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Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial

IMPORTANCE: Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile. OBJECTIVE: To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and c...

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Autores principales: Deftereos, Spyridon G., Giannopoulos, Georgios, Vrachatis, Dimitrios A., Siasos, Gerasimos D., Giotaki, Sotiria G., Gargalianos, Panagiotis, Metallidis, Simeon, Sianos, George, Baltagiannis, Stefanos, Panagopoulos, Periklis, Dolianitis, Konstantinos, Randou, Efthalia, Syrigos, Konstantinos, Kotanidou, Anastasia, Koulouris, Nikolaos G., Milionis, Haralampos, Sipsas, Nikolaos, Gogos, Charalampos, Tsoukalas, George, Olympios, Christoforos D., Tsagalou, Eleftheria, Migdalis, Ilias, Gerakari, Styliani, Angelidis, Christos, Alexopoulos, Dimitrios, Davlouros, Pericles, Hahalis, George, Kanonidis, Ioannis, Katritsis, Demosthenes, Kolettis, Theofilos, Manolis, Antonios S., Michalis, Lampros, Naka, Katerina K., Pyrgakis, Vlasios N., Toutouzas, Konstantinos P., Triposkiadis, Filippos, Tsioufis, Konstantinos, Vavouranakis, Emmanouil, Martinèz-Dolz, Luis, Reimers, Bernhard, Stefanini, Giulio G., Cleman, Michael, Goudevenos, John, Tsiodras, Sotirios, Tousoulis, Dimitrios, Iliodromitis, Efstathios, Mehran, Roxana, Dangas, George, Stefanadis, Christodoulos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315286/
https://www.ncbi.nlm.nih.gov/pubmed/32579195
http://dx.doi.org/10.1001/jamanetworkopen.2020.13136
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author Deftereos, Spyridon G.
Giannopoulos, Georgios
Vrachatis, Dimitrios A.
Siasos, Gerasimos D.
Giotaki, Sotiria G.
Gargalianos, Panagiotis
Metallidis, Simeon
Sianos, George
Baltagiannis, Stefanos
Panagopoulos, Periklis
Dolianitis, Konstantinos
Randou, Efthalia
Syrigos, Konstantinos
Kotanidou, Anastasia
Koulouris, Nikolaos G.
Milionis, Haralampos
Sipsas, Nikolaos
Gogos, Charalampos
Tsoukalas, George
Olympios, Christoforos D.
Tsagalou, Eleftheria
Migdalis, Ilias
Gerakari, Styliani
Angelidis, Christos
Alexopoulos, Dimitrios
Davlouros, Pericles
Hahalis, George
Kanonidis, Ioannis
Katritsis, Demosthenes
Kolettis, Theofilos
Manolis, Antonios S.
Michalis, Lampros
Naka, Katerina K.
Pyrgakis, Vlasios N.
Toutouzas, Konstantinos P.
Triposkiadis, Filippos
Tsioufis, Konstantinos
Vavouranakis, Emmanouil
Martinèz-Dolz, Luis
Reimers, Bernhard
Stefanini, Giulio G.
Cleman, Michael
Goudevenos, John
Tsiodras, Sotirios
Tousoulis, Dimitrios
Iliodromitis, Efstathios
Mehran, Roxana
Dangas, George
Stefanadis, Christodoulos
author_facet Deftereos, Spyridon G.
Giannopoulos, Georgios
Vrachatis, Dimitrios A.
Siasos, Gerasimos D.
Giotaki, Sotiria G.
Gargalianos, Panagiotis
Metallidis, Simeon
Sianos, George
Baltagiannis, Stefanos
Panagopoulos, Periklis
Dolianitis, Konstantinos
Randou, Efthalia
Syrigos, Konstantinos
Kotanidou, Anastasia
Koulouris, Nikolaos G.
Milionis, Haralampos
Sipsas, Nikolaos
Gogos, Charalampos
Tsoukalas, George
Olympios, Christoforos D.
Tsagalou, Eleftheria
Migdalis, Ilias
Gerakari, Styliani
Angelidis, Christos
Alexopoulos, Dimitrios
Davlouros, Pericles
Hahalis, George
Kanonidis, Ioannis
Katritsis, Demosthenes
Kolettis, Theofilos
Manolis, Antonios S.
Michalis, Lampros
Naka, Katerina K.
Pyrgakis, Vlasios N.
Toutouzas, Konstantinos P.
Triposkiadis, Filippos
Tsioufis, Konstantinos
Vavouranakis, Emmanouil
Martinèz-Dolz, Luis
Reimers, Bernhard
Stefanini, Giulio G.
