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Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial.
Cecconi, Alberto; Martinez-Vives, Pablo; Vera, Alberto; Lavilla Olleros, Cristina; Barrios, Ana; Fonseca Aizpuru, Eva; Roquero, Pilar; Hernandez Muñiz, Susana; Olivera, Maria Jose; Ciudad, Marianela; Pampin Sanchez, Ruben; Fernandez-Madera Martínez, Rosa; Bautista-Hernández, Azucena; García Castillo, Elena; Iturricastillo, Gorane; Ávalos, Elena; Prada Cotado, Diana; Alejandre de Oña, Alvaro; Fernandez Carracedo, Eduardo; Marcos-Jimenez, Ana; Sanz-Garcia, Ancor; Alfranca, Aranzazu; Cecconi, Maurizio; de La Fuente, Hortensia; Sanz de Benito, Maria Angeles; Caballero, Paloma; Sanchez-Madrid, Francisco; Ancochea, Julio; Suarez, Carmen; Jimenez-Borreguero, Luis Jesus; Alfonso, Fernando.
  • Cecconi A; Cardiology Department, University Hospital de La Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain. albertocecconi@hotmail.com.
  • Martinez-Vives P; Cardiology Department, University Hospital de La Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain.
  • Vera A; Cardiology Department, University Hospital de La Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain.
  • Lavilla Olleros C; Internal Medicine Department, University Hospital Gregorio Marañon, Madrid, Spain.
  • Barrios A; Internal Medicine Department, University Hospital de la Princesa, Madrid, Spain.
  • Fonseca Aizpuru E; Internal Medicine Department, University Hospital of Cabueñes, Gijón, Spain.
  • Roquero P; Cardiology Department, University Hospital de La Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain.
  • Hernandez Muñiz S; Radiology Department, University Hospital de la Princesa, Madrid, Spain.
  • Olivera MJ; Radiology Department, University Hospital de la Princesa, Madrid, Spain.
  • Ciudad M; Internal Medicine Department, University Hospital de la Princesa, Madrid, Spain.
  • Pampin Sanchez R; Pharmacy Department, University Hospital of Cabueñes, Gijón, Spain.
  • Fernandez-Madera Martínez R; Internal Medicine Department, University Hospital of Cabueñes, Gijón, Spain.
  • Bautista-Hernández A; Internal Medicine Department, University Hospital de la Princesa, Madrid, Spain.
  • García Castillo E; Pneumology Department, University Hospital de la Princesa, Madrid, Spain.
  • Iturricastillo G; Pneumology Department, University Hospital de la Princesa, Madrid, Spain.
  • Ávalos E; Pneumology Department, University Hospital de la Princesa, Madrid, Spain.
  • Prada Cotado D; Geriatric Department, University Hospital de la Princesa, Madrid, Spain.
  • Alejandre de Oña A; Internal Medicine Department, University Hospital Gregorio Marañon, Madrid, Spain.
  • Fernandez Carracedo E; Internal Medicine Department, University Hospital Gregorio Marañon, Madrid, Spain.
  • Marcos-Jimenez A; Immunology Department, University Hospital de la Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, Madrid, Spain.
  • Sanz-Garcia A; Data Analysis Department, University Hospital de la Princesa, Madrid, Spain.
  • Alfranca A; Immunology Department, University Hospital de la Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, Madrid, Spain.
  • Cecconi M; Department of Anaesthesia and Intensive Care, IRCCS Istituto Clinico Humanitas, Humanitas University, Milan, Italy.
  • de La Fuente H; Immunology Department, University Hospital de la Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, Madrid, Spain.
  • Sanz de Benito MA; Clinical Analysis Department, University Hospital de la Princesa, Madrid, Spain.
  • Caballero P; Radiology Department, University Hospital de la Princesa, Madrid, Spain.
  • Sanchez-Madrid F; Immunology Department, University Hospital de la Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, Madrid, Spain.
  • Ancochea J; Pneumology Department, University Hospital de la Princesa, Madrid, Spain.
  • Suarez C; Internal Medicine Department, University Hospital de la Princesa, Madrid, Spain.
  • Jimenez-Borreguero LJ; Cardiology Department, University Hospital de La Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain.
  • Alfonso F; Cardiology Department, University Hospital de La Princesa, CIBER-CV, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, 28006, Madrid, Spain.
Sci Rep ; 12(1): 9208, 2022 06 02.
Article in English | MEDLINE | ID: covidwho-1873557
ABSTRACT
Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number 2020-001841-38; 26/04/2020).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Humans Language: English Journal: Sci Rep Year: 2022 Document Type: Article Affiliation country: S41598-022-13424-6

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Humans Language: English Journal: Sci Rep Year: 2022 Document Type: Article Affiliation country: S41598-022-13424-6