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

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Status and phase: Terminated; Phase 3

Conditions: Respiratory Distress Syndrome, Adult; Covid-19

Treatments: Drug: High-Dose Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04395105

1264

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

High dose Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: High-Dose Dexamethasone

Usual care - low dose Dexamethasone

No Intervention group

Description:

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