Status:
COMPLETED
Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
Lead Sponsor:
Manuel Taboada Muñiz
Conditions:
Covid19
Corticosteroids
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
After RECOVERY trial publication, low dose (6 mg dexamethasone for 10 days) was recommended as the usual care treatment in hospitalized patients with respiratory failure by COVID-19 needing oxygen the...
Detailed Description
Objective: The investigators aim to assess the efficacy of high dose of dexamethasone (20 mg / day 5 days, and 10 mg/day 5 days) versus low dose of dexamethasone (6 mg/day 10 days) in patients with re...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Hospitalized COVID-19 patients admitted to the Hospital.
- Patients requiring supplemental oxygen. Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement
- Patients requiring corticosteroids (dexamethasone) according to Hospital protocol.
Exclusion
- Pregnancy or active lactation.
- Patient is expected to die in the next 48 hours.
- Known history of dexamethasone allergy or known contraindication to the use of corticosteroids.
- Daily use of corticosteroids in the past 15 days.
- Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock).
- Consent refusal for participating in the trial.
- Different level of 4 in Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04726098
Start Date
January 15 2021
End Date
August 31 2021
Last Update
October 20 2021
Active Locations (1)
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1
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15866