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

• Status: Terminated
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Sirio-Libanes; Luiz F. L. Reis, Ph.D.
• Collaborators: Ache Laboratorios Farmaceuticos S.A.; Brazilian Research In Intensive Care Network; Hospital do Coracao; Hospital Israelita Albert Einstein
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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