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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327401
Recruitment Status : Active, not recruiting
First Posted : March 31, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
Hospital Israelita Albert Einstein
Hospital do Coracao
Brazilian Research In Intensive Care Network
Ache Laboratorios Farmaceuticos S.A.
Information provided by (Responsible Party):
Luciano Cesar Pontes de Azevedo, Hospital Sirio-Libanes

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Pneumonia, Viral Acute Respiratory Distress Syndrome Drug: Dexamethasone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Dexamethasone. After randomization, dexamethasone 20mg IV 1x/day for 5 days, followed by 10mg IV 1xd for 5 days + standard treatment (according to the treatment protocol for 2019-nCoV infection).
  2. Standard treatment (according to the treatment protocol for 2019-nCoV infection).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020


Arm Intervention/treatment
Experimental: Intervention group
Dexamethasone. After randomization, dexamethasone [20mg IV 1x/day for 5 days, followed by 10mg IV 1xd for 5 days] + standard treatment (according to the treatment protocol for 2019-nCoV infection).
Drug: Dexamethasone
Dexamethasone administration for 10 consecutive days after randomization.
Other Names:
  • Decadron
  • Dexasone
  • Diodex
  • Hexadrol
  • Maxidex

No Intervention: Control
Standard treatment (according to the treatment protocol for 2019-nCoV infection).



Primary Outcome Measures :
  1. Ventilator-free days [ Time Frame: 28 days after randomization ]
    Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.


Secondary Outcome Measures :
  1. Evaluation of the clinical status [ Time Frame: 15 days after randomization ]
    Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.

  2. All-cause mortality [ Time Frame: 28 days after randomization ]
    All-cause mortality rates at 28 days after randomization.

  3. Mechanical ventilation duration [ Time Frame: 28 days after randomization ]
    Number of days of mechanical ventilation from randomization to day 28.

  4. Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Score at 48 hours, 72 hours and 7 days after randomization ]
    Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization


Other Outcome Measures:
  1. Intensive Care Unit free days [ Time Frame: 28 days after randomization ]
    Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.



Information from the National Library of Medicine

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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:

  • 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

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): NCT04327401


Locations
Show Show 21 study locations
Sponsors and Collaborators
Hospital Sirio-Libanes
Hospital Israelita Albert Einstein
Hospital do Coracao
Brazilian Research In Intensive Care Network
Ache Laboratorios Farmaceuticos S.A.
Investigators
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Principal Investigator: Luciano Cesar Pontes Azevedo, Ph.D Teaching Director of Teaching & Research Institute Sírio-Libanês Hospital
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Responsible Party: Luciano Cesar Pontes de Azevedo, Research Director, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT04327401    
Other Study ID Numbers: CAAE: 30227020.5.1001.0008
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Luciano Cesar Pontes de Azevedo, Hospital Sirio-Libanes:
SARS-CoV2 virus
2019-nCOV
Dexamethasone
ARDS
Corticosteroids
Respiratory failure
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Injury
Dexamethasone
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