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The Data Monitoring Committee recommended to stop the trial based on the Recovery Trial results, which was accepted by the CoDEX Steering Committee.
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| Name | Class |
|---|---|
| Hospital Israelita Albert Einstein | OTHER |
| Hospital do Coracao | OTHER |
| Brazilian Research In Intensive Care Network | NETWORK |
| Ache Laboratorios Farmaceuticos S.A. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Control | No Intervention | Standard treatment (according to the treatment protocol for 2019-nCoV infection). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone administration for 10 consecutive days after randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days | Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization. | 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 days after randomization |
| All-cause mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit free days | Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization. | 28 days after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciano Cesar Pontes Azevedo, Ph.D | Teaching Director of Teaching & Research Institute Sírio-Libanês Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação Social Rural de Colatina | Colatina | Esoírito Santo | Brazil | |||
| Hospital Ana Nery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32876695 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2020 |
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| INDUSTRY |
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All-cause mortality rates at 28 days after randomization. |
| 28 days after randomization |
| Mechanical ventilation duration | Number of days of mechanical ventilation from randomization to day 28. | 28 days after randomization |
| Sequential Organ Failure Assessment (SOFA) Score | Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization | Score at 48 hours, 72 hours and 7 days after randomization |
| Salvador |
| Estado de Bahia |
| Brazil |
| Instituto de Cardiologia do Distrito Federal | Brasília | Federal District | Brazil |
| Hospital Vera Cruz AS | Belo Horizonte | Minas Gerais | Brazil |
| Hospital Maternidade E Pronto Socorro Santa Lucia Ltda | Poços de Caldas | Minas Gerais | Brazil |
| Universidade Estadual de Londrina | Londrina | Paraná | Brazil |
| Eurolatino Natal Pesquisas Médicas Ltda | Natal | Rio Grande do Norte | Brazil |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Maestri E Kormann Consultoria Medico-Cientifica | Blumenau | Santa Catarina | Brazil |
| Sociedade Literaria e Caritativa Santo Agostinho | Criciúma | Santa Catarina | Brazil |
| Fundação Pio XII | Barretos | São Paulo | Brazil |
| Santa Casa de Misericordia de Votuporanga | Votuporanga | São Paulo | Brazil |
| Associacao Beneficente Siria | São Paulo | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP - HCFMRP | São Paulo | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | Brazil |
| Prevent Senior Private Operadora de Saude Ltda | São Paulo | Brazil |
| Real e Benemérita Associação Portuguesa de Beneficência/SP | São Paulo | Brazil |
| Santa Casa de Misericórdia | São Paulo | Brazil |
| Secretaria de Saúde do Estado de São Paulo | São Paulo | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sírio-Libanês | São Paulo | Brazil |
| Universidade Federal de São Paulo | São Paulo | Brazil |
| Aug 5, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011024 | Pneumonia, Viral |
| D012128 | Respiratory Distress Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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