Status:
TERMINATED
COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III
Lead Sponsor:
Hospital Sirio-Libanes
Collaborating Sponsors:
Hospital Israelita Albert Einstein
Hospital do Coracao
Conditions:
Coronavirus Infection
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pati...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2020
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT04327401
Start Date
April 13 2020
End Date
July 22 2020
Last Update
August 7 2020
Active Locations (21)
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1
Fundação Social Rural de Colatina
Colatina, Esoírito Santo, Brazil
2
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
3
Instituto de Cardiologia do Distrito Federal
Brasília, Federal District, Brazil
4
Hospital Vera Cruz AS
Belo Horizonte, Minas Gerais, Brazil