Cleman, Michael
Goudevenos, John
Tsiodras, Sotirios
Tousoulis, Dimitrios
Iliodromitis, Efstathios
Mehran, Roxana
Dangas, George
Stefanadis, Christodoulos
author_sort Deftereos, Spyridon G.
collection PubMed
description IMPORTANCE: Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile. OBJECTIVE: To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19). DESIGN, SETTING, AND PARTICIPANTS: In this prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention), 105 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment. The study took place in 16 tertiary hospitals in Greece. INTERVENTION: Colchicine administration (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily) with standard medical treatment for as long as 3 weeks. MAIN OUTCOMES AND MEASURES: Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death. Secondary end points were (1) the percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events. The primary efficacy analysis was performed on an intention-to-treat basis. RESULTS: A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the colchicine group. Median (interquartile range) peak high-sensitivity cardiac troponin values were 0.0112 (0.0043-0.0093) ng/mL in the control group and 0.008 (0.004-0.0135) ng/mL in the colchicine group (P = .34). Median (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). Mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03). Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04326790
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spelling pubmed-73152862020-06-26 Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial Deftereos, Spyridon G. Giannopoulos, Georgios Vrachatis, Dimitrios A. Siasos, Gerasimos D. Giotaki, Sotiria G. Gargalianos, Panagiotis Metallidis, Simeon Sianos, George Baltagiannis, Stefanos Panagopoulos, Periklis Dolianitis, Konstantinos Randou, Efthalia Syrigos, Konstantinos Kotanidou, Anastasia Koulouris, Nikolaos G. Milionis, Haralampos Sipsas, Nikolaos Gogos, Charalampos Tsoukalas, George Olympios, Christoforos D. Tsagalou, Eleftheria Migdalis, Ilias Gerakari, Styliani Angelidis, Christos Alexopoulos, Dimitrios Davlouros, Pericles Hahalis, George Kanonidis, Ioannis Katritsis, Demosthenes Kolettis, Theofilos Manolis, Antonios S. Michalis, Lampros Naka, Katerina K. Pyrgakis, Vlasios N. Toutouzas, Konstantinos P. Triposkiadis, Filippos Tsioufis, Konstantinos Vavouranakis, Emmanouil Martinèz-Dolz, Luis Reimers, Bernhard Stefanini, Giulio G. Cleman, Michael Goudevenos, John Tsiodras, Sotirios Tousoulis, Dimitrios Iliodromitis, Efstathios Mehran, Roxana Dangas, George Stefanadis, Christodoulos JAMA Netw Open Original Investigation IMPORTANCE: Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile. OBJECTIVE: To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19). DESIGN, SETTING, AND PARTICIPANTS: In this prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention), 105 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment. The study took place in 16 tertiary hospitals in Greece. INTERVENTION: Colchicine administration (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily) with standard medical treatment for as long as 3 weeks. MAIN OUTCOMES AND MEASURES: Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death. Secondary end points were (1) the percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events. The primary efficacy analysis was performed on an intention-to-treat basis. RESULTS: A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the colchicine group. Median (interquartile range) peak high-sensitivity cardiac troponin values were 0.0112 (0.0043-0.0093) ng/mL in the control group and 0.008 (0.004-0.0135) ng/mL in the colchicine group (P = .34). Median (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). Mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03). Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04326790 American Medical Association 2020-06-24 /pmc/articles/PMC7315286/ /pubmed/32579195 http://dx.doi.org/10.1001/jamanetworkopen.2020.13136 Text en Copyright 2020 Deftereos SG et al. JAMA Network Open. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Deftereos, Spyridon G.
Giannopoulos, Georgios
Vrachatis, Dimitrios A.
Siasos, Gerasimos D.
Giotaki, Sotiria G.
Gargalianos, Panagiotis
Metallidis, Simeon
Sianos, George
Baltagiannis, Stefanos
Panagopoulos, Periklis
Dolianitis, Konstantinos
Randou, Efthalia
Syrigos, Konstantinos
Kotanidou, Anastasia
Koulouris, Nikolaos G.
Milionis, Haralampos
Sipsas, Nikolaos
Gogos, Charalampos
Tsoukalas, George
Olympios, Christoforos D.
Tsagalou, Eleftheria
Migdalis, Ilias
Gerakari, Styliani
Angelidis, Christos
Alexopoulos, Dimitrios
Davlouros, Pericles
Hahalis, George
Kanonidis, Ioannis
Katritsis, Demosthenes
Kolettis, Theofilos
Manolis, Antonios S.
Michalis, Lampros
Naka, Katerina K.
Pyrgakis, Vlasios N.
Toutouzas, Konstantinos P.
Triposkiadis, Filippos
Tsioufis, Konstantinos
Vavouranakis, Emmanouil
Martinèz-Dolz, Luis
Reimers, Bernhard
Stefanini, Giulio G.
Cleman, Michael
Goudevenos, John
Tsiodras, Sotirios
Tousoulis, Dimitrios
Iliodromitis, Efstathios
Mehran, Roxana
Dangas, George
Stefanadis, Christodoulos
Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial
title Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial
title_full Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial
title_fullStr Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial
title_full_unstemmed Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial
title_short Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial
title_sort effect of colchicine vs standard care on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019: the grecco-19 randomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315286/
https://www.ncbi.nlm.nih.gov/pubmed/32579195
http://dx.doi.org/10.1001/jamanetworkopen.2020.13136
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