Evidence map›Paper›PMID 33053024›Full record

ArticleRevista Brasileira de terapia intensiva

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

Bruno Martins Tomazini, Israel Silva Maia, Flavia Regina Bueno, Maria Vitoria Aparecida Oliveira Silva, Franca Pellison Baldassare, Eduardo Leite Vieira Costa, Ricardo Antonio Bonifácio Moura, Michele Ouriques Honorato, André Nathan Costa, Alexandre Biasi Cavalcanti and 9 more

Open access · diamondAbstract readClinical Trial Protocol
In one paragraph

Article in Revista Brasileira de terapia intensiva. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
5.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  4. Systemic corticosteroids for the treatment of COVID-19.The Cochrane database of systematic reviews · 2021
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  13. Inflammation, immunity and potential target therapy of SARS-COV-2: A total scale analysis review.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2021
    Review
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  17. Possible therapeutic targets for SARS-CoV-2 infection and COVID-19.Journal of allergy and infectious diseases · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 9 institutions in 2 countries.

Bruno Martins TomaziniHospital Sírio-Libanês - São Paulo (SP), Brasil.ORCID http://orcid.org/0000-0001-6763-6132
Israel Silva MaiaInstituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.ORCID http://orcid.org/0000-0003-3467-5287
Flavia Regina BuenoHospital Sírio-Libanês - São Paulo (SP), Brasil.
Maria Vitoria Aparecida Oliveira SilvaHospital Sírio-Libanês - São Paulo (SP), Brasil.
Franca Pellison BaldassareHospital Sírio-Libanês - São Paulo (SP), Brasil.
Eduardo Leite Vieira CostaHospital Sírio-Libanês - São Paulo (SP), Brasil.ORCID http://orcid.org/0000-0002-6941-3626
Ricardo Antonio Bonifácio MouraHospital Sírio-Libanês - São Paulo (SP), Brasil.
Michele Ouriques HonoratoHospital Sírio-Libanês - São Paulo (SP), Brasil.
André Nathan CostaHospital Sírio-Libanês - São Paulo (SP), Brasil.
Alexandre Biasi CavalcantiInstituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.ORCID http://orcid.org/0000-0003-2798-6263
Regis Goulart RosaBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.
Álvaro AvezumHospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.
Viviane Cordeiro VeigaHospital Beneficência Portuguesa - São Paulo (SP), Brasil.ORCID http://orcid.org/0000-0002-0287-3601
Renato Delascio LopesBrazilian Clinical Research Institute (BCRI) - São Paulo (SP), Brasil.
Lucas Petri DamianiInstituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.
Flávia Ribeiro MachadoBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.
Otavio BerwangerHospital Israelita Albert Einstein - São Paulo (SP), Brasil.
Luciano César Pontes de AzevedoHospital Sírio-Libanês - São Paulo (SP), Brasil.ORCID http://orcid.org/0000-0001-6759-3910
em nome dos investigadores da COALIZÃO COVID-19 BRASIL III
Hospital Sírio-Libanês · BRBrazilian Research in Intensive Care Network · BRUniversidade Brasil · BRBeneficência Portuguesa de São Paulo · BRClinical Research Institute · USHospital Alemão Oswaldo Cruz · BRHospital do Coração · BRHospital Israelita Albert Einstein · BRHospital Moinhos de Vento · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 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. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome 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 acute respiratory distress syndrome due to confirmed or probable COVID-19.

methodsThis is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, 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 intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit 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 Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.

Indexed as

COVID-19COVID-19 Drug TreatmentDexamethasoneGlucocorticoidsRespiratory Distress SyndromeAdultHumansIntensive Care UnitsMulticenter Studies as TopicOrgan Dysfunction ScoresPandemicsPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicRespiration, ArtificialTime FactorsDexamethasoneGlucocorticoids

Identifiers

PMID33053024
PMCPMC7595716
OpenAlexW3091917836

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.