About: COVID-19-associated ARDS treated with DEXamethasone (CoDEX): Study design and rationale for a randomized trial.

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About: COVID-19-associated ARDS treated with DEXamethasone (CoDEX): Study design and rationale for a randomized trial. Goto Sponge NotDistinct Permalink

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

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	COVID-19-associated ARDS treated with DEXamethasone (CoDEX): Study design and rationale for a randomized trial.
Creator	Azevedo, Pontes Cesar, Luciano Silva, A Azevedo, Luciano Lopes, Renato Avezum, Álvaro Berwanger, Otavio Bueno, Flavia Cavalcanti, Alexandre Costa, André Costa, V Damiani, Lucas Honorato, Michele Leite, Eduardo Machado, Flávia Maia, Israel Moura, Ricardo Pellison Baldassare, Franca Rosa, Regis Sírio-Libanês, Hospital Tomazini, Bruno Veiga, Viviane Vitoria, Maria
Source	MedRxiv
abstract	OBJECTIVES: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV2 infection (Coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop Acute Respiratory Distress Syndrome (ARDS). Several clinical trials evaluated the role of corticosteroids in non-COVID-19 ARDS with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe ARDS due to confirmed or probable COVID-19. METHODS: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48h before randomization) moderate or severe ARDS, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (intervention group) or standard treatment without dexamethasone (control group). Patients in the intervention group will receive dexamethasone 20mg IV once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until Intensive Care Unit (ICU) discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment (SOFA) Score evaluation at 48h, 72h and 7 days and ICU-free days within 28. ETHICS AND DISSEMINATION: This trial was approved by the Brazilian National Committee of Ethics in Research (Comissao Nacional de Etica em Pesquisa - CONEP) and National Health Surveillance Agency (ANVISA). An independent data monitoring committee will perform interim analyses and evaluate adverse events throughout the trial. Results will be submitted for publication after enrolment and follow-up are complete.
has issue date	2020-06-26(xsd:dateTime)
bibo:doi	10.1101/2020.06.24.20139303
has license	medrxiv
sha1sum (hex)	7f5dad872bb2a45501c8ca9f01064972bd0c2bc4
schema:url	https://doi.org/10.1101/2020.06.24.20139303
resource representing a document's title	COVID-19-associated ARDS treated with DEXamethasone (CoDEX): Study design and rationale for a randomized trial.
resource representing a document's body	covid:7f5dad872bb2a45501c8ca9f01064972bd0c2bc4#body_text
is schema:about of	named entity 'COVID-19' named entity 'adult' named entity 'number' named entity 'intravenous' named entity 'Coronavirus disease 2019' named entity 'ARDS' named entity 'NON-' named entity 'ROLE' named entity 'CAUSED BY' named entity 'CORTICOSTEROIDS' named entity 'PANDEMIC' named entity 'EVALUATE' named entity 'SARS-COV2 INFECTION' named entity 'COMMON' named entity 'EARLY' named entity 'VARYING' named entity 'COVID-19' named entity 'pandemic' named entity 'patients' named entity 'moderate' named entity 'severe acute respiratory syndrome coronavirus 2' named entity 'infection' named entity 'Acute Respiratory Distress Syndrome' named entity 'COVID-19' named entity 'ARDS' named entity 'Coronavirus disease 2019' named entity 'viral pneumonia' named entity 'ARDS' named entity 'COVID' named entity 'adverse effects' named entity 'infection' named entity 'ARDS' named entity 'open-label trial' named entity 'beta distribution' named entity 'gas exchange' named entity 'critical care' named entity 'preprint' named entity 'preprint' named entity 'invasive mechanical ventilation' named entity 'mechanical ventilation' named entity 'Ordinal Scale' named entity 'preprint' named entity 'corticosteroids' named entity 'controlled clinical trial' named entity 'lactation' named entity 'viral replication' named entity 'Antarctica' named entity 'adverse events' named entity 'ventilator' named entity 'clinical outcomes' named entity 'sample size' named entity 'preprint' named entity 'CC-BY 4.0 International license' named entity '8 days' named entity 'p-value' named entity 'community transmission' named entity 'dexamethasone' named entity 'intravenously' named entity 'preprint' named entity '7.2' named entity 'dexamethasone' named entity 'interleukin (IL)-2' named entity 'medRxiv'

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