Università degli Studi di Milano, ASST Fatebenefratelli-Sacco, Milan, Italy.
⁴ Asl Cagliari, Dipartimento di Area Medica, Struttura Complessa Medicina Interna, Italy.
⁵ Ospedale Classificato Villa Salus, Mestre (VE), Italy.
⁶ Medicina Interna, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
⁷ Fondazione Policlinico Gemelli, IRCCS, Università Cattolica Roma, Italy.
⁸ Medicina d'urgenza, Ospedale Alto Vicentino - AULSS 7 Pedemontana, Santorso (VI), Italy.
⁹ Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
¹⁰ ASST Spedali Civili di Brescia, Brescia, Italy.
¹¹ Laboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic Hospital San Martino, Genoa, Italy.
¹² Ospedale Carlo Urbani - Università Politecnica delle Marche, Ancona, Italy.
¹³ Centro Studi SIR, Società Italiana di Reumatologia, Milan, Italy.
¹⁴ Centro Studi ITS-AIPO, Milan, Italy.
¹⁵ Malattie Infettive, Dipartimento Processi Assistenziali Integrati, Policlinico Tor Vergata, Rome, Italy.
¹⁶ Dipartimento Toracico, Azienda AUSL Romagna, Ospedale G.B. Morgagni, Forlì, Italy; Department of Respiratory Diseases and Allergy, Aarhus University, Aarhus, Denmark.
¹⁷ Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy. Electronic address: roberto.gerli@unipg.it.
¹⁸ Reumatologia, Dipartimento di Medicina e Chirurgia., Università degli Studi di Perugia, Perugia, Italy.
¹⁹ Ospedale di Esine, ASST Valcamonica., Esine (BS).
²⁰ Medicina Interna Ospedale Sacco, Milano, Italy.
²¹ Asl Cagliari, Dipartimento di Area Medica, Struttura Complessa Medicina Interna., Italy.
²² Ospedale Classificato Villa Salus., Mestre (VE), Italy.
²³ Medicina Interna, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia., Perugia, Italy.
²⁴ Fondazione Policlinico Gemelli, IRCCS, Università Cattolica Roma., Italy.
²⁵ Medicina d'urgenza, Ospedale Alto Vicentino - AULSS 7 Pedemontana., Santorso (VI), Italy.
²⁶ Azienda Ospedaliera Ordine Mauriziano., Torino, Italy.
²⁷ ASST Spedali Civili di Brescia., Brescia, Italy.
²⁸ Laboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic Hospital San Martino., Genoa, Italy.
²⁹ Ospedale Carlo Urbani - Università Politecnica delle Marche., Ancona, Italy.
³⁰ Centro Studi SIR, Società Italiana di Reumatologia., Milan, Italy.
³¹ Centro Studi ITS-AIPO., Milan, Italy.
³² Azienda Ospedaliero Universitaria S. Anna, Ferrara, Italy.
³³ A.O.U. Policlinico V.E. Presidio Ospedaliero S. Marco, Catania, Italy.
³⁴ Azienda ULSS n. 4 Veneto Orientale, San Donà di Piave (VE), Italy.
³⁵ Ospedale San Pietro Fatebenefratelli di Roma, Rome, Italy.
³⁶ Centro Regionale di Farmacovigilanza dell'Umbria, Perugia.

PMID: 36396522
PMCID: PMC9618432
DOI: 10.1016/j.ejim.2022.10.016

Randomized Controlled Trial

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

Carlo Perricone et al. Eur J Intern Med. 2023 Jan.

. 2023 Jan:107:30-36.

doi: 10.1016/j.ejim.2022.10.016. Epub 2022 Oct 31.

Authors

Collaborators

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):
Giacomo Cafaro¹⁸, Monia Mendeni¹⁹, Enrico Colombo¹⁹, Marta Del Medico²⁰, Paola Cabras²¹, Mauro Giovanni Schiesaro²², Laura Franco²³, Massimo Fantoni²⁴, Lara Friso²⁵, Valter Gallo²⁶, Franco Franceschini²⁷, Sabrina Paolino²⁸, Fausto Salaffi²⁹, Carlo Scirè³⁰, Anna Zanetti³⁰, Claudia Diana³¹, Angelina Passaro³², Rosario Foti³³, Francesco Saverio Serino³⁴, Maurizio Cassol³⁵, Giampaolo Bucaneve³⁶, Rosalba Elisabetta Rocchi³⁶

