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

NCT04327401 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2020-08-07

No results posted yet for this study

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.

Conditions

  • Coronavirus Infection
  • Pneumonia, Viral
  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Dexamethasone

Dexamethasone administration for 10 consecutive days after randomization.

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Hospital do Coracao

    collaborator OTHER

  • Brazilian Research In Intensive Care Network

    collaborator NETWORK

  • Ache Laboratorios Farmaceuticos S.A.

    collaborator INDUSTRY

  • Hospital Sirio-Libanes

    lead OTHER

Principal Investigators

  • Luciano Cesar Pontes Azevedo, Ph.D · Teaching Director of Teaching & Research Institute Sírio-Libanês Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-13
Primary Completion
2020-07-22
Completion
2020-07-22

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327401 on ClinicalTrials.gov