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10.1001/jamanetworkopen.2020.13136

http://scihub22266oqcxt.onion/10.1001/jamanetworkopen.2020.13136
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suck abstract from ncbi


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pmid32579195      JAMA+Netw+Open 2020 ; 3 (6): e2013136
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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 #MMPMID32579195
  • Deftereos SG; Giannopoulos G; Vrachatis DA; Siasos GD; Giotaki SG; Gargalianos P; Metallidis S; Sianos G; Baltagiannis S; Panagopoulos P; Dolianitis K; Randou E; Syrigos K; Kotanidou A; Koulouris NG; Milionis H; Sipsas N; Gogos C; Tsoukalas G; Olympios CD; Tsagalou E; Migdalis I; Gerakari S; Angelidis C; Alexopoulos D; Davlouros P; Hahalis G; Kanonidis I; Katritsis D; Kolettis T; Manolis AS; Michalis L; Naka KK; Pyrgakis VN; Toutouzas KP; Triposkiadis F; Tsioufis K; Vavouranakis E; Martinez-Dolz L; Reimers B; Stefanini GG; Cleman M; Goudevenos J; Tsiodras S; Tousoulis D; Iliodromitis E; Mehran R; Dangas G; Stefanadis C
  • JAMA Netw Open 2020[Jun]; 3 (6): e2013136 PMID32579195show ga
  • 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.
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Betacoronavirus[MESH]
  • |C-Reactive Protein/*metabolism[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Drug Treatment[MESH]
  • |Cause of Death[MESH]
  • |Colchicine/*therapeutic use[MESH]
  • |Coronavirus Infections/*drug therapy/metabolism[MESH]
  • |Diarrhea/chemically induced[MESH]
  • |Disease Progression[MESH]
  • |Female[MESH]
  • |Fibrin Fibrinogen Degradation Products/*metabolism[MESH]
  • |Greece[MESH]
  • |Hospitalization[MESH]
  • |Humans[MESH]
  • |Inflammation/metabolism[MESH]
  • |Kaplan-Meier Estimate[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Mortality[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*drug therapy/metabolism[MESH]
  • |Respiration, Artificial/statistics & numerical data[MESH]
  • |SARS-CoV-2[MESH]
  • |Time Factors[MESH]
  • |Treatment Outcome[MESH]
  • |Troponin/*metabolism[MESH]


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