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

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ClinicalTrials.gov Identifier: NCT04325061
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborators:
Li Ka Shing Knowledge Institute
Consorcio Centro de Investigación Biomédica en Red, M.P.
Information provided by (Responsible Party):
Jesus Villar, Dr. Negrin University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Caused by COVID-19 Drug: Dexamethasone Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with ARDS caused by confirmed COVID-19 infection
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020


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 Name: dexamethasone Indukern




Primary Outcome Measures :
  1. 60-day mortality [ Time Frame: 60 days ]
    All-cause mortality at 60 days after enrollment


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325061


Contacts
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Contact: Jesús Villar, MD +34606860027 jesus.villar54@gmail.com
Contact: Arthur Slutsky, MD +14168244000 SLUTSKYA@smh.ca

Locations
Show Show 24 study locations
Sponsors and Collaborators
Dr. Negrin University Hospital
Li Ka Shing Knowledge Institute
Consorcio Centro de Investigación Biomédica en Red, M.P.
Investigators
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Principal Investigator: Jesús Villar, MD Hospital Universitario Dr. Negrin
Publications of Results:
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Responsible Party: Jesus Villar, Senior scientist, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT04325061    
Other Study ID Numbers: 2020-001278-31
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesus Villar, Dr. Negrin University Hospital:
ARDS
COVID-19
multiple system organ failure
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action