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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395105
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pablo Oscar Rodriguez, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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: Dexamethasone (high dose) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021


Arm Intervention/treatment
Experimental: High dose Dexamethasone
16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10
Drug: Dexamethasone (high dose)
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 with Low dose Dexamethasone
Usual treatment without using up to 6 mg qd of dexamethasone for 10 days.



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


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

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

  3. Viral shedding [ Time Frame: 28 days after randomization ]
    Frequency of positive PCR on nasopharingeal swab

  4. Serum C-reactive Protein variation [ Time Frame: 10 days after randomization ]
    Change from baseline CPR

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

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

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

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

  9. 90-day mortality [ Time Frame: 90 days after randomization ]
    Death rate within 90 days of randomization



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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
  • Terminal illness with very poor prognosis according to the investigator judgement
  • Do-not-resucitate order
  • Known immunocompromised condition
  • Chronic use of systemic corticosteroids
  • Abscence of informed consent
  • Active participation in other randomized clinical 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): NCT04395105


Contacts
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Contact: Pablo O Rodriguez, MD +541152990100 ext 4307 prodriguez@cemic.edu.ar

Locations
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Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clínicas) Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, 1431
Contact: Pablo O Rodriguez, MD    1152990100 ext 4307    prodriguez@cemic.edu.ar   
Contact: Stella Zarza, SC    1152990100 ext 2543    szarza@cemic.edu.ar   
Principal Investigator: Pablo O Rodriguez, MD         
Sub-Investigator: Luis P Maskin, MD         
Sub-Investigator: Ignacio Bonelli, MD         
Sanatorio Sagrado Corazon Recruiting
Ciudad Autonoma de Buenos Aires, Argentina
Contact: Gabriel Olarte, MD       glolarte@gmail.com   
Principal Investigator: Gabriel Olarte, MD         
Sub-Investigator: Natalio Baredes, MD         
Clínica Bazterrica Recruiting
Ciudad Autónoma de Buenos Aires, Argentina, 1425
Contact: Fernando Palizas       fernandopalizas@yahoo.com.ar   
Principal Investigator: Fernando Palizas, MD         
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
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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: July 20, 2020
Last Verified: July 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
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
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