Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19 (DEXA-COVID19)

February 2, 2021 updated by: Jesus Villar, Dr. Negrin University Hospital

Background: There are no proven therapies specific for Covid-19. The full spectrum of Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial.

Methods: This is an internationally (Spain, Canada, China, USA) designed multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care, or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The acute respiratory distress syndrome (ARDS) is a catastrophic illness of multifactorial etiology characterized by a diffuse, severe inflammatory process of the lung leading to acute hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of ARDS. Clinical and experimental research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of ARDS.

The COVID-19 pandemic is a critical moment for the world. Severe pneumonia is the main condition leading to ARDS requiring weeks of MV with high mortality (40-60%) in COVID-19 patients. There is no specific therapy for Covid-19, although patients are receiving drugs that are already approved for treating other diseases. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties. However, the efficacy of corticosteroids in viral ARDS remains controversial.

We justify the need of this study based on the positive results of a recent clinical trial by our group, showing that dexamethasone for 10 days was able to reduce the duration of mechanical ventilation (MV) and increase hospital survival in patients with ARDS from multiple causes (Villar J et al. Lancet Respir Med 2020). Dexamethasone has never been evaluated in viral ARDS in a randomized controlled fashion. Our goal in this study is to examine the effects of dexamethasone on hospital mortality and on ventilator-free days in patients with moderate-to-severe ARDS due to confirmed COVID-19 infection admitted into a network of Spanish intensive care units (ICUs).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Department of Anesthesia, Hospital Clinic
      • Barcelona, Spain, 08036
        • AVI, Hospital Clinic
      • Barcelona, Spain, 08036
        • Cardiac ICU, Hospital Clinic
      • Barcelona, Spain, 08036
        • Hepatic ICU, Hospital Clínic
      • Barcelona, Spain, 08036
        • UVIR, Hospital Clinic
      • Ciudad Real, Spain, 13005
        • Intensive Care Unit, Hospital General de Ciudad Real
      • Madrid, Spain, 28006
        • Department of Anesthesia, Hospital Universitario La Princesa
      • Madrid, Spain, 28006
        • Intensive Care Unit, Hospital Universitario La Princesa
      • Madrid, Spain, 28040
        • Intensive Care Unit, Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Spain, 28046
        • Department of Anesthesia, Hospital Universitario La Paz
      • Madrid, Spain, 28046
        • Intensive Care Unit, Hospital Universitario La Paz
      • Murcia, Spain, 30120
        • Department of Anesthesia, Hospital Universitario Virgen de Arrixaca
      • Murcia, Spain, 30120
        • Intensive Care Unit, Hospital Universitario Virgen de la Arrixaca
      • Pontevedra, Spain, 36071
        • Department of Anesthesia, Hospital Unversitario Montecelo
      • Valencia, Spain, 46010
        • Anesthesia, Hospital General Universitario de Valencia
      • Valencia, Spain, 46010
        • Department of Anesthesia, Hospital Clínico Universitario
      • Valencia, Spain, 46010
        • Intensive Care Unit, Hospital Clinico Universitario
      • Valladolid, Spain, 47003
        • Department of Anesthesia, Hospital Clínico Universitario
      • Valladolid, Spain, 47012
        • Anesthesia, Hospital Universitario Río Hortega
      • Valladolid, Spain, 47012
        • Intensive Care Unit, Hospital Universitario Río Hortega
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • ICU, Hospital Universitari Mutua Terrassa
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Hospital Universitario Dr. Negrin
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Department of Anesthesia, Hospital Universitario de Cruces
      • Barakaldo, Vizcaya, Spain, 48903
        • Intensive Care Unit, Hospital Universitario de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 years or older;
  • positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample;
  • intubated and mechanically ventilated;
  • acute onset of ARDS, as defined by Berlin criteria as moderate-to-severe ARDS,3 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension, pulmonary capillary wedge pressure <18 mmHg, or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤200 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.

Exclusion Criteria:

  • Routine treatment with corticosteroids during the previous week irrespective of dose;
  • Corticosteroid use within the previous 24 h of more than 20 mg of dexamethasone or equivalent;
  • Patients with a known contraindication to corticosteroids;
  • Decision by a physician that involvement in the trial is not in the patient's best interest;
  • Pregnancy and breast-feeding;
  • Participation in another therapeutic trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Patients will be treated with standard intensive care
ACTIVE_COMPARATOR: Dexamethasone
Standard intensive care plus dexamethasone
Drug: Dexamethasone
Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization
Other Names:
  • dexamethasone Indukern

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
60-day mortality
Time Frame: 60 days
All-cause mortality at 60 days after enrollment
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free days
Time Frame: 28 days
Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment, For patients ventilated 28 days or longer and for subjects who die, VFD is 0.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Negrin University Hospital

Collaborators

Consorcio Centro de Investigación Biomédica en Red, M.P.
Li Ka Shing Knowledge Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2020

Primary Completion (ACTUAL)

June 19, 2020

Study Completion (ACTUAL)

June 19, 2020

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-001278-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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