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Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial.
Perricone, Carlo; Scarsi, Mirko; Brucato, Antonio; Pisano, Paola; Pigatto, Erika; Becattini, Cecilia; Cingolani, Antonella; Tiso, Francesco; Prota, Roberto; Tomasoni, Lina Rachele; Cutolo, Maurizio; Tardella, Marika; Rozza, Davide; Zerbino, Carlo; Andreoni, Massimo; Poletti, Venerino; Bartoloni, Elena; Gerli, Roberto.
  • Perricone C; Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
  • Scarsi M; Ospedale di Esine, ASST Valcamonica, Esine (BS).
  • Brucato A; Università degli Studi di Milano, ASST Fatebenefratelli-Sacco, Milan, Italy.
  • Pisano P; Asl Cagliari, Dipartimento di Area Medica, Struttura Complessa Medicina Interna, Italy.
  • Pigatto E; Ospedale Classificato Villa Salus, Mestre (VE), Italy.
  • Becattini C; Medicina Interna, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
  • Cingolani A; Fondazione Policlinico Gemelli, IRCCS, Università Cattolica Roma, Italy.
  • Tiso F; Medicina d'urgenza, Ospedale Alto Vicentino - AULSS 7 Pedemontana, Santorso (VI), Italy.
  • Prota R; Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
  • Tomasoni LR; ASST Spedali Civili di Brescia, Brescia, Italy.
  • Cutolo M; Laboratory of Experimental Rheumatology, Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic Hospital San Martino, Genoa, Italy.
  • Tardella M; Ospedale Carlo Urbani - Università Politecnica delle Marche, Ancona, Italy.
  • Rozza D; Centro Studi SIR, Società Italiana di Reumatologia, Milan, Italy.
  • Zerbino C; Centro Studi ITS-AIPO, Milan, Italy.
  • Andreoni M; Malattie Infettive, Dipartimento Processi Assistenziali Integrati, Policlinico Tor Vergata, Rome, Italy.
  • Poletti V; Dipartimento Toracico, Azienda AUSL Romagna, Ospedale G.B. Morgagni, Forlì, Italy; Department of Respiratory Diseases and Allergy, Aarhus University, Aarhus, Denmark.
  • Bartoloni E; Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy.
  • Gerli R; Reumatologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Perugia, Perugia, Italy. Electronic address: roberto.gerli@unipg.it.
Eur J Intern Med ; 2022 Oct 31.
Article in English | MEDLINE | ID: covidwho-2244177
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

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal subject: Internal Medicine Year: 2022 Document Type: Article Affiliation country: J.ejim.2022.10.016

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal subject: Internal Medicine Year: 2022 Document Type: Article Affiliation country: J.ejim.2022.10.016