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

Covid-19 Clinical Trial

Official title:

High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04395105
• Other study ID #: 1264
• Status: Terminated
• Phase: Phase 3
• Start date: May 21, 2020
• Est. completion date: May 21, 2021

Study information

• Verified date: May 2021
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 21, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Covid-19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• High-Dose Dexamethasone
IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10

Locations

Country	Name	City	State
Argentina	Hospital Universitario Sede Saaveda - IUC CEMIC	Caba
Argentina	Hospital Universitario Sede Pombo - IUC CEMIC	Ciudad Autonoma de Buenos Aires
Argentina	Sanatorio Sagrado Corazon	Ciudad Autonoma de Buenos Aires
Argentina	Clínica Bazterrica	Ciudad Autónoma de Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free days at 28 days	Days without ventilator support in the first 28 days following randomization	28 days after randomization
Primary	Time to successful discontinuation from mechanical ventilation	Time to event (successful discontinuation from mechanical ventilation)	28 days after randomization
Secondary	28-days mortality	Dead rate within 28 days of randomization	28 days after randomization
Secondary	Rate of nosocomial infections	Rate of ventilator associated pneumonia, blood stream infection, urinary tract infection or candidemia in the first 28 days following randomization	28 days after randomization
Secondary	SOFA variation	Variation in SOFA over the first 10 days after randomization	10 days after randomization
Secondary	Use of prone position	Cumulative hours spent on prone position	10 days after randomization
Secondary	Delirium	Frequency of delirium at ICU discharge	28 days after randomization
Secondary	Muscle weakness	mMRC score at ICU discharge	28 days after randomization
Secondary	90-day mortality	Death rate within 90 days of randomization	90 days after randomization
Secondary	Peak daily blood glucose	Interaction between treatment and daily change in glucose	10 days after randomization

External Links

•   Protocol publication