Official Title
COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)
Brief Summary

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause 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. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.

Detailed Description

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.

Terminated
Coronavirus Infection
Pneumonia, Viral
Acute Respiratory Distress Syndrome

Drug: Dexamethasone

Dexamethasone administration for 10 consecutive days after randomization.
Other Name: Array

Eligibility Criteria

Inclusion Criteria:

- Probable or confirmed infection by SARS-CoV2

- Intubated and mechanically ventilated

- Moderate/severe ARDS defined by the Berlin criteria (PaO2/FiO2 ≤200mmHg with PEEP
≥5cmH20)

- Onset of moderate/severe ARDS in less than 48 hours before randomization

Exclusion Criteria:

- Pregnancy or active lactation

- Known history of dexamethasone allergy

- Daily use of corticosteroids in the past 15 days

- Clinical indication for corticosteroids use for other diseases (i.e refractory septic
shock)

- Patients who did use corticosteroids during hospital stay for periods equal or greater
than two days

- Use of immunosuppressive drugs

- Cytotoxic chemotherapy in the past 21 days

- Neutropenia due to hematological or solid malignancies with bone marrow invasion

- Patient expected to die in the next 24 hours

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Hospital Ana Nery
Salvador, Bahia, Brazil

Instituto de Cardiologia do Distrito Federal
Brasília, Distrito Federal, Brazil

Fundação Social Rural de Colatina
Colatina, Esoírito Santo, Brazil

Hospital Vera Cruz AS
Belo Horizonte, Minas Gerais, Brazil

Hospital Maternidade E Pronto Socorro Santa Lucia Ltda
Poços De Caldas, Minas Gerais, Brazil

Universidade Estadual de Londrina
Londrina, Paraná, Brazil

Eurolatino Natal Pesquisas Médicas Ltda
Natal, Rio Grande Do Norte, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil

Maestri E Kormann Consultoria Medico-Cientifica
Blumenau, Santa Catarina, Brazil

Sociedade Literaria e Caritativa Santo Agostinho
Criciúma, Santa Catarina, Brazil

Fundação Pio XII
Barretos, São Paulo, Brazil

Santa Casa de Misericordia de Votuporanga
Votuporanga, São Paulo, Brazil

Associacao Beneficente Siria
São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP - HCFMRP
São Paulo, Brazil

Hospital Israelita Albert Einstein
São Paulo, Brazil

Prevent Senior Private Operadora de Saude Ltda
São Paulo, Brazil

Real e Benemérita Associação Portuguesa de Beneficência/SP
São Paulo, Brazil

Santa Casa de Misericórdia
São Paulo, Brazil

Secretaria de Saúde do Estado de São Paulo
São Paulo, Brazil

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, Brazil

Universidade Federal de São Paulo
São Paulo, Brazil

Luciano Cesar Pontes Azevedo, Ph.D, Principal Investigator
Teaching Director of Teaching & Research Institute Sírio-Libanês Hospital

Hospital Sirio-Libanes
NCT Number
Keywords
SARS-CoV2 virus
2019-nCOV
dexamethasone
ARDS
Corticosteroids
Respiratory failure
MeSH Terms
Coronavirus Infections
Pneumonia, Viral
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Dexamethasone