Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial

{ 'indexed': {'date-parts': [[2022, 6, 2]], 'date-time': '2022-06-02T12:44:26Z', 'timestamp': 1654173866159}, 'reference-count': 24, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 6, 2]], 'date-time': '2022-06-02T00:00:00Z', 'timestamp': 1654128000000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 6, 2]], 'date-time': '2022-06-02T00:00:00Z', 'timestamp': 1654128000000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [ { 'name': 'Directorate-General for Research, Teaching and Documentation of the Department of ' 'Health of the Community of Madrid'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2022, 12]]}, 'abstract': '<jats:title>Abstract</jats:title><jats:p>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; ' '<jats:italic>p</jats:italic>\u2009=\u20090.533) 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).</jats:p>', 'DOI': '10.1038/s41598-022-13424-6', 'type': 'journal-article', 'created': {'date-parts': [[2022, 6, 2]], 'date-time': '2022-06-02T12:03:42Z', 'timestamp': 1654171422000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe ' 'COVID-19 pneumonia and hyperinflammation: a randomized clinical trial', 'prefix': '10.1038', 'volume': '12', 'author': [ {'given': 'Alberto', 'family': 'Cecconi', 'sequence': 'first', 'affiliation': []}, {'given': 'Pablo', 'family': 'Martinez-Vives', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alberto', 'family': 'Vera', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cristina', 'family': 'Lavilla Olleros', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ana', 'family': 'Barrios', 'sequence': 'additional', 'affiliation': []}, {'given': 'Eva', 'family': 'Fonseca Aizpuru', 'sequence': 'additional', 'affiliation': []}, {'given': 'Pilar', 'family': 'Roquero', 'sequence': 'additional', 'affiliation': []}, {'given': 'Susana', 'family': 'Hernandez Muñiz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Maria Jose', 'family': 'Olivera', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marianela', 'family': 'Ciudad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ruben', 'family': 'Pampin Sanchez', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Rosa', 'family': 'Fernandez-Madera Martínez', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Azucena', 'family': 'Bautista-Hernández', 'sequence': 'additional', 'affiliation': []}, {'given': 'Elena', 'family': 'García Castillo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gorane', 'family': 'Iturricastillo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Elena', 'family': 'Ávalos', 'sequence': 'additional', 'affiliation': []}, {'given': 'Diana', 'family': 'Prada Cotado', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alvaro', 'family': 'Alejandre de Oña', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Eduardo', 'family': 'Fernandez Carracedo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ana', 'family': 'Marcos-Jimenez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ancor', 'family': 'Sanz-Garcia', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aranzazu', 'family': 'Alfranca', 'sequence': 'additional', 'affiliation': []}, {'given': 'Maurizio', 'family': 'Cecconi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hortensia', 'family': 'de La Fuente', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Maria Angeles', 'family': 'Sanz de Benito', 'sequence': 'additional', 'affiliation': []}, {'given': 'Paloma', 'family': 'Caballero', 'sequence': 'additional', 'affiliation': []}, {'given': 'Francisco', 'family': 'Sanchez-Madrid', 'sequence': 'additional', 'affiliation': []}, {'given': 'Julio', 'family': 'Ancochea', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carmen', 'family': 'Suarez', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Luis Jesus', 'family': 'Jimenez-Borreguero', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fernando', 'family': 'Alfonso', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2022, 6, 2]]}, 'reference': [ { 'issue': '8', 'key': '13424_CR1', 'doi-asserted-by': 'publisher', 'first-page': '727', 'DOI': '10.1056/NEJMoa2001017', 'volume': '382', 'author': 'N Zhu', 'year': '2020', 'unstructured': 'Zhu, N. et al. 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