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Coronavirus InfectionPhase 3CoDEXNCT04327401

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

A Phase 3 study testing Dexamethasone in people with Coronavirus Infection and Pneumonia, Viral, run by Hospital Sirio-Libanes at 21 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
299 participants
Where
21 sitesBrazil
Study dates
13 Apr 2020to 22 Jul 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Brazil21 sites

  • Fundação Pio XII

    Barretos, São Paulo

  • Hospital Vera Cruz AS

    Belo Horizonte, Minas Gerais

  • Maestri E Kormann Consultoria Medico-Cientifica

    Blumenau, Santa Catarina

  • Instituto de Cardiologia do Distrito Federal

    Brasília, Federal District

  • Fundação Social Rural de Colatina

    Colatina, Esoírito Santo

  • Sociedade Literaria e Caritativa Santo Agostinho

    Criciúma, Santa Catarina

  • Universidade Estadual de Londrina

    Londrina, Paraná

  • Eurolatino Natal Pesquisas Médicas Ltda

    Natal, Rio Grande do Norte

  • Hospital Maternidade E Pronto Socorro Santa Lucia Ltda

    Poços de Caldas, Minas Gerais

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Ana Nery

    Salvador, Estado de Bahia

  • Associacao Beneficente Siria

    São Paulo

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

    São Paulo

  • Hospital Israelita Albert Einstein

    São Paulo

  • Prevent Senior Private Operadora de Saude Ltda

    São Paulo

  • Real e Benemérita Associação Portuguesa de Beneficência/SP

    São Paulo

  • Santa Casa de Misericórdia

    São Paulo

  • Secretaria de Saúde do Estado de São Paulo

    São Paulo

  • Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

    São Paulo

  • Universidade Federal de São Paulo

    São Paulo

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo

Other trials in Brazil

About this study

Official title: COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)

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.

Read the detailed description

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.

Being tested
Dexamethasone
Keywords
SARS-CoV2 virus, 2019-nCOV, Dexamethasone, ARDS, Corticosteroids, Respiratory failure
Medical subject headings
Coronavirus Infections, Pneumonia, Viral, Respiratory Distress Syndrome, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Decadron, Dexasone, Diodex, Hexadrol

    Dexamethasone administration for 10 consecutive days after randomization.

Study groups in NCT04327401
Study groupRoleWhat they receive
Intervention groupExperimentalDexamethasone. 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).
Receives: Drug: Dexamethasone
ControlNo interventionStandard treatment (according to the treatment protocol for 2019-nCoV infection).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilator-free days

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

    Measured: 28 days after randomization

Secondary outcomes (4)

  1. Evaluation of the clinical status

    Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.

    Measured: 15 days after randomization

  2. All-cause mortality

    All-cause mortality rates at 28 days after randomization.

    Measured: 28 days after randomization

  3. Mechanical ventilation duration

    Number of days of mechanical ventilation from randomization to day 28.

    Measured: 28 days after randomization

  4. Sequential Organ Failure Assessment (SOFA) Score

    Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2020
  2. Study start13 Apr 2020
  3. Primary completion22 Jul 2020
  4. Study completion22 Jul 2020

Why it stopped: The Data Monitoring Committee recommended to stop the trial based on the Recovery Trial results, which was accepted by the CoDEX Steering Committee.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327401
Sponsor's protocol ID
CAAE: 30227020.5.1001.0008
Acronym
CoDEX
Status last verified
Aug 2020
First submitted
26 Mar 2020
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32876695

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone in people with Coronavirus Infection and Pneumonia, Viral, run by Hospital Sirio-Libanes at 21 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Data Monitoring Committee recommended to stop the trial based on the Recovery Trial results, which was accepted by the CoDEX Steering Committee.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilator-free days (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04327401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.

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