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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 et al., Scientific Reports, doi:10.1038/s41598-022-13424-6
Jun 2022  
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Mortality 29% Improvement Relative Risk Ventilation 50% ICU admission 21% Combined NIV/ICU/ventila.. 15% primary Colchicine  Cecconi et al.  LATE TREATMENT  DB RCT Is late treatment with colchicine beneficial for COVID-19? Double-blind RCT 240 patients in Spain (August 2020 - March 2021) Lower ventilation with colchicine (not stat. sig., p=0.29) c19early.org Cecconi et al., Scientific Reports, Jun 2022 Favorscolchicine Favorscontrol 0 0.5 1 1.5 2+
Colchicine for COVID-19
5th treatment shown to reduce risk in September 2020, now with p = 0.00000031 from 56 studies.
No treatment is 100% effective. Protocols combine treatments.
5,000+ studies for 109 treatments. c19early.org
RCT 240 hospitalized patients with COVID-19 pneumonia, mean 9 days from the onset of symptoms, showing no significant differences with colchicine treatment. EudraCT 2020-001841-38.
Although the 29% lower mortality is not statistically significant, it is consistent with the significant 28% lower mortality [17‑37%] from meta analysis of the 43 mortality results to date.
risk of death, 29.4% lower, RR 0.71, p = 0.62, treatment 7 of 119 (5.9%), control 10 of 120 (8.3%), NNT 41.
risk of mechanical ventilation, 49.6% lower, RR 0.50, p = 0.29, treatment 5 of 119 (4.2%), control 10 of 120 (8.3%), NNT 24.
risk of ICU admission, 20.8% lower, RR 0.79, p = 0.67, treatment 11 of 119 (9.2%), control 14 of 120 (11.7%), NNT 41.
combined NIV/ICU/ventilation/death, 15.3% lower, RR 0.85, p = 0.62, treatment 21 of 119 (17.6%), control 25 of 120 (20.8%), NNT 31, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cecconi et al., 2 Jun 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, peer-reviewed, mean age 65.0, 31 authors, study period August 2020 - March 2021, average treatment delay 9.0 days, dosage 1mg day 1, 0.5mg days 2-5. Contact: albertocecconi@hotmail.com.
This PaperColchicineAll
Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial
Alberto Cecconi, Pablo Martinez-Vives, Alberto Vera, Cristina Lavilla Olleros, Ana Barrios, Eva Fonseca Aizpuru, Pilar Roquero, Susana Hernandez Muñiz, Maria Jose Olivera, Marianela Ciudad, Ruben Pampin Sanchez, Rosa Fernandez-Madera Martínez, Azucena Bautista-Hernández, Elena García Castillo, Gorane Iturricastillo, Elena Ávalos, Diana Prada Cotado, Alvaro Alejandre De Oña, Eduardo Fernandez Carracedo, Ana Marcos-Jimenez, Ancor Sanz-Garcia, Aranzazu Alfranca, Maurizio Cecconi, Hortensia De La Fuente, Maria Angeles Sanz De Benito, Paloma Caballero, Francisco Sanchez-Madrid, Julio Ancochea, Carmen Suarez, Luis Jesus Jimenez-Borreguero, Fernando Alfonso
Scientific Reports, doi:10.1038/s41598-022-13424-6
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).
Author contributions Competing interests The authors declare no competing interests.
