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Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19

NCT04325061 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-02-03

No results posted yet for this study

Summary

Background: There are no proven therapies specific for Covid-19. The full spectrum of Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial.

Methods: This is an internationally (Spain, Canada, China, USA) designed multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care, or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

Conditions

  • Acute Respiratory Distress Syndrome Caused by COVID-19

Interventions

DRUG

Dexamethasone

Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization

Sponsors & Collaborators

  • Li Ka Shing Knowledge Institute

    collaborator UNKNOWN

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    collaborator OTHER_GOV

  • Dr. Negrin University Hospital

    lead OTHER

Principal Investigators

  • Jesús Villar, MD · Hospital Universitario Dr. Negrin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2020-06-19
Completion
2020-06-19

Countries

  • Spain

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 NCT04325061 on ClinicalTrials.gov