COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III

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

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2020-07-22

Brief Summary

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The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.

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Detailed Description

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The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract, and its outbreak deemed a pandemic in early March 2020. Estimates show around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which due to its severity, consumes most Intensive Care Units (ICU) resources and is the leading mortality cause in this population. Given its burden, therapies that reduce the duration of mechanical ventilation or decrease the morbimortality are needed. Studies indicate that inflammation and cytokine storm might be involved in the pathophysiological pathway to ARDS in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. A recent small retrospective study evaluating the role of corticosteroids found no association between corticosteroids and hospital length of stay, virus clearance, and symptoms' duration. However, the retrospective nature of data, small sample size (31 patients), and no protocol for corticosteroids administration undermine its results. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in ventilator-free days at 28 days in patients with moderate and severe ARDS due to SARS-CoV2 virus in Brazil.

Conditions

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Coronavirus Infection Pneumonia, Viral Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Dexamethasone. After randomization, dexamethasone 20mg IV 1x/day for 5 days, followed by 10mg IV 1xd for 5 days + standard treatment (according to the treatment protocol for 2019-nCoV infection).
2. Standard treatment (according to the treatment protocol for 2019-nCoV infection).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Dexamethasone. After randomization, dexamethasone \[20mg IV 1x/day for 5 days, followed by 10mg IV 1xd for 5 days\] + standard treatment (according to the treatment protocol for 2019-nCoV infection).

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone administration for 10 consecutive days after randomization.

Control

Standard treatment (according to the treatment protocol for 2019-nCoV infection).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexamethasone

Dexamethasone administration for 10 consecutive days after randomization.

Intervention Type DRUG

Other Intervention Names

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Decadron Dexasone Diodex Hexadrol Maxidex

Eligibility Criteria

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Inclusion Criteria

* Probable or confirmed infection by SARS-CoV2
* Intubated and mechanically ventilated
* Moderate/severe ARDS defined by the Berlin criteria (PaO2/FiO2 ≤200mmHg with PEEP ≥5cmH20)
* Onset of moderate/severe ARDS in less than 48 hours before randomization

Exclusion Criteria

* Pregnancy or active lactation
* Known history of dexamethasone allergy
* Daily use of corticosteroids in the past 15 days
* Clinical indication for corticosteroids use for other diseases (i.e refractory septic shock)
* Patients who did use corticosteroids during hospital stay for periods equal or greater than two days
* Use of immunosuppressive drugs
* Cytotoxic chemotherapy in the past 21 days
* Neutropenia due to hematological or solid malignancies with bone marrow invasion
* Patient expected to die in the next 24 hours

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No