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COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III) : = COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract, and its outbreak deemed a pandemic in early March 2020. Estimates show around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which due to its severity, consumes most Intensive Care Units (ICU) resources and is the leading mortality cause in this population. Given its burden, therapies that reduce the duration of mechanical ventilation or decrease the morbimortality are needed. Studies indicate that inflammation and cytokine storm might be involved in the pathophysiological pathway to ARDS in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. A recent small retrospective study evaluating the role of corticosteroids found no association between corticosteroids and hospital length of stay, virus clearance, and symptoms' duration. However, the retrospective nature of data, small sample size (31 patients), and no protocol for corticosteroids administration undermine its results. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in ventilator-free days at 28 days in patients with moderate and severe ARDS due to SARS-CoV2 virus in Brazil.

Year of Publication: 2020
Published: Bethesda (Maryland), ClinicalTrials.gov, June 4, 2020
Language: English
Full text access: Full text access (free access)
Links: Full Text (clinicaltrials.gov)
Keywords: Acute Lung Injury > MeSH
Acute Respiratory Distress Syndrome
Clinical Study Status: Recruiting
Clinical Study
Clinical Trial, Phase III
Coronavirus Infection
Coronavirus Infections > MeSH
Forschungsbericht
Klinische Studie
Pneumonia, Viral
Pneumonia, Viral > MeSH
Respiratory Distress Syndrome, Adult > MeSH
Respiratory Distress Syndrome, Newborn > MeSH
Severe Acute Respiratory Syndrome > MeSH
Notes: Source: ClinicalTrials.gov (no modifications made)
ClinicalTrials.gov processed this data on June 05, 2020
Last update posted on ClinicalTrials.gov: June 4, 2020
Last updated: 2020-06-08
NCT ID:
    NCT04327401

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