COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III (CoDEX)
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|ClinicalTrials.gov Identifier: NCT04327401|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2020
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection Pneumonia, Viral Acute Respiratory Distress Syndrome||Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Official Title:||COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)|
|Actual Study Start Date :||April 13, 2020|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
Experimental: 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).
Dexamethasone administration for 10 consecutive days after randomization.
No Intervention: Control
Standard treatment (according to the treatment protocol for 2019-nCoV infection).
- Ventilator-free days [ Time Frame: 28 days after randomization ]Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.
- Evaluation of the clinical status [ Time Frame: 15 days after randomization ]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.
- All-cause mortality [ Time Frame: 28 days after randomization ]All-cause mortality rates at 28 days after randomization.
- Mechanical ventilation duration [ Time Frame: 28 days after randomization ]Number of days of mechanical ventilation from randomization to day 28.
- Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Score at 48 hours, 72 hours and 7 days after randomization ]Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization
- Intensive Care Unit free days [ Time Frame: 28 days after randomization ]Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327401
|Principal Investigator:||Luciano Cesar Pontes Azevedo, Ph.D||Teaching Director of Teaching & Research Institute Sírio-Libanês Hospital|