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

NCT04327401 | Terminated Phase 3 DMC

• 1 other identifier: CAAE: 30227020.5.1001.0008
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Coronavirus Infection; Pneumonia, Viral; Acute Respiratory Distress Syndrome

Keywords

SARS-CoV2 virus; 2019-nCOV; Dexamethasone; ARDS; Corticosteroids; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days

  Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.

  28 days after randomization

Secondary Outcomes (4)

• Evaluation of the clinical status

  15 days after randomization

• All-cause mortality

  28 days after randomization

• Mechanical ventilation duration

  28 days after randomization

• Sequential Organ Failure Assessment (SOFA) Score

  Score at 48 hours, 72 hours and 7 days after randomization

Other Outcomes (1)

• Intensive Care Unit free days

  28 days after randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Drug: Dexamethasone

Control

NO INTERVENTION

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

Interventions

Dexamethasone DRUG

Dexamethasone administration for 10 consecutive days after randomization.

Also known as: Decadron, Dexasone, Diodex, Hexadrol, Maxidex

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• Hospital Israelita Albert Einstein: collaborator
• Hospital do Coracao: collaborator
• Brazilian Research In Intensive Care Network: collaborator
• Ache Laboratorios Farmaceuticos S.A.: collaborator

Study Sites (21)

Fundação Social Rural de Colatina

Colatina, Esoírito Santo, Brazil

Location

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Location

Instituto de Cardiologia do Distrito Federal

Brasília, Federal District, Brazil

Location

Hospital Vera Cruz AS

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Maternidade E Pronto Socorro Santa Lucia Ltda

Poços de Caldas, Minas Gerais, Brazil

Location

Universidade Estadual de Londrina

Londrina, Paraná, Brazil

Location

Eurolatino Natal Pesquisas Médicas Ltda

Natal, Rio Grande do Norte, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Maestri E Kormann Consultoria Medico-Cientifica

Blumenau, Santa Catarina, Brazil

Location

Sociedade Literaria e Caritativa Santo Agostinho

Criciúma, Santa Catarina, Brazil

Location

Fundação Pio XII

Barretos, São Paulo, Brazil

Location

Santa Casa de Misericordia de Votuporanga

Votuporanga, São Paulo, Brazil

Location

Associacao Beneficente Siria

São Paulo, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP - HCFMRP

São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Prevent Senior Private Operadora de Saude Ltda

São Paulo, Brazil

Location

Real e Benemérita Associação Portuguesa de Beneficência/SP

São Paulo, Brazil

Location

Santa Casa de Misericórdia

São Paulo, Brazil

Location

Secretaria de Saúde do Estado de São Paulo

São Paulo, Brazil

Location

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

São Paulo, Brazil

Location

Universidade Federal de São Paulo

São Paulo, Brazil

Location

Related Publications (1)

• Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, Avezum A, Lopes RD, Bueno FR, Silva MVAO, Baldassare FP, Costa ELV, Moura RAB, Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, Olivato GB, Righy C, Amendola CP, Roepke RML, Freitas DHM, Forte DN, Freitas FGR, Fernandes CCF, Melro LMG, Junior GFS, Morais DC, Zung S, Machado FR, Azevedo LCP; COALITION COVID-19 Brazil III Investigators. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1307-1316. doi: 10.1001/jama.2020.17021.

  PMID: 32876695 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Pneumonia, Viral; Respiratory Distress Syndrome; Respiratory Insufficiency

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Luciano Cesar Pontes Azevedo, Ph.D

  Teaching Director of Teaching & Research Institute Sírio-Libanês Hospital

  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: Research Director

Model Details: 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).

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: April 13, 2020
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (21)