Affiliations

¹ Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
² Ospedale di Esine, ASST Valcamonica, Esine (BS).
³ Università degli Studi di Milano, ASST Fatebenefratelli-Sacco, Milan, Italy.
⁴ Asl Cagliari, Dipartimento di Area Medica, Struttura Complessa Medicina Interna, Italy.
⁵ Ospedale Classificato Villa Salus, Mestre (VE), Italy.
⁶ Medicina Interna, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
⁷ Fondazione Policlinico Gemelli, IRCCS, Università Cattolica Roma, Italy.
⁸ Medicina d'urgenza, Ospedale Alto Vicentino - AULSS 7 Pedemontana, Santorso (VI), Italy.
⁹ Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
¹⁰ ASST Spedali Civili di Brescia, Brescia, Italy.
¹¹ Laboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic Hospital San Martino, Genoa, Italy.
¹² Ospedale Carlo Urbani - Università Politecnica delle Marche, Ancona, Italy.
¹³ Centro Studi SIR, Società Italiana di Reumatologia, Milan, Italy.
¹⁴ Centro Studi ITS-AIPO, Milan, Italy.
¹⁵ Malattie Infettive, Dipartimento Processi Assistenziali Integrati, Policlinico Tor Vergata, Rome, Italy.
¹⁶ Dipartimento Toracico, Azienda AUSL Romagna, Ospedale G.B. Morgagni, Forlì, Italy; Department of Respiratory Diseases and Allergy, Aarhus University, Aarhus, Denmark.
¹⁷ Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy. Electronic address: roberto.gerli@unipg.it.
¹⁸ Reumatologia, Dipartimento di Medicina e Chirurgia., Università degli Studi di Perugia, Perugia, Italy.
¹⁹ Ospedale di Esine, ASST Valcamonica., Esine (BS).
²⁰ Medicina Interna Ospedale Sacco, Milano, Italy.
²¹ Asl Cagliari, Dipartimento di Area Medica, Struttura Complessa Medicina Interna., Italy.
²² Ospedale Classificato Villa Salus., Mestre (VE), Italy.
²³ Medicina Interna, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia., Perugia, Italy.
²⁴ Fondazione Policlinico Gemelli, IRCCS, Università Cattolica Roma., Italy.
²⁵ Medicina d'urgenza, Ospedale Alto Vicentino - AULSS 7 Pedemontana., Santorso (VI), Italy.
²⁶ Azienda Ospedaliera Ordine Mauriziano., Torino, Italy.
²⁷ ASST Spedali Civili di Brescia., Brescia, Italy.
²⁸ Laboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic Hospital San Martino., Genoa, Italy.
²⁹ Ospedale Carlo Urbani - Università Politecnica delle Marche., Ancona, Italy.
³⁰ Centro Studi SIR, Società Italiana di Reumatologia., Milan, Italy.
³¹ Centro Studi ITS-AIPO., Milan, Italy.
³² Azienda Ospedaliero Universitaria S. Anna, Ferrara, Italy.
³³ A.O.U. Policlinico V.E. Presidio Ospedaliero S. Marco, Catania, Italy.
³⁴ Azienda ULSS n. 4 Veneto Orientale, San Donà di Piave (VE), Italy.
³⁵ Ospedale San Pietro Fatebenefratelli di Roma, Rome, Italy.
³⁶ Centro Regionale di Farmacovigilanza dell'Umbria, Perugia.

PMID: 36396522
PMCID: PMC9618432
DOI: 10.1016/j.ejim.2022.10.016

Abstract

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

Design: This 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.

Results: 152 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.

Conclusion: Colchicine 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.

Keywords: Anti-IL-1; COVID-19; Colchicine; Coronavirus; Inflammation; SARS-CoV-2.

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Comment in

Colchicine and mortality outcomes in patients with coronavirus disease (COVID-19).
Danjuma MI, Kaul R, Alyaarabi T, Elsayed B, Elshafei M. Danjuma MI, et al. Eur J Intern Med. 2023 Jun;112:126-127. doi: 10.1016/j.ejim.2023.02.009. Epub 2023 Feb 16. Eur J Intern Med. 2023. PMID: 36804360 Free PMC article. No abstract available.

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

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References

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