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Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial

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: NCT04395105
Recruitment Status : Terminated (Low rate of recruitment)
First Posted : May 20, 2020
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pablo Oscar Rodriguez, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Study Description
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Brief Summary:

There is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. The current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. Due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2 (COVID-19).

After RECOVERY trial prepublication, low dose (6 mg QD for 10 days) dexamethasone was recommended as the usual care treatment for severe COVID-19. At this time only 3 patients had been included in the trial. Thus, we updated our recommendations for centers and decided to compare two different doses of this glucocorticoid for the treatment of ADRS due to COVID-19.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Covid-19 Drug: High-Dose Dexamethasone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial
Actual Study Start Date : May 21, 2020
Actual Primary Completion Date : April 5, 2021
Actual Study Completion Date : May 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High dose Dexamethasone
Intravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10
 Drug: High-Dose Dexamethasone
IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10
Other Name: Corticosteroid
No Intervention: Usual care - low dose Dexamethasone
Intravenous Dexamethasone 6 mg qd for 10 days based on RECOVERY trial


Outcome Measures
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Primary Outcome Measures :
  1. Ventilator-free days at 28 days [ Time Frame: 28 days after randomization ]
    Days without ventilator support in the first 28 days following randomization

  2. Time to successful discontinuation from mechanical ventilation [ Time Frame: 28 days after randomization ]
    Time to event (successful discontinuation from mechanical ventilation)


Secondary Outcome Measures :
  1. 28-days mortality [ Time Frame: 28 days after randomization ]
    Dead rate within 28 days of randomization

  2. Rate of nosocomial infections [ Time Frame: 28 days after randomization ]
    Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization

  3. SOFA variation [ Time Frame: 10 days after randomization ]
    Variation in SOFA over the first 10 days after randomization

  4. Use of prone position [ Time Frame: 10 days after randomization ]
    Cumulative hours spent on prone position

  5. Delirium [ Time Frame: 28 days after randomization ]
    Frequency of delirium at ICU discharge

  6. Muscle weakness [ Time Frame: 28 days after randomization ]
    mMRC score at ICU discharge

  7. 90-day mortality [ Time Frame: 90 days after randomization ]
    Death rate within 90 days of randomization

  8. Peak daily blood glucose [ Time Frame: 10 days after randomization ]
    Interaction between treatment and daily change in glucose


Eligibility Criteria
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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:

  • ARDS according to Berlin's definition
  • PCR confirmed COVID-19
  • Length of mechanical ventilation less or equal to 72 hours

Exclusion Criteria:

  • Pregnancy or breast-feeding women
  • Terminal illness with very poor prognosis according to the investigator judgement
  • Therapeutic limitation
  • Known immunocompromised condition
  • Chronic use of systemic corticosteroids
  • Participation in another randomized crinical trial
  • More than 5 days of treatment of low dose dexamethasone for COVID-19
  • Abscence of informed consent
  • Active participation in other randomized clinical trial
Contacts and Locations
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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): NCT04395105


Locations
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Argentina
Hospital Universitario Sede Saaveda - IUC CEMIC
Caba, Argentina, 1431
Hospital Universitario Sede Pombo - IUC CEMIC
Ciudad Autonoma de Buenos Aires, Argentina, 1425
Sanatorio Sagrado Corazon
Ciudad Autonoma de Buenos Aires, Argentina
Clínica Bazterrica
Ciudad Autónoma de Buenos Aires, Argentina, 1425
Sponsors and Collaborators
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Investigators
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Principal Investigator: Pablo O Rodriguez, MD Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Principal Investigator: Luis P Maskin, MD Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pablo Oscar Rodriguez, Pulmonary and Critical Care Coordinator, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
ClinicalTrials.gov Identifier: NCT04395105    
Other Study ID Numbers: 1264
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, 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