Treatment with COLchicine in hospitalized patients affected by COVID-19 : The COLVID-19 trial
Copyright © 2022 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved..
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.
| Errataetall: |
CommentIn: Eur J Intern Med. 2023 Jun;112:126-127. - PMID 36804360 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:107 |
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| Enthalten in: |
European journal of internal medicine - 107(2023) vom: 05. Jan., Seite 30-36 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Anti-IL-1 |
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| Anmerkungen: |
Date Completed 03.01.2023 Date Revised 11.08.2023 published: Print-Electronic CommentIn: Eur J Intern Med. 2023 Jun;112:126-127. - PMID 36804360 Citation Status MEDLINE |
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| doi: |
10.1016/j.ejim.2022.10.016 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM349098069 |
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| 100 | 1 | |a Perricone, Carlo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Treatment with COLchicine in hospitalized patients affected by COVID-19 |b The COLVID-19 trial |
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| 500 | |a Date Completed 03.01.2023 | ||
| 500 | |a Date Revised 11.08.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Eur J Intern Med. 2023 Jun;112:126-127. - PMID 36804360 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a OBJECTIVE: To evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anti-IL-1 | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Colchicine | |
| 650 | 4 | |a Coronavirus | |
| 650 | 4 | |a Inflammation | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 7 | |a Colchicine |2 NLM | |
| 650 | 7 | |a SML2Y3J35T |2 NLM | |
| 700 | 1 | |a Scarsi, Mirko |e verfasserin |4 aut | |
| 700 | 1 | |a Brucato, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Pisano, Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Pigatto, Erika |e verfasserin |4 aut | |
| 700 | 1 | |a Becattini, Cecilia |e verfasserin |4 aut | |
| 700 | 1 | |a Cingolani, Antonella |e verfasserin |4 aut | |
| 700 | 1 | |a Tiso, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Prota, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Tomasoni, Lina Rachele |e verfasserin |4 aut | |
| 700 | 1 | |a Cutolo, Maurizio |e verfasserin |4 aut | |
| 700 | 1 | |a Tardella, Marika |e verfasserin |4 aut | |
| 700 | 1 | |a Rozza, Davide |e verfasserin |4 aut | |
| 700 | 1 | |a Zerbino, Carlo |e verfasserin |4 aut | |
| 700 | 1 | |a Andreoni, Massimo |e verfasserin |4 aut | |
| 700 | 1 | |a Poletti, Venerino |e verfasserin |4 aut | |
| 700 | 1 | |a Bartoloni, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Gerli, Roberto |e verfasserin |4 aut | |
| 700 | 0 | |a 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) |e verfasserin |4 aut | |
| 700 | 1 | |a Cafaro, Giacomo |e investigator |4 oth | |
| 700 | 1 | |a Mendeni, Monia |e investigator |4 oth | |
| 700 | 1 | |a Colombo, Enrico |e investigator |4 oth | |
| 700 | 1 | |a Medico, Marta Del |e investigator |4 oth | |
| 700 | 1 | |a Cabras, Paola |e investigator |4 oth | |
| 700 | 1 | |a Schiesaro, Mauro Giovanni |e investigator |4 oth | |
| 700 | 1 | |a Franco, Laura |e investigator |4 oth | |
| 700 | 1 | |a Fantoni, Massimo |e investigator |4 oth | |
| 700 | 1 | |a Friso, Lara |e investigator |4 oth | |
| 700 | 1 | |a Gallo, Valter |e investigator |4 oth | |
| 700 | 1 | |a Franceschini, Franco |e investigator |4 oth | |
| 700 | 1 | |a Paolino, Sabrina |e investigator |4 oth | |
| 700 | 1 | |a Salaffi, Fausto |e investigator |4 oth | |
| 700 | 1 | |a Scirè, Carlo |e investigator |4 oth | |
| 700 | 1 | |a Zanetti, Anna |e investigator |4 oth | |
| 700 | 1 | |a Diana, Claudia |e investigator |4 oth | |
| 700 | 1 | |a Passaro, Angelina |e investigator |4 oth | |
| 700 | 1 | |a Foti, Rosario |e investigator |4 oth | |
| 700 | 1 | |a Serino, Francesco Saverio |e investigator |4 oth | |
| 700 | 1 | |a Cassol, Maurizio |e investigator |4 oth | |
| 700 | 1 | |a Bucaneve, Giampaolo |e investigator |4 oth | |
| 700 | 1 | |a Rocchi, Rosalba Elisabetta |e investigator |4 oth | |
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