About: Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial

Facets (new session)
Description
Metadata
Settings
- owl:sameAs
- Inference Rule:

About: Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial
Creator	Lopes, Maria Zamboni, Dario Borges, Marcos Alves-Filho, José Cunha, Fernando Amaral, Natália Benatti, Maíra Bollela, Valdes Bonjorno, Letícia Cl Almeida, Sérgio Cunha, Larissa Cunha, Thiago Filho, Fonseca, Benedito Giannini, Marcela Laerte, L Leiria, Luiz Louzada-Junior, Paulo Luppino-Assad, Rodrigo Martins, Maria Miranda, Carlos Neto, Eurico Oliveira, Renê Pazin-Filho, Antonio Rezek, Uebe Rodrigues, Tamara Santana, Rodrigo Scheider, Ayda Sousa, Betânia Veras, Flávio Vilar, Fernando
Source	MedRxiv
abstract	Introduction. Neutrophilia and high levels of proinflammatory cytokines and other mediators of inflammation are common finds in patients with severe acute respiratory syndrome due to COVID-19. By its action on leukocytes, we propose colchicine as an intervention worthy of being tested. Objective. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. Methods. We present the interim analysis of a single-center randomized, double-blinded, placebo controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 38 patients allocated 1:1 from April 11 to July 06, 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The first dose was 1.0 mg whether body weight was [≥] 80 kg. Endpoints. The primary endpoints were the need for supplemental oxygen; time of hospitalization; need for admission and length of stay in intensive care units; and death rate and causes of mortality. As secondary endpoints, we assessed: serum C-reactive protein, serum Lactate dehydrogenase and relation neutrophil to lymphocyte of peripheral blood samples from day zero to day 7; the number, type, and severity of adverse events; frequency of interruption of the study protocol due to adverse events; and frequency of QT interval above 450 ms. Results. Thirty-five patients (18 for Placebo and 17 for Colchicine) completed the study. Both groups were comparable in terms of demographic, clinical and laboratory data at baseline. Median (and interquartile range) time of need for supplemental oxygen was 3.0 (1.5-6.5) days for the Colchicine group and 7.0 (3.0-8.5) days for Placebo group (p = 0.02). Median (IQR) time of hospitalization was 6.0 (4.0-8.5) days for the Colchicine group and 8.5 (5.5-11.0) days for Placebo group (p = 0.03). At day 2, 53% vs 83% of patients maintained the need for supplemental oxygen, while at day 7 the values were 6% vs 39%, in the Colchicine and Placebo groups, respectively (log rank; p = 0.01). Hospitalization was maintained for 53% vs 78% of patients at day 5 and 6% vs 17% at day 10, for the Colchicine and Placebo groups, respectively (log rank; p = 0.01). One patient per group needed admission to ICU. No recruited patient died. At day 4, patients of Colchicine group presented significant reduction of serum C-reactive protein compared to baseline (p < 0.001). The majority of adverse events were mild and did not lead to patient withdrawal. Diarrhea was more frequent in the Colchicine group (p = 0.17). Cardiac adverse events were absent. Discussion. The use of colchicine reduced the length of supplemental oxygen therapy and the length of hospitalization. Clinical improvement was in parallel with a reduction on serum levels of C-reactive protein. The drug was safe and well tolerated. Colchicine may be considered a beneficial and not expensive option for COVID-19 treatment. Clinical trials with larger numbers of patients should be conducted to further evaluate the efficacy and safety of colchicine as an adjunctive therapy for hospitalized patients with moderate to severe COVID-19.
has issue date	2020-08-11(xsd:dateTime)
bibo:doi	10.1101/2020.08.06.20169573
has license	medrxiv
sha1sum (hex)	f6c8fba9919f483766d0e53404a6d9e0335d3eba
schema:url	https://doi.org/10.1101/2020.08.06.20169573
resource representing a document's title	Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial
resource representing a document's body	covid:f6c8fba9919f483766d0e53404a6d9e0335d3eba#body_text
is schema:about of	named entity 'inflammation' named entity 'C-reactive protein' named entity 'improvement' named entity 'patients' named entity 'days' named entity 'Colchicine' named entity 'baseline' named entity 'stay' named entity 'C-reactive protein' named entity 'IQR' named entity 'patient' named entity 'death rate' named entity 'Results' named entity 'Colchicine' named entity 'patients' named entity 'Colchicine' covid:arg/f6c8fba9919f483766d0e53404a6d9e0335d3eba named entity 'relation' named entity 'adverse events' named entity 'randomized' named entity 'serum' named entity 'admission' named entity 'presented' named entity 'days' named entity 'group' named entity 'efficacy' named entity 'colchicine' named entity 'length' named entity 'Clinical' named entity 'number' named entity 'Colchicine' named entity 'patients' named entity 'Placebo' named entity 'days' named entity 'severe acute respiratory syndrome' named entity 'log' named entity 'frequency' named entity 'colchicine' named entity 'neutrophil' named entity 'adverse events' named entity 'adverse events' named entity 'C-reactive protein' named entity 'adjunctive therapy' named entity 'inflammation' named entity 'proinflammatory cytokines' named entity 'Lactate dehydrogenase' named entity 'intensive care units' named entity 'severe acute respiratory syndrome' named entity 'serum levels' named entity 'Colchicine' named entity 'QT interval' named entity 'standard treatment' named entity 'Colchicine' named entity 'interim analysis' named entity 'colchicine'

Faceted Search & Find service v1.13.91 as of Mar 24 2020

Alternative Linked Data Documents: Sponger | ODE Content Formats:

RDF

ODATA

Microdata

About

OpenLink Virtuoso version 07.20.3229 as of Jul 10 2020, on Linux (x86_64-pc-linux-gnu), Single-Server Edition (94 GB total memory)
Data on this page belongs to its respective rights holders.
Virtuoso Faceted Browser Copyright © 2009-2024 OpenLink Software