COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III

Last updated: August 5, 2020
Sponsor: Hospital Sirio-Libanes
Overall Status: Terminated

Phase

3

Condition

Respiratory Syncytial Virus (Rsv) Infection

Common Cold

Lung Injury

Treatment

N/A

Clinical Study ID

NCT04327401
CAAE: 30227020.5.1001.0008
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 septicshock)

  • Patients who did use corticosteroids during hospital stay for periods equal or greaterthan 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

Study Design

Total Participants: 299
Study Start date:
April 13, 2020
Estimated Completion Date:
July 22, 2020

Study 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.

Connect with a study center

  • Hospital Ana Nery

    Salvador, Bahia
    Brazil

    Site Not Available

  • Instituto de Cardiologia do Distrito Federal

    Brasília, Distrito Federal
    Brazil

    Site Not Available

  • Fundação Social Rural de Colatina

    Colatina, Esoírito Santo
    Brazil

    Site Not Available

  • Hospital Vera Cruz AS

    Belo Horizonte, Minas Gerais
    Brazil

    Site Not Available

  • Hospital Maternidade E Pronto Socorro Santa Lucia Ltda

    Poços De Caldas, Minas Gerais
    Brazil

    Site Not Available

  • Universidade Estadual de Londrina

    Londrina, Paraná
    Brazil

    Site Not Available

  • Eurolatino Natal Pesquisas Médicas Ltda

    Natal, Rio Grande Do Norte
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Maestri E Kormann Consultoria Medico-Cientifica

    Blumenau, Santa Catarina
    Brazil

    Site Not Available

  • Sociedade Literaria e Caritativa Santo Agostinho

    Criciúma, Santa Catarina
    Brazil

    Site Not Available

  • Fundação Pio XII

    Barretos, São Paulo
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo
    Brazil

    Site Not Available

  • Associacao Beneficente Siria

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo,
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP - HCFMRP

    São Paulo,
    Brazil

    Site Not Available

  • Prevent Senior Private Operadora de Saude Ltda

    São Paulo,
    Brazil

    Site Not Available

  • Real e Benemérita Associação Portuguesa de Beneficência/SP

    São Paulo,
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia

    São Paulo,
    Brazil

    Site Not Available

  • Secretaria de Saúde do Estado de São Paulo

    São Paulo,
    Brazil

    Site Not Available

  • Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

    São Paulo,
    Brazil

    Site Not Available

  • Universidade Federal de São Paulo

    São Paulo,
    Brazil

    Site Not Available

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