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