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

NCT04395105 | Terminated Phase 3

• 1 other identifier: 1264
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Respiratory Distress Syndrome, Adult; Covid-19

Outcome Measures

Primary Outcomes (2)

• Ventilator-free days at 28 days

  Days without ventilator support in the first 28 days following randomization

  28 days after randomization

• Time to successful discontinuation from mechanical ventilation

  Time to event (successful discontinuation from mechanical ventilation)

  28 days after randomization

Secondary Outcomes (8)

• 28-days mortality

  28 days after randomization

• Rate of nosocomial infections

  28 days after randomization

• SOFA variation

  10 days after randomization

• Use of prone position

  10 days after randomization

• Delirium

  28 days after randomization

Study Arms (2)

High dose Dexamethasone

EXPERIMENTAL

Intravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10

Drug: High-Dose Dexamethasone

Usual care - low dose Dexamethasone

NO INTERVENTION

Intravenous Dexamethasone 6 mg qd for 10 days based on RECOVERY trial

Interventions

High-Dose Dexamethasone DRUG

IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10

Also known as: Corticosteroid

High dose Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: lead

Study Sites (4)

Clínica Bazterrica

Buenos Aires, 1425, Argentina

Location

Hospital Universitario Sede Pombo - IUC CEMIC

Buenos Aires, 1425, Argentina

Location

Sanatorio Sagrado Corazon

Buenos Aires, Argentina

Location

Hospital Universitario Sede Saaveda - IUC CEMIC

CABA, 1431, Argentina

Location

Related Publications (1)

• Maskin LP, Olarte GL, Palizas F Jr, Velo AE, Lurbet MF, Bonelli I, Baredes ND, Rodriguez PO. High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Aug 26;21(1):743. doi: 10.1186/s13063-020-04646-y.

  PMID: 32843098 DERIVED

Related Links

• Protocol publication

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

Dexamethasone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary and Critical Care Coordinator

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 20, 2020
• Study Start: May 21, 2020
• Primary Completion: April 5, 2021
• Study Completion: May 21, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (4)