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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-05-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Adult Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High dose Dexamethasone

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

Group Type EXPERIMENTAL

High-Dose Dexamethasone

Intervention Type DRUG

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

Usual care - low dose Dexamethasone

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-Dose Dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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Corticosteroid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No