References
Cai, Obesity and COVID-19 severity in a designated hospital in Shenzhen, China, Diabetes Care
Cecconi, Effects of colchicine on atherosclerotic plaque stabilization: A multimodality imaging study in an animal model, J. Cardiovasc. Transl. Res
Chen, Quach, COVID-19 cytokine storm syndrome: A threshold concept, Lancet Microbe
Cozzi, Chest X-ray in new coronavirus disease 2019 (COVID-19) infection: Findings and correlation with clinical outcome, Radiol. Med
Deftereos, 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, JAMA Netw. Open
Demidowich, Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial, Diabetes Obes. Metab
Diaz, Effect of colchicine vs usual care alone on intubation and 28-day mortality in patients hospitalized with COVID-19: A randomized clinical trial, JAMA Netw. Open
Gao, Associations between body-mass index and COVID-19 severity in 6•9 million people in England: A prospective, community-based, cohort study, Lancet Diabetes Endocrinol
Guo, Cardiovascular implications of fatal outcomes of patients with coronavirus disease 2019 (COVID-19), JAMA Cardiol
Hamer, Gale, Kivimäki, Batty, Overweight, obesity, and risk of hospitalization for COVID-19: A communitybased cohort study of adults in the United Kingdom, Proc. Natl. Acad. Sci. U.S.A
Hyun, Effects of early corticosteroid use in patients with severe coronavirus disease 2019, BMC Infect. Dis
Katz, Regardless of age, obesity and hypertension increase risks with COVID-19, JAMA Intern. Med
Leung, Yao Hui, Kraus, Colchicine-update on mechanisms of action and therapeutic uses, Semin. Arthritis Rheum
Lopes, Beneficial effects of colchicine for moderate to severe COVID-19: A randomised, double-blinded, placebocontrolled clinical trial, RMD Open
Peckham, Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission, Nat. Commun
Reyes, Anti-inflammatory therapy for COVID-19 infection: The case for colchicine, Ann. Rheum. Dis
Roubille, Tardif, Colchicine for secondary cardiovascular prevention in coronary disease, Circulation
Salamanca, COVID-19 "fulminant myocarditis" successfully treated with temporary mechanical circulatory support, JACC Cardiovas. Imaging
Tardif, Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, doubleblinded, adaptive, placebo-controlled, multicentre trial, Lancet Respir. Med, doi:10.1016/S2213-2600(21)00222-8
Tardif, Efficacy and safety of low-dose colchicine after myocardial infarction, N. Engl. J. Med
Zein, Raffaello, Effect of colchicine on mortality in patients with COVID-19-A systematic review and metaanalysis, Diabetes Metab. Syndr
Zhu, A novel coronavirus from patients with pneumonia in China, N. Engl. J. Med
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Effect of colchicine vs usual care alone on intubation ' 'and 28-day mortality in patients hospitalized with COVID-19: A ' 'randomized clinical trial. JAMA Netw. Open 4(12), e2141328–e2141328 ' '(2021).', 'journal-title': 'JAMA Netw. Open'}, { 'issue': '35', 'key': '13424_CR22', 'doi-asserted-by': 'publisher', 'first-page': '21011', 'DOI': '10.1073/pnas.2011086117', 'volume': '117', 'author': 'M Hamer', 'year': '2020', 'unstructured': 'Hamer, M., Gale, C. R., Kivimäki, M. & Batty, G. D. Overweight, obesity, ' 'and risk of hospitalization for COVID-19: A community-based cohort study ' 'of adults in the United Kingdom. Proc. Natl. Acad. Sci. U.S.A. 117(35), ' '21011–21013 (2020).', 'journal-title': 'Proc. Natl. Acad. Sci. U.S.A.'}, { 'issue': '7', 'key': '13424_CR23', 'doi-asserted-by': 'publisher', 'first-page': '1392', 'DOI': '10.2337/dc20-0576', 'volume': '43', 'author': 'Q Cai', 'year': '2020', 'unstructured': 'Cai, Q. et al. Obesity and COVID-19 severity in a designated hospital in ' 'Shenzhen, China. Diabetes Care 43(7), 1392–1398 (2020).', 'journal-title': 'Diabetes Care'}, { 'issue': '7', 'key': '13424_CR24', 'doi-asserted-by': 'publisher', 'first-page': '1642', 'DOI': '10.1111/dom.13702', 'volume': '21', 'author': 'AP Demidowich', 'year': '2019', 'unstructured': 'Demidowich, A. P. et al. Effects of colchicine in adults with metabolic ' 'syndrome: A pilot randomized controlled trial. Diabetes Obes. Metab. ' '21(7), 1642–1651 (2019).', 'journal-title': 'Diabetes Obes. Metab.'}], 'container-title': 'Scientific Reports', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.nature.com/articles/s41598-022-13424-6.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41598-022-13424-6', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41598-022-13424-6.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 6, 2]], 'date-time': '2022-06-02T12:14:17Z', 'timestamp': 1654172057000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.nature.com/articles/s41598-022-13424-6'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 6, 2]]}, 'references-count': 24, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2022, 12]]}}, 'alternative-id': ['13424'], 'URL': 'http://dx.doi.org/10.1038/s41598-022-13424-6', 'relation': {}, 'ISSN': ['2045-2322'], 'subject': ['Multidisciplinary'], 'container-title-short': 'Sci Rep', 'published': {'date-parts': [[2022, 6, 2]]}, 'assertion': [ { 'value': '3 December 2021', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '27 April 2022', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '2 June 2022', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': 'The authors declare no competing interests.', 'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '9208'}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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